Sumamigren coated pills 100mg N2
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Active ingredients
Sumatriptan
Release form
Pills
Composition
1 film tablet contains: Active ingredients Sumatriptan 100 mg. Excipients Lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, silicon dioxide, anhydrous colloid dioxide. The composition of the shell Hypromellose, macrogol 6000, talc, titanium dioxide, triethyl citrate, varnish orange-yellow E110.
Pharmacological effect
Antifungal drug. A specific selective serotonin 5HT1D receptor agonist, does not affect other 5HT serotonin receptor subtypes (5HT2-5HT7). Serotonin 5HT1D receptors are located mainly in the blood vessels of the brain, their stimulation leads to the narrowing of these vessels. Sumatriptan reduces the sensitivity of the trigeminal nerve. Both of these effects underlie the anti-migraine effect of the drug. The clinical effect is observed 30 minutes after taking the drug inside.
Pharmacokinetics
Absorption After taking the drug inside sumatriptan is rapidly absorbed, while in 45 minutes 70% of C max is reached in plasma. 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 Plasma protein binding is 14-21%. Metabolism Biotransformed by MAO type A. The main metabolite is the indole acetic analogue of sumatriptan, which is not active against serotonin 5HT1 and 5HT2 receptors. Withdrawal of T1 / 2 is 2 hours. The main metabolite of sumatriptan is excreted mainly in the urine in the form of free acid or glucuronide conjugate. Migraine attacks do not significantly affect the oral pharmacokinetics of sumatriptan.
Indications
Relief of migraine attacks with or without aura.
Contraindications
hypersensitivity to any component of Sumumagren; hemiplegic, basilar and ophthalmoplegic migraine; IHD (including myocardial infarction, post-infarction cardiosclerosis, Prinzmetal angina), as well as the presence of symptoms suggesting the presence of IHD; occlusive peripheral vascular disease; stroke or transient ischemic attack (includingin history); uncontrolled arterial hypertension; concomitant use with ergotamine or its derivatives (including metisegride); use in patients receiving MAO inhibitors or earlier than 2 weeks after their cancellation; severe impaired liver and / or kidney function; age under 18 and over 65 (safety and efficacy not established); pregnancy; lactation period.
Use during pregnancy and lactation
Consideration should be given to the expected benefit to the mother and the risk to the fetus. Use with caution during lactation. It is not recommended to breastfeed for 24 hours after taking the drug.
Dosage and administration
Tablets are taken entirely inside with water. The recommended single dose is 50 mg (1 tab.), In some cases, you may need to use the drug in a higher dose of 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 prescribed again to relieve an ongoing attack. The drug can be used to relieve subsequent migraine attacks. If the symptoms have decreased or disappeared, and then resumed, you can take a second dose in the next 24 hours. The maximum dose of the drug is 300 mg for 24 hours.
Side effects
Determination of the frequency of side effects: 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); the frequency is unknown (the frequency of development cannot be estimated from the available data). The nervous system: often - dizziness, drowsiness, sensitivity disorders, including paresthesias and hypesthesias; frequency is unknown - convulsive seizures (in some cases they were observed in patients with convulsions in history or in conditions predisposing to the occurrence of seizures; in some patients there were no predisposing factors), tremor, dystonia, nystagmus, scotoma. On the part of the organ of vision: the frequency is unknown - diplopia, flickering before the eyes, reduced visual acuity, partial transient loss of vision or permanent loss of vision. However, it should be borne in mind that visual impairment may be associated with the migraine attack itself. Since the cardiovascular system: often - a transient increase in blood pressure (observed soon after taking sumatriptan), hot flashes; frequency is unknown - bradycardia, tachycardia, lowering blood pressure, cardiac arrhythmias, transient ECG changes in ischemic type, myocardial infarction, coronary artery spasm, angina,Raynaud's syndrome, palpitations. On the part of the digestive system: often - nausea, vomiting; very rarely - dysphagia, a feeling of discomfort in the abdomen; frequency is unknown - ischemic colitis, diarrhea. On the part of the musculoskeletal system: often - a feeling of heaviness (usually transient, may be intense and occur in any part of the body, including the chest and throat), myalgia; infrequently - pain in the joints; frequency is unknown - stiff neck, arthralgia. On the part of the respiratory system: often - shortness of breath; light, transient mucosal irritation or burning sensation in the nasal cavity or throat, nosebleeds. Laboratory indicators: very rarely - minor changes in the activity of hepatic transaminases. Allergic reactions: very rarely - hypersensitivity reactions range from cutaneous manifestations (rash, urticaria, pruritus, erythema) to anaphylaxis. From the skin and subcutaneous tissue: the frequency is unknown - hyperhidrosis. Others: often - feeling hot or cold, pain, feeling of pressure or heaviness (are transient and can occur in any part of the body, including the chest and throat), feeling weak, tired, usually mild or moderate, and also transient. Transient intense pains and chest tightness may occur, extending to the neck area.
Overdose
Taking sumatriptan orally at a dose above 400 mg did not cause any additional side effects. Treatment: in case of overdose, the patient should be monitored for 10 hours, conducting symptomatic therapy as needed. No data on the effect of hemodialysis or peritoneal dialysis on the concentration of sumatriptan in plasma.
Interaction with other drugs
No drug interaction of sumatriptan with propranolol, flunarizine, pizothiphene and ethanol was noted. When taken concomitantly with ergotamine, prolonged vasospasm was observed. Sumatriptan can be prescribed no earlier than 24 hours after administration of preparations containing ergotamine, and preparations containing ergotamine can be administered no earlier than 6 hours after administration of sumatriptan. Interaction between sumatriptan and MAO inhibitors is possible, their simultaneous use is contraindicated.There are very rare reports from post-marketing observations on the development of serotonin syndrome (including mental disorders, autonomic lability and neuromuscular disorders) as a result of the concomitant use of SSRIs and sumatriptan. It was also reported on the development of serotonin syndrome on the background of the simultaneous appointment of triptans with SSRIs.
special instructions
Sumatriptan should be prescribed only if the diagnosis of migraine is not in doubt, while it should be used as soon as possible after the onset of a migraine attack, although it is equally effective when used at any stage of the attack. Drug cannot be used in the preventive purposes. Sumatriptan should be taken with caution in controlled arterial hypertension; diseases in which absorption, metabolism or excretion of the drug (for example, impaired kidney or liver function) may change. There are very rare reports from postmarketing observations on the development of serotonin syndrome (including mental disorders, vegetative lability and neuromuscular disorders) as a result of the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and sumatriptan. It was also reported on the development of serotonin syndrome on the background of simultaneous administration of triptans with selective serotonin and noradrenaline reuptake inhibitors (SSRIs). In the case of simultaneous administration with drugs from the SSRI / SSRI group, the patient’s condition should be carefully monitored. Sumatriptan should be taken with caution in epilepsy and any conditions with a decrease in the convulsive readiness threshold. Concomitant use of other triptans / 5-HT1 agonists with sumatriptan is not recommended. In patients with hypersensitivity to sulfonamides, the use of sumatriptan can cause allergic reactions, the severity of which varies from skin manifestations to anaphylaxis. Data on cross-sensitivity is limited, but care should be taken when prescribing sumatriptan to such patients. As with the use of other anti-migraine drugs, when prescribing sumatriptan in patients with previously undiagnosed migraine or in patients with atypical migraine, other potentially serious neurological conditions should be excluded.It should be noted that patients with migraine have an increased risk of developing certain cerebrovascular complications (stroke or transient cerebral circulation). Sumatriptan should not be prescribed to patients with suspected heart disease without prior examination to exclude cardiovascular disease. Such patients include women in the postmenopausal period, men over the age of 40, and patients with risk factors for developing coronary artery disease. Although the survey 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 pains and chest tightness may occur, extending to the neck area. If there is reason to believe that these symptoms are a manifestation of coronary artery disease, it is necessary to conduct an appropriate diagnostic examination. The abuse of drugs intended to relieve migraine attacks is associated with an increase in headaches in sensitive patients (a headache associated with the abuse of drugs). At the same time, the possibility of drug withdrawal should be considered. Do not exceed the recommended dose of sumatriptan. Impact on the ability to drive vehicles and control mechanisms In patients with migraine, drowsiness may occur, associated both with the disease itself and with the use of sumatriptan, so they should be especially careful when driving and working with moving machinery.