|Dosage and administration||
– Hypersensitivity to sumatriptan or to any of the excipients of the medication.
|Warnings and precautions for use||
– Sumatriptan should only be used where there is a clear diagnosis of migraine.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
During sumatriptan therapy, dizziness, visual disturbance, drowsiness may occur; therefore, sumatriptan tablet should not be taken when driving a motor vehicle and operating machinery.
|Interactions, incompatibilities of medicine||
Sumatriptan should not be taken concurrently with:
|Undesirable effects (ADRs)||
Sumatriptan is generally well tolerated at recommended doses. Most adverse reactions were temporary, mild or moderate. Some common side effects are as follows:
|Overdose and management||
Overdose: Doses in excess of 400 mg orally were not associated with side effects other than those mentioned.
Sumatriptan is a selective 5-hydroxytriptamine (5-HT) receptor agonist. Its antimigraine effects are due to causing vasoconstriction of the arterioles and the arteriovenous anastomata of the carotid vascular bed. It has been proposed that the dilatation of these arterial vessels, and the formation of oedema here, is the underlying cause of a migraine attack in humans.
– Absorption: Following oral administration, sumatriptan is rapidly absorbed but incompletely and undergoes pre-systemic metabolism which results in low absolute oral bioavailability, approximately 14%. Peak plasma concentrations after oral administration are reached within 2 hours.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each tablet contains:
Sumatriptan . . . . . . . . . . . . . . . . . . . . . . 25 mg
(as Sumatriptan succinate . . . . . . . . . . . . 35 mg)
1 blister, 2 blisters of 6 film-coated tablets in a carton box.
For the treatment of acute migraine attacks.