Formethine - instructions for use, doses, side effects, contraindications

Composition:Active substance: metformin hydrochloride - 0.500 g; 0.850 g; 1.000 g. Excipients: povidone (medium-molecular weight polyvinylpyrrolidone, povidone K-30) - 0.017 g; 0.029 g; 0.034 g; croscarmellose sodium (impellose) - 0.008 g; 0.0136 g; 0.016 g; magnesium stearate - 0.005 g; 0.0084 g; 0.010 g.

Description:White tablets are round, flat-cylindrical with a facet and a risk (with a dosage of 0.5 g) and white tablets are oval biconvex with a risk on one side (with a dose of 0.85 g and 1.0 g).

Pharmacotherapeutic group:Hypoglycemic agent for oral administration of the biguanide group.

ATX: & nbsp

A.10.B.A.02 Metformin

Pharmacodynamics:Metformin inhibits gluconeogenesis in the liver, reduces the absorption of glucose from the intestine, enhances peripheral utilization of glucose, and also increases the sensitivity of tissues to insulin.In this case, it has no effect on the secretion of insulin by beta cells of the pancreas, does not cause hypoglycemic reactions. Reduces the level of triglycerides and low density lipoproteins in the blood. Stabilizes or reduces body weight. Has a fibrinolytic effect due to inhibition of the inhibitor of tissue-type plasminogen activator.

Pharmacokinetics:After oral administration metformin is slowly absorbed from the gastrointestinal tract. Bioavailability after taking a standard dose is 50-60%. The maximum concentration in the blood plasma is achieved after 2.5 hours after ingestion. Virtually does not bind to plasma proteins. It accumulates in the salivary glands, muscles, liver and kidneys. It is allocated in an invariable kind by kidneys. The elimination half-life is 1.5-4.5 hours. In cases of kidney dysfunction, cumulation of the drug is possible.

Indications:Diabetes mellitus type 2 with ineffectiveness of diet therapy (especially in patients suffering from obesity).

Contraindications:- diabetic ketoacidosis, diabetic precoma, coma;
- severe renal dysfunction;
- cardiac and respiratory failure, acute phase of myocardial infarction,acute disorders of cerebral circulation, dehydration, chronic alcoholism and other conditions that can contribute to the development of lactic acidosis;
- pregnancy and the period of breastfeeding;
- hypersensitivity to the drug;
- Serious surgical operations and trauma, when insulin therapy is indicated;
- severe infectious diseases;
- impaired liver function;
- Acute alcohol poisoning;
- lactic acidosis (including in the anamnesis);
- use for at least 2 days before and within 2 days after carrying out radioisotope or X-ray studies with the introduction of iodine-containing contrast agent;
- adherence to a hypocaloric diet (less than 1000 calories / day).
It is not recommended to use the drug in people over 60 years of age who perform heavy physical work, due to the increased risk of developing lactic acidosis.

Dosing and Administration:The dose of the drug is set by the doctor individually depending on the level of glucose in the blood.
Take without chewing during or after a meal, with enough water. The initial dose is 0.5 g 1-2 times a day or 0.85 g once a day, gradually (once a week) the dose is increased to 2-3 grams per day. The maximum daily dose is 3 g.
In elderly patients, the daily dose should not exceed 1 g. Due to the increased risk of lactic acidosis, in severe metabolic disorders the dose of the drug should be reduced.

Side effects:On the part of the digestive system: nausea, vomiting, "metallic" taste in the mouth, lack of appetite, diarrhea, flatulence, abdominal pain.
From the side of metabolism: in rare cases, lactic acidosis (requires discontinuation of treatment); with prolonged treatment - hypovitaminosis B₁₂ (impaired absorption).
From the hematopoiesis: in some cases - megaloblastic anemia.
From the endocrine system: hypoglycemia (when used in inadequate doses).
Allergic reactions: skin rash.

Overdose:With an overdose of metformin, it is possible to develop lactic acidosis with a fatal outcome. The cause of the development of lactic acidosis may also be cumulation of the drug due to impaired renal function. The early symptoms of lactic acidosis are general weakness, nausea, vomiting, diarrhea, lower body temperature, abdominal pain, muscle pain, lowering blood pressure, reflex bradyarrhythmia, there may be more breathing, dizziness, impaired consciousness and coma development. Treatment: In case of signs of lactic acidosis, metformin treatment should be stopped immediately, the patient immediately hospitalized and, having determined the concentration of lactate, confirm the diagnosis. The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Conduct also symptomatic treatment.

Interaction:When used simultaneously with derivatives of sulfonylurea, acarbose, insulin, non-steroidal anti-inflammatory agents, monoamine oxidase inhibitors, oxytetracycline, angiotensin converting enzyme inhibitors, clofibrate derivatives, cyclophosphamide, (3-adrenoblockers, hypoglycemic effect of metformin may be enhanced.
When used simultaneously with glucocorticosteroids, oral contraceptives, epinephrine, sympathomimetics, glucagon, thyroid hormones, thiazide and loop diuretics, phenothiazine derivatives, nicotinic acid derivatives, a decrease in the hypoglycemic effect of metformin is possible.
Cimetidine slows the excretion of metformin, which increases the risk of developing lactic acidosis.
Metformin can weaken the effect of anticoagulants (coumarin derivatives). With the simultaneous use of alcohol may develop lactic acidosis. Nifedipine increases absorption, maximum concentration, slows the excretion of metformin.
Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, vancomycin), secreted in the tubules, compete for the tubular transport systems and with prolonged therapy can increase the maximum concentration of the drug by 60%.

Special instructions:During the treatment it is necessary to monitor the kidney function. At least 2 times a year, as well as the appearance of myalgia should determine the content of lactate in the plasma.
It is possible to use Formethine in combination with sulfonylurea derivatives. In this case, a particularly careful monitoring of blood glucose levels is necessary.

Effect on the ability to drive transp. cf. and fur:When used in monotherapy Formethine does not affect the ability to drive vehicles and work with mechanisms.
When combining Formin with other hypoglycemic agents (derivatives of sulfonylureas,insulin, etc.), it is possible to develop hypoglycemic conditions, in which the ability to drive vehicles and engage in other potentially hazardous activities that require increased attention and rapid psychomotor reactions deteriorates.

Form release / dosage:Tablets 0.5 g, 0.85 g and 1.0 g.

Packaging:at production at OJSC "Pharmstandard-Tomskkhimpharm", Russia
10 tablets per contour cell pack. 3, 6 or 10 contour mesh packages together with instructions for use in a pack of cardboard.
at production at OJSC "Pharmstandard-Leksredstva", Russia
For 10 or 12 tablets in a contour mesh package. 3, 5, 6 or 10 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:List B. In dry the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-003304/07

Date of registration:22.10.2007 / 16.03.2015

Expiration Date:Unlimited

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Information update date: & nbsp2016-09-28

Illustrated instructions

Instructions

Formethin® (Formetine)