Dosage and administration	Dosage: Sumatriptan should not be used prophylactically. Sumatriptan is recommended as monotherapy for the treatment of an acute migraine attack. It is advisable that sumatriptan be given as early as possible after the onset of a migraine headache in adults. The initial recommended oral dose of sumatriptan is 50 mg tablet, dose less than 25 mg may be initially given dependent on patient‘s clinical condition. Doses of 50 mg-100 mg have shown to be more effective than placebo in clinical trials but 25 mg is statistically significantly less effective than 50 mg and 100 mg. Some patients may require 100 mg if dose of 50 mg is not effective. In case the symptoms recur, a second dose may be given provided that there is a minimum interval of two hours between the two doses. No more than 300 mg sumatriptan should be taken in any 24 hour period. Special population: – Children aged less than 10 years: The efficacy and safety of sumatriptan tablets have not been demonstrated in the clinical trials performed in children under 18 years of age. Therefore, the use of sumatriptan tablets in this age group is not recommended. – Elderly (over 65 years of age): Since experience of the use of sumatriptan tablets in patients aged over 65 years is limited, the use of sumatriptan in this age group is not recommended. Administration: Swallow tablets whole; do not crush or chew.
Contraindications	– Hypersensitivity to sumatriptan or to any of the excipients of the medication. – Sumatriptan should not be used for migraine prophylaxis or management of hemiplegic, basilar, or ophthalmoplegic migraine. – Myocardial infarction or ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease. – Cerebrovascular accident (CVA) or transient ischaemic attack (TIA). – Peripheral vascular disease (including colonic ischemia). – Uncontrolled hypertension. – Concurrent administration of monoamine oxidase inhibitors (Sumatriptan may be used after discontinuing MAOIs for at least 14 days). – Sumatriptan succinate tablets and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should sumatriptan succinate and another 5- HT agonist. – Severe hepatic failure.
Warnings and precautions for use	– Sumatriptan should only be used where there is a clear diagnosis of migraine. – Sumatriptan should not be used before cardiovascular examination in patients at risk of coronary artery disease (such as patients with hypertension, familial hypercholesterolemia, diabetes, heavy smokers, postmenopausal women and men over 40 years of age). – Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat. Where such symptoms are thought to indicate ischaemic heart disease; therefore, an appropriate evaluation should be carried out. – Sumatriptan should be given with caution in patients with mild controlled hypertension since transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients. – Sumatriptan should be used with caution in patients with impaired hepatic or renal function and a history of seizures. – Do not use sumatriptan for an abnormal headache since it may be a warning signal of brain injury, cerebral ischemic stroke or cerebral hemorrhage. Patients with migraine are at higher risk for these conditions. – Sumatriptan should not be given concomitantly with other drugs (see Interactions). – Shock or anaphylactic reactions sometimes may occur when taking sumatriptan (especially in patients with a history of allergy)
Recommendation for pregnancy and breastfeeding	Pregnancy: There are no controlled studies in pregnant women, so administration of sumatriptan should only be considered if the expected benefits to the mother are greater than any possible risk to the foetus. Lactation: Sumatriptan is excreted in human milk. Therefore, infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan succinate tablets.
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: – Ergotamine-containing preparations or its derivatives such as dihydroergotamine, methysergide (see Contraindications). – MAO-A inhibitors which reduce sumatriptan clearance (see Contraindications). – Selective serotonin reuptake inhibitors such as fluoxetine, fluvoxamine, paroxetine, sertraline (which may increase serotonin levels in the brain, increase serotonin-related side effects). In case of compulsory use of the above drugs, the doctor's supervision is required.
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: Clinical trials: Common, ADR > 1/10: Nervous system disorders: Dizziness, drowsiness, sensory disturbance (paraesthesia and hypoaesthesia). Vascular disorders: Transient increases in blood pressure arising soon after treatment, flushing. Respiratory: Dyspnoea. Gastrointestinal disorders: Nausea and vomiting occurred in some patients, but it is unclear if this is related to sumatriptan or the underlying condition. Musculoskeletal and connective tissue disorders: Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat). Body as a whole: Pain, sensations of heat or cold, pressure or tightness. Feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient). Study: Very rare, ADR <1/10000: Minor disturbances in liver function tests have occasionally been observed. Post marketing surveillance study: Very rare, ADR <1/10000: Immune system disorders: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylactic reactions. Nervous system disorders: Seizures, a history of seizures or concurrent conditions predisposing to seizures. Tremor, dystonia, nystagmus, scotoma. Eyes: Visual disorders, double vision, reduced vision, loss of vision (sometimes permanently). However, visual disorders may also occur during a migraine attack itself. Cardiac disorders: Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes. Vascular disorders: Raynaud's phenomenon, hypotension. Gastrointestinal disorders: Ischaemic colitis. Musculoskeletal and connective tissue disorders: Neck stiffness. Guidelines for ADR management: Drug-induced ADRs occur within 1 hour of ingestion, usually disappear within 1 hour. Drug-induced ADR incidence does not change or decrease with repeated sumatriptan, but with higher doses than recommended, the incidence of ADRs increases. Severe cardiac ADRs should be limited by avoiding sumatriptan for people with a history of cardiovascular disease.
Overdose and management	Overdose: Doses in excess of 400 mg orally were not associated with side effects other than those mentioned. Management: If overdose occurs, the patient should be monitored for at least 10 hours and standard supportive treatment applied as required. It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.
Pharmacodynamic properties	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.
Pharmacokinetic properties	– 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. – Distribution: Plasma protein binding is low (14-21%). – Metabolism: Sumatriptan is extensively metabolized in the liver primarily via monoamine oxidase A (MAO-A). – Elimination: The elimination half-life is approximately 2 hours. Most of a radiolabeled dose of sumatriptan excreted in the urine is the inactive metabolite indole acetic acid (IAA), or the IAA glucuronide. Sumatriptan and its metabolites also appear in the feces. A small amount of sumatriptan is excreted into breast milk.
Storage conditions, shelf-life, quality specification of the medicine	Storage conditions: Protect from humidity and light, below 30 degrees C. Shelf – life: 36 months from the manufacture date. Quality specification: In house specification.

SUTAGRAN®25

Related products

Login

SUTAGRAN^®25