In the U.S.—

In Canada—

• Antimigraine agent

Sumatriptan (soo-ma-TRIP-tan) is used to treat severe migraine headaches. Many people find that their headaches go away completely after they take sumatriptan. 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. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. IMITREX is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan injection is also used to treat cluster headaches.

Sumatriptan has caused 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 IMITREX as well as the good that it can do.

Sumatriptan is available only with your doctor's prescription, in the following dosage forms:

Nasal
• Nasal spray (U.S. and Canada)

Oral
• Tablets (U.S. and Canada)

Parenteral
• Injection (U.S. and Canada)

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

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

Pregnancy—Sumatriptan has not been studied in pregnant women. However, in some animal studies, sumatriptan caused harmful effects to the fetus. Before taking IMITREX, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Sumatriptan passes into human breast milk. Breast-feeding mothers should discuss the risks and benefits of IMITREX with their doctors.

Children—IMITREX has been tested in a limited number of children aged 12 to 17 years, however use is not recommend in children younger than 18 years of age.

Older adults—Use of sumatriptan in elderly patients is not recommended.

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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine, especially other prescription medicine for migraine headaches, or if you smoke tobacco.

When you are taking sumatriptan, it is especially important that your health care professional know if you are taking the following:

• 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 sumatriptan 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.

• Angina (chest pain) or
• Fast or irregular heartbeat or
• Heart or blood vessel disease or
• High blood pressure or
• Kidney disease or
• Liver disease or
• Stroke (history of)—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 sumatriptan, your doctor may need to do some tests to make sure that you do not have any of these conditions.

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

To relieve your migraine as soon as possible, use sumatriptan 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 sumatriptan. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.

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

If you are not much better in 1 or 2 hours after an injection of sumatriptan or after sumatriptan nasal solution, or in 2 to 4 hours after a tablet is taken, do not use any more of IMITREX for the same migraine. A migraine that is not relieved by the first dose of sumatriptan probably will not be relieved by a second dose, either. Ask your doctor ahead of time about other medicine to be taken if sumatriptan does not work. After taking the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by sumatriptan are sometimes caused by conditions that need other treatment. However, even if sumatriptan does not relieve one migraine, it may still relieve the next one.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, you may use more sumatriptan. However, use IMITREX only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan 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 sumatriptan or pain relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

For patients taking sumatriptan tablets:

• Sumatriptan tablets are to be swallowed whole with a full glass of water. Do not break, crush, or chew the tablets before swallowing them.

For patients using sumatriptan injection:

• IMITREX comes with patient directions. Read them carefully before using the medicine, and check with your health care professional if you have any questions.
• Your health care professional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your health care professional if you have any problems using the medicine.
• After you have finished injecting the medicine, be sure to follow the precautions in the patient directions about safely discarding the empty cartridge and the needle. Always return the empty cartridge and needle to their container before discarding them. Do not throw away the autoinjector unit, because refills are available.

• IMITREX comes with patient directions. Read them carefully before using the medicine, and check with your health care professional if you have any questions.

Dosing—

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

• For nasal dosage form (nasal solution):
  • For migraine headaches:
    • Adults—5 milligrams (mg) (1 spray into one nostril) or 10 mg (2 sprays in one nostril or 1 spray in each nostril) or 20 mg (1 spray into one nostril). If pain is not relieved, another spray (5 mg, 10 mg, or 20 mg) should not be used for the same migraine attack. Another spray (5 mg, 10 mg, or 20 mg) may be used for a migraine that occurs at a later time as long as it has been at least two hours since the last spray. Do not use more than 40 mg in a twenty-four-hour period (one day).
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For migraine headaches:
    • Adults—25, 50 or 100 mg as a single dose. If you get some relief, or if the migraine comes back after being relieved, another dose may be taken two hours after the last dose. Do not take more than 200 mg in any twenty-four-hour period. If you are taking the tablets after using an injection, you may take single doses up to 100 mg a day with two hours between doses. Do not take more than 200 mg in a twenty-four-hour period.
    • Children—Use and dose must be determined by your doctor.
• For parenteral dosage form (injection):
  • For migraine or cluster headaches:
    • Adults—One 6-mg injection. One more 6-mg dose may be injected, if necessary, if the migraine comes back after being relieved. However, the second injection should not be given any sooner than one hour after the first one. Do not use more than two 6-mg injections in a twenty-four-hour period (one day). However, some people may be directed to use no more than two 6-mg doses in a forty-eight-hour period (two days).
    • Children—Use and dose must be determined by your doctor.

Storage—

To store IMITREX:

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