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RELPAX®(eletriptan hydrobromide)

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RELPAX® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

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

Limitations of Use...

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2 DOSAGE AND ADMINISTRATION

The maximum recommended single dose is 40 mg.

In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater...

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3 DOSAGE FORMS AND STRENGTHS

20 mg Tablets: Orange, round, convex shaped, film-coated, with "PFIZER" and "REP20" debossed.

40 mg Tablets: Orange, round, convex...

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4 CONTRAINDICATIONS

RELPAX is contraindicated in patients with:

  • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary...
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5 WARNINGS AND PRECAUTIONS

RELPAX should only be used where a clear diagnosis of migraine has been established.

5.1 Myocardial Ischemia, Myocardial Infarction, and...

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6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in other sections of the prescribing information:

  • Myocardial ischemia and myocardial infarction, and Prinzmetal's angina...
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7 DRUG INTERACTIONS

7.1 Ergot-Containing Drugs Including Other 5-HT1B/1D Agonists

Ergot-containing drugs have been reported to cause...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available human data on...

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10 OVERDOSAGE

The elimination half-life of eletriptan is about 4 hours [see Clinical Pharmacology (12.3)], therefore monitoring of patients after overdose with eletriptan...

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11 DESCRIPTION

RELPAX (eletriptan hydrobromide) tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Eletriptan binds with high affinity to 5-HT1B, 5-HT1D and 5-HT...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

The efficacy of RELPAX in the acute treatment of migraines was evaluated in eight randomized, double-blind placebo-controlled studies. All eight studies used 40 mg. Seven studies evaluated an 80 mg dose...

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16 HOW SUPPLIED/STORAGE AND HANDLING

RELPAX Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. RELPAX Tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing.

...
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17 PATIENT COUNSELING INFORMATION

See

Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospastic Reactions, and Cerebrovascular Events

Inform...

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Resources

RELPAX Savings Card
For questions regarding the RELPAX Savings Card, please call (800) 304-4825
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