RELPAX

What it is

RELPAX MIGRAINE is a tablet containing eletriptan hydrobromide equivalent to 40 mg eletriptan. The tablets are orange, round, convex, film-coated tablets, with "VLE" on one side and "REP40" on the other side.

Approved indications

— For the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.

Dosing overview

The recommended initial dose is 40 mg. The maximum single dose is 40 mg. If a second dose is required, it should not be taken within 2 hours of the initial dose. The maximum daily dose should not exceed 80 mg. RELPAX MIGRAINE 40 mg tablet should be taken as early as possible after the onset of migraine headache, but they are also effective if taken at a later stage. RELPAX MIGRAINE tablets should not be used prophylactically.

Key safety warnings

RELPAX MIGRAINE should be used only where a clear diagnosis of migraine has been made by a doctor. RELPAX MIGRAINE is not indicated for the management of hemiplegic, ophthalmoplegic, or basilar migraine. Patients with migraine that persist for longer than 24 hours should seek advice from a doctor. Patients whose migraine symptoms appear for the first time after age 50 should seek advice from their doctor as there may be a more serious underlying cause. Patients who experience four or more migraine attacks per month should be referred to a doctor for ongoing management. Within the clinical dose range, slight and transient increases in blood pressure have been seen with eletriptan doses of 60 mg or greater, with the effect more pronounced in renally impaired and elderly subjects. 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. Excessive use of any anti-migraine medicinal product can lead to daily chronic headaches; prolonged use of any type of pain killers for headaches can make migraine worse; and overuse of all triptans has been reported primarily in patients with chronic daily headache. Women with migraine who are taking the combined oral contraceptive pill have an increased risk of stroke and should seek medical advice from their doctor if migraine attacks started recently (within the last 3 months), migraine symptoms have worsened or they have migraine with aura.

Contraindications

Hypersensitivity to any component of the preparation. Severe hepatic impairment. Patients with uncontrolled hypertension; patients with confirmed coronary heart disease, including ischaemic heart disease (angina pectoris, previous myocardial infarction or confirmed silent ischaemia); patients with coronary artery vasospasm, objective or subjective symptoms of ischaemic heart disease or Prinzmetal's angina; patients with peripheral vascular disease; and patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). Administration of ergotamine, or derivatives of ergotamine (including methysergide) within 24 hours before or after treatment with eletriptan. Concomitant administration of other 5-HT₁ receptor agonists. Within 48 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, erythromycin, clarithromycin, amprenavir, ritonavir, indinavir, saquinavir, nelfinavir and nefazodone.

PBS listing

The 40 mg tablet is listed on the PBS with a restriction of restricted supply, with an ex-manufacturer price of A$12.68.

Regulatory history

RELPAX eletriptan hydrobromide 40 mg tablets were first listed on the ARTG on 2000-10-13. RELPAX MIGRAINE eletriptan hydrobromide 40 mg tablets represent a variant that was first listed on the ARTG on 2020-12-16.