Relpax Special Precautions

Serotonin Syndrome: Co-administration of eletriptan with other drugs having serotonergic activity, such as SNRIs and SSRIs, should be undertaken with caution due to reports of the development of serotonin syndrome in isolated cases of concomitant use of a triptan with other serotonergic drugs (see Interactions).
Eletriptan use with potent CYP3A4 inhibitors, e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, josamycin and protease inhibitors (ritonavir, indinavir and nelfinavir), is not recommended (see Interactions).
As with other 5-HT₁ receptor agonists, RELPAX should only be used where a clear diagnosis of migraine has been established. RELPAX is not indicated for the management of hemiplegic, ophthalmoplegic, or basilar migraine.
As with other 5-HT₁ receptor agonists, RELPAX should not be given for the treatment of "atypical" headaches, i.e. headaches which may be related to a possibly serious condition (stroke, aneurysm rupture) where cerebrovascular vasoconstriction may be harmful.
Cardiovascular evaluation prior to commencement of treatment with eletriptan is recommended for patients in whom cardiovascular disease is likely or in patients at risk of cardiovascular disease or patients at risk of coronary artery disease (CAD) (e.g. patients with hypertension, diabetes, smokers, men over 40 years of age, post-menopausal women and those with a strong family history of CAD). Patients in whom CAD is established should not be treated with eletriptan (see Contraindications).
Eletriptan has not been systematically evaluated for use in patients with heart failure. As with other 5-HT₁ receptor agonists, use in these patients is not recommended.
Within the clinical dose range, slight and transient increases in blood pressure have been seen with eletriptan doses of 60 mg or greater. The effect was more pronounced in renally impaired and elderly subjects. In a clinical pharmacology study, a single oral 80 mg dose was administered to normal (n=6) subjects and to subjects with severe (n=5), moderate (n=5) and mild (n=6) degrees of renal impairment. The maximum increase from baseline in subjects with renal impairment ranged from 14 to 17 mmHg for systolic blood pressure or 14 to 21 mmHg for diastolic blood pressure and was greater than that observed in the normal subjects (3-4 mmHg).
Excessive use of any anti-migraine medicinal product can lead to daily chronic headaches. Overuse of all triptans has been reported primarily in patients with chronic daily headache.
Effects on Ability to Drive and Operate Machinery: Migraine or treatment with some 5-HT₁ receptor agonists, including eletriptan, may cause drowsiness or dizziness in some patients. Therefore, caution is recommended in patients performing skilled tasks (e.g. driving or operating machinery) during the migraine attack and following administration of eletriptan.