sumatriptan succinate
Generic: SUMATRIPTAN SUCCINATE
Basic Information
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
9485cc30-15e8-4b53-876d-db317145474b
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan succinate 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 succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks.
Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.
Sumatriptan succinate is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
( 1 ) 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 succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks.
Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.
Sumatriptan succinate is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
( 1 ) 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 Sun Pharmaceutical Industries, Inc.
at 1-800-818-4555 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 succinate 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 Succinate Tablets and at a Greater Frequency than Placebo Adverse Reaction Percent of Patients Reporting Sumatriptan Succinate Tablets 25 mg (n = 417) Sumatriptan Succinate Tablets 50 mg (n = 771) Sumatriptan Succinate 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 succinate 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 succinate or a combination of these factors.
Cardiovascular Hypotension, palpitations.
Neurological Dystonia, tremor.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.
at 1-800-818-4555 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 succinate 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 Succinate Tablets and at a Greater Frequency than Placebo Adverse Reaction Percent of Patients Reporting Sumatriptan Succinate Tablets 25 mg (n = 417) Sumatriptan Succinate Tablets 50 mg (n = 771) Sumatriptan Succinate 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 succinate 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 succinate or a combination of these factors.
Cardiovascular Hypotension, palpitations.
Neurological Dystonia, tremor.