Sumatriptan
Generic: SUMATRIPTAN
Basic Information
Manufacturer
Bionpharma Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e90b0eea-c424-4f00-98da-6ed6e80de1f6
Indications & Usage
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 established.
If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.
Sumatriptan is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.
(1) Not indicated for the prophylactic therapy of migraine attacks.
(1) Not indicated for the treatment of cluster headache.
(1)
Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.
If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.
Sumatriptan is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.
(1) Not indicated for the prophylactic therapy of migraine attacks.
(1) Not indicated for the treatment of cluster headache.
(1)
Adverse Reactions
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 and Precautions (5.1)] Arrhythmias [see Warnings and Precautions (5.2)] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] Cerebrovascular events [see Warnings and Precautions (5.4)] Other vasospasm reactions [see Warnings and Precautions (5.5)] Medication overuse headache [see Warnings and Precautions (5.6)] Serotonin syndrome [see Warnings and Precautions (5.7)] Increase in blood pressure [see Warnings and Precautions (5.8)] Hypersensitivity reactions [see Contraindications (4), Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Most common adverse reactions (≥2% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc.
at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug.
Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with sumatriptan tablets and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1.
Adverse Reactions Reported by at Least 2% of Patients Treated with Sumatriptan Tablets and at a Greater Frequency than Placebo Adverse Reaction Percent of Patients Reporting Sumatriptan Tablets 25 mg (n = 417) Sumatriptan Tablets 50 mg (n = 771) Sumatriptan Tablets 100 mg (n = 437) Placebo (n = 309) Atypical sensations 5 6 6 4 Paresthesia (all types) 3 5 3 2 Sensation warm/cold 3 2 3 2 Pain and other pressure sensations 6 6 8 4 Chest - pain/tightness/ pressure and/or heaviness 1 2 2 1 Neck/throat/jaw - pain/ tightness/pressure <1 2 3 <1 Pain - location specified 2 1 1 1 Other - pressure/tightness/ heaviness 1 1 3 2 Neurological Vertigo <1 <1 2 <1 Other Malaise/fatigue 2 2 3 <1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan injection.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to sumatriptan or a combination of these factors.
Cardiovascular Hypotension, palpitations.
Neurological Dystonia, tremor.
Reproductive System and Breast Disorders Breast pain [see Use in Specific Populations (8.2)] .
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc.
at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug.
Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with sumatriptan tablets and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1.
Adverse Reactions Reported by at Least 2% of Patients Treated with Sumatriptan Tablets and at a Greater Frequency than Placebo Adverse Reaction Percent of Patients Reporting Sumatriptan Tablets 25 mg (n = 417) Sumatriptan Tablets 50 mg (n = 771) Sumatriptan Tablets 100 mg (n = 437) Placebo (n = 309) Atypical sensations 5 6 6 4 Paresthesia (all types) 3 5 3 2 Sensation warm/cold 3 2 3 2 Pain and other pressure sensations 6 6 8 4 Chest - pain/tightness/ pressure and/or heaviness 1 2 2 1 Neck/throat/jaw - pain/ tightness/pressure <1 2 3 <1 Pain - location specified 2 1 1 1 Other - pressure/tightness/ heaviness 1 1 3 2 Neurological Vertigo <1 <1 2 <1 Other Malaise/fatigue 2 2 3 <1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan injection.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to sumatriptan or a combination of these factors.
Cardiovascular Hypotension, palpitations.
Neurological Dystonia, tremor.
Reproductive System and Breast Disorders Breast pain [see Use in Specific Populations (8.2)] .