Drug monograph for the active ingredient in Maxalt

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

RIZATRIPTAN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Maxalt
• Maxalt-MLT

† Not commercially available in Canada.

Category

• Antimigraine

Description

Rizatriptan (rye-za-TRIP-tan) is used to treat severe migraine headaches. Many people find that their headaches go away completely after they take rizatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone.

Rizatriptan is not an ordinary pain reliever. It should not be used to relieve any kind of pain other than migraine headaches.

Rizatriptan may cause serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the good that it can do.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)
• Orally disintegrating tablets (U.S.)

Before Using This Medicine

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 rizatriptan, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rizatriptan or aspartame. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Rizatriptan has not been studied in pregnant women. However, in some animal studies, rizatriptan caused harmful effects to the fetus. These unwanted effects usually occurred when rizatriptan was given in amounts that were large enough to cause harmful effects in the mother. Rizatriptan crosses the placenta in animals.

Breast-feeding—It is not known whether rizatriptan passes into human breast milk. However, it has been shown to pass into the milk of nursing animals.

Children—There is no specific information comparing use of rizatriptan in children with use in other age groups.

Older adults—Rizatriptan has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking rizatriptan, it is especially important that your health care professional know if you are taking any of the following:

• Dihydroergotamine
• Ergotamine
• Methysergide
• Other 5-hydroxytryptamine agonists (naratriptan [e.g., Amerge], sumatriptan [e.g., Imitrex], zolmitriptan [e.g., Zomig])—Taking these medications with rizatriptan may increase the effects of rizatriptan

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking rizatriptan while you are taking or within 2 weeks of taking MAO inhibitors may cause sudden high body temperature, extremely high blood pressure, and severe convulsions; at least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other.

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

• Angina (chest pain) or
• Heart or blood vessel disease or
• High blood pressure (uncontrolled) or
• Kidney disease or
• Liver disease—The chance of side effects may be increased. Heart or blood vessel disease and high blood pressure sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use rizatriptan, your doctor may need to do some tests to make sure that you do not have any of these conditions

Proper Use of This Medicine

Take this medicine exactly as directed by your doctor . It will work only if taken correctly.

Do not use rizatriptan for a headache that is different from your usual migraines . Instead, check with your doctor.

To relieve your migraine as soon as possible, use rizatriptan as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using rizatriptan.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

Ask your doctor ahead of time about any other medicine you may take if rizatriptan does not work. After you take the other medicine, check with your doctor as soon as possible . Headaches that are not relieved by rizatriptan are sometimes caused by conditions that need other treatment.

If you feel much better after a dose of rizatriptan, but your headache comes back or gets worse after a while, you may use more rizatriptan. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed . Using too much rizatriptan may increase the chance of side effects.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur . Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of rizatriptan or other pain medicines that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing—The dose of rizatriptan 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 rizatriptan. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets and orally disintegrating tablets):
  • For migraine headaches:
    • Adults—5 or 10 mg as a single dose. If the migraine comes back after being relieved, another dose may be taken two hours after the last dose.
• Children—Use and dose must be determined by your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine, or after taking rizatriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Side Effects of This Medicine

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 as soon as possible if any of the following side effects occur:

More common

Chest pain; heaviness, tightness, or pressure in chest and/or neck; pounding heartbeat; sensation of burning, warmth, heat, numbness, tightness, or tingling; shortness of breath

Less common

Increased heartbeat; irregular heartbeat; slow heartbeat

Symptoms of overdose

Dizziness; fainting; headache, severe or continuing; sleepiness; slow heartbeat; vomiting

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Dizziness; dry mouth; hot flashes; nausea and/or vomiting; sleepiness; unusual tiredness or muscle weakness

Less common

Agitation; anxiety; blurred vision; chills; confusion; constipation; depression; diarrhea; difficulty swallowing; dry eyes; eye irritation; feeling of constant movement of self or surroundings; gas; headache; heartburn; heat sensitivity; inability to sleep; increased sweating; increased thirst; irritability; itching of the skin; muscle or joint stiffness, tightness, or rigidity; muscle pain or spasms; ringing or buzzing in ears; sudden large increase in frequency or quantity of urine; trembling of hands or feet; unusual feeling of well-being; warm and/or cold sensations

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

Developed: 11/11/1998

The information contained in the Thomson Healthcare products 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.

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Copyright © 2004 Thomson Healthcare Inc. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.

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