RELPAX® (eletriptan hydrobromide) Tablets Contraindications

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Prescribing Information

RELPAX^® (eletriptan hydrobromide) Tablets
Contraindications


	Return to the RELPAX Product Center

RELPAX Tablets should not be given to patients with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms, or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's variant angina, or other significant underlying cardiovascular disease (see WARNINGS).

RELPAX Tablets should not be given to patients with cerebrovascular syndromes including (but not limited to) strokes of any type as well as transient ischemic attacks (see WARNINGS).

RELPAX Tablets should not be given to patients with peripheral vascular disease including (but not limited to) ischemic bowel disease (see WARNINGS).

Because RELPAX Tablets may increase blood pressure, it should not be given to patients with uncontrolled hypertension (see WARNINGS).

RELPAX Tablets should not be administered to patients with hemiplegic or basilar migraine.

RELPAX Tablets should not be used within 24 hours of treatment with another 5- HT₁ agonist, an ergotamine-containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide.

RELPAX Tablets should not be used in patients with known hypersensitivity to eletriptan or any of its inactive ingredients.

RELPAX Tablets should not be given to patients with severe hepatic impairment.

PRINTER-FRIENDLY

RELPAX Safety Information

Important Safety Information

RELPAX is indicated for the acute treatment of migraine with or without aura in adults.

The maximum recommended single dose of RELPAX is 40 mg. The maximum daily dose should not exceed 80 mg.

RELPAX is generally well tolerated. Most adverse reactions are mild and transient.

The most common adverse events reported with RELPAX 40 mg compared with placebo were dizziness (6% vs 3%), somnolence (6% vs 4%), asthenia (5% vs 3%), and nausea (5% vs 5%).

As with other 5-HT₁ agonists, it is recommended that RELPAX not be given to patients with known or suspected coronary artery disease, uncontrolled hypertension, peripheral vascular disease, a history of cerebrovascular accident or transient ischemic attack, severe renal impairment, severe hepatic impairment, or concomitant administration of other 5-HT₁ agonists.

Potentially life-threatening serotonin syndrome may occur with triptans, particularly during combined use with SSRIs or SNRIs.

RELPAX is metabolized by the CYP3A4 enzyme; RELPAX does not inhibit or induce CYP3A4. RELPAX should not be used within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir.

Please see full prescribing information.

RELPAX^® (eletriptan HBr) Tablets

relpax_safety_information.htm