Sumatriptan is a selective serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine attacks, with or without aura, in adults.

Limitations of Use:

• Should be used only when a definite diagnosis of migraine has been established.
• Not intended for the prevention (prophylaxis) of migraine attacks.
• Not indicated for the treatment of cluster headache.

Sumatriptan is a selective agonist of a vascular 5-hydroxytryptamine (5-HT1B/1D) receptor subtype. It has minimal affinity for other serotonin receptor subtypes and does not significantly interact with alpha- or beta-adrenergic, dopamine, muscarinic, or benzodiazepine receptors. The targeted 5-HT receptor subtype is present in cranial blood vessels, including the human basilar artery and the vasculature of the dura mater. Activation of these receptors leads to vasoconstriction, which is associated with relief of migraine symptoms. Additionally, studies suggest that sumatriptan stimulates 5-HT receptors located on peripheral terminals of the trigeminal nerve supplying cranial blood vessels. This action may further contribute to its antimigraine effects.

Sumatriptan nasal spray: Single-dose of 10 mg of nasal spray. The maximum dose in a 24 hour period is 30 mg; separate doses by at least one hour or as directed by the physician.

Sumatriptan tablets: In controlled clinical trials, single doses of 25, 50, or 100 mg of Sumatriptan tablets were effective for the acute treatment of migraine in adults. There is evidence that doses of 50 and 100 mg may provide a greater effect than 25 mg. There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg. Individuals may vary in response to doses of Sumatriptan tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events.

If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg. If a headache returns following an initial treatment with Sumatriptan Injection, additional single Sumatriptan Tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Use in children and adolescents: Sumatriptan is not recommended for use in patients younger than 18 years of age.

How to use the Nasal Spray

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine mist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows:

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid applying additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Sumatriptan nasal spray should not be used with ergot-containing drugs, monoamine oxidase-A (MAO-A) inhibitors, other 5-HT1 agonists, or selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) due to the risk of serious adverse reactions.

• History of coronary artery disease or coronary vasospasm
• Wolff-Parkinson-White syndrome or other cardiac conduction disorders
• History of stroke, transient ischemic attack (TIA), or hemiplegic/basilar migraine
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled hypertension
• Use of another 5-HT1 agonist or ergot-containing drug within the last 24 hours
• Use of MAO-A inhibitors within the past 2 weeks
• Hypersensitivity to sumatriptan (e.g., angioedema, anaphylaxis)
• Severe hepatic impairment

Common side effects include unpleasant taste, burning, numbness or tingling in the nose or throat, and runny or blocked nose after use. Rare side effects include anxiety, burning sensation, discomfort in the nasal cavity or throat, general weakness or fatigue, and visual disturbances.

Pregnancy Category C. Adequate and controlled studies in pregnant women are not available. Sumatriptan is excreted in breast milk; to reduce infant exposure, breastfeeding should be avoided for at least 12 hours after use.

• Cardiac ischemia/infarction and Prinzmetal’s angina: Cardiac evaluation is advised in high-risk patients
• Arrhythmias: Discontinue if occurs
• Chest, throat, neck or jaw discomfort: Evaluate for cardiac disease if high risk
• Cerebral hemorrhage or stroke: Discontinue if occurs
• Gastrointestinal ischemia and peripheral vasospasm: Discontinue if occurs
• Medication overuse headache: May require withdrawal
• Serotonin syndrome: Discontinue if symptoms appear
• Blood pressure increase: Risk of hypertensive crisis
• Hypersensitivity: Risk of angioedema or anaphylaxis
• Seizures: Use cautiously in epileptic patients
• Local irritation: Burning or abnormal taste may occur

No specific information is available regarding overdose of Sumatriptan 10 mg nasal spray.

5-HT Agonists

Store at 20°C–25°C. Do not refrigerate or freeze. Do not prime or test before use.