Suma 10 mg/spray

INDICATIONS

Sumatriptan 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.

PHARMACOLOGY

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.

DOSAGE

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.

INTERACTION

Sumatriptan 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.

SIDE EFFECTS

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 & LACTATION

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.

PRECAUTIONS & WARNINGS

Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors
Arrhythmias: Discontinue Sumatriptan 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 Sumatriptan if occurs
Gastrointestinal ischemia and reactions, peripheral vasospastic reactions: Discontinue Sumatriptan if occurs
Medication overuse headache: Detoxification may be necessary
Serotonin syndrome: Discontinue Sumatriptan 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

THERAPEUTIC CLASS

5-HT Agonists

STORAGE CONDITIONS

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