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Basic Drug Info
Drug Name:ZOMIG
Manufacturer:AstraZeneca Pharmaceuticals LP
Other Info:

The name of your medicine is ZOMIG Tablets.

It can be obtained only by prescription from your doctor.

The decision to use ZOMIG Tablets is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances.

If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over the age of 40), you should tell your doctor, who should evaluate you for heart disease in order to determine if ZOMIG Tablets are appropriate for you.

This medicine was prescribed for you to treat your particular condition and should not be used by others or for any other condition.The Purpose of Your Medicine: ZOMIG Tablets are intended to relieve your migraine, but not to prevent or reduce the number of attacks you experience.

Use ZOMIG Tablets only to treat an actual migraine attack.Important Questions to Consider Before Taking ZOMIG Tablets: If the answer to any of the following questions is YES or if you do not know the answer, then you must discuss it with your doctor before you use ZOMIG Tablets.Do you have any chest pain, heart disease, shortness of breath, or irregular heartbeats? Have you had a heart attack?Do you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over the age of 40)?Do you have high blood pressure?Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you not using adequate contraception? Are you breast feeding an infant?If you are taking ZOMIG-ZMT®, are you sensitive to phenylalanine (a component of the artificial sweetener aspartame)?Have you ever had to stop taking this or any other medication because of an allergy or other problems?Are you taking any other migraine medications, including 5-HT1 agonists (triptans) or migraine medications containing ergotamine, dihydroergotamine, or methysergide?Are you taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders? Common SSRIs are CELEXA® (citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC® (fluoxetine), SYMBYAX® (olanzapine/fluoxetine), ZOLOFT® (sertraline), SARAFEM® (fluoxetine), and LUVOX® (fluvoxamine).

Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® (venlafaxine).Are you taking cimetidine for gastrointestinal symptoms?Have you had, or do you have, any disease of the liver or kidney?Have you had, or do you have, epilepsy or seizures?Is this headache different from your usual migraine attacks?Remember, if you answered YES to any of the above questions, then you must discuss it with your doctor.The Use of ZOMIG Tablets During Pregnancy: Do not use ZOMIG Tablets if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception, unless you have discussed this with your doctor.How to Use ZOMIG Tablets and ZOMIG-ZMT Orally Disintegrating Tablets: Adults should be started on a 2.5 mg dose or lower administered by mouth.

A dose lower than 2.5 mg can be achieved by manually breaking the conventional film-coated, scored 2.5 mg tablet in half.

It is not recommended to break the ZOMIG-ZMT Tablet.

If your headache comes back after your initial dose, a second dose may be administered anytime after 2 hours of taking the dose.

For any attack where you have no response to the first dose, do not take a second dose without first consulting with your doctor.

Do not take more than a total of 10 mg of ZOMIG in any 24-hour period.

Discard any unused tablets or its portion that have been removed from the blister packaging.

Do not take ZOMIG with any other drug in the same class (triptans) within 24 hours or within 24 hours of taking ergotamine-type medications such as ergotamine, dihydroergotamine or methysergide to treat your migraine.Additionally for ZOMIG-ZMT Tablets, the blister pack should be peeled open and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.Side Effects to Watch for: Some patients experience pain or tightness in the chest or throat, including muscle aches and pains, when using ZOMIG.

If this happens to you, then discuss it with your doctor before using any more ZOMIG.

If the chest pain is severe or does not go away, call your doctor immediately.

As with other drugs in this class (triptans), there have been very rare reports of heart attack occurring in patients with and without risk factors for heart and blood vessel disease.Some people experience: alterations of heart rate; temporary increase in blood pressure; sudden and severe stomach pain.

Call your doctor immediately if you have any of these symptoms after taking ZOMIG.Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face, or lips; or a skin rash, skin lumps, or hives happens rarely.

If it happens to you, then tell your doctor immediately.

Do not take any more ZOMIG unless your doctor tells you to do so.Some people may have feelings of dry mouth, tingling, heat, heaviness, or pressure after treatment with ZOMIG.

A few people may feel drowsy, dizzy, tired, or sick.

Tell your doctor immediately if you have symptoms that you do not understand.

Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use ZOMIG.

In particular, this reaction may occur when they use ZOMIG together with certain types of antidepressants known as SSRIs or SNRIs.

Symptoms may include confusion, hallucinations, fast heart beat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea.

Call your doctor immediately if you have any of these symptoms after taking ZOMIG.What To Do If An Overdose Is Taken: If you have taken more medication than you have been told, contact either your doctor, hospital emergency department, or nearest poison control center immediately.

Storing Your Medicine: Keep your medicine in a safe place where children cannot reach it.

It may be harmful to children.

Store your medication away from light and moisture, and at a controlled room temperature.

If your medication has expired (the expiration date is printed on the treatment pack), throw it away as instructed.

If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to.

Throw away your medicine as instructed.

Be sure that discarded tablets are out of the reach of children.ZOMIG and ZOMIG-ZMT are registered trademarks of the AstraZeneca group of companies.Other brands mentioned are trademarks of their respective owners and are not trademarks of the AstraZeneca group of companies.

The makers of these brands are not affiliated with AstraZeneca or its products.© AstraZeneca 2007ZOMIG®(zolmitriptan) TabletsManufactured for:AstraZeneca Pharmaceuticals LPWilmington, Delaware 19850By: IPR Pharmaceuticals, Inc.Carolina, Puerto Rico 00984-1967ZOMIG-ZMT® (zolmitriptan) Orally Disintegrating Tablets Manufactured for:AstraZeneca Pharmaceuticals LPWilmington, Delaware 19850By: CIMA Labs, Inc.Eden Prairie, Minnesota 55344Rev 01/07SIC 30086–02



Clinical Trials:


Indications and Usage

ZOMIG is indicated for the acute treatment of migraine with or without aura in adults.ZOMIG is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS).

Safety and effectiveness of ZOMIG have not been established for cluster headache, which is present in an older, predominantly male population.
Migraine Disorders -- neural condition characterized by a severe recurrent vascular headache, usually on one side of the head, often accompanied by nausea, vomiting, and photophobia, sometimes preceded by sensory disturbances; triggers include allergic reactions, excess carbohydrates or iodine in the diet, alcohol, bright lights or loud noises.

Cluster Headache -- A primary headache disorder that is characterized by severe, strictly unilateral PAIN which is orbital, supraorbital, temporal or in any combination of these sites, lasting 15-180 min. occurring 1 to 8 times a day. The attacks are associated with one or more of the following, all of which are ipsilateral: conjunctival injection, lacrimation, nasal congestion, rhinorrhea, facial SWEATING, eyelid EDEMA, and miosis. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

Contraindications

ZOMIG should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease (see WARNINGS).Because ZOMIG may increase blood pressure, it should not be given to patients with uncontrolled hypertension (see WARNINGS).ZOMIG should not be used within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide.ZOMIG should not be administered to patients with hemiplegic or basilar migraine.Concurrent administration of MAO-A inhibitors or use of zolmitriptan within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated (see CLINICAL PHARMACOLOGY: Drug Interactionsand PRECAUTIONS: Drug Interactions).

ZOMIG is contraindicated in patients who are hypersensitive to zolmitriptan or any of its inactive ingredients.
Angina Pectoris -- The symptom of paroxysmal pain consequent to MYOCARDIAL ISCHEMIA usually of distinctive character, location and radiation. It is thought to be provoked by a transient stressful situation during which the oxygen requirements of the MYOCARDIUM exceed that supplied by the CORONARY CIRCULATION.

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Ischemia -- A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Myocardial Ischemia -- A disorder of cardiac function caused by insufficient blood flow to the muscle tissue of the heart. The decreased blood flow may be due to narrowing of the coronary arteries (CORONARY ARTERY DISEASE), to obstruction by a thrombus (CORONARY THROMBOSIS), or less commonly, to diffuse narrowing of arterioles and other small vessels within the heart. Severe interruption of the blood supply to the myocardial tissue may result in necrosis of cardiac muscle (MYOCARDIAL INFARCTION).

Coronary Artery Vasospasm -- Spasm of the large- or medium-sized coronary arteries.

Prinzmetal angina -- A clinical syndrome characterized by the development of CHEST PAIN at rest with concomitant transient ST segment elevation in the ELECTROCARDIOGRAM, but with preserved exercise capacity.

Cardiovascular Diseases -- Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

ZOMIG should only be used where a clear diagnosis of migraine has been established.Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events: ZOMIG should not be given to patients with documented ischemic or vasospastic coronary artery disease (see CONTRAINDICATIONS).

It is strongly recommended that zolmitriptan not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease.

The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best.

If, during the cardiovascular evaluation, the patient’s medical history, electrocardiographic or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, zolmitriptan should not be administered (see CONTRAINDICATIONS).

For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of zolmitriptan take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received zolmitriptan.

Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following ZOMIG, in these patients with risk factors.It is recommended that patients who are intermittent long-term users of ZOMIG and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use ZOMIG.The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to zolmitriptan.

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