RELPAX 40MG 6TAB

Indications

Approved Uses

Acute treatment of migraine attacks with or without aura in adults

Dosage & Administration

Dosing by Condition

Acute migraine (adults): 40 mg PO once at onset; if headache improves then returns, may repeat 40 mg after ≥2 hours; maximum 80 mg in 24 hours. (Some references allow 20 mg as an alternative initial dose for tolerability.)

Initial Dose

40mg orally at onset of migraine attack

Maintenance Dose

40mg per attack; second dose of 40mg may be taken if needed after 2 hours

Maximum Dose

80mg in any 24-hour period.

Children's Dosage

Not recommended for use in patients under 18 years of age.

Dose Adjustment Notes

Contraindicated with potent CYP3A4 inhibitors and within 72 hours of their use (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir); not recommended in severe hepatic impairment; no adjustment generally needed in mild-moderate hepatic impairment or renal impairment.

How to Take

Swallow the 40 mg film‑coated tablet whole with water at the onset of a migraine headache (as early as possible after pain starts); may be taken with or without food.

Side Effects

Common Side Effects

Asthenia/fatigue, dizziness, somnolence, nausea, paresthesia/tingling, dry mouth, dyspepsia/indigestion; flushing and chest/neck tightness/pressure can occur.

Side Effect Frequency

Common (≥1% to <10%): asthenia/fatigue, nausea, dizziness, somnolence, paresthesia, dry mouth, flushing, chest/neck/throat tightness or pressure sensations, dyspepsia; Uncommon (<1%): palpitations/tachycardia, hypertension, myalgia, tremor, anxiety.

Safety & Warnings

Contraindications

Ischemic heart disease or coronary artery vasospasm (Prinzmetal), history of stroke/TIA, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, hemiplegic or basilar migraine, severe hepatic impairment, hypersensitivity to eletriptan; use within 24 hours of another triptan or ergot-type drug; use within at least 72 hours of potent CYP3A4 inhibitors

Warnings & Precautions

Use only for acute treatment of confirmed migraine (not prophylaxis); perform cardiovascular evaluation in patients with risk factors and avoid in known cardiovascular disease; avoid use with other triptans/ergots within 24 hours and with potent CYP3A4 inhibitors within ≥72 hours; monitor for serotonin syndrome with serotonergic drugs; monitor blood pressure; medication-overuse headache can occur with frequent use (≈10+ days/month); not for hemiplegic or basilar migraine

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - avoid/contraindicated within ≥72 hours; other triptans/5‑HT1 agonists - avoid within 24 hours; ergotamine/ergot-type meds - avoid within 24 hours; SSRIs/SNRIs/other serotonergic drugs - serotonin syndrome risk; propranolol - modest increase in exposure (usually no adjustment but monitor)

Interaction Severity

MAJOR/Contraindicated: potent CYP3A4 inhibitors (avoid eletriptan during and for 72 hours after), other triptans or ergotamine-type drugs within 24 hours. MODERATE: SSRIs/SNRIs/other serotonergic drugs (serotonin syndrome risk-monitor), and other vasoconstrictive agents; propranolol may increase exposure but is usually not clinically prohibitive.

Food Interaction

May be taken with or without food; no clinically significant food restriction.

Special Populations

Pregnancy

Not adequately studied; animal studies show adverse effects; use only if potential benefit justifies potential risk to fetus.

Children

Not recommended for use in patients under 18 years of age.

Elderly

Standard adult dosing; use with caution due to increased risk of cardiovascular disease; cardiovascular assessment recommended before use

Kidney Impairment

No dose adjustment generally required in renal impairment, but use caution and monitor blood pressure (especially in severe renal impairment)

Liver Impairment

No dose adjustment is necessary for mild-to-moderate hepatic impairment. Not recommended for use in patients with severe hepatic impairment.

Storage & Patient Advice

Missed Dose

Not applicable (PRN use): take a dose when a migraine starts; if it helps and the headache returns, a second dose may be taken after ≥2 hours; do not exceed 80 mg in 24 hours.

Stopping the Medicine

Safe to stop anytime; used on an as-needed basis only

Patient Counseling

Take at onset of migraine (not for prevention). If the first dose provides no relief, do not take a second dose for the same attack; if it helps and the headache returns, you may take a second dose after ≥2 hours (max 80 mg/24 h). Avoid use within 24 hours of another triptan or any ergot medicine, and avoid eletriptan with strong CYP3A4 inhibitors (and for 72 hours after). May cause dizziness/somnolence-use caution driving. Seek urgent care for chest/neck/jaw pain, shortness of breath, weakness, or severe allergic symptoms; limit use to avoid medication-overuse headache (e.g., >10 days/month).

Monitoring Requirements

No routine labs required; assess cardiovascular risk before first use in patients with risk factors and monitor for blood pressure elevation and ischemic symptoms (chest/neck/jaw pain, shortness of breath).

Pharmacology

Mechanism of Action

Selective serotonin 5‑HT1B/5‑HT1D receptor agonist (with some 5‑HT1F activity), producing cranial vasoconstriction and inhibition of trigeminal neurotransmission/neuropeptide release to abort migraine.

Onset of Action

Onset of relief often begins within ~30-60 minutes; peak plasma concentration occurs around ~1.5 hours after a dose.

Duration of Effect

Clinical benefit may last up to 24 hours (recurrence can occur; hence allowance for a second dose).

Half-Life

Approximately 4 hours.

Bioavailability

Approximately 50%.

Metabolism

Primarily hepatic metabolism via CYP3A4; an N-demethylated metabolite is formed and has pharmacologic activity but contributes minimally to overall clinical effect.

Excretion

Primarily non-renal elimination: ~90% recovered in feces and ~10% in urine; <1% excreted unchanged in urine.

Protein Binding

Approximately 85% protein bound.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 40mg eletriptan as eletriptan hydrobromide

Pain Type

Migraine

Nsaid

No

Opioid

No

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