Sumatriptan Teva
Sumatriptan-Teva: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Sumatriptan-Teva
ATX code: N02CC01
Active ingredient: Sumatriptan (Sumatriptan)
Manufacturer: TEVA Pharmaceutical Enterprises, Ltd. (TEVA Pharmaceutical Industries, Ltd.) (Israel)
Description and photo update: 2020-17-01
Prices in pharmacies: from 107 rubles.
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Sumatriptan-Teva is an oral anti-migraine drug.
Release form and composition
Sumatriptan-Teva is available in the form of film-coated tablets:
- tablets 50 mg: oval, pink or pink with a yellowish tinge, with a dividing line on both sides and engraving "5" and "0" on one side; a white or almost white core is visible on the fracture;
- tablets 100 mg: oval, white or almost white, engraved with "100" on one side; a white or almost white core is visible at the fracture.
Tablets with a dosage of 50 mg and 100 mg are packed in blisters of 2, 6, 12 or 30 pcs., In a cardboard box 1 blister and instructions for the use of Sumatriptan-Teva.
Composition for 1 tablet:
- active substance: sumatriptan (in the form of sumatriptan succinate) - 50 mg or 100 mg;
- auxiliary components of the tablet core: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, croscarmellose sodium;
- film shell: for tablets 50 mg - Opadray II 33G23092 peach (titanium dioxide, macrogol-3000, hypromellose, triacetin, lactose monohydrate, dye iron oxide yellow, dye iron oxide red, dye iron oxide black); for tablets 100 mg - Opadray II 33G28707 white (titanium dioxide, macrogol-3000, hypromellose, triacetin, lactose monohydrate).
Pharmacological properties
Pharmacodynamics
Sumatriptan is a specific selective agonist of 5-hydroxytryptamine-1-like serotonin receptors (5HT1D), which are located primarily in the blood vessels of the brain. As a result of stimulation of these receptors, narrowing of the blood vessels occurs. The drug has no effect on serotonin receptors of other subtypes (5HT2-5HT7).
It has been established that the main mechanism of the onset of migraine is edema and / or expansion of these vessels. Experimental studies have shown that sumatriptan selectively narrows the carotid arteries that supply blood to intracranial and extracranial tissues, including the lining of the brain. At the same time, it does not significantly affect cerebral blood flow.
It has also been shown that the drug inhibits the activity of receptors located at the endings of the afferent fibers of the trigeminal nerve.
Sumatriptan-Teva eliminates photophobia and nausea associated with migraine attacks.
Pharmacokinetics
The drug is rapidly absorbed after oral administration. After 45 minutes, the plasma concentration of sumatriptan reaches 70% of the maximum. After taking a dose of Sumatriptan-Teva 100 mg, the maximum plasma concentration is about 54 ng / ml and is observed after approximately 2–2.5 hours. Due to incomplete absorption and first-pass metabolism, the absolute oral bioavailability is approximately 14%. About 14-21% of the active substance binds to plasma proteins, and Vd (total volume of distribution) is on average 170 l (or 2.4 l / kg).
Metabolism occurs mainly under the influence of the isoenzyme A monoamine oxidase (MAO). As a result, several metabolites are formed, the main of which is the inactive indoleacetic analogue of sumatriptan, as well as its glucuronide.
T 1/2 (half-life) is from 2 to 2.5 hours. Clearance from plasma is on average 1160 ml / min, and renal clearance is 260 ml / min. After taking Sumatriptan-Teva orally, extrarenal clearance is about 40%. The main part of sumatriptan is excreted by the kidneys as metabolites. No more than 3% is excreted through the intestines.
Indications for use
Sumatriptan-Teva is used to relieve migraine attacks with or without aura.
Contraindications
Absolute:
- basilar, ophthalmoplegic and hemiplegic forms of migraine;
- severe renal and / or hepatic impairment;
- coronary heart disease (including Prinzmetal's angina pectoris, postinfarction cardiosclerosis and myocardial infarction);
- uncontrolled arterial hypertension;
- transient disorders of cerebral circulation or stroke (including a history);
- the presence of risk factors for the development of coronary heart disease;
- peripheral vascular occlusive disease;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
- co-administration with MAO inhibitors, as well as a period up to 2 weeks after their cancellation;
- simultaneous use with triptans / agonists of 5HT1-serotonin receptors or ergot alkaloids and derivatives of ergot alkaloids;
- lactation period;
- children and adolescents under 18 years of age;
- advanced age over 65;
- hypersensitivity to the main or auxiliary components of the drug.
Relative (Sumatriptan-Teva is used with caution):
- mild to moderate impairment of kidney and / or liver function;
- controlled arterial hypertension;
- organic lesions of the brain;
- epilepsy or a history of indications of other conditions that are accompanied by a decrease in the seizure threshold;
- period of pregnancy.
Sumatriptan-Teva, instructions for use: method and dosage
The tablets are taken orally, swallowed whole and washed down with plenty of water.
At the beginning of treatment, a dose of Sumatriptan-Teva 50 mg is recommended. If necessary, it is increased to 100 mg.
If, after taking the first dose of the drug, the symptoms of migraine do not decrease and do not disappear, you should not take the second dose in order to stop the ongoing migraine attack. Subsequent migraine attacks (if symptoms disappear or diminish, and then resume) can be stopped by taking a second dose of Sumatriptan-Teva over the next 24 hours, but only if the interval between doses is at least 2 hours.
The maximum oral dose of Sumatriptan-Teva is 300 mg per day.
Side effects
- digestive system: often - vomiting, nausea, a slight increase in the activity of liver enzymes; very rarely - abdominal discomfort, diarrhea, ischemic colitis;
- respiratory system: often - a burning sensation or transient irritation of the mucous membrane of the nasal cavity / throat, shortness of breath;
- cardiovascular system: very rarely - arrhythmia, coronary vasospasm, bradycardia, decreased blood pressure, tachycardia, flushing, transient signs of myocardial ischemia on the ECG, Raynaud's syndrome, transient increase in blood pressure at the beginning of therapy, myocardial infarction;
- nervous system: often - drowsiness, dizziness, hypesthesia and paresthesia; very rarely - the appearance of seizures (more often if there is information about a history of seizures); frequency unknown - anxiety, dystonia, tremor;
- sense organs: infrequently - nystagmus, decreased visual acuity, flashing before the eyes of "flies", double vision, scotoma; very rarely - partial transient loss of vision (it should be borne in mind that visual disturbances can be caused by the migraine attack itself);
- musculoskeletal system: often - muscle pain; frequency unknown - joint pain, stiff neck;
- allergic reactions: very rarely - itchy skin, urticaria, erythema, skin rash, anaphylactic reactions;
- other reactions: often - nosebleeds, feeling tired and / or weak, tingling, pain, feeling of heaviness or tightness, feeling of heat; frequency unknown - hyperhidrosis.
Overdose
Oral ingestion of sumatriptan in a dose of more than 400 mg did not cause any unusual adverse reactions other than the adverse events listed above.
In case of an overdose, the patient is washed the stomach and given activated charcoal. Treatment is symptomatic. The patient must remain under observation for at least 10 hours.
There are no data on the effect of peritoneal dialysis and hemodialysis on the plasma concentration of sumatriptan.
special instructions
Sumatriptan-Teva is not intended to prevent migraine attacks. The drug is taken only in cases where the diagnosis of migraine is accurately established.
The tablet should be taken as early as possible after the onset of a migraine attack, but sumatriptan is equally effective regardless of the stage of the attack. If there is no effect after taking the first dose, the diagnosis must be clarified. In migraine with atypical symptoms, as well as in patients who have not previously been diagnosed with migraine, the likelihood of other potentially dangerous neurological diseases should be excluded. It is recommended to take into account the fact that patients with migraine have a risk of cerebrovascular complications (including transient cerebrovascular accidents or stroke).
Before prescribing Sumatriptan-Teva, cardiovascular diseases should be excluded, especially in those at risk (men over 40 years old, women in the postmenopausal period and patients with risk factors for coronary heart disease).
Very rarely, after taking sumatriptan, transient pain and chest tightness may appear. Sometimes the pain is intense and spreads to the neck (pharynx) area. If you suspect coronary heart disease, the drug should be discontinued and an appropriate examination should be carried out.
Sumatriptan-Teva is used with caution in mild and moderate impairment of liver or kidney function, since these diseases can significantly alter the absorption, metabolism and excretion of the drug.
In persons with hypersensitivity to sulfonamides, taking sumatriptan can lead to the development of allergic reactions of varying severity (from mild skin manifestations to severe anaphylactic reactions). Cross-sensitivity has not been established, but care should be taken.
It is not recommended to abuse drugs that are intended to relieve migraine attacks, because in sensitive patients, headaches may worsen. In such cases, the question should be raised about the abolition of Sumatriptan-Teva.
Influence on the ability to drive vehicles and complex mechanisms
Sumatriptan can cause drowsiness, therefore, during the period of its use, care must be taken when driving vehicles and performing other work that requires a high concentration of attention and a quick reaction.
Application during pregnancy and lactation
Data on the use of the drug during pregnancy are very limited. In pregnant women, Sumatriptan-Teva is used only in cases where the expected benefit to the mother outweighs the possible risk to the fetus.
Sumatriptan Teva is contraindicated during lactation. Breastfeeding can be started no earlier than 24 hours after the end of the intake of sumatriptan.
Pediatric use
Sumatriptan-Teva should not be administered to children and adolescents under the age of 18.
With impaired renal function
Sumatriptan Teva is contraindicated in severe renal failure.
For mild to moderate renal impairment, tablets are used with caution.
For violations of liver function
Sumatriptan-Teva is not indicated for patients with severe hepatic impairment.
In persons with mild to moderate liver dysfunction, the use of the drug requires caution.
Use in the elderly
Experience with the use of an anti-migraine drug in persons over 65 years of age is limited. The pharmacokinetic characteristics of sumatriptan in patients of this population do not differ significantly from those in younger patients. But it is recommended to start taking Sumatriptan-Teva for elderly patients after completing additional clinical studies.
Drug interactions
Sumatriptan should not be used simultaneously with ergot alkaloids and their derivatives, as well as other 5HT1-serotonin receptor / triptan agonists, since there is a high risk of ischemia and prolonged vasospasm. Sumatriptan-Teva is used no earlier than 24 hours after taking the listed drugs. In turn, ergot alkaloids can be taken no earlier than 6 hours after the use of sumatriptan, and other 5HT1-serotonin receptor agonists / triptans - no earlier than 24 hours.
The drug is not recommended for use in conjunction with selective serotonin reuptake inhibitors, since the development of serotonin syndrome (including neuromuscular disorders, mental disorders and autonomic lability) is possible.
Sumatriptan-Teva should not be used simultaneously with MAO inhibitors.
In the case of a combination with St. John's wort preparations, the side effects of sumatriptan may increase.
No interaction has been established with pizotifen, flunarizine, ethyl alcohol and propranolol.
Analogs
The analogues of Sumatriptan-Teva are Imigran, Amigrenin, Sumamigren, Sumatriptan, Sumatriptan Canon, Sumatriptan Adipharm, Sumatriptan-OBL, Sumarin, Sumitran, Rapimed, etc.
Terms and conditions of storage
Keep out of the reach of children. Store at a temperature not exceeding 25 ° C.
The shelf life of the drug is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Sumatriptan-Teva
According to reviews, Sumatriptan Teva is an effective remedy for relieving migraine attacks. It acts gently and quickly, causing a minimum of adverse reactions. The tablets are small and easy to take. The drug is cheaper than some similar products. Patients note that after taking sumatriptan, it is recommended to stay in silence in a dark room for 1–2 hours.
Some patients indicate the development of side effects in the form of a feeling of weightlessness, poor concentration of attention, a feeling of unreality of what is happening. Other users complain that Sumatriptan-Teva is short-lived.
Price for Sumatriptan-Teva in pharmacies
Approximate prices for Sumatriptan-Teva in the form of film-coated tablets:
- Sumatriptan-Teva 50 mg (2 pcs. In a package) - 105-140 rubles;
- Sumatriptan-Teva 100 mg (2 pcs. In a package) - 155-180 rubles.
Sumatriptan Teva: prices in online pharmacies
Drug name Price Pharmacy |
Sumatriptan-Teva 50 mg film-coated tablets 2 pcs. 107 RUB Buy |
Sumatriptan-Teva 100 mg film-coated tablets 2 pcs. 162 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!