Description
Release form
Sumamigraine. The tablets, coated with a pink film coating, are oblong, biconvex at a break – white.
Packing
2 pcs – blisters (1) – packs of cardboard.
Pharmacological action
Antimigraine drug. A specific selective agonist of serotonin 5HT1D receptors does not affect other subtypes of 5HT serotonin receptors (5HT2-5HT7). Serotonin 5HT1D receptors are located mainly in the blood vessels of the brain, their stimulation leads to a narrowing of these vessels. Sumatriptan reduces trigeminal sensitivity. Both of these effects underlie the anti-migraine effect of the drug.
The clinical effect is noted 30 minutes after ingestion of the drug.
Pharmacokinetics
Absorption
After taking the drug inside, sumatriptan is rapidly absorbed, and after 45 minutes in plasma reaches 70% of max. When taking the drug in a dose of 100 mg, Cmax averages 54 ng / ml. Oral bioavailability averages 14% due to presystemic metabolism and incomplete absorption.
Distribution of
Plasma protein binding is 14-21%.
Metabolism
Biotransformed under the influence of MAO type A. The main metabolite is the indole-acetic analog of sumatriptan, which does not have activity against serotonin 5HT1 and 5HT2 receptors.
Excretion of
T1 / 2 is 2 hours. The main metabolite of sumatriptan is excreted mainly in the urine as a free acid or glucuronide conjugate. Migraine attacks do not significantly affect the pharmacokinetics of sumatriptan taken orally.
Indications
Relief of migraine attacks with or without aura.
Contraindications
hypersensitivity to any component of Sumumigren
hemiplegic, basilar and ophthalmoplegic form of migraine
ischemic heart disease (including myocardial infarction, postinfarction cardiosclerosis, angina pectoris, and angina pectoris) suggesting the presence of coronary artery disease
occlusive peripheral vascular disease
stroke or transient ischemic attack (including a history of)
uncontrolled arterial hypertension
concomitant use with ergotamine or its derivatives (including metisegrid) against the use of Mrdlp or than 2 weeks after their cancellation
severe liver and / or kidney dysfunction
age up to 18 years and over 65 years of age (safety and efficacy not established)
pregnancy
lactation period.
Use in pregnancy and lactation
The use of sumatriptan is contraindicated in pregnancy. At the time of treatment should stop breastfeeding. In the case of taking the drug, breastfeeding is possible no earlier than after 24 hours.
Composition
1 coated tablet contains:
Active ingredients
Sumatriptan 50 mg.
Excipients
Lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, anhydrous colloidal silicon dioxide.
Shell composition
Hypromellose, macrogol 6000, talc, titanium dioxide, triethyl citrate, cochineal red varnish (E124).
Dosage and administration
Tablets are taken orally as a whole, washed down with water.
The recommended single dose is 50 mg (1 tab.), in some cases, the use of the drug in a higher dose of 100 mg may be required. If the symptoms of migraine do not disappear and do not decrease after taking the first dose, then the drug should not be prescribed again to stop the ongoing attack. The drug can be used to stop subsequent migraine attacks.
If symptoms have decreased or disappeared, and then resumed, you can take a second dose over the next 24 hours. The maximum dose of the drug is 300 mg for 24 hours.
Side effects of
Depending on the frequency of occurrence, the following groups of side effects are distinguished: very often (> 1/10)
often (> 1/100,
infrequently (> 1/1000,
rarely (> 1/10 000,
very rarely (
From the nervous system: often – dizziness, drowsiness, sensory disturbances, including paresthesia and hypesthesia, very rarely – convulsive attacks (in some cases they were observed in patients with a history of seizures or in conditions predisposing to the occurrence of seizures in some patients predisposing factors was not observed), tremor, dystonia, nystagmus, scotoma.
From the side of the organ of vision: very rarely – diplopia, flickering before the eyes, decreased visual acuity, partial transient loss of vision. that visual impairment may be associated with a migraine attack itself.
From the cardiovascular system: often – transient increase in blood pressure (observed shortly after taking sumatriptan), flashes very rarely – bradycardia, tachycardia, decrease in blood pressure, heart rhythm disturbances, transient ECG changes in ischemic type, myocardial infarction, coronary spasm arteries, angina pectoris, Raynaud’s syndrome.
From the digestive system: often – nausea, vomiting very rarely – ischemic colitis, dysphagia, a feeling of discomfort in the abdomen.
From the musculoskeletal system: often – a feeling of heaviness (usually transient, can be intense and occur in any part of the body, including the chest and throat) very rarely – stiff neck.
From the respiratory system: often – shortness of breath, mild, transient irritation of the mucous membrane or burning sensation in the nasal cavity or throat, nosebleeds.
Laboratory indicators: very rarely – slight changes in the activity of hepatic transaminases.
Allergic reactions: very rare – hypersensitivity reactions range from skin manifestations (rash, urticaria, itching, erythema) to cases of anaphylaxis.
Other: often – a feeling of heat or cold, pain, a feeling of constriction or heaviness (are transient and can occur in any part of the body, including the chest and throat), a feeling of weakness, a feeling of tiredness, are usually mild or moderate and are also transient . Transient intense pain and chest tightness may occur, extending to the neck.
Drug Interaction
No drug interaction of sumatriptan with propranolol, flunarizine, pizotifen and ethanol.
Long-term vascular spasm was observed with ergotamine. Sumatriptan can be prescribed no earlier than 24 hours after taking ergotamine-containing drugs, and ergotamine-containing drugs can be prescribed no earlier than 6 hours after sumatriptan.
Interaction between sumatriptan and MAO inhibitors is possible, their simultaneous use is contraindicated.
There are very rare reports from post-marketing surveillance of the development of serotonin syndrome (including mental disorders, autonomic lability and neuromuscular disorders) as a result of concomitant use of SSRIs and sumatriptan. The development of serotonin syndrome has also been reported on the background of the concomitant administration of tryptans with SSRIs.
Overdose
Ingestion of sumatriptan in a dose above 400 mg did not cause any additional side effects.
Treatment: in case of overdose, the patient should be observed for 10 hours, conducting symptomatic therapy as needed. There are no data on the effect of hemodialysis or peritoneal dialysis on plasma sumatriptan concentration.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.
Expiration
5 years.
Deystvuyuschee substances
sumatriptan
drugstore terms and conditions Prescription
dosage form
dosage form
tablets
Polpharma, Poland
