Sumatriptan
Generic: SUMATRIPTAN
Basic Information
Manufacturer
Lannett Company, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
NASAL
FDA Set ID
64efe12a-cc43-47e6-b3dc-21dab6ddae06
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan nasal spray, USP is 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 nasal spray, USP have not been established for cluster headache.
Sumatriptan 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, 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 nasal spray, USP have not been established for cluster headache.
Sumatriptan 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 )] Local irritation [see Warnings and Precautions ( 5.9 )] Hypersensitivity reactions [see Contraindications ( 4 ), Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (≥1% and >placebo) were burning sensation, disorder/discomfort of nasal cavity/sinuses, throat discomfort, nausea and/or vomiting, bad/unusual taste, and dizziness/vertigo.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc.
at 1-844-834-0530 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 worldwide placebo-controlled clinical trials in 3,419 patients with migraine.
Only treatment-emergent adverse reactions that occurred at a frequency of 1% or more in the group treated with sumatriptan nasal spray, USP 20 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1.
Adverse Reactions Reported by at Least 1% of Patients and at a Greater Frequency than Placebo in Controlled Migraine Clinical Trials Percent of Patients Reporting Adverse Reaction Sumatriptan Nasal Spray, USP 5 mg (n = 496) Sumatriptan Nasal Spray, USP 10 mg (n = 1,007) Sumatriptan Nasal Spray, USP 20 mg (n = 1,212) Placebo (n = 704) Atypical sensations Burning sensation 0.4 0.6 1.4 0.1 Ear, nose, and throat Disorder/discomfort of nasal cavity/sinuses Throat discomfort 2.8 0.8 2.5 1.8 3.8 2.4 2.4 0.9 Gastrointestinal Nausea and/or vomiting 12.2 11.0 13.5 11.3 Neurological Bad/unusual taste Dizziness/vertigo 13.5 1.0 19.3 1.7 24.5 1.4 1.7 0.9 The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients; use of prophylactic medications; or presence of aura.
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.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc.
at 1-844-834-0530 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 worldwide placebo-controlled clinical trials in 3,419 patients with migraine.
Only treatment-emergent adverse reactions that occurred at a frequency of 1% or more in the group treated with sumatriptan nasal spray, USP 20 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1.
Adverse Reactions Reported by at Least 1% of Patients and at a Greater Frequency than Placebo in Controlled Migraine Clinical Trials Percent of Patients Reporting Adverse Reaction Sumatriptan Nasal Spray, USP 5 mg (n = 496) Sumatriptan Nasal Spray, USP 10 mg (n = 1,007) Sumatriptan Nasal Spray, USP 20 mg (n = 1,212) Placebo (n = 704) Atypical sensations Burning sensation 0.4 0.6 1.4 0.1 Ear, nose, and throat Disorder/discomfort of nasal cavity/sinuses Throat discomfort 2.8 0.8 2.5 1.8 3.8 2.4 2.4 0.9 Gastrointestinal Nausea and/or vomiting 12.2 11.0 13.5 11.3 Neurological Bad/unusual taste Dizziness/vertigo 13.5 1.0 19.3 1.7 24.5 1.4 1.7 0.9 The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients; use of prophylactic medications; or presence of aura.
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.