Hot PLR Article Directory Guernsey: September 2016

Friday, September 16, 2016

Beyaz

Generic Name: drospirenone, ethinyl estradiol, and levomefolate (Oral route)

droe-SPYE-re-none, ETH-i-nil es-tra-DYE-ol, lee-voe-me-FOE-late KAL-see-um, lee-voe-me-FOE-late KAL-see-um

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke .

Commonly used brand name(s)

In the U.S.

Beyaz

Safyral

Available Dosage Forms:

Tablet

Uses For Beyaz

Drospirenone, ethinyl estradiol, and levomefolate combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and drospirenone, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms a few days before their menstrual flow starts.

This medicine also contains levomefolate, which is a form of folic acid. Folic acid is one of the B vitamins that pregnant women need to help prevent neural tube defects in a baby.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

Before Using Beyaz

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of drospirenone, ethinyl estradiol, and levomefolate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of drospirenone, ethinyl estradiol, and levomefolate combination have not been performed in the geriatric population. This medicine should not be used in elderly women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Boceprevir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Boceprevir

Felbamate

Isotretinoin

Paclitaxel

Paclitaxel Protein-Bound

Theophylline

Tizanidine

Tranexamic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alprazolam

Amoxicillin

Ampicillin

Amprenavir

Aprepitant

Atazanavir

Bacampicillin

Betamethasone

Bexarotene

Bosentan

Carbamazepine

Colesevelam

Cyclosporine

Darunavir

Delavirdine

Doxycycline

Efavirenz

Etravirine

Fosamprenavir

Fosaprepitant

Fosphenytoin

Ginseng

Griseofulvin

Lamotrigine

Licorice

Minocycline

Modafinil

Mycophenolate Mofetil

Mycophenolic Acid

Nelfinavir

Nevirapine

Oxcarbazepine

Oxytetracycline

Phenobarbital

Phenytoin

Pioglitazone

Prednisolone

Primidone

Rifabutin

Rifampin

Rifapentine

Ritonavir

Roflumilast

Rosuvastatin

Rufinamide

Selegiline

St John's Wort

Telaprevir

Tetracycline

Tipranavir

Topiramate

Troglitazone

Troleandomycin

Valdecoxib

Voriconazole

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine

Grapefruit Juice

Proper Use of drospirenone, ethinyl estradiol, and levomefolate

This section provides information on the proper use of a number of products that contain drospirenone, ethinyl estradiol, and levomefolate. It may not be specific to Beyaz. Please read with care.

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day, after the evening meal or at bedtime. You may take this medicine with or without food.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (e.g., another pill, patch, vaginal ring) to using Beyaz® or Safyral™, take this medicine on the first day of your period. If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using Beyaz® or Safyral™, take the medicine on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days you take this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 Start) or on the first Sunday after your menstrual period starts (called Sunday Start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days.

For oral dosage form (tablets):
- For contraception (to prevent pregnancy), PMDD, or acne:
  - Adults and teenagers—One tablet taken at the same time each day for 28 days.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Beyaz

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

If this should occur, continue with your regular dosing schedule.

The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.

If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more pink tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you suspect that you may be pregnant, stop using this medicine immediately and check with your doctor. You should continue to take folate supplements.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using this medicine.

Check with your doctor immediately if you have problems wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or certain medical tests.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Beyaz Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Breast pain or tenderness

headache, severe and throbbing

heavy nonmenstrual vaginal bleeding

irregular menstrual periods

nausea

normal menstrual bleeding occurring earlier, possibly lasting longer than expected

Less common

Longer or heavier menstrual periods

unusual tiredness or weakness

vomiting

Incidence not known

Abdominal or stomach pain

chills

clay-colored stools

dark urine

difficulty with breathing

dizziness

fever

headache

itching

loss of appetite

pain in the chest, groin, or legs, especially the calves

rash

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sudden, unexplained shortness of breath

unpleasant breath odor

unusual tiredness or weakness

vision changes

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Crying

decreased interest in sexual intercourse

delusions of persecution, mistrust, suspiciousness, and/or combativeness

false or unusual sense of well-being

inability to have or keep an erection

irritability

loss in sexual ability, desire, drive, or performance

mental depression

quick to react or overreact emotionally

rapidly changing moods

weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Beyaz side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Beyaz resources

Beyaz Side Effects (in more detail)
Beyaz Use in Pregnancy & Breastfeeding
Beyaz Drug Interactions
Beyaz Support Group
58 Reviews for Beyaz - Add your own review/rating

Beyaz Prescribing Information (FDA)

Beyaz Consumer Overview

Beyaz MedFacts Consumer Leaflet (Wolters Kluwer)

Safyral Prescribing Information (FDA)

Safyral Consumer Overview

Safyral MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Beyaz with other medications

Acne
Birth Control
Premenstrual Dysphoric Disorder

Betoptic-S Drops

Pronunciation: be-TAX-oh-lol
Generic Name: Betaxolol
Brand Name: Betoptic-S

Betoptic-S Drops are used for:

Treating increased pressure in the eye (ocular hypertension) and open-angle glaucoma. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Betoptic-S Drops are a beta-blocker for use in the eye. It works by decreasing fluid production and pressure inside the eye.

Do NOT use Betoptic-S Drops if:

you are allergic to any ingredient in Betoptic-S Drops

you have greater than first-degree heart block, shock caused by severe heart problems, uncontrolled heart failure, or a very slow heartbeat

Contact your doctor or health care provider right away if any of these apply to you.

Before using Betoptic-S Drops:

Some medical conditions may interact with Betoptic-S Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have bronchitis, narrow-angle glaucoma (angle-closure glaucoma), double vision, a drooping eyelid, an eye infection or injury, certain muscle problems (eg, myasthenia gravis, muscle weakness), or an overactive thyroid

if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), heart problems (eg, heart failure, irregular heartbeat), diabetes, low blood sugar levels (hypoglycemia), or blood vessel problems (eg, in the brain, in the hands and feet)

if you have had or will be having eye surgery

if you are taking an oral beta-blocker (eg, metoprolol)

Some MEDICINES MAY INTERACT with Betoptic-S Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diltiazem, flecainide, or verapamil because they may increase the risk of Betoptic-S Drops's side effects

Alfuzosin or prazosin because if low blood pressure occurs after their first dose, Betoptic-S Drops may cause it to be more severe or to last longer

Clonidine because high blood pressure may occur in some cases, especially if you suddenly stop taking clonidine while taking Betoptic-S Drops

Insulin or oral diabetes medicines (eg, glyburide) because the risk of low blood sugar levels may be increased

Reserpine because the risk of its side effects may be increased by Betoptic-S Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Betoptic-S Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Betoptic-S Drops:

Use Betoptic-S Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

If you use other medicines in the eye, use them at least 10 minutes before using Betoptic-S Drops.

Shake well before each use.

To use Betoptic-S Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Instill Betoptic-S Drops into your eye as directed. Gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid (unless you recently had eye surgery) for 1 to 2 minutes. Do not blink.

Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.

Ask your doctor how to use your contact lenses while using Betoptic-S Drops.

To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.

Using Betoptic-S Drops at the same time each day will help you remember to use it.

Continue to use Betoptic-S Drops even if you feel well. Do not miss any doses.

If you miss a dose of Betoptic-S Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Betoptic-S Drops.

Important safety information:

Betoptic-S Drops may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Betoptic-S Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Tell your doctor or dentist that you take Betoptic-S Drops before you receive any medical or dental care, emergency care, or surgery.

If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Betoptic-S Drops.

Diabetes patients - Betoptic-S Drops may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Betoptic-S Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

Lab tests, including eye pressure checks, may be performed while you use Betoptic-S Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Betoptic-S Drops while you are pregnant. It is not known if Betoptic-S Drops are found in breast milk. If you are or will be breast-feeding while you use Betoptic-S Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Betoptic-S Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; crusty lashes; dry eyes; mild burning, stinging, itching, or tearing; mild eye discomfort, pain, redness, or discharge; sensation of something in the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); drooping eyelid; red, swollen, blistered, or peeling skin; sensitivity to light; severe or persistent dizziness; shortness of breath; slow or irregular heartbeat; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; unusual weakness; vision changes (eg, decreased vision clearness, double vision); wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Betoptic-S side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; fainting; shortness of breath; slow heartbeat; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet. Betoptic-S Drops may be harmful if swallowed.

Proper storage of Betoptic-S Drops:

Store Betoptic-S Drops upright between 36 and 77 degrees F (2 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Betoptic-S Drops out of the reach of children and away from pets.

General information:

If you have any questions about Betoptic-S Drops, please talk with your doctor, pharmacist, or other health care provider.

Betoptic-S Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Betoptic-S Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Betoptic-S resources

Betoptic-S Side Effects (in more detail)
Betoptic-S Use in Pregnancy & Breastfeeding
Betoptic-S Drug Interactions
0 Reviews for Betoptic-S - Add your own review/rating

Compare Betoptic-S with other medications

Glaucoma, Open Angle
Intraocular Hypertension

Bexxar 131 Iodine

Pronunciation: EYE-oh-dine/tos-IT-too-moe-mab
Generic Name: Iodine I 131/Tositumomab
Brand Name: Bexxar 131 Iodine

Bexxar 131 Iodine may cause serious allergic reactions, especially in patients who have received murine proteins previously. Seek immediate medical attention if you experience rash, itching, swelling, severe dizziness, or trouble breathing. Bexxar 131 Iodine may cause serious (possibly life-threatening) decreases in the number of white blood cells and platelets your body produces. This effect may last for a long period of time. Additional treatment may be needed to manage this effect. Serious infections or bleeding could occur as a result of low blood cell levels. Contact your doctor immediately if you experience fever, persistent sore throat, any other sign of infection, or unusual bruising or bleeding. Bexxar 131 Iodine must not be used during pregnancy because fetal harm can result. Contact your doctor immediately if you suspect that you could be pregnant.

Bexxar 131 Iodine is used for:

Treating certain forms of non-Hodgkin lymphoma in patients who have not responded to other therapy.

Bexxar 131 Iodine is a radioactive monoclonal antibody protein. It works by recognizing a protein receptor on cancer cells and then delivering radiation that increases the killing effect of the antibody.

Do NOT use Bexxar 131 Iodine if:

you are allergic to any ingredient in Bexxar 131 Iodine or to mouse proteins

you have bone marrow depression or a serious blood disorder such as low hemoglobin, white blood cells, or platelets

you are pregnant

you are unable to take a thyroid blocker (eg, methimazole)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bexxar 131 Iodine:

Some medical conditions may interact with Bexxar 131 Iodine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are planning to become pregnant or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have an infection, thyroid problems, or kidney problems

if you are scheduled to receive a vaccine

Some MEDICINES MAY INTERACT with Bexxar 131 Iodine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Medicines that decrease blood clotting (eg, aspirin, clopidogrel, ibuprofen, warfarin) and medicines that affect the immune system (eg, azathioprine, corticosteroids, cyclosporine) because serious side effects, such as risk of bleeding or infections, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bexxar 131 Iodine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bexxar 131 Iodine:

Use Bexxar 131 Iodine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Bexxar 131 Iodine is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor any question that you may have about Bexxar 131 Iodine.

If you miss a dose of Bexxar 131 Iodine, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Bexxar 131 Iodine.

Important safety information:

Bexxar 131 Iodine may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Bexxar 131 Iodine. Using Bexxar 131 Iodine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Bexxar 131 Iodine may reduce the number of certain blood cells, including red blood cells, white blood cells, and platelets. This may increase your risk of infection and bleeding. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding or bruising; blood in stools; or black, tarry stools to your doctor.

Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Bexxar 131 Iodine.

As with other cancer medicines, Bexxar 131 Iodine can cause a secondary cancer. Discuss the benefits and risks of using Bexxar 131 Iodine with your doctor.

After receiving Bexxar 131 Iodine, the radioactive part of the dose will be in your body for several days. Follow all instructions you are given to minimize the exposure of others around you to this radioactivity.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Bexxar 131 Iodine.

Bexxar 131 Iodine may reduce the levels of thyroid hormone your thyroid produces. Thyroid tests will be done before your doses and every year thereafter to monitor for any change in function of the thyroid gland.

Some patients may develop an immune response called HAMA (human anti-murine antibody) after using Bexxar 131 Iodine. This antibody may interfere with certain lab test results. Be sure all of your doctors and laboratory personnel know that you are being treated, or have been treated, with Bexxar 131 Iodine.

Both men and women capable of having children who receive Bexxar 131 Iodine should use reliable methods of birth control (eg, condoms) during and for at least 1 year after receiving Bexxar 131 Iodine.

LAB TESTS, including complete blood cell counts, platelet counts, thyroid function tests, and kidney function tests, will be required to monitor your progress and check for side effects. Frequent monitoring will be done for up to 12 weeks after treatment. Be sure to keep all doctor and lab appointments.

Caution is advised when using Bexxar 131 Iodine in the ELDERLY because they may be more sensitive to the effect Bexxar 131 Iodine has on blood cells.

PREGNANCY and BREAST-FEEDING: Do not use Bexxar 131 Iodine if you are pregnant. If you think that you may be pregnant, contact your doctor immediately. Bexxar 131 Iodine is excreted in breast milk. Do not breast-feed while receiving Bexxar 131 Iodine.

Possible side effects of Bexxar 131 Iodine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; headache; muscle aches; nausea; pain, swelling, or redness at the injection site; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; easy bruising or bleeding; fast heartbeat; flu-like symptoms such as chills, cough, or sweating; infection; itching; lightheadedness; loss of appetite; lung infection; new growths or lumps; pain, including chest, stomach, muscle, neck, back, or joint pain; pale skin; persistent sore throat or fever; shortness of breath; sudden weight loss; swelling of the hands or feet; unusual tiredness or weakness; vomit that looks like coffee grounds.

See also: Bexxar31 Iodine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Bexxar 131 Iodine:

Bexxar 131 Iodine is radioactive and must be stored in the lead pot provided. It is usually handled and stored by a health care professional. Keep Bexxar 131 Iodine out of reach of children and away from pets.

General information:

If you have any questions about Bexxar 131 Iodine, please talk with your doctor, pharmacist, or other health care provider.

Bexxar 131 Iodine is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Bexxar 131 Iodine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Bexxar 131 Iodine resources

Bexxar 131 Iodine Side Effects (in more detail)
Bexxar 131 Iodine Use in Pregnancy & Breastfeeding
Bexxar 131 Iodine Drug Interactions
Bexxar 131 Iodine Support Group
0 Reviews for Bexxar31 Iodine - Add your own review/rating

Compare Bexxar 131 Iodine with other medications

Non-Hodgkin's Lymphoma

betaxolol ophthalmic

Generic Name: betaxolol ophthalmic (bay TAX oh lol off THAL mik)

Brand names: Betoptic S, Betoptic

What is betaxolol ophthalmic?

Betaxolol is a beta-blocker that reduces pressure inside the eye.

Betaxolol ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Betaxolol ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about betaxolol ophthalmic?

Do not use this medication if you are allergic to betaxolol, or if you have asthma, or severe chronic obstructive pulmonary disease (COPD), slow heartbeats, or a heart condition called "AV block."

Before using this medication, tell your doctor if you have breathing problems such as bronchitis or emphysema, a history of heart disease or congestive heart failure, diabetes, history of stroke, blood clot, or circulation problems, a thyroid disorder, or a muscle disorder such as myasthenia gravis.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Betaxolol ophthalmic is sometimes given together with other eye medications. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using betaxolol ophthalmic. Do not use the medications at the same time.

Betaxolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly. Do not use this medication while you are wearing contact lenses. Betaxolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using betaxolol before putting your contact lenses in.

What should I discuss with my healthcare provider before using betaxolol ophthalmic?

Do not use this medication if you are allergic to betaxolol, or if you have:

asthma, or severe chronic obstructive pulmonary disease (COPD);

slow heartbeats; or

a heart condition called "AV block."

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

breathing problems such as bronchitis or emphysema;

a history of heart disease or congestive heart failure;

diabetes;

history of stroke, blood clot, or circulation problems;

a thyroid disorder; or

a muscle disorder such as myasthenia gravis.

FDA pregnancy category C. It is not known whether betaxolol ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether betaxolol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use betaxolol ophthalmic?

Use betaxolol ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using the eye drops. Do not use this medication while you are wearing contact lenses. Betaxolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using betaxolol before putting your contact lenses in.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Tell your doctor right away if you have any eye injury or infection. If you have any type of surgery, including eye surgery, tell the surgeon ahead of time that you are using betaxolol ophthalmic. You may need to stop using the medicine for a short time. Store this medication at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, feeling short of breath, swelling, rapid weight gain, or fainting.

What should I avoid while using betaxolol ophthalmic?

Betaxolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Betaxolol ophthalmic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;

drainage, crusting, or oozing of your eyes or eyelids;

bronchospasm (wheezing, chest tightness, trouble breathing);

slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

feeling short of breath, even with mild exertion; or

swelling, rapid weight gain.

Less serious side effects may include:

mild burning, stinging, itching, or discomfort of your eyes;

dry eyes, blurred vision;

mildly swollen or puffy eyes;

feeling like something is in your eye;

headache, dizziness, spinning sensation;

depression;

sleep problems (insomnia);

muscle weakness; or

altered sense of taste or smell.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Betaxolol ophthalmic Dosing Information

Usual Adult Dose for Intraocular Hypertension:

Instill 1 to 2 drops in the affected eye(s) twice daily.

Usual Adult Dose for Glaucoma (Open Angle):

Instill 1 to 2 drops in the affected eye(s) twice daily.

What other drugs will affect betaxolol ophthalmic?

Before using betaxolol ophthalmic, tell your doctor if you are using any of the following drugs:

oral betaxolol (Blocadren);

digoxin (digitalis, Lanoxin);

reserpine;

insulin or diabetes medications you take by mouth;

any other beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others;

a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan); or

medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), or thioridazine (Mellaril).

This list is not complete and there may be other drugs that can interact with betaxolol ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More betaxolol ophthalmic resources

Betaxolol ophthalmic Dosage
Betaxolol ophthalmic Use in Pregnancy & Breastfeeding
Betaxolol ophthalmic Drug Interactions
Betaxolol ophthalmic Support Group
0 Reviews for Betaxolol - Add your own review/rating

Betoptic Prescribing Information (FDA)

Betoptic S Prescribing Information (FDA)

Betoptic S eent Monograph (AHFS DI)

Betoptic S Advanced Consumer (Micromedex) - Includes Dosage Information

Compare betaxolol ophthalmic with other medications

Glaucoma, Open Angle
Intraocular Hypertension

Where can I get more information?

Your pharmacist can provide more information about betaxolol ophthalmic.

bexarotene topical

Generic Name: bexarotene topical (beks AIR oh teen)

Brand Names: Targretin Topical

What is bexarotene topical?

The exact way bexarotene works is unknown, but it is believed to inhibit the growth of tumor cells.

Bexarotene topical is used to treat skin lesions of cutaneous T-cell lymphoma (CTCL) (Stage 1A and 1B) in patients who have not responded to or not tolerated other therapies.

Bexarotene topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about bexarotene topical?

Avoid prolonged exposure to sunlight or artificial ultraviolet light (e.g. sunlamps). Bexarotene topical may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Do not use bexarotene topical if you are pregnant or if you could become pregnant. Bexarotene topical is in the FDA pregnancy category X. This means that bexarotene topical will cause birth defects in an unborn baby. You must take a pregnancy test and have negative results within one week before starting treatment with bexarotene topical, and a pregnancy test should be repeated monthly during treatment. Bexarotene topical should be started on the second or third day of a normal menstrual period. Also, you will need to use two reliable forms of birth control at the same time for one month before starting treatment with bexarotene topical, during treatment with bexarotene topical, and for at least 1 month following the end of your treatment. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop using bexarotene topical and notify your doctor. Men using bexarotene topical with sexual partners who are pregnant, possibly pregnant, or who could become pregnant, must use condoms during sexual intercourse while using bexarotene topical and for at least one month after the last dose of bexarotene topical.

Who should not use bexarotene topical?

Do not use bexarotene topical without first talking to your doctor if you are allergic to other retinoids such as isotretinoin (Accutane), acitretin (Soriatane), etretinate (Tegison), or tretinoin (Vesinoid). Before using bexarotene topical, tell your doctor if you have kidney or liver disease. You may not be able to use bexarotene topical, or you may require a dosage adjustment or special monitoring during treatment. Do not use bexarotene topical if you are pregnant or if you could become pregnant. Bexarotene topical is in the FDA pregnancy category X. This means that bexarotene topical will cause birth defects in an unborn baby. You must take a pregnancy test and have negative results within one week before starting treatment with bexarotene topical, and a pregnancy test should be repeated monthly during treatment. Bexarotene topical should be started on the second or third day of a normal menstrual period. Also, you will need to use two reliable forms of birth control at the same time for one month before starting treatment with bexarotene topical, during treatment with bexarotene topical, and for at least 1 month following the end of your treatment. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop using bexarotene topical and notify your doctor. Men using bexarotene topical with sexual partners who are pregnant, possibly pregnant, or who could become pregnant, must use condoms during sexual intercourse while using bexarotene topical and for at least one month after the last dose of bexarotene topical. It is not known whether bexarotene topical passes into breast milk. Do not take bexarotene topical without first talking to your doctor if you are breast-feeding a baby.

How should I use bexarotene topical?

Use bexarotene topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands with soap and water before and after applying this medication.

Apply enough gel to cover the affected area with a generous coating. Proper application should leave some gel visible on the surface of the lesion. Allow the gel to dry for 5 to 10 minutes before covering with clothing.

Do not use bandages, dressings, or other coverings, other than loose clothing, that block the flow of air to the treated area. Do not apply bexarotene topical to unaffected skin. In addition, do not apply the gel near the eyes, mouth, nostrils, lips, vagina, tip of the penis, rectum, or anus. If you get medication on any of these areas, rinse it off with water.

Mild, non-deodorant soap is recommended for bathing or showering. Wait for 20 minutes after bathing or showering before applying bexarotene topical. Wait for at least 3 hours after applying bexarotene topical before bathing, showering, or swimming.

Bexarotene topical is initially applied once every other day for the first week. The application frequency is then usually increased at weekly intervals to once daily, then three times daily, and finally four times daily according to how well treatment is tolerated. If the affected area becomes irritated, the frequency of application can be reduced. If severe irritation occurs, application can be temporarily stopped for a few days until the irritation is reduced. Follow your doctor's instructions.

Avoid scratching the treated areas.

It may take many weeks of treatment to see the effects of this drug. Do not stop using bexarotene topical if you do not see results immediately. Treatment with bexarotene topical should continue for as long as beneficial effects are being obtained.

Store bexarotene topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next application, skip the missed application and apply only the next regularly scheduled dose.Do Notapply a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, or if bexarotene topical has been ingested, call an emergency room or poison control center near you.

What should I avoid while using bexarotene topical?

Wait for at least 3 hours after applying bexarotene topical before bathing, showering, or swimming.

Avoid scratching the treated areas.

Vitamin A may increase side effects when using bexarotene topical. Limit your use of vitamin A supplements to not more than the recommended daily allowance (RDA) of 4000 to 5000 International Units (IU) a day.

Do not use insect repellents or other products that contain DEET (N,N-diethyl-m-toluamide) while using bexarotene topical. Bexarotene topical may increase DEET toxicity, which could be dangerous.

Avoid using other topical products on the affected area at the same time as bexarotene topical unless otherwise directed by your doctor. These products may interfere with the effects or absorption of bexarotene topical.

The Targretin Topical gel brand of bexarotene topical contains alcohol and should be kept away from open flames.

Bexarotene topical side effects

Serious side effects are not likely to occur. Stop using bexarotene topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some redness, itching, warmth, swelling, burning, scaling, or other irritation while you are using bexarotene topical. If these side effects are excessive, talk to your doctor. Your doctor may prescribe less frequent applications of bexarotene topical.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Bexarotene topical Dosing Information

Usual Adult Dose for Cutaneous T-cell Lymphoma:

A sufficient quantity of gel to cover the lesion(s) with a generous coating should be applied topically initially once every other day for the first week. Thereafter, the frequency of application should be increased at weekly intervals to once a day, then twice a day, then three times a day, and finally to four times a day according to individual lesion tolerance. Generally, most patients are able to tolerate twice a day to four times a day applications.

What other drugs will affect bexarotene topical?

Vitamin A my increase side effects when using bexarotene topical. Limit your use of vitamin A supplements to not more than 15, 000 units (IU) a day.

Do not use insect repellents or other products that contain DEET (N,N-diethyl-m-toluamide) while using bexarotene topical. Bexarotene topical may increase DEET toxicity, which could be dangerous.

Avoid using other topical products on the affected area at the same time as bexarotene topical unless otherwise directed by your doctor. These products may interfere with the effects or

Drugs other than those listed here may also interact with bexarotene topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Compare bexarotene topical with other medications

Cutaneous T-cell Lymphoma

Where can I get more information?

Your pharmacist has additional information about bexarotene topical written for health professionals that you may read.

Betatar Gel

Generic Name: coal tar topical (KOL TAR TOP ik al)

Brand Names: Balnetar, Betatar Gel, Coal Tar, Cutar, Denorex, Denorex Dry Scalp, Denorex Extra Strength, Denorex Medicated Shampoo and Conditioner, DHS Tar Shampoo, Doak Tar, Doak Tar Oil, Elta Tar, Fototar, G-TAR, Ionil T, Ionil T Plus, MG 217 Psoriasis, MG217 Medicated Tar, Neutrogena T/Derm, Neutrogena T/Gel, Neutrogena T/Gel Extra Strength, Oxipor VHC, PC Tar, Pentrax, Pentrax Gold, Polytar, Psoriasin, Psorigel, T/Gel Conditioner, Tegrin Medicated, Tegrin Medicated Soap, Therapeutic, Theraplex T, Zetar

What is coal tar?

Coal tar is a by-product of coal processing.

Coal tar topical (for the skin) is used to treat the skin symptoms of psoriasis, including dryness, redness, flaking, scaling, and itching. Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.

Coal tar may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about coal tar?

You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.

Do not use coal tar to treat the skin of your groin or rectal area.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result. Stop using coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.

Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.

What should I discuss with my health care provider before using coal tar?

You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coal tar passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Coal tar products may contain lanolin, mineral oil, or other emulsifiers. Check the label of any coal tar product you are using. Talk with your doctor before using coal tar if you are allergic to any of the ingredients.

How should I use coal tar?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Apply coal tar cream, lotion, ointment, or solution according the directions on the medication label. Some forms of coal tar may be applied 1 to 4 times per day.

To use coal tar bath oil, pour 1 to 3 capfuls into a warm bath before bathing. The oil can make the bathtub slippery. Take care to avoid a fall.

Shake the coal tar shampoo well just before each use. Use enough shampoo to create a rich lather. Massage the shampoo into your scalp and rinse thoroughly. Apply the shampoo a second time and leave it on your scalp for 5 minutes. Rinse thoroughly. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.

Coal tar shampoo may discolor blond or colored hair. This effect is usually temporarily.

Some forms of coal tar can stain fabric or other surfaces.

Store coal tar at room temperature away from moisture and heat. Keep the medicine tightly closed with not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a coal tar overdose are not known.

What should I avoid while using coal tar?

Avoid getting this medication in your eyes. If this does occur, rinse with water.

Do not use coal tar to treat the skin of your groin or rectal area.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result.

Coal tar side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin.

Less serious side effects may include mild skin irritation or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect coal tar?

Do not use coal tar together with other psoriasis medications unless your doctor tells you to.

There may be other drugs that can interact with coal tar. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Betatar Gel resources

Betatar Gel Use in Pregnancy & Breastfeeding
Betatar Gel Support Group
0 Reviews for Betatar - Add your own review/rating

Betatar Gel Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Coal Tar Foam MedFacts Consumer Leaflet (Wolters Kluwer)

Denorex Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)

Doak Tar Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)

Fototar Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

MG217 Medicated Tar Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

Psoriasin Prescribing Information (FDA)

Compare Betatar Gel with other medications

Dermatitis
Psoriasis
Seborrheic Dermatitis

Where can I get more information?

Your pharmacist can provide more information about coal tar.

Betimol

Generic Name: timolol ophthalmic (TIM oh lol off THAL mik)

Brand Names: Betimol, Istalol, Timoptic Ocudose, Timoptic Ocumeter, Timoptic Ocumeter Plus, Timoptic-XE

What is Betimol (timolol ophthalmic)?

Timolol is a beta-blocker that also reduces pressure inside the eye.

Timolol ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Timolol ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Betimol (timolol ophthalmic)?

Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using timolol ophthalmic. Do not use the medications at the same time.

Timolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

What should I discuss with my healthcare provider before using Betimol (timolol ophthalmic)?

Do not use this medication if you are allergic to timolol, or if you have:

asthma or severe chronic obstructive pulmonary disease (COPD);

certain serious heart conditions, especially "AV block"; or

severe or uncontrolled congestive heart failure.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

breathing problems such as bronchitis or emphysema;

a history of heart disease or congestive heart failure;

diabetes;

history of stroke, blood clot, or circulation problems;

a thyroid disorder;

a muscle disorder such as myasthenia gravis;

kidney disease; or

liver disease.

FDA pregnancy category C. It is not known whether timolol ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Timolol ophthalmic passes into breast milk and could cause harm to a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine for a child younger than 2 years old.

How should I use Betimol (timolol ophthalmic)?

Use timolol ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using the eye drops. Do not use this medication while you are wearing contact lenses. Timolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using timolol before putting your contact lenses in.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

If you need to have any type of surgery, especially eye surgery, tell the surgeon ahead of time that you are using timolol ophthalmic. You may need to stop using the medicine for a short time.

Store this medication at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling dizzy or short of breath, headache, slow heart beat, chest pain, or fainting.

What should I avoid while using Betimol (timolol ophthalmic)?

Timolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Betimol (timolol ophthalmic) side effects

swelling or redness of your eyelids;

eye redness, discomfort, or sensitivity to light;

drainage, crusting, or oozing of your eyes or eyelids;

depressed mood, confusion, hallucinations, unusual thoughts or behavior;

wheezing, gasping, or other breathing problems;

swelling, rapid weight gain;

chest pain, slow or uneven heart rate; or

feeling short of breath, even with mild exertion.

Less serious side effects may include:

blurred vision, double vision, drooping eyelid;

burning or stinging in your eye;

headache, weakness, drowsiness;

numbness, tingling, or cold feeling in your hands or feet;

ringing in your ears;

dry mouth;

nausea, diarrhea, loss of appetite, upset stomach;

skin rash or worsening psoriasis;

sleep problems (insomnia); or

cough, stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Betimol (timolol ophthalmic)?

Before using timolol ophthalmic, tell your doctor if you are using any of the following drugs:

clonidine (Catapres);

quinidine (Cardioquin, Quinadex, Quinaglute);

reserpine;

digitalis (digoxin, Lanoxin, Lanoxicaps);

acetazolamide (Diamox), dichlorphenamide (Daranide), or methazolamide (Neptazane);

oral timolol (Blocadren);

any other beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

a calcium channel blocker such as diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

This list is not complete and there may be other drugs that can interact with timolol ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Betimol resources

Betimol Side Effects (in more detail)
Betimol Use in Pregnancy & Breastfeeding
Betimol Drug Interactions
Betimol Support Group
0 Reviews for Betimol - Add your own review/rating

Betimol Prescribing Information (FDA)

Betimol Advanced Consumer (Micromedex) - Includes Dosage Information

Betimol Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Timolol Ophthalmic Prescribing Information (FDA)

Istalol Prescribing Information (FDA)

Istalol Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Istalol Consumer Overview

Compare Betimol with other medications

Glaucoma, Open Angle
Intraocular Hypertension

Where can I get more information?

Your pharmacist can provide more information about timolol ophthalmic.

See also: Betimol side effects (in more detail)

Bexxar

tositumomab

Dosage Form: injection
Bexxar®

(Tositumomab and Iodine I 131 Tositumomab)

WARNINGS

Hypersensitivity Reactions, including Anaphylaxis: Serious hypersensitivity reactions, including some with fatal outcome, have been reported with the Bexxar therapeutic regimen. Medications for the treatment of severe hypersensitivity reactions should be available for immediate use. Patients who develop severe hypersensitivity reactions should have infusions of the Bexxar therapeutic regimen discontinued and receive medical attention (see WARNINGS).

Prolonged and Severe Cytopenias: The majority of patients who received the Bexxar therapeutic regimen experienced severe thrombocytopenia and neutropenia. The Bexxar therapeutic regimen should not be administered to patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve (see WARNINGS and ADVERSE REACTIONS).

Pregnancy Category X: The Bexxar therapeutic regimen can cause fetal harm when administered to a pregnant woman.

Special requirements: The Bexxar therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) contains a radioactive component and should be administered only by physicians and other health care professionals qualified by training in the safe use and handling of therapeutic radionuclides. The Bexxar therapeutic regimen should be administered only by physicians who are in the process of being or have been certified by GlaxoSmithKline in dose calculation and administration of the Bexxar therapeutic regimen.

Bexxar Description

The Bexxar therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is an anti-neoplastic radioimmunotherapeutic monoclonal antibody-based regimen composed of the monoclonal antibody, Tositumomab, and the radiolabeled monoclonal antibody, Iodine I 131 Tositumomab.

Tositumomab

Tositumomab is a murine IgG2a lambda monoclonal antibody directed against the CD20 antigen, which is found on the surface of normal and malignant B lymphocytes. Tositumomab is produced in an antibiotic-free culture of mammalian cells and is composed of two murine gamma 2a heavy chains of 451 amino acids each and two lambda light chains of 220 amino acids each. The approximate molecular weight of Tositumomab is 150 kD.

Tositumomab is supplied as a sterile, pyrogen-free, clear to opalescent, colorless to slightly yellow, preservative-free liquid concentrate. It is supplied at a nominal concentration of 14 mg/mL Tositumomab in 35 mg and 225 mg single-use vials. The formulation contains 10% (w/v) maltose, 145 mM sodium chloride, 10 mM phosphate, and Water for Injection, USP. The pH is approximately 7.2.

Iodine I 131 Tositumomab

Iodine I 131 Tositumomab is a radio-iodinated derivative of Tositumomab that has been covalently linked to Iodine-131. Unbound radio-iodine and other reactants have been removed by chromatographic purification steps. Iodine I 131 Tositumomab is supplied as a sterile, clear, preservative-free liquid for IV administration. The dosimetric dosage form is supplied at nominal protein and activity concentrations of 0.1 mg/mL and 0.61 mCi/mL (at date of calibration), respectively. The therapeutic dosage form is supplied at nominal protein and activity concentrations of 1.1 mg/mL and 5.6 mCi/mL (at date of calibration), respectively. The formulation for the dosimetric and the therapeutic dosage forms contains 4.4%−6.6% (w/v) povidone, 1−2 mg/mL maltose (dosimetric dose) or 9−15 mg/mL maltose (therapeutic dose), 8.5−9.5 mg/mL sodium chloride, and 0.9−1.3 mg/mL ascorbic acid. The pH is approximately 7.0.

Bexxar Therapeutic Regimen

The Bexxar therapeutic regimen is administered in two discrete steps: the dosimetric and therapeutic steps. Each step consists of a sequential infusion of Tositumomab followed by Iodine I 131 Tositumomab. The therapeutic step is administered 7-14 days after the dosimetric step. The Bexxar therapeutic regimen is supplied in two distinct package configurations as follows:

Bexxar Dosimetric Packaging

A carton containing two single-use 225 mg vials and one single-use 35 mg vial of Tositumomab supplied by McKesson BioServices and

A package containing a single-use vial of Iodine I 131 Tositumomab (0.61 mCi/mL at calibration), supplied by MDS Nordion.

Bexxar Therapeutic Packaging

A carton containing two single-use 225 mg vials and one single-use 35 mg vial of Tositumomab, supplied by McKesson BioServices and

A package containing one or two single-use vials of Iodine I 131 Tositumomab (5.6 mCi/mL at calibration), supplied by MDS Nordion.

Physical/Radiochemical Characteristics of Iodine-131

Iodine-131 decays with beta and gamma emissions with a physical half-life of 8.04 days. The principal beta emission has a mean energy of 191.6 keV and the principal gamma emission has an energy of 364.5 keV (Ref 1).

External Radiation

The specific gamma ray constant for Iodine-131 is 2.2 R/millicurie hour at 1 cm. The first half-value layer is 0.24 cm lead (Pb) shielding. A range of values is shown in Table 1 for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb. To facilitate control of the radiation exposure from this radionuclide, the use of a 2.55 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

Table 1: Radiation Attenuation by Lead Shielding
Shield Thickness (Pb) cm	Attenuation Factor
0.24	0.5
0.89	10-1
1.60	10-2
2.55	10-3
3.7	10-4

The fraction of Iodine-131 radioactivity that remains in the vial after the date of calibration is calculated as follows:

Fraction of remaining radioactivity of Iodine-131 after x days = 2-(x/8.04).

Physical decay is presented in Table 2.

Table 2: Physical Decay Chart: Iodine-131: Half-Life 8.04 Days
Days	Fraction Remaining
0*	1.000
1	0.917
2	0.842
3	0.772
4	0.708
5	0.650
6	0.596
7	0.547
8	0.502
9	0.460
10	0.422
11	0.387
12	0.355
13	0.326
14	0.299

* (Calibration day)

Bexxar - Clinical Pharmacology

General Pharmacology

Tositumomab binds specifically to the CD20 (human B-lymphocyte−restricted differentiation antigen, Bp 35 or B1) antigen. This antigen is a transmembrane phosphoprotein expressed on pre-B lymphocytes and at higher density on mature B lymphocytes (Ref. 2). The antigen is also expressed on >90% of B-cell non-Hodgkin’s lymphomas (NHL) (Ref. 3). The recognition epitope for Tositumomab is found within the extracellular domain of the CD20 antigen. CD20 does not shed from the cell surface and does not internalize following antibody binding (Ref. 4).

Mechanism of Action

Possible mechanisms of action of the Bexxar therapeutic regimen include induction of apoptosis (Ref. 5), complement-dependent cytotoxicity (CDC) (Ref. 6), and antibody-dependent cellular cytotoxicity (ADCC) (Ref. 5) mediated by the antibody. Additionally, cell death is associated with ionizing radiation from the radioisotope.

Pharmacokinetics/Pharmacodynamics

The phase 1 study of Iodine I 131 Tositumomab determined that a 475 mg predose of unlabeled antibody decreased splenic targeting and increased the terminal half-life of the radiolabeled antibody. The median blood clearance following administration of 485 mg of Tositumomab in 110 patients with NHL was 68.2 mg/hr (range: 30.2−260.8 mg/hr). Patients with high tumor burden, splenomegaly, or bone marrow involvement were noted to have a faster clearance, shorter terminal half-life, and larger volume of distribution. The total body clearance, as measured by total body gamma camera counts, was dependent on the same factors noted for blood clearance. Patient-specific dosing, based on total body clearance, provided a consistent radiation dose, despite variable pharmacokinetics, by allowing each patient’s administered activity to be adjusted for individual patient variables. The median total body effective half-life, as measured by total body gamma camera counts, in 980 patients with NHL was 67 hours (range: 28-115 hours).

Elimination of Iodine-131 occurs by decay (see Table 2) and excretion in the urine. Urine was collected for 49 dosimetric doses. After 5 days, the whole body clearance was 67% of the injected dose. Ninety-eight percent of the clearance was accounted for in the urine.

Administration of the Bexxar therapeutic regimen results in sustained depletion of circulating CD20 positive cells. The impact of administration of the Bexxar therapeutic regimen on circulating CD20 positive cells was assessed in two clinical studies, one conducted in chemotherapy naïve patients and one in heavily pretreated patients. The assessment of circulating lymphocytes did not distinguish normal from malignant cells. Consequently, assessment of recovery of normal B cell function was not directly assessed. At seven weeks, the median number of circulating CD20 positive cells was zero (range: 0-490 cells/mm3). Lymphocyte recovery began at approximately 12 weeks following treatment. Among patients who had CD20 positive cell counts recorded at baseline and at 6 months, 8 of 58 (14%) chemotherapy naïve patients had CD20 positive cell counts below normal limits at six months and 6 of 19 (32%) heavily pretreated patients had CD20 positive cell counts below normal limits at six months. There was no consistent effect of the Bexxar therapeutic regimen on post-treatment serum IgG, IgA, or IgM levels.

Radiation Dosimetry

Estimations of radiation-absorbed doses for Iodine I 131 Tositumomab were performed using sequential whole body images and the MIRDOSE 3 software program. Patients with apparent thyroid, stomach, or intestinal imaging were selected for organ dosimetry analyses. The estimated radiation-absorbed doses to organs and marrow from a course of the Bexxar therapeutic regimen are presented in Table 3.

Table 3: Estimated Radiation-Absorbed Organ Doses

		Bexxar	Bexxar
		mGy/MBq	mGy/MBq
		Median	Range
From Organ ROIs
	Thyroid	2.71	1.4 - 6.2
	Kidneys	1.96	1.5 - 2.5
	ULI Wall	1.34	0.8 - 1.7
	LLI Wall	1.30	0.8 - 1.6
	Heart Wall	1.25	0.5 - 1.8
	Spleen	1.14	0.7 - 5.4
	Testes	0.83	0.3 - 1.3
	Liver	0.82	0.6 - 1.3
	Lungs	0.79	0.5 - 1.1
	Red Marrow	0.65	0.5 - 1.1
	Stomach Wall	0.40	0.2 - 0.8
From Whole Body ROIs
	Urine Bladder Wall	0.64	0.6 - 0.9
	Bone Surfaces	0.41	0.4 - 0.6
	Pancreas	0.31	0.2 - 0.4
	Gall Bladder Wall	0.29	0.2 - 0.3
	Adrenals	0.28	0.2 - 0.3
	Ovaries	0.25	0.2 - 0.3
	Small Intestine	0.23	0.2 - 0.3
	Thymus	0.22	0.1 - 0.3
	Uterus	0.20	0.2 - 0.2
	Muscle	0.18	0.1 - 0.2
	Breasts	0.16	0.1 - 0.2
	Skin	0.13	0.1 - 0.2
	Brain	0.13	0.1 - 0.2
	Total Body	0.24	0.2 - 0.3

Clinical Studies

The efficacy of the Bexxar therapeutic regimen was evaluated in 2 studies conducted in patients with low-grade, transformed low-grade, or follicular large-cell lymphoma. Determination of clinical benefit of the Bexxar therapeutic regimen was based on evidence of durable responses without evidence of an effect on survival. All patients had received prior treatment without an objective response or had progression of disease following treatment. Patients were required to have a granulocyte count >1500 cells/mm3, a platelet count ≥100,000/mm3, an average of ≤25% of the intratrabecular marrow space involved by lymphoma, and no evidence of progressive disease arising in a field irradiated with >3500 cGy within 1 year of completion of irradiation.

Study 1 was a multicenter, single-arm study of 40 patients whose disease had not responded to or had progressed after at least four doses of Rituximab therapy. The median age was 57 (range: 35−78); the median time from diagnosis to protocol entry was 50 months (range: 12−170); and the median number of prior chemotherapy regimens was 4 (range: 1−11). The efficacy outcome data from this study, as determined by an independent panel that reviewed patient records and radiologic studies, are summarized in Table 4.

Among the forty patients in the study, twenty-four patients had disease that did not respond to their last treatment with Rituximab, 11 patients had disease that responded to Rituximab for less than 6 months, and five patients had disease that responded to Rituximab, with a duration of response of 6 months or greater. Overall, 35 of the 40 patients met the definition of “Rituximab refractory”, defined as no response or a response of less than 6 months duration. In this subset of patients the overall objective response was 63% (95% confidence interval 45%, 79%) with a median duration of 25 months (range of 4 - 38+ months). The complete response in this subset of patients was 29% (95% CI of 15%, 46%) with a median duration of response not yet reached (range of 4 - 38+ months).

Study 2 was a multicenter, single arm, open-label study of 60 chemotherapy refractory patients. The median age was 60 (range 38-82), the median time from diagnosis to protocol entry was 53 months (range: 9-334), and the median number of prior chemotherapy regimens was 4 (range 2-13). Fifty-three patients had not responded to prior therapy and 7 patients had responded with a duration of response of<6 months. The efficacy outcome data from this study, as determined by an independent panel that reviewed patient records and radiologic studies are also summarized in Table 4. Investigators continued to follow eight patients with complete response after the last independent review panel assessment. The updated duration of ongoing response as per investigators was reported to range from 42 to 85 months.

Table 4: Efficacy Outcomes in Bexxar Clinical Studies
	Study 1 (n = 40)	Study 2 (n = 60)
Overall Response
Rate 95% CI a	68% (51%, 81%)	47% (34%, 60%)
Response Duration (mos)
Median 95% CI a Range	16 (10, NRb) 1+ to 38+	12 (7, 47) 2 to 47
Complete Response c
Rate 95% CI a	33% (19%, 49%)	20% (11%, 32%)
Complete response c duration (mos)
Median 95% CI a Range	NR b (15, NR) 4 to 38+	47 (47, NR) 9 to 47

a CI = Confidence Interval

b NR = Not reached, Median duration of follow up: Study 1 = 26 months; Study 2 = 30 months

c Complete response rate = Pathologic and clinical complete responses

The results of these studies were supported by demonstration of durable objective responses in three single-arm studies. In these studies, 130 patients with Rituximab-naïve follicular non-Hodgkin’s lymphoma with or without transformation were evaluated for efficacy. All patients had relapsed following, or were refractory to, chemotherapy. The overall response rates ranged from 49% to 64% and the median durations of response ranged from 13 to 16 months. Due to small sample sizes in the supportive studies, as in studies 1 and 2, the 95% confidence intervals for the median durations of response are wide.

Indications and Usage for Bexxar

The Bexxar therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is indicated for the treatment of patients with CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin’s lymphoma. Determination of the effectiveness of the Bexxar therapeutic regimen is based on overall response rates in patients whose disease is refractory to chemotherapy alone or to chemotherapy and Rituximab. The effects of the Bexxar therapeutic regimen on survival are not known.

The Bexxar therapeutic regimen is not indicated for the initial treatment of patients with CD20 positive non-Hodgkin’s lymphoma. (See ADVERSE REACTIONS, Immunogenicity.)

The Bexxar therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the Bexxar therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.

Contraindications

The Bexxar therapeutic regimen is contraindicated in patients with known hypersensitivity to murine proteins or any other component of the Bexxar therapeutic regimen.

PREGNANCY CATEGORY X

Iodine I 131 Tositumomab (a component of the Bexxar therapeutic regimen) is contraindicated for use in women who are pregnant. Iodine-131 may cause harm to the fetal thyroid gland when administered to pregnant women. Review of the literature has shown that transplacental passage of radioiodide may cause severe, and possibly irreversible, hypothyroidism in neonates. While there are no adequate and well-controlled studies of the Bexxar therapeutic regimen in pregnant animals or humans, use of the Bexxar therapeutic regimen in women of childbearing age should be deferred until the possibility of pregnancy has been ruled out. If the patient becomes pregnant while being treated with the Bexxar therapeutic regimen, the patient should be apprised of the potential hazard to the fetus (see BOXED WARNING, Pregnancy Category X).

Warnings

Prolonged and Severe Cytopenias (see BOXED WARNINGS; ADVERSE REACTIONS, Hematologic Events)

The most common adverse reactions associated with the Bexxar therapeutic regimen were severe or life-threatening cytopenias (NCI CTC grade 3 or 4) with 71% of the 230 patients enrolled in clinical studies experiencing grade 3 or 4 cytopenias. These consisted primarily of grade 3 or 4 thrombocytopenia (53%) and grade 3 or 4 neutropenia (63%). The time to nadir was 4 to 7 weeks and the duration of cytopenias was approximately 30 days. Thrombocytopenia, neutropenia, and anemia persisted for more than 90 days following administration of the Bexxar therapeutic regimen in 16 (7%), 15 (7%), and 12 (5%) patients respectively (this includes patients with transient recovery followed by recurrent cytopenia). Due to the variable nature in the onset of cytopenias, complete blood counts should be obtained weekly for 10-12 weeks. The sequelae of severe cytopenias were commonly observed in the clinical studies and included infections (45% of patients), hemorrhage (12%), a requirement for growth factors (12% G- or GM-CSF; 7% Epoetin alfa) and blood product support (15% platelet transfusions; 16% red blood cell transfusions). Prolonged cytopenias may also influence subsequent treatment decisions.

The safety of the Bexxar therapeutic regimen has not been established in patients with >25% lymphoma marrow involvement, platelet count<100,000 cells/mm3 or neutrophil count <1,500 cells/mm3.

Hypersensitivity Reactions Including Anaphylaxis (see BOXED WARNINGS; ADVERSE REACTIONS, Hypersensitivity Reactions and Immunogenicity)

Serious hypersensitivity reactions, including some with fatal outcome, were reported during and following administration of the Bexxar therapeutic regimen. Emergency supplies including medications for the treatment of hypersensitivity reactions, e.g., epinephrine, antihistamines and corticosteroids, should be available for immediate use in the event of an allergic reaction during administration of the Bexxar therapeutic regimen. Patients who have received murine proteins should be screened for human anti-mouse antibodies (HAMA). Patients who are positive for HAMA may be at increased risk of anaphylaxis and serious hypersensitivity reactions during administration of the Bexxar therapeutic regimen.

Secondary Malignancies

Myelodysplastic syndrome (MDS) and/or acute leukemia were reported in 10% (24/230) of patients enrolled in the clinical studies and 3% (20/765) of patients included in expanded access programs, with median follow-up of 39 and 27 months, respectively. Among the 44 reported cases, the median time to development of MDS/leukemia was 31 months following treatment; however, the cumulative rate continues to increase.

Additional non-hematological malignancies were also reported in 54 of the 995 patients enrolled in clinical studies or included in the expanded access program. Approximately half of these were non-melanomatous skin cancers. The remainder, which occurred in 2 or more patients, included colorectal cancer (7), head and neck cancer (6), breast cancer (5), lung cancer (4), bladder cancer (4), melanoma (3), and gastric cancer (2). The relative risk of developing secondary malignancies in patients receiving the Bexxar therapeutic regimen over the background rate in this population cannot be determined, due to the absence of controlled studies (see ADVERSE REACTIONS).

Pregnancy Category X

(see BOXED WARNINGS; CONTRAINDICATIONS).

Hypothyroidism

Administration of the Bexxar therapeutic regimen may result in hypothyroidism (see ADVERSE REACTIONS, Hypothyroidism). Thyroid-blocking medications should be initiated at least 24 hours before receiving the dosimetric dose and continued until 14 days after the therapeutic dose (see DOSAGE and ADMINISTRATION). All patients must receive thyroid-blocking agents; any patient who is unable to tolerate thyroid-blocking agents should not receive the Bexxar therapeutic regimen. Patients should be evaluated for signs and symptoms of hypothyroidism and screened for biochemical evidence of hypothyroidism annually.

Precautions

Radionuclide Precautions

Iodine I 131 Tositumomab is radioactive. Care should be taken, consistent with the institutional radiation safety practices and applicable federal guidelines, to minimize exposure of medical personnel and other patients.

Renal Function

Iodine I 131 Tositumomab and Iodine-131 are excreted primarily by the kidneys. Impaired renal function may decrease the rate of excretion of the radiolabeled iodine and increase patient exposure to the radioactive component of the Bexxar therapeutic regimen. There are no data regarding the safety of administration of the Bexxar therapeutic regimen in patients with impaired renal function.

Immunization

The safety of immunization with live viral vaccines following administration of the Bexxar therapeutic regimen has not been studied. The ability of patients who have received the Bexxar therapeutic regimen to generate a primary or anamnestic humoral response to any vaccine has not been studied.

Information for Patients

Prior to administration of the Bexxar therapeutic regimen, patients should be advised that they will have a radioactive material in their body for several days upon their release from the hospital or clinic. After discharge, patients should be provided with both oral and written instructions for minimizing exposure of family members, friends and the general public. Patients should be given a copy of the written instructions for use as a reference for the recommended precautionary actions.

The pregnancy status of women of childbearing potential should be assessed and these women should be advised of the potential risks to the fetus (see CONTRAINDICATIONS). Women who are breastfeeding should be instructed to discontinue breastfeeding and should be apprised of the resultant potential harmful effects to the infant if these instructions are not followed.

Patients should be advised of the potential risk of toxic effects on the male and female gonads following the Bexxar therapeutic regimen, and be instructed to use effective contraceptive methods during treatment and for 12 months following the administration of the Bexxar therapeutic regimen.

Patients should be informed of the risks of hypothyroidism and be advised of the importance of compliance with thyroid blocking agents and need for life-long monitoring.

Patients should be informed of the possibility of developing a HAMA immune response and that HAMA may affect the results of in vitro and in vivo diagnostic tests as well as results of therapies that rely on murine antibody technology.

Patients should be informed of the risks of cytopenias and symptoms associated with cytopenia, the need for frequent monitoring for up to 12 weeks after treatment, and the potential for persistent cytopenias beyond 12 weeks.

Patients should be informed that MDS, secondary leukemia, and solid tumors have also been observed in patients receiving the Bexxar therapeutic regimen.

Due to lack of controlled clinical studies, and high background incidence in the heavily pretreated patient population, the relative risk of development of myelodysplastic syndrome/acute leukemia and solid tumors due to the Bexxar therapeutic regimen cannot be determined.

Laboratory Monitoring

A complete blood count (CBC) with differential and platelet count should be obtained prior to, and at least weekly following administration of the Bexxar therapeutic regimen. Weekly monitoring of blood counts should continue for a minimum of 10 weeks or, if persistent, until severe cytopenias have completely resolved. More frequent monitoring is indicated in patients with evidence of moderate or more severe cytopenias (see BOXED WARNINGS and WARNINGS). Thyroid stimulating hormone (TSH) level should be monitored before treatment and annually thereafter. Serum creatinine levels should be measured immediately prior to administration of the Bexxar therapeutic regimen.

Drug Interactions

No formal drug interaction studies have been performed. Due to the frequent occurrence of severe and prolonged thrombocytopenia, the potential benefits of medications that interfere with platelet function and/or anticoagulation should be weighed against the potential increased risk of bleeding and hemorrhage.

Drug/Laboratory Test Interactions

Administration of the Bexxar therapeutic regimen may result in the development of HAMA. The presence of HAMA may affect the accuracy of the results of in vitro and in vivo diagnostic tests and may affect the toxicity profile and efficacy of therapeutic agents that rely on murine antibody technology. Patients who are HAMA positive may be at increased risk for serious allergic reactions and other side effects if they undergo in vivo diagnostic testing or treatment with murine monoclonal antibodies.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to establish the carcinogenic or mutagenic potential of the Bexxar therapeutic regimen or to determine its effects on fertility in males or females. However, radiation is a potential carcinogen and mutagen. Administration of the Bexxar therapeutic regimen results in delivery of a significant radiation dose to the testes. The radiation dose to the ovaries has not been established. There have been no studies to evaluate whether administration of the Bexxar therapeutic regimen causes hypogonadism, premature menopause, azoospermia and/or mutagenic alterations to germ cells. There is a potential risk that the Bexxar therapeutic regimen may cause toxic effects on the male and female gonads. Effective contraceptive methods should be used during treatment and for 12 months following administration of the Bexxar therapeutic regimen.

Pregnancy Category X

(See CONTRAINDICATIONS; WARNINGS.)

Nursing Mothers

Radioiodine is excreted in breast milk and may reach concentrations equal to or greater than maternal plasma concentrations. Immunoglobulins are also known to be excreted in breast milk. The absorption potential and potential for adverse effects of the monoclonal antibody component (Tositumomab) in the infant are not known. Therefore, formula feedings should be substituted for breast feedings before starting treatment. Women should be advised to discontinue nursing.

Pediatric Use

The safety and effectiveness of the Bexxar therapeutic regimen in children have not been established.

Geriatric Use

Clinical studies of the Bexxar therapeutic regimen did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In clinical studies, 230 patients received the Bexxar therapeutic regimen at the recommended dose. Of these, 27% (61 patients) were age 65 or older and 4% (10 patients) were age 75 or older. Across all studies, the overall response rate was lower in patients age 65 and over (41% vs. 61%) and the duration of responses was shorter (10 months vs. 16 months); however, these findings are primarily derived from 2 of the 5 studies. While the incidence of severe hematologic toxicity was lower, the duration of severe hematologic toxicity was longer in those age 65 or older as compared to patients less than 65 years of age. Due to the limited experience greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

The most serious adverse reactions observed in the clinical trials were severe and prolonged cytopenias and the sequelae of cytopenias which included infections (sepsis) and hemorrhage in thrombocytopenic patients, allergic reactions (bronchospasm and angioedema), secondary leukemia and myelodysplasia (see BOXED WARNINGS and WARNINGS).

The most common adverse reactions occurring in the clinical trials included neutropenia, thromobocytopenia, and anemia that are both prolonged and severe. Less common but severe adverse reactions included pneumonia, pleural effusion and dehydration.

Data regarding adverse events were primarily obtained in 230 patients with non-Hodgkin’s lymphoma enrolled in five clinical trials using the recommended dose and schedule. Patients had a median follow-up of 39 months and 79% of the patients were followed at least 12 months for survival and selected adverse events. Patients had a median of 3 prior chemotherapy regimens, a median age of 55 years, 60% male, 27% had transformation to a higher grade histology, 29% were intermediate grade and 2% high grade histology (IWF) and 68% had Ann Arbor stage IV disease. Patients enrolled in these studies were not permitted to have prior hematopoietic stem cell transplantation or irradiation to more than 25% of the red marrow. In the expanded access program, which included 765 patients, data regarding clinical serious adverse events and HAMA and TSH levels were used to supplement the characterization of delayed adverse events (see ADVERSE REACTIONS, Hypothyroidism, Secondary Leukemia and Myelodysplastic Syndrome, Immunogenicity).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Hematologic Events

Hematologic toxicity was the most frequently observed adverse event in clinical trials with the Bexxar therapeutic regimen (Table 6). Sixty-three (27%) of 230 patients received one or more hematologic supportive care measures following the therapeutic dose: 12% received G-CSF; 7% received Epoetin alfa; 15% received platelet transfusions; and 16% received packed red blood cell transfusions. Twenty-eight (12%) patients experienced hemorrhagic events; the majority were mild to moderate.

Infectious Events

One hundred and four of the 230 (45%) patients experienced one or more adverse events possibly related to infection. The majority were viral (e.g., rhinitis, pharyngitis, flu symptoms, or herpes) or other minor infections. Twenty of 230 (9%) patients experienced infections that were considered serious because the patient was hospitalized to manage the infection. Documented infections included pneumonia, bacteremia, septicemia, bronchitis, and skin infections.

Hypersensitivity Reactions

Fourteen patients (6%) experienced one or more of the following adverse events: allergic reaction, face edema, injection site hypersensitivity, a

Friday, September 16, 2016

Commonly used brand name(s)

Uses For Beyaz

Before Using Beyaz

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of drospirenone, ethinyl estradiol, and levomefolate

Dosing

Missed Dose

Storage

Precautions While Using Beyaz

Beyaz Side Effects

More Beyaz resources

Compare Beyaz with other medications

Betoptic-S Drops are used for:

Do NOT use Betoptic-S Drops if:

Before using Betoptic-S Drops:

How to use Betoptic-S Drops:

Important safety information:

Possible side effects of Betoptic-S Drops:

If OVERDOSE is suspected:

General information:

More Betoptic-S resources

Compare Betoptic-S with other medications

Bexxar 131 Iodine is used for:

Do NOT use Bexxar 131 Iodine if:

Before using Bexxar 131 Iodine:

How to use Bexxar 131 Iodine:

Important safety information:

Possible side effects of Bexxar 131 Iodine:

If OVERDOSE is suspected:

General information:

More Bexxar 131 Iodine resources

Compare Bexxar 131 Iodine with other medications

What is betaxolol ophthalmic?

What is the most important information I should know about betaxolol ophthalmic?

What should I discuss with my healthcare provider before using betaxolol ophthalmic?

How should I use betaxolol ophthalmic?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using betaxolol ophthalmic?

Betaxolol ophthalmic side effects

Betaxolol ophthalmic Dosing Information

What other drugs will affect betaxolol ophthalmic?

More betaxolol ophthalmic resources

Compare betaxolol ophthalmic with other medications

Where can I get more information?

What is bexarotene topical?

What is the most important information I should know about bexarotene topical?

Who should not use bexarotene topical?

How should I use bexarotene topical?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using bexarotene topical?

Bexarotene topical side effects

Bexarotene topical Dosing Information

What other drugs will affect bexarotene topical?

More bexarotene topical resources

Compare bexarotene topical with other medications

Where can I get more information?

What is coal tar?

What is the most important information I should know about coal tar?

What should I discuss with my health care provider before using coal tar?

How should I use coal tar?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using coal tar?

Coal tar side effects

What other drugs will affect coal tar?

More Betatar Gel resources

Compare Betatar Gel with other medications

Where can I get more information?

What is Betimol (timolol ophthalmic)?

What is the most important information I should know about Betimol (timolol ophthalmic)?

What should I discuss with my healthcare provider before using Betimol (timolol ophthalmic)?