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USP DI Vol. II - NARATRIPTAN (Systemic)

NARATRIPTAN (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Amerge

Category

  • Antimigraine agent

Description

Naratriptan (NAR-a-trip-tan) is used to treat severemigraine headaches. Many people find that their headaches go away completelyafter they take naratriptan. 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. Naratriptan often relievessymptoms that occur together with a migraine headache, such as nausea, vomiting,sensitivity to light, and sensitivity to sound.

Naratriptan is not an ordinary pain reliever. It should not be used torelieve any kind of pain other than migraine headaches.

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

Naratriptan is available only with your doctor's prescription, in the followingdosage form:

    Oral
  • 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 willdo. This is a decision you and your doctor will make. For naratriptan, thefollowing should be considered:

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

Pregnancy?Naratriptan has not been studied in pregnant women.However, in some animal studies, naratriptan caused harmful effects to thefetus. These unwanted effects usually occurred when naratriptan was givenin amounts that were large enough to cause harmful effects in the mother.

Breast-feeding?Although most medicines pass into breast milk insmall amounts, many of them may be used safely while breast-feeding. Motherswho are taking this medicine and who wish to breast-feed should discuss thiswith their doctor.

Children?This medicine has been tested in a limited numberof children 12 years of age or older. In effective doses, the medicine hasnot been shown to cause different side effects or problems than it does inadults.

Older adults?Although there is no specific informationcomparing the use of naratriptan in the elderly with use in other age groups,use of this medicine is not recommended in older adults.

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 headachesor depression.

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

  • Angina (chest pain) 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 naratriptan, 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 naratriptan for a headache that is different from your usual migraines. Instead, check with your doctor.

To relieve your migraine as soon as possible, use naratriptan 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 naratriptan.

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

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

If you feel much better after a dose of naratriptan, but your headachecomes back or gets worse after a while, you may use more naratriptan. 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 naratriptan 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 naratriptan or other pain medicines that you need.If you do not notice any improvement after several weeks of headache-preventingtreatment, check with your doctor.

Dosing?The dose of naratriptan will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of naratriptan. If your dose is different,do not change it unless your doctor tells you to do so.

  • For oral dosage form (tablets):
    • For migraine headaches:
      • Adults?1 or 2.5 mg as a single dose. If the migraine comesback after being relieved, another dose may be taken four hours after thelast dose. Do not take more than 5 mg in any twenty-four-hourperiod (one day).
        Patients with kidney or liver disease should take less than 2.5 mg as asingle dose once daily and should not exceed 2.5 mg in a twenty-four-hourperiod.
      • 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.
  • 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

Drinkingalcoholic 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 takingnaratriptan 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.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

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

      More common

        Chest pain (severe); heaviness, tightness,or pressure in chest, throat, and/or neck; sensationof burning, warmth, heat, numbness, tightness, or tingling

      Less common or rare

        Convulsions (seizures); irregular heartbeat; slow heartbeat

Other sideeffects may occur that usually do not need medical attention. Some of thefollowing effects, such as nausea, vomiting, drowsiness, dizziness, and generalfeeling of illness or tiredness, often occur during or after a migraine, evenwhen naratriptan has not been used. However, check with your doctor if anyof the following side effects continue or are bothersome:

    More common

      Dizziness; drowsiness; increased tiredness; nausea and/or vomiting

    Less common or rare

      Acne; anxiety; blurred vision; bone or skeletal pain; change in taste sensation; chills and/orfever; confusion; constipation; diarrhea; difficulty sleeping; eye problems; fainting; fluid imbalance; increasedthirst; itching of the skin; joint pain; mood or mental changes; muscle or joint stiffness, tightness, or rigidity; muscle pain or spasms; pounding heartbeat; restlessness; skin rash; stomach discomfort and/or pain; sudden large increase in frequency and amount of urine; trembling or shaking of hands or feet; unusual tirednessor weakness

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


Developed: 07/07/1998