Sumatriptan

Selected tablets, conventional nasal spray, Tosymra and subcutaneous injection treat migraine with or without aura in adults. Reconsider the diagnosis if the first treated attack does not respond; exclude serious neurologic causes of atypical headache. They are not indicated for prevention.

Selected Imitrex injection also treats acute adult cluster headache; lower injection doses have not established efficacy for cluster attacks. Tablets/conventional nasal/Tosymra do not have established cluster indications. Pediatric and fixed sumatriptan/naproxen combination regimens, intranasal powder and other devices require separate labels.

After an initial Imitrex injection, its tablet label permits additional tablets up to 100 mg/day for returning migraine, with at least 2 hours between tablet doses. Tosymra permits a dose at least 1 hour after another sumatriptan product; this is not permission to combine every maximum. Use a clinician-written cross-route plan. In mild/moderate hepatic impairment, the oral maximum single dose is 50 mg; severe hepatic impairment is contraindicated across selected products. Do not apply the oral 50 mg rule to nasal/injection products.

Take the prescribed tablets orally. Injection is subcutaneous only, never IM or IV; train users with the specific STATdose device and appropriate sites. Conventional spray and Tosymra are single-use nasal devices: do not prime/test, spray into eyes or save for another dose. Follow each IFU, since positioning differs. The selected STATdose needle shield contains dry natural rubber, relevant to latex allergy.

Selected tablet/conventional spray labels have not established safety for treating an average of more than 4 headaches in 30 days. Acute-medication use on 10 or more days/month can worsen headache; seek reassessment of acute and preventive treatment. These are separate evidence/overuse concepts, not a claim that 4 treated attacks automatically cause overuse headache. Tablet and conventional-spray highlights condition repeat dosing on some initial response, while their full dose text also mentions unresolved attacks; the chart retains the response condition and requires a prescriber’s plan. No validated renal dose algorithm is supplied.

Selected labels contraindicate ischemic/vasospastic CAD; WPW or other accessory-pathway arrhythmias; stroke/TIA or hemiplegic/basilar migraine history; peripheral vascular or ischemic bowel disease; uncontrolled hypertension; triptan/ergot use within 24 hours; MAO-A inhibitor use concurrently or within 2 weeks; sumatriptan/product hypersensitivity; and severe hepatic impairment.

The selected U.S. labels have no boxed warning. Their vascular, interaction and hepatic contraindications and serious warnings still govern eligibility.

Tablets commonly produce tingling, warm/cold sensations, pressure/tightness, vertigo or fatigue. Injection adds injection-site reactions, flushing and numbness. Conventional nasal spray often causes unpleasant taste and nasal/throat discomfort; Tosymra adds application-site irritation, altered taste and throat irritation. Breast pain, palpitations, hypotension, dystonia and tremor appear in selected postmarketing reports. Do not directly compare trial rates across formulations.

Do not use another triptan or ergot-type medicine within 24 hours because additive vasospasm can occur. Product-specific repeat sumatriptan directions do not authorize taking an unrelated triptan during that window.

Concurrent use or use within the preceding 2 weeks is contraindicated. MAO-A inhibition increases sumatriptan exposure, markedly after oral treatment; route-specific PK differences do not remove the contraindication.

SSRIs, SNRIs and TCAs can increase serotonin-syndrome risk with triptans. Review all medicines, counsel about symptoms and assess promptly if they arise. The selected labels do not make every SSRI/SNRI combination a formal contraindication; MAO-A restrictions remain distinct.

Registry/epidemiologic data have not detected an increased frequency or consistent pattern of birth defects, but sample size limits definitive conclusions and animal studies showed developmental toxicity. Discuss maternal migraine and treatment risks. Sumatriptan enters milk after injection; selected labels lack adequate infant/milk-production outcome data. They describe avoiding breastfeeding for 12 hours after treatment to minimize infant exposure, with individualized feeding and treatment planning.

Selected products have unestablished pediatric safety/effectiveness and are not recommended under 18. Other pediatric migraine drugs or combination approvals must not be transferred to sumatriptan alone. Older-adult studies are limited; select doses cautiously and assess cardiovascular risk.

Oral mild/moderate hepatic impairment limits the single dose to 50 mg. Severe hepatic impairment is contraindicated. Moderate hepatic impairment did not significantly change injected-drug PK in the studied subjects; conventional nasal hepatic data and Tosymra hepatic PK are not directly established. Renal PK/validated adjustment evidence is insufficient; do not invent a numerical renal or dialysis dose.

Sumatriptan agonism at 5-HT1B/1D receptors on intracranial vessels and trigeminal sensory nerves is thought to produce cranial vasoconstriction and inhibit pro-inflammatory neuropeptide release. The same vasospastic potential underlies vascular contraindications.

Oral bioavailability is about 15%, conventional intranasal about 17%, and subcutaneous about 97%. Oral peak levels occur around 2 hours; selected 6 mg SC peaks around 12 minutes. Tosymra 10 mg has a median peak around 10 minutes and a distinct exposure profile. These are PK measurements, not guaranteed symptom-relief times or conversion ratios. Sumatriptan is metabolized mainly by MAO-A to inactive metabolites; half-life is roughly 2–2.5 hours, with urinary/fecal elimination.

Check diagnosis, BP, vascular contraindications, CV risk factors and interacting medicines. Track headache and acute-medication days, response and adverse effects. Arrange supervised first-dose/ECG assessment when indicated. Reassess need for prevention with frequent attacks; no universal routine lab schedule is supplied.

Keep a written product-specific rescue plan and headache diary. Seek urgent care for chest pain, dyspnea, focal weakness, speech changes, severe abdominal pain/bloody diarrhea, serious allergy or serotonin-syndrome symptoms. Dizziness/somnolence may impair tasks. Learn the specific nasal/injection technique, keep single-dose devices packaged until use and avoid test sprays. Discuss pregnancy and breastfeeding.

Obtain urgent medical assessment. The oral label calls for monitoring at least 12 hours or while symptoms persist; injection/conventional nasal/Tosymra labels specify at least 10 hours or while symptoms persist. Dialysis effects are unknown. These observation intervals are clinical guidance, not permission to observe a suspected overdose at home.

Appearance

White, triangular, film-coated

Debossing

IMITREX 50 · chevron on reverse

Example package

NDC 0173-0736-01 · blister of 9

Distributor

GlaxoSmithKline

Selected tablets contain 25/50/100 mg sumatriptan base as succinate. Selected STATdose cartridges contain 4 or 6 mg base in 0.5 mL (5.6/8.4 mg succinate). Selected Cipla conventional spray delivers 20 mg in one device; although its PI discusses lower doses, those devices are not established by the selected package. Tosymra delivers 10 mg in a single-dose unit. Intranasal powder, other injection devices and fixed combinations are outside this profile.

Selected tablets, injection and conventional spray:2–30°C; protect injection/conventional spray from light. Tosymra:20–25°C, excursions 15–30°C; do not refrigerate/freeze. Keep nasal devices sealed until use and do not prime/test them. Dispose of used injection sharps safely after device training; each cartridge/nasal device is single-dose.