Label: SUMATRIPTAN tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 8, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS. SUMATRIPTAN tablets, for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosing Information - The recommended dose of sumatriptan tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg ...
  • 3 DOSAGE FORMS AND STRENGTHS
    25 mg Tablets: yellow colored, film coated, triangular biconvex debossed with “S” on one side and “102” on the other side. 50 mg Tablets: pink colored, film coated, triangular biconvex debossed ...
  • 4 CONTRAINDICATIONS
    Sumatriptan tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina - The use of sumatriptan tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings ...
  • 7 DRUG INTERACTIONS
    7.1 Ergot-Containing Drugs - Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a ...
  • 10 OVERDOSAGE
    Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without ...
  • 11 DESCRIPTION
    Sumatriptan tablets, USP contain sumatriptan succinate USP, a selective 5‑HT1B/1D receptor agonist. Sumatriptan succinate, USP is chemically designated as ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Sumatriptan binds with high affinity to human cloned 5‑HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - In carcinogenicity studies in mouse and rat, sumatriptan was administered orally for 78 and 104 weeks ...
  • 14 CLINICAL STUDIES
    The efficacy of sumatriptan tablets in the acute treatment of migraine headaches was demonstrated in 3 randomized, double-blind, placebo-controlled trials. Patients enrolled in these 3 trials were ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7436 - NDC: 50090-7436-0 9 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - Sumatriptan (sue-mah-TRIP-tan) Tablets, USP - What is the most important information I should know about sumatriptan tablets? Sumatriptan tablets can cause serious side ...
  • Sumatriptan
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  • INGREDIENTS AND APPEARANCE
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