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USP DI Vol. II - SUMATRIPTAN (Systemic)

SUMATRIPTAN (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Imitrex

In Canada?

  • Imitrex

Category

  • Antimigraine agent

Description

Sumatriptan (soo-ma-TRIP-tan) is used to treat severemigraine headaches. Many people find that their headaches go away completelyafter they take sumatriptan. Other people find that their headaches are muchless painful, and that they are able to go back to their normal activitieseven though their headaches are not completely gone. Sumatriptan often relievesother 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 kindof pain other than migraine headaches. This medicine is usually used for peoplewhose headaches are not relieved by acetaminophen, aspirin, or other painrelievers.

Sumatriptan injection is also used to treat cluster headaches.

Sumatriptan has caused serious side effects in some people, especiallypeople who have heart or blood vessel disease. Be sure that you discuss withyour doctor the risks of using this medicine as well as the good that it cando.

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

    Nasal
  • Nasal spray (U.S. and Canada)
    Oral
  • Tablets (U.S. and Canada)
    Parenteral
  • Injection (U.S. and Canada)


Before Using This Medicine

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 followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to sumatriptan. Also tell your health care professionalif 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 thefetus. Before taking this medicine, make sure your doctor knows if you arepregnant or if you may become pregnant.

Breast-feeding?Sumatriptan passes into human breast milk. Breast-feedingmothers should discuss the risks and benefits of this medicine with theirdoctors.

Children?This medicine has been tested in a limited numberof children aged 12 to 17 years, however use is not recommend in childrenyounger than 18 years of age.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional 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 healthcare 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 sumatriptanwhile you are taking or within 2 weeks of taking MAO inhibitors may causesudden high body temperature, extremely high blood pressure and severe convulsions;at least 14 days should be allowed between stopping treatment with one medicineand starting treatment with the other.

Other medical problems?The presence of other medicalproblems may affect the use of sumatriptan. Make sure you tell your doctorif you have any other medical problems, especially:

  • 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 causeany symptoms, so some people do not know that they have these problems. Beforedeciding whether you should use sumatriptan, your doctor may need to do sometests to make sure that you do not have any of these conditions.

Proper Use of This Medicine

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 asthe 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 fromoccurring. However, even if you do not use sumatriptan until your migrainehas been present for several hours, the medicine will still work.

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

If you are not much better in 1 or 2 hours after an injection of sumatriptanor after sumatriptan nasal solution, or in 2 to 4 hours after a tablet istaken, do not use any more of this medicine for the samemigraine. A migraine that is not relieved by the first dose of sumatriptanprobably will not be relieved by a second dose, either. Ask your doctor aheadof time about other medicine to be taken if sumatriptan does not work. Aftertaking the other medicine, check with your doctor as soon as possible. Headachesthat are not relieved by sumatriptan are sometimes caused by conditions thatneed 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 headachecomes back or gets worse after a while, you may use more sumatriptan. However, use this medicine only as directed by your doctor. Donot use more of it, and do not use it more often, than directed. Usingtoo 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 medicinesmay take several weeks to start working. Even after they do start working,your headaches may not go away completely. However, your headaches shouldoccur less often, and they should be less severe and easier to relieve. Thiscan reduce the amount of sumatriptan or pain relievers that you need. If youdo 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 ofwater. Do not break, crush, or chew the tablets beforeswallowing them.

For patients using sumatriptan injection:

  • This medicine comes with patient directions. Read them carefully before using the medicine, and check with yourhealth care professional if you have any questions.
  • Your health care professional will teach you how to inject yourselfwith the medicine. Be sure to follow the directions carefully.Check with your health care professional if you have any problems using themedicine.
  • After you have finished injecting the medicine, be sure to followthe precautions in the patient directions about safely discarding the emptycartridge and the needle. Always return the empty cartridge and needle totheir container before discarding them. Do not throw away the autoinjectorunit, because refills are available.
For patients using sumatriptan nasal solution:
  • This medicine comes with patient directions. Read them carefully before using the medicine, and check with yourhealth care professional if you have any questions.

Dosing?The dose of sumatriptan will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 intoone 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 asit 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 somerelief, or if the migraine comes back after being relieved, another dose maybe taken two hours after the last dose. Do not take morethan 200 mg in any twenty-four-hour period. If you are taking the tabletsafter using an injection, you may take single doses up to 100 mg a day withtwo hours between doses. Do not take more than 200 mg in a twenty-four-hourperiod.
      • 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, thesecond injection should not be given any sooner than one hour after the firstone. Do not use more than two 6-mg injections in a twenty-four-hourperiod (one day). However, some people may be directed to use no morethan 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 this medicine:

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

Precautions While Using This Medicine

Checkwith your doctor if you have used sumatriptan for three headaches, and havenot had good relief. Also, check with your doctor if your migraine headachesare worse, or if they are occurring more often, than before you started usingsumatriptan.

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

Some people feel drowsy or dizzy during or after a migraine, or after takingsumatriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else thatcould 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.Most side effects of sumatriptan are milder and occur less often with thetablets than with the injection. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

    Stop using this medicineand check with your doctor immediately if any of the following side effectsoccur:

      Rare

        Chest pain (severe); changes in skincolor on face; convulsions (seizures); fast or irregular breathing; puffinessor swelling of eyelids, area around the eyes, face, or lips; shortness of breath, troubled breathing, or wheezing

    Check with your doctor right away if any of the following side effects continuefor more than 1 hour. Even if they go away in less than 1 hour, check with your doctor before using any more sumatriptan ifany of the following side effects occur:

      Less common

        Chest pain (mild); heaviness, tightness,or pressure in chest and/or neck

    Also check with your doctor as soon as possibleif any of the following side effects occur:

      Less common

        Difficulty in swallowing; pounding heartbeat; skin rash, hives, itching, or bumps on skin

Other side effects may occur that usually do not need medical attention.Some of the following effects, such as nausea, vomiting, drowsiness, dizziness,and general feeling of illness or tiredness, often occur during or after amigraine, even when sumatriptan has not been used. Most of the side effectscaused by sumatriptan go away within a short time (less than 1 hour afteran injection or 2 hours after a tablet). However, check with your doctor ifany of the following side effects continue or are bothersome:

    More common

      Burning, discharge, pain, and/or soreness in the nose; burning, pain, or redness at place of injection; change in sense of taste; discomfortin jaw, mouth, tongue, throat, nose, or sinuses; dizziness; drowsiness; feeling of burning, warmth, heat, numbness, tightness, or tingling; feeling cold, ?strange,? or weak; flushing; lightheadedness; muscle aches, cramps, or stiffness; nausea or vomiting

    Less common or rare

      Anxiety; general feeling of illnessor tiredness; vision changes

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


Revised: 12/06/2004