Sumatriptan-OBL pills p o. 100mg N2
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Active ingredients
Sumatriptan
Release form
Pills
Composition
Sumatriptan 100mg; Excipients: lactose, calcium phosphate, magnesium stearate, povidone.
Pharmacological effect
Sumatriptan is a specific selective agonist of 5-HT1-serotonin receptors, localized predominantly in the blood vessels of the brain and their stimulation leads to the narrowing of these vessels. It does not affect other 5-HT-serotonin receptor subtypes (5-HT2-7). Activates the sensitivity of the trigeminal receptor. The therapeutic effect usually occurs 30 minutes after administration.
Pharmacokinetics
After ingestion 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 oxylase (predominantly isoenzyme A) to form metabolites, the main ones being the indole acetic analogue of sumatriptan, which does not have pharmacological activity against 5-HT1-serotonin receptors, and its glucuronide. 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, ischemic heart disease or the presence of symptoms suggesting its presence, history of myocardial infarction, pharmacologically uncontrolled arterial hypertension, occlusive peripheral vascular disease, stroke or transient blood circulation, occlusive peripheral vascular disease, stroke or circulatory arterial hypertension, occlusive peripheral vascular disease, occlusion or arterial hypertension, occlusive peripheral vascular diseases impaired liver and kidney function; simultaneous administration with ergotamine or its derivatives and within 24 hours after their administration; more than 2 weeks after discontinuation of these drugs; age up to 18 and over 65 years old (efficacy and safety not established); pregnancy; breastfeeding (breastfeeding is possible no earlier than 24 hours after taking the drug; congenital galactosemia, glucose malabsorption syndrome / galactose, congenital lactose deficiency; With care: epilepsy (includingany condition with a reduced epileptic threshold), pharmacologically controlled hypertension, impaired liver or kidney function, increased sensitivity to sulfonamides (administration of sumatriptan can cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis).
Use during pregnancy and lactation
Contraindicated during pregnancy and during breastfeeding.
Dosage and administration
Inside, the pill should be swallowed whole with water. Treatment should begin as early as possible in the event 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 relieve the same attack. For relieving subsequent attacks (with reduction or disappearance of symptoms and then ) 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
On the part of the nervous system: often - dizziness, drowsiness, sensitivity disorders, including parasthesia and decreased sensitivity. From the cardiovascular system: often - a transient increase in blood pressure (observed soon after taking the drug), "flushes". From the respiratory system and organs cell group: often - dyspnea, lung, transient irritation of the mucous membrane or burning sensation in the nasal cavity or throat, nosebleeds. On the side of the gastrointestinal tract: often - nausea, vomiting. On the part of the musculoskeletal system and sole 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, feeling cold or heat, feeling pressure or contraction (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 - minor deviations of liver function tests.
Overdose
Symptoms: when taken orally up to 400 mg, no other adverse reactions other than those listed above are observed. Treatment: monitoring the patient for 10 hours, symptomatic therapy.
Interaction with other drugs
With the simultaneous administration of ergotamine and ergotamine-containing drugs, prolonged vasospasm is possible. Interaction between sumatriptan and MAO inhibitors is possible (decrease in the intensity of metabolism of sumatriptan, increase in its concentration). hyperreflexia and impaired coordination of movements. Sumatriptan and propranolol, flu Nirizine, pizothiphene and ethanol.
special instructions
It is not intended for the prevention of migraine (administration during a migraine aura before the onset of other symptoms may not prevent the development of headache). If there is no effect on the first dose, the diagnosis should be clarified. It must be borne in mind that patients with migraine, there is a risk of stroke or transient disorders of cerebral circulation. When prescribed during lactation, it is not recommended to breastfeed for 24 hours after taking sumatriptan. development of allergic reactions (from skin manifestations to anaphylactic shock). Patients at risk from the cardiovascular system do not start therapy without a preliminary body examinations (women in post-menopausal period, men over 40 years old, people with risk factors for IHD). Before the appointment of sumatriptan to patients with newly diagnosed or atypically proceeding migraine, other potentially dangerous neurological diseases should be excluded. (there is no significant difference in pharmacokinetics compared with younger patients). After sumatriptan, pain and chest 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 artery disease, it is necessary to conduct an appropriate examination. Impact on the ability to drive vehicles and control mechanisms. During the period of treatment, care must be taken when driving vehicles and occupying others.potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions.