Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan Nasal Spray is a clear, pale yellow solution supplied in boxes of 6 nasal spray devices. Each unit dose supplies 20 mg of sumatriptan: Sumatriptan Nasal Spray, USP 20 mg (NDC 63629-8703-1) Store between 36°F and 86°F (2°C and 30°C). Protect from light.; Sumatriptan 20 mg Nasal Spray, #6 Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan Nasal Spray is a clear, pale yellow solution supplied in boxes of 6 nasal spray devices. Each unit dose supplies 20 mg of sumatriptan: Sumatriptan Nasal Spray, USP 20 mg (NDC 63629-8703-1) Store between 36°F and 86°F (2°C and 30°C). Protect from light.
- Sumatriptan 20 mg Nasal Spray, #6 Label
Overview
Sumatriptan Nasal Spray, USP contains sumatriptan, a selective 5-HT 1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure: The empirical formula is C 14 H 21 N 3 O 2 S, representing a molecular weight of 295.4. Sumatriptan is a white to pale yellow powder that is very slightly soluble in water. Each Sumatriptan Nasal Spray contains 5 or 20 mg of sumatriptan in a 100-microL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, benzalkonium chloride solution NF, edetate disodium dihydrate USP and purified water USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg Sumatriptan Nasal Spray, respectively.
Indications & Usage
Sumatriptan Nasal Spray 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 Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks. • Sumatriptan is not indicated for the prevention of migraine attacks. • Safety and effectiveness of Sumatriptan Nasal Spray 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. 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)
Dosage & Administration
The recommended adult dose of Sumatriptan Nasal Spray for the acute treatment of migraine is 5 mg, 10 mg, or 20 mg. The 20-mg dose may provide a greater effect than the 5-mg and 10-mg doses, but may have a greater risk of adverse reactions [see Clinical Studies (14) ] . The 5-mg and 20-mg doses are given as a single spray in 1 nostril. The 10-mg dose may be achieved by the administration of a single 5-mg dose in each nostril. If the migraine has not resolved by 2 hours after taking Sumatriptan Nasal Spray, or returns after a transient improvement, 1 additional dose may be administered at least 2 hours after the first dose. The maximum daily dose is 40 mg in a 24-hour period. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. • Single dose of 5 mg, 10 mg, or 20 mg of nasal spray. (2) • A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. (2) • Maximum dose in a 24-hour period: 40 mg. (2)
Warnings & Precautions
• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. (5.1) • Arrhythmias: Discontinue Sumatriptan Nasal Spray if occurs. (5.2) • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. (5.3) • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue Sumatriptan Nasal Spray if occurs. (5.4) • Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue Sumatriptan Nasal Spray if occurs. (5.5) • Medication overuse headache: Detoxification may be necessary. (5.6) • Serotonin syndrome: Discontinue Sumatriptan Nasal Spray if occurs. (5.7) • Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. (5.11) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina The use of Sumatriptan Nasal Spray is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Sumatriptan Nasal Spray. Some of these reactions occurred in patients without known CAD. Sumatriptan Nasal Spray may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan Nasal Spray. If there is evidence of CAD or coronary artery vasospasm, Sumatriptan Nasal Spray is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of Sumatriptan Nasal Spray in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of Sumatriptan Nasal Spray. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of Sumatriptan Nasal Spray. 5.2 Arrhythmias Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue Sumatriptan Nasal Spray if these disturbances occur. Sumatriptan Nasal Spray is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. 5.3 Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw may occur after treatment with Sumatriptan Nasal Spray and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of Sumatriptan Nasal Spray is contraindicated in patients with CAD and those with Prinzmetal’s variant angina. 5.4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue Sumatriptan Nasal Spray if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan Nasal Spray is contraindicated in patients with a history of stroke or TIA. 5.5 Other Vasospasm Reactions Sumatriptan Nasal Spray may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5‑HT 1 agonist, rule out a vasospastic reaction before using additional Sumatriptan Nasal Spray. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT 1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT 1 agonists has not been clearly established. 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Serotonin Syndrome Serotonin syndrome may occur with Sumatriptan Nasal Spray, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.4) ] . Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue Sumatriptan Nasal Spray if serotonin syndrome is suspected. 5.8 Increase in Blood Pressure Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT 1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with sumatriptan. Sumatriptan Nasal Spray is contraindicated in patients with uncontrolled hypertension. 5.9 Local Irritation Local irritative symptoms such as burning, numbness, paresthesia, discharge, and pain or soreness were reported in approximately 5% of patients in controlled clinical trials and were noted to be severe in about 1%. The symptoms were transient and generally resolved in less than 2 hours. Limited examinations of the nose and throat did not reveal any clinically noticeable injury in these patients. The consequences of extended and repeated use of Sumatriptan Nasal Spray on the nasal and/or respiratory mucosa have not been systematically evaluated in patients. 5.10 Anaphylactic/Anaphylactoid Reactions Anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Sumatriptan Nasal Spray is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan. 5.11 Seizures Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent. Sumatriptan Nasal Spray should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
Contraindications
Sumatriptan Nasal Spray is contraindicated in patients with: • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1) ] • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2) ] • History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4) ] • Peripheral vascular disease [see Warnings and Precautions (5.5) ] • Ischemic bowel disease [see Warnings and Precautions (5.5) ] • Uncontrolled hypertension [see Warnings and Precautions (5.8) ] • Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions ( 7.1 , 7.3 )] • Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ] • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.10) ] • Severe hepatic impairment [see Clinical Pharmacology (12.3) ] • History of coronary artery disease or coronary artery vasospasm (4) • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4) • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4) • Peripheral vascular disease (4) • Ischemic bowel disease (4) • Uncontrolled hypertension (4) • Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan) or of an ergotamine-containing medication. (4) • Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor. (4) • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen). (4) • Severe hepatic impairment (4)
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 Perrigo at 1-866-634-9120 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 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 Adverse Reaction Percent of Patients Reporting Sumatriptan Nasal Spray 5 mg (n = 496) Sumatriptan Nasal Spray 10 mg (n = 1,007) Sumatriptan Nasal Spray 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 2.8 2.5 3.8 2.4 Throat discomfort 0.8 1.8 2.4 0.9 Gastrointestinal Nausea and/or vomiting 12.2 11.0 13.5 11.3 Neurological Bad/unusual taste 13.5 19.3 24.5 1.7 Dizziness/vertigo 1.0 1.7 1.4 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.
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 ergot-type medications (like dihydroergotamine or methysergide) and Sumatriptan Nasal Spray within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by up to 7-fold. Therefore, the use of Sumatriptan Nasal Spray in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3) ] . 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, coadministration of Sumatriptan Nasal Spray and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. 7.4 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) ] .
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