FORMETIN

Active material: Metformin
When ATH: A10BA02
CCF: Oral hypoglycemic agents
ICD-10 codes (testimony): E11
When CSF: 15.02.02
Manufacturer: OAO Pharmstandard-Leksredstva (Russia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills white, round, Valium, a facet and Valium.

Excipients: povidone srednemolekulyarnыy (polyvinylpyrrolidone), sodium croscarmellose, magnesium stearate.

10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (6) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.

Pills white, Oval, lenticular, scored on both sides.

Excipients: povidone srednemolekulyarnыy (polyvinylpyrrolidone), sodium croscarmellose, magnesium stearate.

10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (6) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.

Pharmacological action

Oral hypoglycemic agents from the group of biguanides. Inhibits hepatic gluconeogenesis, reduces glucose absorption from the intestine, increases peripheral glucose utilization, and improves the sensitivity of tissues to insulin. It has no effect on insulin secretion β-cells of the pancreas, It does not cause hypoglycemic reactions.

It reduces levels of triglycerides and LDL.

Stabilizes or reduces body weight.

It has a fibrinolytic action due to suppression of tissue plasminogen activator inhibitor type.

Pharmacokinetics

Absorption

After oral administration, metformin is absorbed from the gastrointestinal tract. The bioavailability after administration of a standard dose 50-60%. C_max achieved after ingestion by 2.5 no.

Distribution

Almost does not bind to plasma proteins. It accumulates in the salivary glands, muscle, liver, kidney.

Deduction

Excreted unchanged in the urine. T_1/2 is 1.5-4.5 no.

Pharmacokinetics in special clinical situations

If the kidney function possible drug accumulation.

Testimony

- Diabetes mellitus type 2 the poor diet (especially in patients, Obese).

Dosage regimen

Individually adjusted according to the level of glucose in the blood.

The initial dose is 500 mg 1-2 times / day or 850 mg 1 time / day. Later gradually (1 once a week) increase the dose to 2-3 g / day. The maximum daily dose – 3 g.

The daily dose, exceeding 850 mg, it is recommended to take in two (in the morning and in the evening).

In elderly patients daily dose should not exceed 1 g.

Due to the increased risk of lactic acidosis, when metformin patients with severe metabolic disturbances dose should be reduced.

The drug is intended for long-term use.

Tablets should be taken during or after a meal, not chewing and drinking plenty of fluids.

Side effect

From the digestive system: nausea, vomiting, metallic taste in mouth, anorexia, diarrhea, flatulence, stomach ache.

Metabolism: rarely – Lactic acidosis (It requires discontinuation of treatment), prolonged use – In gipovitaminoz₁₂ (malabsorption).

From the hematopoietic system: in some cases – megaloblastnaya anemia.

On the part of the endocrine system: gipoglikemiâ (when used in inadequate doses).

Allergic reactions: skin rash.

Contraindications

- Diabetic ketoacidosis, diabetic precoma, coma;

- Severe renal dysfunction;

- Abnormal liver function;

- Acute alcohol poisoning;

- Severe infections;

- State, which may contribute to the development of lactic acidosis, incl. cardiac and respiratory failure, acute phase of myocardial infarction, acute ischemic stroke, degidratatsiya, Saint Martin's evil;

- Lactic acidosis and guidance to him in history;

- Major surgery or injury (In these cases, it is shown holding insulin);

- Application for a 2 days before and 2 days after the radioisotope or radiological examinations with the introduction of iodinated contrast agents;

- Compliance with a reduced-calorie diet (less 1000 cal / day);

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

It is not recommended to use the drug in patients over 60 years, performing heavy physical work, due to the increased risk of lactic acidosis.

Pregnancy and lactation

Formetin^® contraindicated during pregnancy and lactation (breast-feeding).

Cautions

During the period of use of the drug should be monitored renal function. At least 2 once a year, and when a myalgia should be determined in plasma lactate.

Perhaps the use of Formetina^® in combination with sulfonylureas or insulin, and there must be particularly careful monitoring of blood glucose.

Effects on ability to drive vehicles and management mechanisms

When used as a monotherapy drug has no effect on the ability to transport and work with mechanisms.

When combined Formetina^® with other hypoglycemic drugs (sulfonylureas, insulin) may develop hypoglycaemia, where the deteriorating ability to drive vehicles and other potentially dangerous activities, require increased attention and psychomotor speed reactions.

Overdose

Symptoms: may develop fatal lactic acidosis. The reason for the development of lactic acidosis may also be the accumulation of the drug due to renal dysfunction. Early symptoms of lactic acidosis are weakness, nausea, vomiting, diarrhea, declination of fever, stomach ache, muscle aches, decrease in blood pressure, reflektornaya bradycardia, further possible shortness of breath, dizziness, impaired consciousness and coma.

Treatment: when the signs of lactic acidosis, metformin therapy should be stopped, and the patient hospitalized immediately, determine the concentration of lactate, confirm the diagnosis. Hemodialysis is the most effective for the excretion of lactate and metformin. If necessary spend symptomatic therapy.

Drug Interactions

While the use of sulfonylureas, akarʙozoj, insulinom, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, clofibrate derivatives, cyclophosphamide, and beta-blockers may increase the hypoglycemic effect of metformin.

At simultaneous application with Valium, oral contraceptives, epinephrine (adrenaline), simpatomimetikami, glucagon, thyroid hormone, and thiazide “loop” Diuretics, phenothiazine derivatives and nicotinic acid may reduce the hypoglycemic effect of metformin.

Cimetidine slows down metformin, thereby increasing the risk of lactic acidosis.

Metformin may weaken the effect of anticoagulants (coumarin derivatives).

At simultaneous reception with ethanol may develop lactic acidosis.

With simultaneous application of nifedipine increases absorption of metformin and C_max, slows down.

Cationic drugs (amlodipine, Digoxin, morphine, prokaynamyd, quinidine, quinones, ranitidine, triamterene, vancomycin), secreted into the tubules, compete for tubular transport systems and long-term therapy may increase C_max preparation on 60%.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life – 2 year. Do not use after the expiry date, on the package.