MigraTen

Generic Name: acetaminophen, caffeine, and isometheptene (a SEET a MIN o fen, KAF een, EYE soe meth EP teen)
Brand Names: MigraTen, Prodrin

What is MigraTen?

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MigraTen contains a combination of acetaminophen, caffeine, and isometheptene. Acetaminophen is a pain reliever and a fever reducer.

Isometheptene and caffeine cause constriction (narrowing) of blood vessels (arteries and veins). This is important in the treatment of headaches.

MigraTen is used to treat tension (or muscle contraction) and vascular (migraine) headaches.

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

Important information about MigraTen

Do not take MigraTen if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. Do not use more of MigraTen than is recommended. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day.

When taking MigraTen do not use diet pills, stimulants, or any other cold, allergy, pain, migraine, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") and caffeine are contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen or caffeine. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or caffeine.

If you drink more than 3 alcoholic beverages per day, talk with your doctor before taking any medication that contains acetaminophen. Alcohol may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking MigraTen?

Do not take MigraTen if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), o tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. You should not take MigraTen if you are allergic to acetaminophen (Tylenol), caffeine, or isometheptene, or if you have:

• glaucoma;

• severe kidney disease;

• severe liver disease (especially cirrhosis);

• severe or uncontrolled high blood pressure; or

• heart disease.

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

• kidney or liver disease;

• a history of alcoholism;

• high blood pressure;

• blood circulation problems; or

• if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether MigraTen is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take MigraTen, tell your doctor if you are pregnant. This medication can pass into breast milk and may harm a nursing baby. Do not use this MigraTen without telling your doctor if you are breast-feeding a baby.

How should I take MigraTen?

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

Do not use more of MigraTen than is recommended. An overdose of acetaminophen can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day. Take the medicine with a full glass of water.

To treat migraine headache pain:

• Take the first dose of MigraTen as soon as you notice headache symptoms, or after an attack has already begun.

• If your headache does not completely go away, take 1 tablet or capsule every hour until you feel relief.

• Do not take more than a total of 5 tablets or capsules in any 12-hour period to treat a migraine.

• If you still have migraine symptoms after taking a total of 5 tablets or capsules, call your doctor.

To treat tension headache pain:

• Take the first dose of MigraTen as soon as you notice tension headache symptoms.

• If your headache does not completely go away, take 1 tablet or capsule every 4 hours until you feel relief.

• Do not take more than a total of 8 tablets or capsules in any 24-hour period to treat a tension headache.

• If you still have tension headache pain after taking a total of 8 tablets or capsules, call your doctor.

Acetaminophen may cause false urine glucose test results. Talk to your doctor if you have diabetes and you notice changes in glucose test results while taking MigraTen.

Store MigraTen at room temperature away from heat and moisture.

What happens if I miss a dose?

Since MigraTen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking MigraTen?

Avoid drinking alcohol. Alcohol may increase your risk of liver damage while taking acetaminophen. Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. They can add to the side effects of the caffeine in the medication.

When taking MigraTen do not use diet pills, stimulants, or any other cold, allergy, pain, migraine, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") and caffeine are contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen or caffeine. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or caffeine.

MigraTen side effects

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

• low fever with nausea, stomach pain, and loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Less serious MigraTen side effects may include:

• dizziness;

• mild skin rash;

• sleep problems (insomnia); or

• feeling nervous, irritable, or jittery.

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 MigraTen?

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

Where can I get more information?

• Your pharmacist can provide more information about MigraTen.

• Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2009 Cerner Multum, Inc. Version: 3.01. Revision Date: 06/22/2009 9:35:58 AM.

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