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Tosymra Generic Name & Formulations
Legal Class
Rx
General Description
Sumatriptan 10mg; per nasal spray.
Pharmacological Class
Selective 5-HT1B/1D receptor agonist.
How Supplied
Nasal spray (single dose)—6
Manufacturer
Generic Availability
NO
Mechanism of Action
Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT1B/1D 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.
Tosymra Indications
Indications
Acute treatment of migraine with or without aura.
Limitations of Use
Confirm diagnosis; reconsider if no response after treatment. Not for prevention of migraine attacks. Not for treatment of cluster headache.
Tosymra Dosage and Administration
Adult
≥18yrs: 10mg as single spray in one nostril. Reevaluate if no response. Max cumulative dose: 30mg in 24hrs with each dose separated by at least 1hr. May also be given at least 1hr following another sumatriptan product.
Children
<18yrs: not recommended.
Tosymra Contraindications
Contraindications
Ischemic coronary artery disease (CAD) (eg, angina, history of MI, silent ischemia). Coronary artery vasospasm (including Prinzmetal’s angina). Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. History of stroke or TIA. History of hemiplegic or basilar migraine. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. Within 24hrs of ergo-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT1 agonists. During or within 2 weeks of an MAO-A inhibitor. Severe hepatic impairment.
Tosymra Boxed Warnings
Not Applicable
Tosymra Warnings/Precautions
Warnings/Precautions
Avoid excessive use. Exclude underlying neurologic or cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with multiple risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD). Monitor BP, cardiovascular function in long-term intermittent use. Discontinue if serious arrhythmias or cerebrovascular events occur or if serotonin syndrome is suspected. Medication overuse headache. Peripheral or GI vascular ischemia and infarction following other 5-HT1 agonists. History, or risk of seizures. Elderly. Pregnancy. Nursing mothers: avoid for 12hrs after treatment.
Tosymra Pharmacokinetics
Elimination
Renal. Half-life: 2.44 ± 1.00 hours.
Tosymra Interactions
Interactions
Ergotamines, other 5-HT1 agonists, MAO-A inhibitors: see Contraindications. Increased risk of serotonin syndrome with SSRIs, SNRIs, tricyclics, or MAO inhibitors.
Tosymra Adverse Reactions
Adverse Reactions
Tingling, dizziness/vertigo, flushing, warm/hot/burning sensation, feeling of heaviness/tightness, pressure sensation, numbness, application site reaction, dysgeusia, throat irritation; rare: serious cardiac and cerebrovascular events (including fatalities), vision loss, hypertensive crisis, hypersensitivity reactions.
Tosymra Clinical Trials
See Literature
Tosymra Note
Not Applicable
Tosymra Patient Counseling
See Literature
