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.