Metformin Teva film-coated pills 1000 mg N60
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Active ingredients
Metformin
Release form
Pills
Composition
Metformin hydrochloride 1000 mg; Auxiliary substances: Povidone K30 - 31.6 mg, Povidone K90 - 22.6 mg, silicon dioxide colloid - 2.4 mg, magnesium stearate - 5.4 mg.; Shell composition: white yadhra Y-1-7000H (hypromellose (E464) - 20 mg, titanium dioxide (E171) - 10 mg, macrogol 400 - 2 mg).
Pharmacological effect
Metformin is an oral hypoglycemic agent from the biguanide group. In patients with diabetes, reduces the concentration of glucose in the blood by inhibiting gluconeogenesis in the liver, reducing the absorption of glucose from the gastrointestinal tract and increasing its utilization in the tissues by increasing their insulin sensitivity (mainly the striated muscles, to a lesser extent - adipose tissue). Does not stimulate insulin secretion, does not cause hypoglycemic reactions. It affects lipid metabolism - reduces the concentration in the serum of triglycerides, cholesterol and low density lipoprotein. Stimulates intracellular glycogenesis by activating glycogen synthase.
Pharmacokinetics
Absorption; After taking the drug inside Metformin completely absorbed from the gastrointestinal tract. Absolute bioavailability is 50-60%. The maximum concentration (Cmax) in plasma is approximately 2 μg / ml or 15 μmol / l and is reached after 2.5 h. After 7 h, absorption from the gastrointestinal tract ends, and the concentration of metformin in the plasma gradually decreases. With the simultaneous ingestion of food, the absorption of metformin decreases and slows down.; Distribution; Metformin practically does not bind to plasma proteins and is rapidly distributed in the tissues of the body. Gets into red blood cells. Accumulates in the salivary glands, liver and kidneys. The apparent volume of distribution is 63-276 l.; Metabolism and excretion; excreted by the kidneys unchanged. The clearance of metformin in healthy individuals is 400 ml / min, which indicates active glomerular filtration and tubular secretion. The half-life (T1 / 2) is approximately 6.5 hours; Pharmacokinetics in special clinical situations; In patients with renal insufficiency, the renal clearance of metformin decreases in proportion to the decrease in creatinine clearance, T1 / 2 increases, which leads to an increase in the concentration of metformin in the blood. Cumulation is possible.
Indications
- diabetes mellitus type 2 in adults (especially in patients with obesity) with ineffective diet and exercise as monotherapy or in combination with other oral hypoglycemic agents or insulin.
Contraindications
- Hypersensitivity to metformin or to any auxiliary substance of the drug; - diabetic ketoacidosis, diabetic precoma, coma; - renal failure or impaired renal function (CC less than 60 ml / min); - Acute conditions occurring at risk of developing renal dysfunction; - dehydration (with diarrhea, vomiting), fever, severe infectious diseases; - states of hypoxia (shock, sepsis, renal infections, bronchopulmonary diseases); - clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including heart or respiratory failure, acute myocardial infarction); - extensive surgeries and injuries when insulin therapy is indicated; - liver failure, abnormal liver function; - chronic alcoholism, acute alcohol poisoning; - lactic acidosis (including history); - use for at least 48 hours before and within 48 hours after conducting radioisotope or x-ray studies with the introduction of iodine-containing contrast agent; - a period of at least 48 hours before and within 48 hours after surgery under general anesthesia, spinal or epidural anesthesia; - compliance with a low-calorie diet (less than 1000 kcal / day); - Children under the age of 18.; With caution: in persons over 60 years of age who perform heavy physical work (increased risk of developing lactic acidosis).
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and during breastfeeding. When planning or the occurrence of pregnancy, Metformin-Teva should be canceled and insulin therapy should be prescribed. The patient should be warned about the need to notify the doctor in the event of pregnancy. Mother and baby should be monitored.; It is not known whether metformin is excreted in breast milk. If necessary, the use of the drug during lactation should stop breastfeeding.
Dosage and administration
Inside, during or immediately after a meal. Monotherapy and combination therapy with other oral hypoglycemic agents; Initial dose: 500-1000 mg once a day in the evening. After 7-15 days in the absence of adverse effects on the gastrointestinal tract, 500-1000 mg are prescribed 2 times a day, morning and evening. Perhaps a further gradual increase in dose, depending on the concentration of glucose in the blood.; Maintenance dose: 1500-2000 mg / day. To reduce side effects from the gastrointestinal tract, the dose should be divided into 2-3 doses. Maximum dose: 3000 mg / day in 3 divided doses. Slowly increasing the dose may help improve the gastrointestinal tolerance of the drug. Patients taking metformin at doses of 2,000–3,000 mg / day can be transferred to a dose of 1,000 mg. The maximum recommended dose: 3000 mg / day in 3 divided doses. When switching to therapy with another hypoglycemic agent, you should stop taking another agent and start taking Metformin-Teva at the dose indicated above; Combinations with insulin; Metformin-Teva and insulin can be used as a combination therapy to achieve better glycemic control .; The drug Metformin-Teva is prescribed in the usual initial dose of 500 mg or 850 mg 2-3 times a day. The dose of insulin is selected based on the results of measuring blood glucose. After 10-15 days, the dose is adjusted depending on the concentration of glucose in the blood. The maximum dose of metformin in the combined treatment: 2 g / day in 2-3 doses.; In elderly patients, the daily dose should not exceed 1000 mg / day.
Side effects
Side effects are classified according to the following frequency: very often - at least 10%; often not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including isolated cases; On the part of the central nervous system: often - a violation of taste (metallic taste in the mouth) .; On the part of the digestive system: very often - nausea, vomiting, abdominal pain, lack of appetite, in the initial period of treatment and in most cases spontaneously passing; isolated cases - impaired liver function or hepatitis, completely disappearing after drug withdrawal.; Allergic reactions: very rarely - erythema, pruritus, rash.; Metabolism: very often - lactic acidosis (requires discontinuation of the drug); Other: very rarely - with prolonged use hypovitaminosis B12 develops.
Overdose
Symptoms; When using metformin at a dose of 85 g, hypoglycemia was not observed, but the development of lactic acidosis was noted. The early symptoms of lactic acidosis are nausea, vomiting, diarrhea, decrease in body temperature, abdominal pain, muscle pain, there may be an increase in breathing, dizziness, impaired consciousness and the development of coma in the future; Treatment; If signs of lactic acidosis appear, treatment with the drug should be stopped immediately. , the patient is urgently hospitalized and, having determined the concentration of lactate, to clarify the diagnosis. The most effective measure for the elimination of lactate and metformin from the body is hemodialysis. Symptomatic treatment is also performed.
Interaction with other drugs
Not recommended combinations; With simultaneous use of metformin with danazol, a hyperglycemic effect may develop. If necessary, treatment with danazol and after discontinuation of its administration requires dose adjustment of metformin under glycemic control. With simultaneous use of metformin with alcohol and ethanol-containing drugs, the risk of developing lactic acidosis increases during acute alcohol intoxication, especially when fasting or following a low-calorie diet, as well as liver failure .; Combinations requiring special care; Chlorpromazine in high doses (100 mg / day) reduces the release of insulin and increases the concentration of glucose eskers in the blood. With simultaneous use with neuroleptics and after discontinuation of their administration, dose adjustment of metformin is required under glycemic control. Glucocorticosteroids (GCS) reduce glucose tolerance and increase the concentration of glucose in the blood, in some cases causing ketosis. If it is necessary to use such a combination after discontinuation of GCS, a dose adjustment of metformin is required under glycemic control. With the simultaneous use of “loop” diuretics and metformin, there is a risk of developing lactic acidosis due to the possible appearance of functional renal failure. cause the development of lactic acidosis in patients with diabetes mellitus on the background of functional renal failure.The use of metformin should be discontinued 48 hours before and not resumed earlier than 48 hours after x-ray examination using radiopaque agents. The administration in the form of beta2-adrenomimetic injections reduces the hypoglycemic effect of metformin due to the stimulation of beta2-adrenoreceptors. In this case, monitor the concentration of glucose in the blood and, if necessary, prescribe insulin. Angiotensin-converting enzyme inhibitors and other antihypertensive drugs can reduce the concentration of glucose in the blood. If necessary, adjust the dose of metformin. With the simultaneous use of metformin with sulfonylurea derivatives, insulin, acarbose and sapicylates, hypoglycemic action may be enhanced. Loop diuretics and NSAIDs increase the risk of reduced kidney function. In this case, care must be taken when using metformin.
special instructions
During the period of treatment with Metformin-Teva, it is necessary to regularly monitor the concentration of fasting blood glucose and after eating. The patient should be warned about the need to stop taking the drug and consult a doctor if vomiting, abdominal pain, muscle pain, general weakness and severe malaise occur. These symptoms may be a sign of incipient lactic acidosis. The drug Metformin-Teva should be canceled 48 hours before and within 48 hours after the X-ray examination (including urography, intravenous angiography) with the use of radiopaque agents. The drug Metformin-Teva should be canceled 48 hours before and within 48 hours after surgery under general anesthesia, spinal or epidural anesthesia. Since metformin is eliminated by the kidneys, CC should be determined regularly before starting treatment: in patients with preserved renal function 1 time per year, in patients with low CC and in elderly patients 2–4 times per year. Special caution should be exercised in violation of kidney function, for example, in the initial period of treatment with antihypertensive drugs, diuretics, NSAIDs; You should inform the patient about the need to consult a doctor if symptoms of a bronchopulmonary infection or urinary tract infection appear authorities.Against the background of the use of the drug Metformin-Teva should refrain from alcohol intake, due to the increased risk of hypoglycemia and disulfiram-like effect. Hypovitaminosis B12 when taking the drug Metformin-Teva is caused by a violation of the absorption of vitamin B12 and is reversible. With the abolition of the drug Metformin-Teva, the signs of hypovitaminosis B12 quickly disappear.; Impact on the ability to drive vehicles and control mechanisms; Monotherapy with Metformin-Teva does not cause hypoglycemia and therefore does not affect the ability to drive and work with mechanisms. When using the drug Metformin-Teva with other hypoglycemic agents (sulfonylurea derivatives, insulin, etc.), hypoglycemic states can develop, in which the ability to drive motor vehicles and engage in other potentially hazardous activities requiring increased attention and psychomotor reactions is deteriorating.