SUMAREX 50/MG FC TAB 6/FC TAB

Indications

Approved Uses

Acute treatment of migraine attacks with or without aura in adults

Off-Label Uses

Not indicated for cluster headaches

Dosage & Administration

Dosing by Condition

Acute migraine (oral): 25 mg, 50 mg, or 100 mg as a single dose (50 mg commonly used); if there is partial response or the headache returns, a second dose may be taken ≥2 hours after the first; maximum 200 mg in 24 hours. If there is no response to the first dose, do not repeat for the same attack.

Initial Dose

50mg to 100mg orally at the onset of migraine symptoms.

Maintenance Dose

25 mg, 50 mg, or 100 mg as a single dose; if headache returns or partial response, second dose ≥2 hours after first; maximum 200 mg/24 hours

Maximum Dose

200 mg orally in 24 hours (max single oral dose 100 mg; may repeat once after ≥2 hours).

Children's Dosage

Not approved for children. Off-label use has been reported.

Dose Adjustment Notes

Hepatic impairment: in mild to moderate hepatic impairment, the maximum single oral dose is 50 mg; severe hepatic impairment is contraindicated. Renal impairment: no dosage adjustment generally required.

How to Take

Swallow the film‑coated tablet whole with water (do not crush or chew); take at the first sign of migraine headache; may be taken with or without food.

Side Effects

Common Side Effects

Tingling/paresthesia, flushing, sensations of warmth/cold, dizziness, fatigue/weakness, drowsiness/somnolence, nausea; chest/neck/throat/jaw tightness or pressure may occur.

Safety & Warnings

Warnings & Precautions

Use only for acute treatment after a clear migraine diagnosis (not prophylaxis); assess cardiovascular risk and consider CV evaluation before first use in patients with risk factors; avoid in unrecognized CAD; watch for chest/neck/jaw symptoms and BP elevation; risk of serotonin syndrome with serotonergic drugs; medication-overuse headache can occur (avoid frequent use, e.g., >10 days/month); use caution in mild-moderate hepatic impairment and in patients with seizure risk.

Age Restriction

Not approved/recommended for patients <18 years (safety and efficacy not established).

Drug Interactions

Interaction Severity

MAJOR/Contraindicated: MAO-A inhibitors (and within 2 weeks of stopping), ergotamine/ergot derivatives (avoid within 24 hours), other 5-HT1 agonists/triptans (avoid within 24 hours). MODERATE: SSRIs/SNRIs (serotonin syndrome risk).

Special Populations

Children

Not approved for children. Off-label use has been reported.

Elderly

Use with caution, as elderly patients are more likely to have decreased hepatic function and unrecognized coronary artery disease.

Kidney Impairment

No dosage adjustment required in renal impairment.

Liver Impairment

Mild to moderate impairment: Maximum single oral dose of 50mg. Severe impairment: Contraindicated.

Storage & Patient Advice

Missed Dose

Not applicable-used as needed for acute migraine; do not take an extra dose unless criteria for a second dose are met (≥2 hours after first and headache returns/partial response).

Stopping the Medicine

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

Overdose

Symptoms can include hypertension, tachycardia/arrhythmias, chest pain/ischemia, seizures/convulsions, tremor, and other neurologic/respiratory abnormalities; management is supportive with cardiovascular monitoring for at least 10 hours and urgent medical evaluation.

Patient Counseling

Take at the first sign of migraine (not for prevention). If no relief from the first dose, do not repeat for the same attack; if relief occurs then headache returns/partial response, a second dose may be taken ≥2 hours later. Do not exceed 200 mg in 24 hours. Avoid using within 24 hours of another triptan or ergot-containing medicine; do not use with MAO-A inhibitors (or within 2 weeks). May cause dizziness/drowsiness-use caution driving. Seek urgent care for chest/neck/jaw tightness, shortness of breath, or symptoms of stroke; limit use to avoid medication-overuse headache (e.g., frequent use >10 days/month).

Monitoring Requirements

No routine laboratory monitoring; assess cardiovascular risk and consider cardiac evaluation before first use in patients with multiple CV risk factors, and counsel to seek care for ischemic symptoms.

Pharmacology

Mechanism of Action

Selective 5‑HT1B/5‑HT1D receptor agonist that constricts dilated intracranial vessels and inhibits trigeminal neurotransmission/neuropeptide release to abort migraine.

Duration of Effect

Clinical effect is typically within a few hours; recurrence can occur within 24 hours (no fixed 24-hour duration of effect).

Bioavailability

Approximately 14% oral bioavailability.

Metabolism

Primarily hepatic metabolism by monoamine oxidase A (MAO-A) to an inactive indole acetic acid metabolite.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 50mg sumatriptan (as sumatriptan succinate)

Generic Availability

Yes

OTC Alternatives

OTC options for mild migraine pain include NSAIDs (e.g., ibuprofen, naproxen) and acetaminophen/paracetamol; there is no OTC triptan alternative for migraine-specific therapy in this context.

Pain Type

Migraine

Nsaid

No

Opioid

No

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