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  • Imitrex
    / GSK


    Active Ingredient
    Sumatriptan (as succinate) 50 mg, 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    6 X 50 mg

    partial basket chart 9594 9042

    Film Coated Tablets

    6 X 100 mg

    partial basket chart 8417 9185

    Related information


    Dosage

    Sumatriptan should not be used prophylactically. It is advisable that sumatriptan be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered.
    Populations
    Adults: The recommended dose of oral sumatriptan fast disintegrating tablet is a single 50 mg tablet. Some patients may require 100 mg. If a patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. Sumatriptan fast disintegrating tablets may be taken for subsequent attacks. If the patient has responded to the first dose, but the symptoms recur a second dose may be given in the next 24 h, provided that not more than 300 mg is taken in any 24-h period. The tablets should be swallowed whole with water. Patients with swallowing difficulties may choose to disperse a tablet in a small amount of water before administration. Sumatriptan fast disintegrating tablets dispersed in water have a bitter taste.
    Children & Adolescents (under 18 years of age): Sumatriptan fast disintegrating tablets have not been studied in adolescents or children.
    Elderly (over 65 years of age): Experience of the use of standard sumatriptan tablets in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population, but until further clinical data are available, the use of sumatriptan fast disintegrating tablets in patients aged over 65 years is not recommended.


    Indications

    Relief of acute migraine attacks, with or without aura. Not to be used prophylactically. Injections: also for cluster headache.


    Contra-Indications

    Hypersensitivity, ischaemia heart disease, previous myocardial infarction, prinzmetal angina, uncontrolled hypertension, hemiplegic migraine, concurrent use of MAOI’S selective 5 Ht re-uptake inhibitors, lithium.


    Special Precautions

    Should only be used where there is a clear diagnosis of migraine. Recommended doses should not be exceeded. Patients in whom unrecognized cardiac disease is likely without a prior evaluation of underlying cardiovascular disease. Post-menopausal women, males over 40, patients with risk factors for coronary artery disease. Controlled hypertension. Impaired hepatic or renal function. Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold. Known hypersensitivity to sulphonamides.
    Pregnancy and lactation: Administration should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Caution should be exercised when administered to nursing mothers.


    Side Effects

    The most common side effect is taste. Following administration of the nasal spray mild, transient irritation or burning sensation in the nose or throat or epistaxis. Sensations of tingling, heat, heaviness, pressure or tightness of the chest and throat. Mild to moderate in intensity and transient: Flushing, dizziness, paraesthesia and feeling of weakness. Fatigue and drowsiness have been reported. Hypotension, bradycardia, tachycardia, transient increases in blood pressure. Visual disorders.
    See prescribing information for full details.


    Drug interactions

    There is no evidence of interactions with propanolol, flunarizine, pizotifen or alcohol.
    Prolonged vasospastic reactions have been reported with ergotamine. As these effects may be additive, 24 h should elapse before sumatriptan can be taken following any ergotamine containing preparation. Conversely, ergotamine containing preparations should not be taken until 6 h have elapsed following sumatriptan administration. An interaction may occur between sumatriptan and MAOIs and concomitant administration is contraindicated. There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs.


    Pregnancy and Lactation

    Pregnancy: Caution should be exercised by considering the expected benefit to the mother against possible risk to the foetus. Post-marketing data from multiple prospective pregnancy registries have documented the pregnancy outcomes in over 1,000 women exposed to sumatriptan. Although there is insufficient information to draw definitive conclusions, the findings have not detected an increase in the frequency of birth defects nor a consistent pattern of birth defects, amongst women exposed to sumatriptan compared with the general population.
    Lactation: It has been demonstrated that following subcutaneous administration sumatriptan is excreted into breast milk. Infant exposure can be minimised by avoiding breast feeding for 12 h after treatment.


    Overdose

    Symptoms and Signs: Doses up to 100 mg orally were not associated with side effects other than those mentioned.
    Treatment: If overdose occurs, the patient should be monitored for at least 10 h and standard supportive treatment applied as required.It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.


    Manufacturer
    GlaxoSmithKline Pharmaceuticals, Poland
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