SUMAREX 100/MG FC TAB 6/FC TAB

Indications

Approved Uses

Acute treatment of migraine attacks with or without aura in adults (oral sumatriptan tablets).

Off-Label Uses

Safety and effectiveness for cluster headache have not been established

Dosage & Administration

Dosing by Condition

Acute migraine (adults, oral): 25 mg, 50 mg, or 100 mg once at onset; if symptoms recur or partial response occurs, may repeat after ≥2 hours; maximum 200 mg in 24 hours. A second dose should only be considered if some response to the first dose was observed.

Initial Dose

50mg to 100mg orally at onset of migraine attack

Maintenance Dose

Initial dose: 25 mg, 50 mg, or 100 mg once at onset. Second dose (if needed): at least 2 hours after first dose. Maximum 200 mg in 24 hours.

Maximum Dose

200 mg orally in 24 hours (e.g., 50-100 mg at onset; may repeat once after ≥2 hours if needed; do not exceed 200 mg/day).

Dose Adjustment Notes

Hepatic impairment: in mild to moderate impairment, do not exceed 50 mg as a single oral dose; severe hepatic impairment is contraindicated. Renal impairment: no dose adjustment generally required.

How to Take

Swallow tablet whole with water; take as soon as migraine symptoms begin; do not crush or chew

Side Effects

Common Side Effects

Tingling/paresthesia, flushing, dizziness, fatigue/asthenia, drowsiness/somnolence, nausea; chest/neck/throat/jaw tightness/pressure can occur (usually transient).

Safety & Warnings

Contraindications

Hypersensitivity to sumatriptan; ischemic coronary artery disease (including history of myocardial infarction) or coronary artery vasospasm (Prinzmetal’s angina); history of stroke or TIA; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; hemiplegic or basilar migraine; severe hepatic impairment; concomitant MAO-A inhibitor use or within 2 weeks of stopping an MAO-A inhibitor; use within 24 hours of ergotamine/ergot derivatives or another 5‑HT1 agonist (another triptan).

Warnings & Precautions

For acute treatment only (not prophylaxis); do not use for hemiplegic or basilar migraine; perform cardiovascular evaluation before use in patients with multiple cardiovascular risk factors and consider first-dose supervision; discontinue and evaluate if chest/neck/jaw tightness suggests ischemia; risk of medication-overuse headache with frequent use (commonly >10 days/month); caution in controlled hypertension, hepatic impairment (avoid severe), history of seizures, and when combined with serotonergic drugs due to serotonin syndrome risk.

Age Restriction

Not approved under 18 years.

Drug Interactions

Interaction Severity

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

Special Populations

Elderly

Use with caution, as elderly patients are more likely to have cardiovascular disease and decreased hepatic function. A cardiovascular evaluation should be considered prior to use.

Kidney Impairment

No adjustment needed.

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; take at onset of attack and follow repeat-dose limits if symptoms recur.

Stopping the Medicine

May be stopped at any time; no taper is required (use is PRN for acute migraine).

Patient Counseling

Take at the first sign of migraine (not for prevention). If no relief from the first dose, do not take a second dose for the same attack. If partial relief or headache returns, you may repeat after ≥2 hours. Do not exceed 200 mg in 24 hours. Seek urgent care for chest pain/tightness, shortness of breath, or stroke-like symptoms; avoid driving if drowsy/dizzy; avoid use with MAO inhibitors, ergots, or other triptans within 24 hours; limit frequent use to avoid medication-overuse headache.

Pharmacology

Mechanism of Action

Selective 5-HT1B/5-HT1D receptor agonist causing cranial vasoconstriction and inhibition of trigeminal neurotransmission/neuropeptide release to abort migraine.

Duration of Effect

Clinical effect is typically within ~2 hours; recurrence can occur within 24 hours (hence the option to repeat dosing), rather than a guaranteed effect lasting 24 hours.

Bioavailability

Approximately 15% oral bioavailability, primarily due to presystemic metabolism and partly due to incomplete absorption

Metabolism

Hepatic metabolism primarily by monoamine oxidase A (MAO-A) to an inactive indole acetic acid metabolite (major pathway).

Product Information

Available Dosage Forms

Film-coated tablet, subcutaneous injection, nasal spray

Composition per Dose

Each film-coated tablet: 100mg sumatriptan (as sumatriptan succinate)

Generic Availability

Yes

Pain Type

Migraine

Nsaid

No

Opioid

No

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