Expiration date: 04/2022
The composition and form of issue:
Tablets, film-coated. 1 tablet contains:
sumatriptan (as succinate) 0.05 or 0.1 g
other ingredients: microcrystalline cellulose milk sugar potato starch sodium carboximetilkrahmal magnesium stearinovokisly oksipropiltselljuloza or oksipropilmetiltselljuloza PVP peg 4000 talc titanium dioxide
in a contour acheikova packing or in the Bank dark glass 2 or 10 PCs. in cardboard pack 1 pack or Bank.
Description pharmaceutical form:
Tablets, coated white or white with a grayish-cream tint in color, with a concave surface.
Interacts with 5-hydroxytryptamine receptor type 1 located in the smooth muscles of the walls of the blood vessels of the brain.
When administered sumatriptan is rapidly absorbed. 70% of the C Max in serum is reached after 45 min. Average absolute bioavailability is 14% due to presystemic metabolism and incomplete absorption. The degree of binding with plasma proteins is small (14-21%), T1/2 is 2 h. the Main metabolite (indelicacy analogue of sumatriptan) is excreted mainly with urine in the form of the free acid and its glucuronide conjugate.
Description pharmacological action:
Selectively narrows the blood vessels in the system of carotid arteries, inhibits the activity of the trigeminal nerve. Helps reduce the severity of pain in migraine. The clinical effect observed after 30 min.
Relief of acute migraine attacks (with aura and without it).
Individual drug intolerance, coronary artery disease, including angina, hemiplegic, basilar or oftalmologicheskiy forms of migraine, occlusive peripheral arterial disease, uncontrolled hypertension, stroke or transient ischemic stroke in history, liver failure, pregnancy, lactation, infancy, advanced age (over 65 years), concomitant use of ergotamine and its derivatives.
Caution — epilepsy (including any condition with a lowered epileptic threshold), hypertension (controlled), the simultaneous admission of MAO inhibitors and the period up to 14 days after their cancellation.
A sensation of tingling, heat, heaviness, pressure in various parts of the body, redness of the skin and mucous membranes, dizziness, fatigue, weakness, drowsiness, angina, hypotension, tachycardia, palpitations, transient increase in blood pressure, transient ECG changes of ischemic type, bradycardia, and in rare cases — Raynaud's syndrome is a feeling of abdominal discomfort, dysphagia, nausea, vomiting, ischemic colitis visual disturbances (diplopia, scotoma, decreased visual acuity) allergic reactions (rash, urticaria, itching, erythema, anaphylaxis) changes in liver function tests myalgia.
Unacceptable simultaneous reception of the preparations containing ergot alkaloids, lithium drugs, inhibitors of reverse neuronal capture of serotonin, and MAO inhibitors.
Method of application and dose:
Inside. Swallow the tablet whole with water. Adults single dose — 0.05 g (in some cases, 0.1 g), the maximum daily dose is 0.3 g. If the migraine symptoms do not disappear or shrink after taking the first dose receive a second dose for the relief of this attack should not be assigned. If symptoms have decreased or gone, and then again resumed, you can take a second dose for the next 24 hours Interval between doses no less than 2 hours
In case of overdose, the patient should be observed for 10 h, by conducting, if necessary, symptomatic therapy.
You should not use Amigrenin prophylactic. Before prescribing sumatriptan, patients with newly diagnosed or occurring atypical migraine to exclude other potentially dangerous neurological disease. It must be borne in mind that patients suffering from migraine there is a risk of stroke and transient disorders of cerebral circulation. Should not be prescribed to patients with presumed heart disease without prior examination. The first 2-3 doses should be under medical supervision (possible spasm of the coronary arteries). In patients with hypersensitivity to sulfonamides with the introduction of sumatriptan increases the risk of allergic reactions (cutaneous manifestations to anaphylactic shock). In the absence of effect of the first dose administration should clarify the diagnosis. Experience with the use of sumatriptan in patients over 65 years is limited (significant difference in pharmacokinetics compared to younger patients is not observed). Since the use of Amigrenin may cause drowsiness, use caution when driving and operating machinery.