ELETRIPTAN (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Relpax

? Not commercially available in Canada.

Category

• Antimigraine agent

Description

Eletriptan (el-ih-TRIP-tan) is used to treatsevere migraine headaches. Many people find that their headaches go away completelyafter they take eletriptan. 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. Eletriptan often relievesother symptoms that occur together with a migraine headache, such as nausea,vomiting, sensitivity to light, and sensitivity to sound.

Eletriptan 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.

Eletriptan has caused 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.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

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 eletriptan, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to eletriptan. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Eletriptan has not been studied in pregnant women.However, studies in animals have shown that eletriptan causes birth defectsand other problems. Before taking this medicine, make sure your doctor knowsif you are pregnant or if you may become pregnant.

Breast-feeding?Eletriptan passes into human breast milk. Cautionshould be used if you are breast feeding. If you are breast feeding, you shoulddiscuss the risks and benefits of this medicine with your doctor.

Children?Studies on this medicine have been done only ona small number of adolescents (11 to 17 years of age). However, eletriptanis not recommended for use in patients younger than 18 years of age.

Older adults?Many medicines have not been studiedspecifically in older people. Therefore, it may not be known whether theywork exactly the same way they do in younger adults. However, eletriptan hasbeen shown to remain in the body longer in elderly patients. It has also beenshown to increase blood pressure.

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. When you are taking eletriptan, it is especially importantthat your doctor and pharmacist know if you are taking any of the following:

• CYP3A4 inhibitors (clarithromycin [e.g., Biaxin], itraconazole [e.g.,Sporonox], ketoconazole [e.g., Nizoral], nefazodone [e.g., Serzone], nelfinavir[e.g., Viracept], ritonavir [e.g., Norvir], troleandomycin [e.g., Tao])?Donot use eletriptan within 72 hours of taking these medicines.

• 5-hydroxytryptamine agonists (almotriptan [e.g., Axert], frovatriptan[e.g., Frova], naratriptan [e.g., Amerge], rizatriptan [e.g., Maxalt], sumatriptan[e.g., Imitrex], zolmitriptan [e.g., Zomig]) or
• Ergot-containing or ergot-type medicines (bromocriptine [e.g., Parlodel],cabergoline [e.g., Dostinex], dihydroergotamine [e.g., D.H.E. 45, Migranal],ergoloid mesylates [e.g., Hydergine], ergonovine [e.g., Ergotrate], ergotamine[e.g., Bellergal, Cafergot, Wigraine], methylergonovine [e.g., Methergine],methysergide [e.g., Sansert], pergolide [e.g., Permax])?Taking eletriptanwithin 24 hours of taking these medicines may cause serious heart problems.

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

• Basilar migraine or
• Cerebrovascular syndrome, such as
• Stroke or
• Transient ischemic attack (TIA) or
• Coronary artery disease, such as
• Angina (chest pain) or
• Decreased blood flow to your heart or
• Heart attack, history of, or
• Other heart conditions or
• Hemiplegic migraine or
• High blood pressure, not treated or
• Liver problems, severe or
• Peripheral vascular disease, such as
• Bowel disease or
• Raynaud's syndrome?Eletriptan should not be used if you haveany of these conditions.

• Cerebrovascular event?Eletriptan should be used with cautionin patients who have an increased risk of bleeding in the brain, stroke, ortransient ischemic attack (TIA).

• Coronary artery disease, predisposition to?Eletriptan and similarmedicines may cause serious heart problems, especially if you have a predispositionfor heart problems.

• High blood pressure, treated?Eletriptan may cause high bloodpressure in patients already being treated for high blood pressure.

• Kidney problems?Eletriptan may cause increased blood pressurein patients who have kidney problems.

• Liver problems, mild or moderate?This could cause higher bloodlevels of eletriptan.

Proper Use of This Medicine

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

To relieve your migraine as soon as possible, use eletriptan as soon asthe headache pain begins.

You may get additional benefit from eletriptan if you lie down in a quiet,dark room after taking eletriptan.

Ask your doctor ahead of time about any other medicine you may take ifeletriptan does not work. After you take the other medicine,check with your doctor as soon as possible.

If you feel much better after a dose of eletriptan,but your headache comes back or gets worse after 2 or more hours, you mayuse one additional dose of eletriptan. Do not take a second tablet if thefirst did not help your headache at all. 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.

Dosing?The dose of eletriptan will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of eletriptan. If your dose is different,do not change it unless your doctor tells you to do so.

Follow your doctor's orders for preventing migraine.

• For oral dosage form (tablets):
  • For migraine headaches:
    • Adults?20 milligrams (mg) or 40 mg as a single dose. If themigraine comes back after being relieved, another dose be taken two hoursor more after the first dose. Do not take more than 2doses in any twenty-four-hour period
    • Children?Use and dose must be determined by your doctor.

Storage?To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Store away from heat and direct light.
• 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 may make headaches worse or cause new headaches to occur.People who suffer from severe headaches should probably avoid alcoholic beverages.

Call your doctor if your usual dose of eletriptan does not relieve threeconsecutive headaches, or the frequency or severity of headaches increases.

Call your doctor right away if you have severe chest pains or shortnessof breath.

This medicine may cause some people to become drowsy, dizzy, or less alertthan they are normally. Make sure you know how you reactto this medicine before you 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 medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

Less common

Chest pain or tightness; difficultyswallowing

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

More Common

Dizziness; lack or loss of strength; nausea; sleepiness orunusual drowsiness

Less common

Acid or sour stomach; belching; burning, crawling, itching, numbness, prickling, ?pinsand needles?, or tingling feelings; dry mouth; feeling of warmth; headache; heartburn; indigestion; redness of the face, neck, arms, and occasionallyupper chest; stomach soreness or discomfort; stomach upset or pain

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