Nomigran Tablet

Nomigran is a serotonin (5-HT1B/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.
• Not indicated for the prophylactic therapy of migraine attacks.
• Not indicated for the treatment of cluster headache.

Sumatriptan is an agonist for a vascular 5‑hydroxytryptamine receptor subtype (probably a member of the 5‑HT family) having only a weak affinity for 5‑HT , 5‑HT , and 5‑HT receptors and no significant affinity (as measured using standard radioligand binding assays) or pharmacological activity at 5‑HT, 5‑HT or 5‑HT receptor subtypes or at alpha‑adrenergic or beta‑adrenergic; dopamine; dopamine; muscarinic; or benzodiazepine receptors. The vascular 5‑HT receptor subtype that sumatriptan activates is present on cranial arteries in both dog and primate, on the human basilar artery, and in the vasculature of human dura mater and mediates vasoconstriction. This action in humans correlates with the relief of migraine headache. In addition to causing vasoconstriction, experimental data from animal studies show that sumatriptan also activates 5‑HT receptors on peripheral terminals of the trigeminal nerve innervating cranial blood vessels. Such an action may also contribute to the antimigrainous effect of sumatriptan in humans.

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 moist 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 to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Nomigran nasal spray is contraindicated with Ergot-Containing Drugs, Monoamine Oxidase-A Inhibitors, Other 5-HT1 Agonists and Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors.

• History of coronary artery disease or coronary vasospasm
• Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
• History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled hypertension
• Recent (within 24 hours) use of another 5 HT1 agonist (e.g., another triptan) or of an ergotamine containing medication
• Concurrent or recent (past 2 weeks) use of monoamine oxidase A inhibitor
• Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
• Severe hepatic impairment

Common side effects: Unusual or unpleasant taste in the mouth; pain, burning, numbness, or tingling in the nose or throat; runny or stuffy nose after using the nasal medicine. Rare side effects: Anxiety, burning sensation, discomfort of the nasal cavity and throat, general feeling of illness or tiredness & vision changes.

Pregnancy Category C. There are no adequate and well-controlled trials in pregnant women. Sumatriptan is excreted in human milk following subcutaneous administration. Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with Sumatriptan Tablets.

• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors
• Arrhythmias: Discontinue Nomigran if occurs
• 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
• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue Nomigran if occurs
• Gastrointestinal ischemia and reactions, peripheral vasospastic reactions: Discontinue Nomigran if occurs
• Medication overuse headache: Detoxification may be necessary
• Serotonin syndrome: Discontinue Nomigran if occurs
• Increase in blood pressure: Hypertensive crisis can occur
• Hypersensitivity reactions: Angioedema and anaphylaxis can occur
• Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold
• Local irritation: Burning and abnormal taste can occur

No specific data is available on the overdose of Nomigran 10 mg nasal spray.

5-HT Agonists

Store between 20°C-25°C temperature. Do not store in the refrigerator or freezer. Do not test before use