Sumamigren tablets p/o 50mg №6×1

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Sumamigren tabl p/o 50mg in a blister. in pack. No. 6×1
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Film-coated tablets of light pink color, oblong, biconvex, with a dividing risk on one side; on a white break. The main active ingredient is sumatriptan succinate Form of release Tablets Dosage 50 mg Special instructions Sumatriptan should be prescribed only if the diagnosis of migraine is not in doubt, while it should be used as early as possible after the onset of a migraine attack, although it is equally effective when used at any stage of the attack. The drug can not be used for prophylactic purposes. Sumatriptan should be taken with caution in controlled arterial hypertension of the I degree of severity, because. in some cases, against the background of admission, a transient increase in blood pressure and peripheral vascular resistance was observed; diseases in which absorption, metabolism or excretion of the drug may change (for example, impaired renal or hepatic function). There are very rare post-marketing reports of the development of serotonin syndrome (including mental disorders, autonomic lability and neuromuscular disorders) as a result of the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and sumatriptan. The development of serotonin syndrome has also been reported against the background of the simultaneous appointment of triptans with selective serotonin and norepinephrine reuptake inhibitors (SNRIs). In the case of simultaneous administration with drugs from the SSRI / SNRI group, the patient’s condition should be carefully monitored. Sumatriptan should be used with caution in epilepsy and other risk factors in history, accompanied by a decrease in the seizure threshold, since such patients may develop seizures while taking sumatriptan. The concomitant use of other triptans/5-HT1 receptor agonists with sumatriptan is not recommended. In patients with hypersensitivity to sulfonamides, the use of sumatriptan may cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis. Cross-sensitivity data are limited, but caution should be exercised when prescribing sumatriptan to such patients. As with other anti-migraine agents, when prescribing sumatriptan in patients with previously undiagnosed migraine or in patients with atypical migraine, other potentially serious neurological conditions must be excluded. It should be noted that patients with migraine have an increased risk of developing certain cerebrovascular complications (stroke or transient ischemic attack). Sumatriptan should not be given to patients with suspected cardiac disease without prior evaluation to rule out cardiovascular disease. These patients include postmenopausal women, men over the age of 40 and patients with risk factors for coronary artery disease, as well as smokers and using nicotine replacement therapy. Although the examination does not always reveal heart disease in some patients, in very rare cases they develop side effects from the cardiovascular system. After taking sumatriptan, transient intense pain and tightness in the chest may occur, extending to the neck. If there is reason to believe that these symptoms are a manifestation of coronary artery disease, you should stop taking the drug and conduct an appropriate diagnostic examination. The misuse of migraine medications has been associated with an increase in headaches in sensitive patients (medication abuse headache). If you develop or suspect a headache associated with the abuse of drugs, you should consult a doctor. In this case, the possibility of discontinuing the drug should be considered. Undesirable effects may be observed more often during the use of triptans and herbal preparations containing St. John’s wort (Hypericum perforatum). Do not exceed the recommended dose of sumatriptan. Impact on the ability to drive vehicles and control mechanisms Patients with migraine may experience drowsiness associated both with the disease itself and with taking sumatriptan, so they should be especially careful when driving and working with moving mechanisms. Pharmacological action Pharmacodynamics Sumatriptan is a specific selective serotonin 5HT1D receptor agonist that does not affect other subtypes of 5HT serotonin receptors (5HT2-5HT7). 5HT1D receptors are located mainly in the blood vessels of the brain, and their stimulation leads to constriction of these vessels. Reduces the sensitivity of the trigeminal nerve. Both effects may underlie the anti-migraine effect of the drug. The clinical effect is usually observed within 30 minutes after taking the drug inside. Pharmacokinetics Absorption After taking the drug orally, sumatriptan is rapidly absorbed, 70% of Cmax in plasma is reached after 45 minutes. After taking 100 mg Cmax averages 54 ng / ml. Bioavailability averages 14% due to intensive first pass metabolism and incomplete absorption. Distribution Plasma protein binding is low and amounts to 14-21%. Metabolism and excretion Biotransformed under the action of monoamine oxidase (MAO) type A. The main metabolite is the indolacetic analogue of sumatriptan, which is excreted mainly by the kidneys, in the form of a free acid and a conjugate with glucuronic acid. This metabolite is inactive at serotonin 5HT1 and 5HT2 receptors. Migraine attacks do not significantly affect the pharmacokinetics of oral sumatriptan. Indications for use Relief of migraine attacks with or without aura. Dosing and Administration Inside, during a meal or on an empty stomach, the drug should be swallowed whole with water. The recommended dose is 50 mg. Some patients may require a higher dose – 100 mg. If the symptoms of migraine do not disappear and do not decrease after taking the first dose, then the drug should not be taken again to stop the same attack. In this case, treatment can be carried out with paracetamol, acetylsalicylic acid, NSAIDs. However, Sumamigren® can be used to relieve subsequent migraine attacks. If the patient feels better after the first dose, and then symptoms recur, a second dose can be taken within the next 24 hours, provided that the interval between doses is at least 2 hours. The maximum daily dose of sumatriptan should not exceed 300 mg. Patients with hepatic insufficiency The recommended dose is 50 mg. Children and adolescents under 18 years of age Sumatriptan is not recommended for use in children and adolescents due to lack of safety and efficacy data. Elderly patients (over 65 years of age) Experience with the use of sumatriptan in patients over the age of 65 years is limited. The pharmacokinetics of the drug does not differ significantly from that in younger patients, however, until additional clinical data are obtained, the use of sumatriptan in patients over the age of 65 years is not recommended. Use during pregnancy and lactation The use of sumatriptan is contraindicated during 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. Interaction with other drugs There was no interaction of sumatriptan with propranolol, flunarizine, pizotifen and ethyl alcohol. When taken concomitantly with ergotamine or other triptans/5-HT1 receptor agonists, prolonged vasospasm has been observed. Sumatriptan can be given no earlier than 24 hours after taking drugs containing ergotamine or other triptans / 5-HT1 receptor agonists, conversely, drugs containing ergotamine can be prescribed no earlier than 6 hours after taking sumatriptan, and triptans / 5-HT1 receptor agonists -HT1 – not earlier than 24 hours after taking sumatriptan. An interaction between sumatriptan and MAO inhibitors is possible, their simultaneous use is contraindicated. There are very rare post-marketing reports of the development of serotonin syndrome (including mental disorders, autonomic lability and neuromuscular disorders) as a result of the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and sumatriptan. The development of serotonin syndrome has also been reported against the background of the simultaneous appointment of triptans with selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Contraindications hypersensitivity to any component of the drug; lactase deficiency, lactose intolerance, glucose-galactose malabsorption; hemiplegic, basilar and ophthalmoplegic forms of migraine; IHD (including myocardial infarction, postinfarction cardiosclerosis, Prinzmetal’s angina), as well as the presence of symptoms suggesting the presence of IHD; occlusive diseases of peripheral vessels; stroke or transient ischemic attack (including history); arterial hypertension of severity; uncontrolled arterial hypertension; simultaneous reception with ergotamine or its derivatives (including metizergide); concomitant use with other triptans / agonists of the 5-HT1 receptor; use while taking MAO inhibitors or earlier than 2 weeks after their cancellation; severe violations of the liver and / or kidneys; age up to 18 years and over 65 years (safety and efficacy have not been established); pregnancy; lactation period. Sumatriptan succinate 70 mg, equivalent to sumatriptan 50 mg Shell composition: hypromellose – 3.07 mg, macrogol 6000 – 1.2 mg, talc – 1.31 mg, titanium dioxide – 0.9 mg, triethyl citrate – 0.98 mg, crimson dye Ponceau 4R – 0.04 mg. OverdoseSymptoms: Taking sumatriptan orally at a dose above 400 mg did not cause any additional side effects, in addition to those listed above. Treatment: in case of overdose, the condition of patients should be observed for at least 10 hours, if necessary, symptomatic therapy should be carried out. There are no data on the effect of hemodialysis or peritoneal dialysis on the plasma concentration of sumatriptan. Side effects Depending on the frequency of occurrence, the following groups of side effects are distinguished: very often (≥1 / 10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10,000, <1/1000); very rarely (<1/10,000, including isolated cases); frequency unknown: the frequency of development cannot be estimated from the available data. From the nervous system: often - dizziness, drowsiness, sensitivity disorders, including paresthesia and hypoesthesia; the frequency is unknown - convulsive seizures (in some cases they were observed in patients with a history of convulsions or in conditions predisposing to the occurrence of convulsions; no predisposing factors were identified in some patients), tremor, dystonia, nystagmus, scotoma. On the part of the organ of vision: the frequency is unknown - diplopia, flickering before the eyes, decreased visual acuity, partial transient loss of vision or persistent loss of vision. However, it should be borne in mind that visual impairment may be associated with the migraine attack itself. From the side of the cardiovascular system: often - a transient increase in blood pressure (observed shortly after taking sumatriptan), "hot flashes"; the frequency is unknown - bradycardia, tachycardia, decreased blood pressure, cardiac arrhythmias, transient ECG changes of the ischemic type, myocardial infarction, spasm of the coronary arteries, angina pectoris, Raynaud's syndrome, palpitations. From the gastrointestinal tract: often - nausea, vomiting; very rarely - dysphagia, a feeling of discomfort in the abdomen; frequency unknown - ischemic colitis, diarrhea. 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), myalgia; infrequently - pain in the joints; frequency unknown - stiff neck, arthralgia. From the respiratory system and chest organs: often - shortness of breath; mild, transient mucosal irritation or burning sensation in the nasal cavity or throat, epistaxis. Laboratory indicators: very rarely - slight changes in the activity of hepatic transaminases. Allergic reactions: very rarely - hypersensitivity reactions vary from skin manifestations (rash, urticaria, itching, erythema) to cases of anaphylaxis. From the skin and subcutaneous tissue: the frequency is unknown - hyperhidrosis. Other: often - a feeling of heat or cold, pain, a feeling of pressure or heaviness (they are transient and can occur in any part of the body, including the chest and throat), a feeling of weakness, a feeling of fatigue, usually mild or moderate and are also transient. There may be transient intense pain and tightness in the chest, extending to the neck area. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. 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