Description
Release form
Tablets, film-coated.
Packaging
2 pcs in a pack.
Pharmacological action of
Sumatriptan is a specific selective agonist of 5-HT1-serotonin receptors located mainly in the blood vessels of the brain and their stimulation leads to the narrowing of these vessels. Does not affect other subtypes of 5-HT-serotonin receptors (5-HT2-7). Activates trigeminal receptor sensitivity. The therapeutic effect usually occurs 30 minutes after administration.
Pharmacokinetics
After oral administration, it is rapidly absorbed. 70% of the maximum plasma concentration is reached after 45 minutes. Cmax in plasma is 54 ng / ml. Bioavailability – 14% (due to presystemic metabolism and incomplete absorption). Plasma protein binding is 14-21%.
Metabolized by oxidation with the participation of monoamine oxidase (mainly isoenzyme A) with the formation of metabolites, the main of which are the indole acetic analog of sumatriptan, which does not have pharmacological activity against 5-HT1-serotonin receptors, and its glucuronide. It is excreted by the kidneys, mainly in the form of metabolites.
Indications
Relief of migraine attacks with or without aura.
Contraindications
hemiplegic, basilar or ophthalmoplegic forms of migraine
coronary artery disease or the presence of symptoms suggesting its presence
myocardial infarction
pharmacologically uncontrolled heart disease and hypertension history)
severe dysfunction of the liver and kidneys
simultaneous administration with ergotamine or its derivatives and within 24 hours after their administration srdlk p use on the background of taking monoamine oxidase inhibitors or earlier, less than 2 weeks after discontinuation of these drugs
age 18 and older 65 years (efficacy and safety not established)
pregnancy
breastfeeding (breastfeeding is possible no earlier than 24 hours after taking the
drug congenital galactosemia, glucose / galactose malabsorption syndrome , congenital lactose deficiency
Caution: epilepsy (including any condition with a reduced epileptic threshold), pharmacologically controlled arterial hypertension, impaired liver or kidney function, yshennaya sensitivity to sulfonamides (introduction of sumatriptan may cause allergic reactions, the severity of which varies from cutaneous manifestations of anaphylaxis).
Special instructions
Not intended for the prevention of migraine (administration during a migraine aura before other symptoms occur may not prevent the development of a headache).
If there is no effect on the first dose, the diagnosis should be clarified. It must be borne in mind that in patients suffering from migraine, there is a risk of a stroke or transient cerebrovascular accident.
When prescribed during lactation, it is not recommended to breast-feed a baby within 24 hours after taking sumatriptan.
In patients with hypersensitivity to sulfonamides, the administration of sumatriptan has an increased risk of allergic reactions (from skin manifestations to anaphylactic shock).
Patients at risk from the cardiovascular system do not start therapy without preliminary examination (women in the postmenopausal period, men over the age of 40, people with risk factors for CHD).
Before prescribing sumatriptan to patients with newly diagnosed or atypically occurring migraines, other potentially dangerous neurological diseases should be excluded.
Experience with the use of sumatriptan in patients over 65 years of age is limited (there is no significant difference in pharmacokinetics compared with younger patients).
After taking sumatriptan, chest pain and tightness may occur. The pain can be intense and radiating to the neck. If there is reason to believe that these symptoms are a manifestation of coronary heart disease, it is necessary to conduct an appropriate examination.
Influence on the ability to drive vehicles and control mechanisms
During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
Active ingredient:
freeze-dried donor pig liver cells (Hepar suis) 0.2 g
Capsule shell:
gelatin
titanium pigment E171
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sumatriptan 100mg
Auxiliaries:
lactose,
calcium hydrogen phosphate,
magnesium stearate,
povidone.
Dosage and administration
Inside, the tablet should be swallowed whole, washed down with water. Treatment should begin as early as possible in case of a migraine attack. The recommended dose is 50 mg, if necessary 100 mg.
If the symptoms of migraine do not disappear and do not decrease after taking the first dose, then the drug is not used again to stop the same attack.
To stop subsequent seizures (if symptoms decrease or disappear, and then resume), you can take a second dose over the next 24 hours, provided that the interval between doses is at least 2 hours.
The maximum daily dose is 300 mg.
Side effects of
From the nervous system: often – dizziness, drowsiness, sensory disturbances, including parasthesia and decreased sensitivity.
From the cardiovascular system: often – a transient increase in blood pressure (observed shortly after taking the drug), “hot flashes.”
From the respiratory system and organs by a group of cells: often – dyspnea, lung, transient irritation of the mucous membrane or burning sensation in the nasal cavity or throat, nosebleeds.
From the gastrointestinal tract: often – nausea, vomiting.
From the musculoskeletal system and connective tissue: often – a feeling of heaviness (usually transient, can be intense and occur in any part of the body, including the chest and throat).
General and local reactions: often – pain, a feeling of cold or heat, a feeling of pressure or constriction (usually transient, can be intense and occur in any part of the body, including the chest and throat) weakness, fatigue (usually mild or moderate, transient).
Laboratory indicators: very rarely – slight deviations in liver function tests.
Drug Interactions
With simultaneous administration with ergotamine and ergotamine-containing drugs, prolonged vasospasm is possible.
Interaction between sumatriptan and MAO inhibitors is possible (decrease in the intensity of sumatriptan metabolism, increase in its concentration).
With the simultaneous use of sumatriptan and drugs from the group of selective serotonin reuptake inhibitors, weakness, hyperreflexion, and impaired coordination of movements may develop.
No interaction of sumatriptan with propranolol, flunirizin, pisotifen and ethanol was noted.
overdose
Symptoms: no adverse reactions other than those listed above are observed with up to 400 mg orally.
Treatment: monitoring the patient for 10 hours, symptomatic therapy.
Storage Conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Shelf life
2 years.
Deystvuyushtee substance
Sumatriptan
prescription pharmacy
vacation conditions
drugstore terms recipe
dosage form
tablets
Possible product names
Sumatriptan-OBL tab p / o 100mg N2
SUMATRIPTAN-OBL TAB. P.O. 100MG No. 2
SUMATRIPTAN-OBL TAB. P / O CAPTURE. 100MG No. 2
Sumatriptan-OBL tab. p.p.o. 100mg N2 Russia
Sumatriptan-OBL tablets are coated. 100 mg 2 pcs.
Obolensky AF Russian
