Zomig ZMT Disintegrating Tablets

Pronunciation: ZOLE-mi-TRIP-tan
Generic Name: Zolmitriptan
Brand Name: Zomig ZMT

Zomig ZMT Disintegrating Tablets are used for:

Treating migraine headaches with or without aura (flashing lights, wavy lines, dark spots) in adults. It is not intended to prevent migraines.

Zomig ZMT Disintegrating Tablets are a serotonin 5-HT₁ receptor agonist ("triptan"). It works by narrowing blood vessels in the brain, which helps to relieve migraines.

Do NOT use Zomig ZMT Disintegrating Tablets if:

• you are allergic to any ingredient in Zomig ZMT Disintegrating Tablets


• you have certain types of irregular heartbeat (eg, symptomatic Wolff-Parkinson-White syndrome)


• you have a history of ischemic heart disease (eg, angina, a heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, a stroke, a transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)


• you have uncontrolled high blood pressure


• you have certain types of migraines (eg, hemiplegic, basilar)


• you have used an ergot alkaloid (eg, ergotamine) or another "triptan" migraine medicine in the last 24 hours


• you are taking sibutramine


• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

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

Before using Zomig ZMT Disintegrating Tablets:

Some medical conditions may interact with Zomig ZMT Disintegrating Tablets. 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 history of liver or kidney problems, seizures (eg epilepsy), heart problems (eg, irregular heartbeat), other types of headaches (eg, cluster headaches), or phenylketonuria (PKU)


• if you have shortness of breath, chest pain, or a history of high blood pressure, a heart attack, a stroke, high cholesterol, diabetes, or smoking


• if you are a woman who is past menopause


• if you are a man who is over 40 years old


• if you are very overweight


• if a family member has had heart disease or a stroke

Some MEDICINES MAY INTERACT with Zomig ZMT Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), or sibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea


• Cimetidine or MAOIs (eg, phenelzine) because they may increase the risk of Zomig ZMT Disintegrating Tablets's side effects


• Ergot derivatives (eg, dihydroergotamine, methysergide) or other serotonin 5-HT₁ receptor agonists (eg, eletriptan, rizatriptan) because the risk of their side effects may be increased by Zomig ZMT Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zomig ZMT Disintegrating Tablets 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 Zomig ZMT Disintegrating Tablets:

Use Zomig ZMT Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Zomig ZMT Disintegrating Tablets. Talk to your pharmacist if you have questions about this information.


• Take Zomig ZMT Disintegrating Tablets by mouth with or without food.


• It is best to use Zomig ZMT Disintegrating Tablets as soon as you notice the headache symptoms of a migraine attack.


• Open tablet blister pack with dry hands and place the tablet on the tongue. Do not try to split the tablets.


• Take the tablet immediately after removing it from its blister. Do not store the removed tablet for future use. Throw away any unused tablets or portions that have been removed from the blister pack.


• The tablet will dissolve rapidly on the tongue and can be swallowed with saliva. It is not necessary to take Zomig ZMT Disintegrating Tablets with liquid.


• If your migraine symptoms go away and then come back, you may take a second dose as directed by your doctor. Wait at least 2 hours between doses.


• If your symptoms do not get better after the first dose, do not take a second dose for the same attack. Contact your doctor.


• Do NOT take more than the amount prescribed by your doctor in a 24-hour period or treat more than 3 headaches within 30 days without checking with your doctor.


• If your medicine has expired, throw it away.


• If you miss a dose of Zomig ZMT Disintegrating Tablets and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure of what to do if you miss a dose. Do NOT use Zomig ZMT Disintegrating Tablets more often than prescribed. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Zomig ZMT Disintegrating Tablets.

Important safety information:

• Zomig ZMT Disintegrating Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Zomig ZMT Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Overuse of Zomig ZMT Disintegrating Tablets can cause your headache to become worse. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.


• Rarely, serious heart problems (eg, heart attack, irregular heartbeat) have been reported within a few hours of using Zomig ZMT Disintegrating Tablets. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Zomig ZMT Disintegrating Tablets. Your risk may be greater if you take Zomig ZMT Disintegrating Tablets with certain other medicines (eg, SSRIs, SNRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• Zomig ZMT Disintegrating Tablets should not be used to prevent or reduce the number of migraine headaches you have. If you have a headache that is different than your usual migraine headaches, check with your doctor before using Zomig ZMT Disintegrating Tablets.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Lab tests, including heart function, may be performed while you use Zomig ZMT Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Zomig ZMT Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Zomig ZMT Disintegrating Tablets should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Zomig ZMT Disintegrating Tablets:

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:

Burning, numbness, or tingling of the skin; dizziness; drowsiness; dry mouth; feeling of heaviness or pressure; nausea; warm or hot sensation; weakness.

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; unusual hoarseness); bloody diarrhea; chest pain; confusion; fainting; fast or irregular heartbeat; numbness or tingling of an arm or leg; one-sided weakness; pain, tightness, or pressure in the jaw, neck, or chest; severe headache, dizziness, or vomiting; severe stomach pain; shortness of breath; speech changes; very cold or blue fingers or toes; vision changes or loss of 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: Zomig ZMT 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 unusual drowsiness.

Proper storage of Zomig ZMT Disintegrating Tablets:

Store Zomig ZMT Disintegrating Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zomig ZMT Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Zomig ZMT Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Zomig ZMT Disintegrating Tablets 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 Zomig ZMT Disintegrating Tablets. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zomig ZMT resources

• Zomig ZMT Side Effects (in more detail)
• Zomig ZMT Use in Pregnancy & Breastfeeding
• Drug Images
• Zomig ZMT Drug Interactions
• Zomig ZMT Support Group
• 7 Reviews for Zomig ZMT - Add your own review/rating

Compare Zomig ZMT with other medications

• Cluster Headaches
• Cyclic Vomiting Syndrome
• Migraine

progesterone

proe-JES-ter-one

Oral route(Capsule, Liquid Filled)

Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported with estrogen plus progestin therapy. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration possible .

Commonly used brand name(s)

In the U.S.

• Prometrium

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Progestin

Uses For progesterone

Progesterone is used to help prevent changes in the uterus (womb) in women who are taking conjugated estrogens after menopause. It is also used to properly regulate the menstrual cycle and treat unusual stopping of menstrual periods (amenorrhea) in women who are still menstruating.

progesterone is available only with your doctor's prescription.

Before Using progesterone

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 progesterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to progesterone 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

Use of progesterone is not indicated in children. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of progesterone have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving progesterone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of progesterone. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or


• Allergy to peanuts or peanut oil or


• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or


• Breast cancer, known, suspected, or a history of or


• Heart attack, active or history of or


• Liver disease or


• Stroke, active or history of—Should not be used in patients with these conditions.

• Asthma or


• Diabetes or


• Edema (fluid retention or body swelling) or


• Endometriosis or


• Epilepsy (seizures) or


• Heart disease or


• Hypercalcemia (high calcium in the blood) or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertension (high blood pressure) or


• Kidney disease or


• Migraine headache or


• Systemic lupus erythematosus (SLE) or


• Thyroid problems—Use with caution. May make these conditions worse.

Proper Use of progesterone

It is very important that you use progesterone only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

progesterone comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For women who use progesterone after menopause, it will be given together with an estrogen medicine. Carefully follow the schedule your doctor gives you for both medicines.

If you have trouble swallowing progesterone, take it with a glass of water while standing up. Talk to your doctor or pharmacist if this does not help.

Dosing

The dose of progesterone 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 progesterone. 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.

• For oral dosage form (capsules):
  
  • For prevention of thickening of the lining of the uterus (endometrial hyperplasia):
    
    • Adults—200 milligrams (mg) per day, taken as a single dose at bedtime, for 12 continuous days per 28-day menstrual cycle.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For treatment of unusual stopping of menstrual period (amenorrhea):
    
    • Adults—400 milligrams (mg) per day, taken as a single dose at bedtime, for 10 days.
    
    
    • Children—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of progesterone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 progesterone

It is very important that your doctor check your progress at regular visits to make sure progesterone is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.

Using progesterone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Stop using progesterone 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 progesterone.

There is a very slight chance that progesterone could increase the risk of breast cancer and endometrial (lining of the uterus) cancer in some women. Talk to your doctor about this risk. Make sure your doctor knows if anyone in your family has had breast cancer or endometrial cancer.

Using large doses of progesterone over a long period of time and using it with an estrogen medicine may increase your risk of heart attack, stroke, blood clots, or dementia. Talk with your doctor about these risks.

Your risk of heart disease or stroke from progesterone is higher if you smoke. Your risk is also increased if you have diabetes or 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.

Tell the medical doctor or dentist in charge that you are using progesterone before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using progesterone.

Stop using progesterone and check with your doctor immediately if sudden loss of vision or any other change in vision occurs while you are using progesterone. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

progesterone may cause some people to become dizzy or drowsy. Make sure you know how you react to progesterone before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before you have any medical tests, tell the medical doctor in charge that you are taking progesterone. The results of some tests may be affected by progesterone.

progesterone 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

• Chest pain


• chills


• cold or flu-like symptoms


• cough or hoarseness


• fever


• problems with urination

Less common

• Clear or bloody discharge from the nipple


• dimpling of the breast skin


• inverted nipple


• lump in the breast or under the arm


• persistent crusting or scaling of the nipple


• redness or swelling of the breast


• sore on the skin of the breast that does not heal

Incidence not known

• Abdominal or stomach pain


• bloating


• blurred vision


• change in vaginal discharge


• clay-colored stools


• cleft lip or palate


• confusion


• constipation


• darkened urine


• diarrhea


• difficult or labored breathing


• difficulty with swallowing


• difficulty with walking


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, pounding, or irregular heartbeat or pulse


• headache


• hives


• indigestion


• irregular heartbeat


• irritation


• itching


• joint pain, stiffness, or swelling


• lightheadedness


• loss of appetite


• nausea


• nervousness


• noisy breathing


• numbness or tingling in the face, arms, or legs


• pain or feeling of pressure in the pelvis


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• redness of the skin


• shortness of breath


• slow heartbeat


• spontaneous abortion


• stomach or pelvic discomfort, aching, or heaviness


• sweating


• swelling of the eyelids, face, lips, hands, or feet


• tightness in the chest


• trouble speaking, thinking, or walking


• unpleasant breath odor


• unusual tiredness or weakness


• vaginal bleeding


• vomiting


• vomiting of blood


• wheezing


• 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:

More common

• Breast pain or tenderness


• depression


• muscle or joint pain


• white or brownish vaginal discharge


• worry

Incidence not known

• Attack, assault, or force


• blurred or loss of vision


• change in walking and balance


• changes in behavior


• changes in patterns and rhythms of speech


• choking


• clumsiness or unsteadiness


• confusion about identity, place, and time


• continuing ringing or buzzing or other unexplained noise in the ears


• decreased awareness or responsiveness


• difficulty with moving


• disturbed color perception


• double vision


• drowsiness


• extreme dizziness or drowsiness


• feeling drunk


• feeling of constant movement of self or surroundings


• feeling of unreality


• hair loss or thinning of the hair


• halos around lights


• hearing loss


• hives or welts


• longer or heavier menstrual periods


• loss of consciousness


• muscle cramps


• muscle stiffness


• night blindness


• normal menstrual bleeding occurring earlier, possibly lasting longer than expected


• overbright appearance of lights


• redness of the skin


• relaxed and calm


• sensation of spinning


• sense of detachment from self or body


• severe sleepiness


• sleepiness


• slurred speech


• swollen tongue


• thoughts of killing oneself


• tunnel vision


• weight changes

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.

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.

Sertra Basics

Sertra Basics may be available in the countries listed below.

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Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertra Basics in the following countries:

• Germany

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Dipivefrina

Dipivefrina may be available in the countries listed below.

Ingredient matches for Dipivefrina

Dipivefrine

Dipivefrina (DCIT) is also known as Dipivefrine (Rec.INN)

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Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Zonatuss

Generic Name: benzonatate (ben ZOE na tate)

Brand Names: Tessalon, Tessalon Perles, Zonatuss

What is Zonatuss (benzonatate)?

Benzonatate is a non-narcotic cough medicine. It works by numbing the throat and lungs, making the cough reflex less active.

Benzonatate is used to relieve coughing.

Benzonatate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zonatuss (benzonatate)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of benzonatate include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal to a child.

What should I discuss with my healthcare provider before taking Zonatuss (benzonatate)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). FDA pregnancy category C. It is not known whether benzonatate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether benzonatate 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. Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal, especially to a child.

How should I take Zonatuss (benzonatate)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Always ask a doctor before giving a cough medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take each dose with a full glass of water. Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects. Store at room temperature away from moisture, heat, and light.

See also: Zonatuss dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzonatate can be fatal, especially to a child. Accidental death has occurred in children under 2 years old who took only 1 or 2 capsules.

Overdose symptoms may include numbness in the mouth or throat, feeling restless or very sleepy, tremors or shaking, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking Zonatuss (benzonatate)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using benzonatate

Zonatuss (benzonatate) 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 taking benzonatate and call your doctor at once if you have a serious side effect such as:

• 
  

  a choking feeling;

  
  


• 
  

  chest pain or numbness;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  confusion; or

  
  


• 
  

  hallucinations.

  
  

Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  drowsiness;

  
  


• 
  

  nausea, vomiting, constipation; or

  
  


• 
  

  mild itching or skin rash.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zonatuss (benzonatate)?

Before taking benzonatate, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to drowsiness and other side effects of benzonatate.

There may be other drugs that can interact with benzonatate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Zonatuss resources

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

• Zonatuss Prescribing Information (FDA)


• Zonatuss Advanced Consumer (Micromedex) - Includes Dosage Information


• Benzonatate Prescribing Information (FDA)


• Benzonatate Professional Patient Advice (Wolters Kluwer)


• Benzonatate MedFacts Consumer Leaflet (Wolters Kluwer)


• Benzonatate Monograph (AHFS DI)


• Tessalon Prescribing Information (FDA)

Compare Zonatuss with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about benzonatate.

See also: Zonatuss side effects (in more detail)

Ranamp

Ranamp may be available in the countries listed below.

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Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Ranamp in the following countries:

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Ingredient matches for La-Fu

Fluorouracil

Fluorouracil is reported as an ingredient of La-Fu in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Tamsulosin-Teva

Tamsulosin-Teva may be available in the countries listed below.

Ingredient matches for Tamsulosin-Teva

Tamsulosin

Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulosin-Teva in the following countries:

• Italy


• Slovakia


• Switzerland

International Drug Name Search

Haemiton

Haemiton may be available in the countries listed below.

Ingredient matches for Haemiton

Clonidine

Clonidine hydrochloride (a derivative of Clonidine) is reported as an ingredient of Haemiton in the following countries:

• Germany

International Drug Name Search

Carbamazepin Hexal

Carbamazepin Hexal may be available in the countries listed below.

Ingredient matches for Carbamazepin Hexal

Carbamazepine

Carbamazepine is reported as an ingredient of Carbamazepin Hexal in the following countries:

• Germany


• Luxembourg

International Drug Name Search

ZORprin Controlled-Release Tablets

Pronunciation: AS-pir-in
Generic Name: Aspirin
Brand Name: Examples include Bayer Low Adult Strength and ZORprin

ZORprin Controlled-Release Tablets are used for:

Relieving arthritis symptoms. It may also be used for other conditions as determined by your doctor.

ZORprin Controlled-Release Tablets are a salicylate. It works by inhibiting several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Do NOT use ZORprin Controlled-Release Tablets if:

• you are allergic to any ingredient in ZORprin Controlled-Release Tablets


• you are a child or teenager with influenza (flu) or chicken pox


• you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets


• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness), to aspirin, tartrazine, or an NSAID (eg, ibuprofen, naproxen, celecoxib)


• you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

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

Before using ZORprin Controlled-Release Tablets:

Some medical conditions may interact with ZORprin Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 or other substances


• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day


• if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chicken pox, or vitamin K deficiency


• if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with ZORprin Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease ZORprin Controlled-Release Tablets's effectiveness


• Anticoagulants (eg, heparin, warfarin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because the risk of their side effects, including risk of bleeding, may be increased by ZORprin Controlled-Release Tablets


• Insulin and oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by ZORprin Controlled-Release Tablets


• Methotrexate or valproic acid because the risk of their actions and side effects may be increased by ZORprin Controlled-Release Tablets


• Angiotensin-converting enzyme inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by ZORprin Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if ZORprin Controlled-Release Tablets 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 ZORprin Controlled-Release Tablets:

Use ZORprin Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take ZORprin Controlled-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow ZORprin Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing unless directed by your health care provider.


• Take ZORprin Controlled-Release Tablets with a full glass of water (8 oz/240 mL).


• Use ZORprin Controlled-Release Tablets exactly as directed on the package, unless instructed differently by your doctor. If you are taking ZORprin Controlled-Release Tablets without a prescription, follow any warnings and precautions on the label.


• If you miss a dose of ZORprin Controlled-Release Tablets and you are taking it regularly, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use ZORprin Controlled-Release Tablets.

Important safety information:

• ZORprin Controlled-Release Tablets has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Talk to your doctor before you take ZORprin Controlled-Release Tablets or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of ZORprin Controlled-Release Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking ZORprin Controlled-Release Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• ZORprin Controlled-Release Tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Aspirin has been linked to a serious illness called Reye syndrome. Do not give ZORprin Controlled-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.


• If ZORprin Controlled-Release Tablets has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.


• Tell your doctor or dentist that you take ZORprin Controlled-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Do not take ZORprin Controlled-Release Tablets for at least 7 days after any surgery unless directed by your health care provider.


• Do not take ZORprin Controlled-Release Tablets for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.


• Diabetes patients-ZORprin Controlled-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use ZORprin Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially those with a blood coagulation disorder.


• Different brands of ZORprin Controlled-Release Tablets may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ZORprin Controlled-Release Tablets while you are pregnant. ZORprin Controlled-Release Tablets are not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. ZORprin Controlled-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use ZORprin Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ZORprin Controlled-Release Tablets:

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:

Heartburn; nausea; upset stomach.

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); black or bloody stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; vomiting.

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: ZORprin 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 agitation; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting.

Proper storage of ZORprin Controlled-Release Tablets:

Store ZORprin Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep ZORprin Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about ZORprin Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• ZORprin Controlled-Release Tablets 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 ZORprin Controlled-Release Tablets. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More ZORprin resources

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

Compare ZORprin with other medications

• Angina
• Angina Pectoris Prophylaxis
• Ankylosing Spondylitis
• Antiphospholipid Syndrome
• Aseptic Necrosis
• Back Pain
• Fever
• Heart Attack
• Ischemic Stroke
• Ischemic Stroke, Prophylaxis
• Juvenile Rheumatoid Arthritis
• Kawasaki Disease
• Myocardial Infarction, Prophylaxis
• Niacin Flush
• Osteoarthritis
• Pain
• Prevention of Thromboembolism in Atrial Fibrillation
• Prosthetic Heart Valves
• Prosthetic Heart Valves, Mechanical Valves
• Revascularization Procedures, Prophylaxis
• Rheumatic Fever
• Rheumatoid Arthritis
• Sciatica
• Systemic Lupus Erythematosus
• Thromboembolic Stroke Prophylaxis
• Transient Ischemic Attack

Zevalin In-111

Generic Name: ibritumomab (Intravenous route)

eye-bri-TOOM-oh-mab tye-UX-e-tan

Intravenous route(Solution)

Serious infusion reactions, including fatalities, have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. Most fatal infusion reactions (80%) occurred with the first rituximab infusion. Administration also results in severe and prolonged cytopenias in most patients. The ibritumomab tiuxetan therapeutic regimen should not be administered to patients with 25% or greater lymphoma marrow involvement and/or impaired bone marrow reserve. Severe cutaneous and mucocutaneous reactions, some with fatal outcome, can occur with therapy. The dose of Y-90 ibritumomab tiuxetan should not exceed the absolute maximum allowable dose of 32 millicurie (1184 megabecquerels) .

Commonly used brand name(s)

In the U.S.

• Zevalin In-111


• Zevalin Y-90

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Zevalin In-111

Ibritumomab injection is a monoclonal antibody. It is used together with another monoclonal antibody (rituximab) and one radioactive medication (Y-90). Ibritumomab is used to treat a type of cancer called non-Hodgkin's lymphoma (NHL) in patients who have never received any treatment and for those who have received other cancer medicines.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Zevalin In-111

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 have not been performed on the relationship of age to the effects of ibritumomab injection in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibritumomab injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Acute myelogenous leukemia (AML) or


• Myelodysplastic syndrome (MDS) or


• Neutropenia (low white blood cells in the blood) or


• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use of ibritumomab tiuxetan

This section provides information on the proper use of a number of products that contain ibritumomab tiuxetan. It may not be specific to Zevalin In-111. Please read with care.

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Zevalin In-111

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are receiving this medicine and for 12 months after stopping it. Tell your doctor right away if you think you have become pregnant while using the medicine.

This medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, chest tightness, swelling in your face or hands, lightheadedness, or if you feel like fainting within a few hours after you receive it.

If you have a severe skin reaction with this medicine, you should seek medical attention right away. Symptoms may include blistering or loosening of the skin; red, swollen, irritated, or scaly skin; fever; chills; headache; or diarrhea.

While you are being treated with ibritumomab, and after you stop treatment with it, do not have any immunizations (live vaccines) without your doctor's approval. Ibritumomab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Ibritumomab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid sports or other situations where bruising or injury could occur.

If ibritumomab accidentally seeps out of the vein where it is injected, it may damage the tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

This medicine contains albumin, which is derived from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

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 or vitamin supplements.

Zevalin In-111 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 or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• cough or hoarseness


• coughing up blood


• difficulty with breathing or swallowing


• dizziness


• fever or chills


• headache


• increased menstrual flow or vaginal bleeding


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lower back or side pain


• noisy breathing


• nosebleeds


• painful or difficult urination


• pale skin


• paralysis


• pinpoint red spots on the skin


• prolonged bleeding from cuts


• red or dark brown urine


• red stools


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• tightness in the chest


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

Less common

• Bloody nose that does not stop after pinching the nose together and holding it for 5 to 10 minutes


• bluish lips or skin


• chest pain or discomfort


• confusion


• diarrhea


• fainting


• fast heartbeat


• hives


• itching


• lightheadedness


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid, shallow breathing


• skin rash


• small red or purple spots on the skin


• unusual vaginal bleeding


• vomiting blood or material that looks like coffee grounds

Rare

• Agitation


• anxiety


• back pain


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site


• blurred vision


• coma


• drowsiness


• fast, pounding, or irregular heartbeat or pulse


• hallucinations


• inability to speak


• irritability


• mood or mental changes


• nausea


• redness of the skin


• seizures


• severe headache


• slurred speech


• stiff neck


• temporary blindness


• vomiting


• weakness in the arm or leg on one side of the body, sudden and severe


• welts

Incidence not known

• Blistering, peeling, or loosening of the skin


• cracks in the skin


• joint or muscle pain


• loss of heat from the body


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• skin blisters

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:

More common

• Abdominal or stomach pain


• bruising


• constipation


• difficult or labored breathing


• difficulty with moving


• faintness or lightheadedness when getting up from a lying or sitting position


• fear


• feeling of warmth


• full or bloated feeling or pressure in the stomach


• joint pain


• lack or loss of strength


• large, flat, blue or purplish patches in the skin


• loss of appetite


• muscle aching or cramping


• muscle pain or stiffness


• nervousness


• pain


• rash


• redness of the face, neck, arms and occasionally, upper chest


• runny nose


• sleeplessness


• sneezing


• stuffy nose


• sudden or increased sweating


• swelling of the abdominal or stomach area


• swelling of the hands, ankles, feet, or lower legs


• swollen joints


• throat irritation


• trouble with sleeping


• unable to sleep


• weight loss

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain


• swelling or redness in the joints

For several months after receiving this therapy, it may still produce some side effects that need attention. During this period of time check with your doctor immediately if you notice any of the following:

• Bleeding gums


• bone pain


• headache, sudden and severe


• inability to speak


• increased menstrual flow or vaginal bleeding


• red or black, tarry stools


• red or dark brown urine


• temporary blindness

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: Zevalin In-111 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 Zevalin In-111 resources

• Zevalin In-111 Side Effects (in more detail)
• Zevalin In-111 Use in Pregnancy & Breastfeeding
• Zevalin In-111 Drug Interactions
• Zevalin In-111 Support Group
• 0 Reviews for Zevalin In-111 - Add your own review/rating

Compare Zevalin In-111 with other medications

• Non-Hodgkin's Lymphoma

Warfarin tablets 5mg B.P.

1. Name Of The Medicinal Product

Warfarin Tablets 5mg

2. Qualitative And Quantitative Composition

Each tablet contains 5 mg warfarin sodium ( as clathrate).

3. Pharmaceutical Form

Round pink uncoated tablet, scored and marked 'W5' on one side with company logo on reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

For prophylaxis against venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. For the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.

4.2 Posology And Method Of Administration

Warfarin tablets are for oral administration.

An initial daily dose of 10mg on the first two days. Subsequent daily doses should be adjusted according to the results of the prothrombin time or other appropriate coagulation tests. The single daily maintenance requirement is usually between 5mg and 12mg, but can vary between 2mg and 30mg.

The maintenance dose is omitted if the prothrombin time is excessively prolonged.

Use in elderly patients: The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight for weight basis than younger patients.

Target INR

By referring to the target INR (see below), the dosage of warfarin can be adjusted depending on the deviation of the patient's INR from the target value. An INR within 0.5 INR units of the target is considered to be generally satisfactory.

The following target INR values are based on guidelines from The British Society for Haematology:

Indication	Target INR
Pulmonary embolus	2.5
Proximal deep vein thrombosis	2.5
Calf vein thrombosis in non-surgical patients with no persistent risk factors	2.5
Post-operative calf vein thrombosis without persistent risk factors	2.5
Recurrence of venous thromboembolism when no longer on warfarin therapy	2.5
Recurrence of venous thromboembolism whilst on warfarin therapy	3.5
Symptomatic inherited thrombophilia	2.5
Antiphospholipid syndrome	3.5
Non-rheumatic atrial fibrillation	2.5
Atrial fibrillation due to rheumatic heart disease, congenital heart disease, thyrotoxicosis	2.5
Cardioversion	2.5
Mural thrombus	2.5
Cardiomyopathy	2.5
Mechanical prosthetic heart valve	3.5

4.3 Contraindications

• Known hypersensitivity to warfarin or to any of the excipients

• Haemorrhagic stroke (see section 4.4 for further details)

• Clinically significant bleeding

• Within 72 hours of major surgery with risk of severe bleeding (for information on other surgery, see section 4.4)

• Within 48 hours postpartum

• Pregnancy (first and third trimesters, see section 4.6)

Drugs where interactions may lead to a significantly increased risk of bleeding (see section 4.5)

4.4 Special Warnings And Precautions For Use

Most adverse events reported with warfarin are a result of over anticoagulation therefore it is important that the need for therapy is reviewed on a regular basis and therapy discontinued when no longer required.

Patients should be given a patient-held information booklet ('warfarin card') and informed of symptoms for which they should seek medical attention.

Commencement of therapy

Monitoring

When warfarin is started using a standard dosing regimen the INR should be determined daily or on alternate days in the early days of treatment. Once the INR has stabilised in the target range the INR can be determined at longer intervals.

INR should be monitored more frequently in patients at an increased risk of over coagulation e.g. patients with severe hypertension, liver or renal disease.

Patients for whom adherence may be difficult should be monitored more frequently.

Thrombophilia

Patients with protein C deficiency are at risk of developing skin necrosis when starting warfarin treatment. In patients with protein C deficiency, therapy should be introduced without a loading dose of warfarin even if heparin is given. Patients with protein S deficiency may also be at risk and it is advisable to introduce warfarin therapy slowly in these circumstances.

Risk of haemorrhage

The most frequently reported adverse effect of all oral anticoagulants is haemorrhage. Warfarin should be given with caution to patients where there is a risk of serious haemorrhage (e.g. concomitant NSAID use, recent ischaemic stroke, bacterial endocarditis, previous gastrointestinal bleeding).

Risk factors for bleeding include high intensity of anticoagulation (INR>4.0), age

Checking the INR and reducing or omitting doses depending on INR level is essential, following consultation with anticoagulation services if necessary. If the INR is found to be too high, reduce dose or stop warfarin treatment; sometimes it will be necessary to reverse anticoagulation. INR should be checked within 2–3 days to ensure that it is falling.

Any concomitant anti-platelet drugs should be used with caution due to an increased risk of bleeding.

Haemorrhage

Haemorrhage can indicate an overdose of warfarin has been taken. For advice on treatment of haemorrhage see section 4.9.

Unexpected bleeding at therapeutic levels should always be investigated and INR monitored.

Ischaemic stroke

Anticoagulation following an ischaemic stroke increases the risk of secondary haemorrhage into the infarcted brain. In patients with atrial fibrillation long term treatment with warfarin is beneficial, but the risk of early recurrent embolism is low and therefore a break in treatment after ischaemic stroke is justified. Warfarin treatment should be re-started 2–14 days following ischaemic stroke, depending on the size of the infarct and blood pressure. In patients with large embolic strokes, or uncontrolled hypertension, warfarin treatment should be stopped for 14 days.

Surgery

For surgery where there is no risk of severe bleeding, surgery can be performed with an INR of <2.5.

For surgery where there is a risk of severe bleeding, warfarin should be stopped 3 days prior to surgery.

Where it is necessary to continue anticoagulation e.g. risk of life-threatening thromboembolism, the INR should be reduced to <2.5 and heparin therapy should be started.

If surgery is required and warfarin cannot be stopped 3 days beforehand, anticoagulation should be reversed with low-dose vitamin K.

The timing for re-instating warfarin therapy depends on the risk of post-operative haemorrhage. In most instances warfarin treatment can be re-started as soon as the patient has an oral intake.

Dental Surgery

Warfarin need not be stopped before routine dental surgery, eg, tooth extraction.

Active peptic ulceration

Due to a high risk of bleeding, patients with active peptic ulcers should be treated with caution. Such patients should be reviewed regularly and informed of how to recognise bleeding and what to do in the event of bleeding occurring.

Interactions

Many drugs and foods interact with warfarin and affect the prothrombin time (see section 4.5). Any change to medication, including self-medication with OTC products, warrants increased monitoring of the INR. Patients should be instructed to inform their doctor before they start to take any additional medications including over the counter medicines, herbal remedies or vitamin preparations.

Thyroid disorders

The rate of warfarin metabolism depends on thyroid status. Therefore patients with hyper- or hypo-thyroidism should be closely monitored on starting warfarin therapy.

Additional circumstances where changes in dose may be required

The following also may exaggerate the effect of warfarin tablets, and necessitate a reduction of dosage:

• Loss of weight

• Acute illness

• Cessation of smoking

The following may reduce the effect of warfarin tablets, and require the dosage to be increased:

• Weight gain

• Diarrhoea

• Vomiting

Other warnings

Acquired or inherited warfarin resistance should be suspected if larger than usual daily doses of warfarin are required to achieve the desired anticoagulant effect.

Genetic information

Genetic variability particularly in relation to CYP2C9 and VKORC1 can significantly affect dose requirements for warfarin. If a family association with these polymorphisms is known extra care is warranted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Warfarin has a narrow therapeutic range and care is required with all concomitant therapy. The individual product information for any new concomitant therapy should be consulted for specific guidance on warfarin dose adjustment and therapeutic monitoring. If no information is provided the possibility of an interaction should be considered. Increased monitoring should be considered when commencing any new therapy if there is any doubt as to the extent of interaction.

Pharmacodynamic interactions

Drugs which are contraindicated

Concomitant use of drugs used in the treatment or prophylaxis of thrombosis, or other drugs with adverse effects on haemostasis may increase the pharmacological effect of warfarin, increasing the risk of bleeding.

Fibrinolytic drugs such as streptokinase and alteplase are contraindicated in patients receiving warfarin.

Drugs which should be avoided if possible

The following examples should be avoided, or administered with caution with increased clinical and laboratory monitoring:

• Clopidogrel

• NSAIDs (including aspirin and cox-2 specific NSAIDS)

• Sulfinpyrazone

• Thrombin inhibitors such as bivalirudin, dabigatran

• Dipyridamole

• Unfractionated heparins and heparin derivatives, low molecular weight heparins

• Fondaparinux, rivaroxaban

• Glycoprotein IIb/IIIa receptor antagonists such as eptifibatide, tirofiban and abciximab

• Prostacyclin

• SSRI and SNRI antidepressants

• Other drugs which inhibit haemostasis, clotting or platelet action

Low-dose aspirin with warfarin may have a role in some patients but the risk of gastrointestinal bleeding is increased. Warfarin may initially be given with a heparin in the initial treatment of thrombosis, until the INR is in the correct range.

Metabolic interactions

Warfarin is a mixture of enantiomers which are metabolised by different CYPP450 cytochromes. R-warfarin is metabolised primarily by CYP1A2 and CYP3A4. S-warfarin is metabolised primarily by CYP2C9. The efficacy of warfarin is affected primarily when the metabolism of S-warfarin is altered.

Drugs that compete as substrates for these cytochromes or inhibit their activity may increase warfarin plasma concentrations and INR, potentially increasing the risk of bleeding. When these drugs are co-administered, warfarin dosage may need to be reduced and the level of monitoring increased.

Conversely, drugs which induce these metabolic pathways may decrease warfarin plasma concentrations and INR, potentially leading to reduced efficacy. When these drugs are co-administered, warfarin dosage may need to be increased and the level of monitoring increased.

There are a small subsets of drugs for which interactions are known; however their clinical effect on the INR is variable. In these cases increased monitoring on starting and stopping therapy is advised.

Care should also be taken when stopping or reducing the dose of a metabolic inhibitor or inducer, once patients are stable on this combination (offset effect).

Listed below are drugs which are known to interact with warfarin in a clinically significant way.

Examples of drugs which potentiate the effect of warfarin

allopurinol, capecitabine, erlotinib, disulfiram, azole antifungals (ketoconazole, fluconazole etc) omeprazole, paracetamol (prolonged regular use), propafenone, amiodarone, tamoxifen, methylphenidate zafirlukast, fibrates, statins (not pravastatin; predominantly associated with fluvastatin) erythromycin, sulfamethoxazole, metronidazole

Examples of drugs which antagonise the effect of warfarin

Barbiturates, primidone, carbamazepine, griseofulvin, oral contraceptives, rifampicin, azathioprine, phenytoin

Examples of drugs with variable effect

Corticosteroids, nevirapine, ritonavir

Other drug interactions

Broad spectrum antibiotics may potentiate the effect of warfarin by reducing the gut flora which produce vitamin K. Similarly, orlistat may reduce absorption of vitamin K. Cholestyramine and sucralfate potentially decrease absorption of warfarin.

Increased INR has been reported in patients taking glucosamine and warfarin. This combination is not recommended.

Interactions with herbal products

Herbal preparations containing St John's Wort (Hypericum perforatum) must not be used whilst taking warfarin due to a proven risk of decreased plasma concentrations and reduced clinical effects of warfarin.

Many other herbal products have a theoretical effect on warfarin; however most of these interactions are not proven. Patients should generally avoid taking any herbal medicines or food supplements whilst taking warfarin, and should be told to advise their doctor if they are taking any, as more frequent monitoring is advisable.

Alcohol

Acute ingestion of a large amount of alcohol may inhibit the metabolism of warfarin and increase INR. Conversely, chronic heavy alcohol intake may induce the metabolism of warfarin. Moderate alcohol intake can be permitted.

Interactions with food and food supplements

Individual case reports suggest a possible interaction between warfarin and cranberry juice, in most cases leading to an increase in INR or bleeding event. Patients should be advised to avoid cranberry products. Increased supervision and INR monitoring should be considered for any patient taking warfarin and regular cranberry juice.

Limited evidence suggests that grapefruit juice may cause a modest rise in INR in some patients taking warfarin.

Certain foods such as liver, broccoli, Brussels sprouts and green leafy vegetables contain large amounts of vitamin K. Sudden changes in diet can potentially affect control of anticoagulation. Patients should be informed of the need to seek medical advice before undertaking any major changes in diet.

Many other food supplements have a theoretical effect on warfarin; however most of these interactions are not proven. Patients should generally avoid taking any food supplements whilst taking warfarin, and should be told to advise their doctor if they are taking any, as more frequent monitoring is advisable.

Laboratory tests

Heparins and danaparoid may prolong the prothrombin time, therefore a sufficient time interval should be allowed after administration before performing the test.

4.6 Pregnancy And Lactation

Pregnancy:

Based on human experience warfarin causes congenital malformations and foetal death when administered during pregnancy.

Warfarin is contraindicated in pregnancy in the first and third trimester.

Women of child-bearing age who are taking Warfarin Tablets should use effective contraception during treatment.

Lactation:

Warfarin is excreted in breast milk in small amounts. However, at therapeutic does of warfarin no effects on the breast-feeding child are anticipated. Warfarin can be used during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Nil.

4.8 Undesirable Effects

MedDRA system organ class	Adverse Reaction
Infections and infestations	Fever
Immune system disorders	Hypersensitivity
Nervous system disorders	Cerebral haemorrhage; Cerebral subdural haematoma
Vascular disorders	Haemorrhage
Respiratory, thoracic and mediastinal disorders	Haemothorax, epistaxis
Gastrointestinal disorders	Gastroinestinal haemorrhage, rectal haemorrhage, haematemesis; pancreatitis; diarrhoea; nausea; vomiting; melaena
Hepatobiliary disorders	Jaundice; hepatic dysfunction
Skin and subcutaneous disorders	Rash; alopecia; purpura; 'purple toes' syndrome; erythematous swollen skin patches leading to ecchymosis, infarction and skin necrosis
Renal and Urinary disorders	Haematuria
Investigations	Unexplained drop in haematocrit; haemoglobin decreased

4.9 Overdose

The benefit of gastric decontamination is uncertain. If the patient presents within 1 hour of ingestion of more than 0.25 mg/kg or more than the patient's therapeutic dose, consider activated charcoal (50 g for adults; 1 g/kg for children)

In cases of life-threatening haemorrhage

Stop warfarin treatment, give prothrombin complex concentrate (factors II, VII, IX, and X) 30–50 units/kg or (if no concentrate available) fresh frozen plasma 15 mL/kg. Discuss with local haematologist or National Poisons Information Service, or both.

Non-life threatening haemorrhage

Where anticoagulation can be suspended, give slow intravenous injection of phytomenadione (vitamin K₁) 10–20 mg for adults (250 micrograms/kg for a child)

Where rapid re-anticoagulation is desirable (eg, valve replacements) give prothrombin complex concentrate (factors II, VII, IX, and X) 30–50 units/kg or (if no concentrate available) fresh frozen plasma 15 mL/kg.

Monitor INR to determine when to restart normal therapy. Monitor INR for at least 48 hours post overdose.

For patients on long-term warfarin therapy without major haemorrhage

• INR> 8·0, no bleeding or minor bleeding—stop warfarin, and give phytomenadione (vitamin K₁) 0·5–1 mg for adults, 0·015–0·030 mg/kg (15–30 micrograms/kg) for children by slow intravenous injection or 5 mg by mouth (for partial reversal of anticoagulation give smaller oral doses of phytomenadione eg, 0·5–2·5 mg using the intravenous preparation orally); repeat dose of phytomenadione if INR still too high after 24 hours. Large doses of phytomenadione may completely reverse the effects of warfarin and make re-establishment of anticoagulation difficult.

• INR 6·0–8·0, no bleeding or minor bleeding—stop warfarin, restart when INR <5·0

• INR < 6·0 but more than 0·5 units above target value—reduce dose or stop warfarin, restart when INR <5·0

For patients NOT on long-term anticoagulants without major haemorrhage

Measure the INR (prothrombin time) at presentation and sequentially every 24–48 hours after ingestion depending on the initial dose and initial INR.

• If the INR remains normal for 24–48 hours and there is no evidence of bleeding, there should be no further monitoring necessary.

• Give vitamin K₁ (phytomenadione) if:

a) there is no active bleeding and the patient has ingested more than 0·25 mg/kg;

OR

b) the prothrombin time is already significantly prolonged (INR>4·0).

The adult dose of vitamin K₁ is 10–20 mg orally (250 micrograms/kg body weight for a child). Delay oral vitamin K₁ at least 4 hours after any activated charcoal has been given. Repeat INR at 24 hours and consider further vitamin K₁.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Warfarin is a coumarin anticoagulant which depresses the hepatic vitamin K-dependent synthesis of coagulation factors II (Prothrombin), VII, IX and X. It acts indirectly, with no effect on existing clots.

5.2 Pharmacokinetic Properties

Warfarin Sodium is readily absorbed from the gastro-intestinal tract; it can also be absorbed through the skin. It is extensively bound to plasma proteins and its plasma half-life is about 37 hours. It crosses the placenta but does not occur in significant quantities in breast milk. Warfarin is administered as a racemic mixture. The s-isomer is reported to be more potent; the R and S isomers are both metabolised in the liver, though at different rates; the stereo-isomers may also be affected differently by other drugs. The inactive metabolites are excreted in the urine following reabsorption from the bile.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose, Maize Starch, Sodium Starch Glycollate, Magnesium Stearate, Erythrosine Lake (E127), Alumina.

6.2 Incompatibilities

None Known

6.3 Shelf Life

Securitainers: 5 years

HDPE containers: 5 years

Blister packs: 3 years

6.4 Special Precautions For Storage

Store below 25°C.

Protect from light and moisture.

6.5 Nature And Contents Of Container

Antigen International Ltd.: Polypropylene securitainers with tamper evident lid.

APS Ltd.: HDPE containers with LDPE lids or child resistant caps.

Pack size : 100 tablets, 500 tablets.

Blister strips of 14 tablets.

Pack size: 28 tablets, 56 tablets.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by the physician.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 02848/0187

9. Date Of First Authorisation/Renewal Of The Authorisation

22 November 1995

10. Date Of Revision Of The Text

16/04/2010