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What is SUMATRIPTAN?
Sumatriptan Nasal Spray contains sumatriptan, a selective 5-HT 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 CHNOS, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is readily soluble in water and in saline.
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, 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.
What does SUMATRIPTAN look like?
What are the available doses of SUMATRIPTAN?
Nasal spray: 5 mg and 20 mg (, )
What should I talk to my health care provider before I take SUMATRIPTAN?
Pregnancy: Based on animal data, may cause fetal harm. ()
How should I use SUMATRIPTAN?
Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
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 .
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.
What interacts with SUMATRIPTAN?
Sorry No Records found
What are the warnings of SUMATRIPTAN?
Sorry No Records found
What are the precautions of SUMATRIPTAN?
Sorry No Records found
What are the side effects of SUMATRIPTAN?
Sorry No records found
What should I look out for while using SUMATRIPTAN?
Sumatriptan Nasal Spray is contraindicated in patients with:
What might happen if I take too much SUMATRIPTAN?
In clinical trials, the highest single doses of Sumatriptan Nasal Spray administered without significant reactions were 40 mg to 12 volunteers and 40 mg to 85 subjects with migraine, which is twice the highest single recommended dose. In addition, 12 volunteers were administered a total daily dose of 60 mg (20 mg 3 times daily) for 3.5 days without significant adverse reactions.
Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
The elimination half‑life of sumatriptan is approximately 2 hours , and therefore monitoring of patients after overdose with Sumatriptan Nasal Spray should continue for at least 10 hours or while symptoms or signs persist.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
How should I store and handle SUMATRIPTAN?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.Sumatriptan Nasal Spray 5 mg (NDC 0781-6524-86) and 20 mg (NDC 0781-6523-86) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20 mg, respectively, of sumatriptan.Store between 2°C and 30°C (36°F and 86°F). Protect from light.Sumatriptan Nasal Spray 5 mg (NDC 0781-6524-86) and 20 mg (NDC 0781-6523-86) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20 mg, respectively, of sumatriptan.Store between 2°C and 30°C (36°F and 86°F). Protect from light.
Chemical StructureNo Image found
Sumatriptan binds with high affinity to human cloned 5-HT receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5‑HT receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
Non-Clinical ToxicologySumatriptan Nasal Spray is contraindicated in patients with:
The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension.
Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
As the Lidocaine and Epinephrine Injections contain a vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dose-dependent hypertension and bradycardia with possible heart block.
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.
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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