3. Trileptal is an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Of the 2,257 births with first-trimester exposure to Sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]). Sumatriptan tablets are not recommended for use in patients younger than 18 years of age.Two controlled clinical trials evaluated Sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. Radiolabeled The pharmacokinetics of Sumatriptan in patients with severe hepatic impairment has not been studied. Contact a … Heart problems may lead to death.Stop taking Sumatriptan tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack:What should I tell my healthcare provider before taking Sumatriptan tablets?Tell your healthcare provider about all the medicines you take,What should I avoid while taking Sumatriptan tablets?What are the possible side effects of Sumatriptan tablets?Sumatriptan tablets may cause serious side effects.Keep Sumatriptan tablets and all medicines out of the reach of children.General information about the safe and effective use of Sumatriptan tablets.PHARMACIST: Dispense the patient information leaflet with the drug product.PHARMACIST: Dispense the patient information leaflet with the drug product.PHARMACIST: Dispense the patient information leaflet with the drug product.We comply with the HONcode standard for trustworthy health information - Trileptal is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Sumatriptan is not indicated for the prevention of migraine attacks. A few of these symptoms include confusion, hallucinations, diarrhea, and difficulty walking. Of the 415 women who redeemed prescriptions for Sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for Sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group. Patients were instructed to treat a moderate to severe headache. A myocardial infarction has been reported in a 14‑year‑old male following the use of oral Sumatriptan; clinical signs occurred within 1 day of drug administration. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. The Estimated Probability of Patients Taking a Second Dose of Sumatriptan Tablets or Other Medication to Treat Migraine over the 24 Hours following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3aRisk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events[see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)][see Contraindications (4), Warnings and Precautions (5.9)]Concomitant Use With Other Triptans or Ergot Medications[see Contraindications (4), Drug Interactions (7.1, 7.3)][see Warnings and Precautions (5.7), Drug Interactions (7.4)].What is the most important information I should know about Sumatriptan tablets?Sumatriptan tablets can cause serious side effects, including:Heart attack and other heart problems. In most … Plasma exposure at the lowest dose tested was approximately 2 times that in humans at the MRHD.The efficacy of Sumatriptan tablets in the acute treatment of migraine headaches was demonstrated in 3 randomized, double-blind, placebo-controlled trials. The components of opadry white used in the formulation of 100 mg tablets are hypromellose, titanium dioxide, and polyethylene glycol 400.Sumatriptan binds with high affinity to human cloned 5‑HTSignificant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension In healthy volunteers (N = 18), a trial evaluating the effects of Sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance.Transient increases in blood pressure observed in some patients in clinical trials carried out during Sumatriptan’s development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate.The mean maximum concentration following oral dosing with 25 mg is 18 ng/mL (range: 7 to 47 ng/mL) and 51 ng/mL (range: 28 to 100 ng/mL) following oral dosing with 100 mg of Sumatriptan.