Forminum

General characteristics. Structure:

1 tablet, coated, contains:

Active agent: 850 mg of Metforminum of a hydrochloride.

Excipients:
sodium starch is glikolit, corn starch, povidone, silicon dioxide, magnesium stearate, a gidroksipropilmetiltsellyuloz, propylene glycol, titanium E-171 dioxide, polyethyleneglycol 6000, talc.

Description

Tablets, coated, white color, a round form, with biconvex surfaces.

Pharmacological properties:

Pharmacodynamics. Forminum reduces the increased glucose level in blood at patients with a non-insulin-dependent diabetes mellitus. The mechanism of effect of drug is finally not found out. Possibly, drug strengthens peripheral utilization of glucose, brakes a gluconeogenesis in a liver, reduces absorption of carbohydrates from digestive tract, and also increases sensitivity of fabrics to insulin, improving its linkng with receptors and facilitating its action at the post-receptor level. Drug has insignificant effect on secretion of an insuyolin. Forminum reduces the level of triglycerides of blood and has anticoagulative effect.

Toxicity researches at animals did not reveal both specific toxic, and teratogenic and oncogenous effect of drug.

Pharmacokinetics. After oral administration Forminum is not completely soaked up from digestive tract. Bioavailability after reception of a usual dose makes 50-60%. The maximum concentration in a blood plasma is reached in 2 h, drug vsayosyvatsya completely in 6 h after reception. Forminum practically does not contact proteins of plasma. Collects in sialadens, a duodenum, kidneys and a liver. The volume of distribution makes 63-276 l. It is allocated with kidneys in not changed look, time of semi-removal from plasma makes 1,5-4,5 h.

The second phase of allocation in a quantitative sense is less, T ½ of deep layers makes 8,9-19 h. The renal clearance of Forminum makes 350-550 ml/min. and correlates with clearance of creatinine that indicates an active canalicular sekreyotion of drug at allocation. At patients with an impaired renal function accumulation of drug in an organism is possible.

Indications to use:

Diabetes mellitus of the II tiyop (non-insulin-dependent), especially at the patients having obesity at inefficiency of a diyetoyoterapiya.

Route of administration and doses:

In an initiation of treatment usually appoint on 1 tablet (850 mg) a day. Then the dose on an extent from several days to two weeks a dose is gradually increased before achievement of therapeutic effect. The maintenance dose of drug usually makes 2 tablets. The maximum dose - 3 tablets a day. For an umensheyoniya of by-effects from digestive tract the daily dose should be divided into two receptions, to accept in time or after food. A pill is taken entirely, without chewing and washing down with water.

Owing to the increased risk of development of lactic acidosis, the dose of Forminum needs to be reduced at heavy metabolic disturbances and at appointment of advanced age as the patient.

In the beginning Forminum it is possible to appoint treatments as monotherapy or in combination with sulphonylurea drugs at attentive assessment of contraindications.

Interaction with other lekarstvennymisredstvo.

During treatment by Forminum it is necessary to avoid alcohol intake as it dopolniyotelno reduces glucose level in blood and causes increase in concentration of molochyony acid.

Use of Forminum in combination with other medicines (insulin, drugs of sulphonylurea and acarbose) can strengthen hypoglycemic action. Also some other medicines as, for example, non-steroidal anti-inflammatory drugs, the MAO inhibitors, Oxytetracyclinum, APF inhibitors derivative of Clofibratum, cyclophosphamide and its derivatives, β-adrenoblockers can strengthen this action.......... Action of Forminum decreases at its simultaneous use with some medicines: glucocorticoids, combination of estrogen and gestagen, adrenaline and other sympathomimetics, glucagon, hormones of a thyroid gland, thiazide and "loopback" diuretics, diazoxide, fenotiazina, derivatives of a nicotinic kisyolota.

Cimetidinum slows down an eliminatsiyuformin owing to what the risk of development of lactic acidosis increases.

Forminum can weaken effect of anticoagulants (proyoizvodny coumarin).

Features of use:

Before purpose of Forminum Pliva, and also through in 4 weeks from the beginning of therapy it is necessary to determine creatinine level in blood serum and to regularly control it 1-2 times a year.
 
With care and after ratio assessment between advantage and risk of use patients of advanced age should appoint Formin Pliva (65 years are more senior). Such patients need to define before its appointment clearance of creatinine since increase in level of creatinine in blood serum is not a reliable indicator of a renal failure at patients of this age group.
 
Pliva it is possible to appoint Forminum as motor-therapy or in combination with sulphonylurea drugs. Simultaneous use of Forminum Pliva with drugs of sulphonylurea or insulin can cause a hypoglycemia therefore it is necessary to carry out control of level of glucose to blood. The combined treatment by Forminum Pliva and insulin should be carried out in a hospital before establishment of an adequate dose of each drug.
 
At continuous therapy Pliva it is necessary to determine by Forminum concentration of cyanocobalamine (B12 vitamin) in blood serum in connection with possible reduction of its absorption once a year.
 
During treatment by Forminum Pliva it is necessary to avoid alcohol intake.
 
Influence on ability to driving of motor transport and to control of mechanisms
 
At a combination therapy Pliva and drug of sulphonylurea is not recommended by Forminum performance of the work demanding the increased concentration of attention and speed of psychomotor reactions because of possible risk of development of a hypoglycemia.

Side effects:

Forminum is usually well transferred in spite of the fact that in an initiation of treatment 5-20% of patients have disturbances from a digestive tract in the form of nausea, vomiting, abdominal pains, diarrhea, lack of appetite, emergence of metal taste in a mouth. The specified by-effects do not demand drug withdrawal. At use of small doses in an initiation of treatment and their gradual increase, at administration of drug in time or after food the frequency of emergence of side effects decreases. If the specified disturbances are observed longer time, treatment by Forminum it is necessary to stop.

The lactic acidosis caused Forminum arises in exclusively exceptional cases, however is a serious by-effect with a possible fatal outcome. Except overdose, lactic acidosis can develop owing to a renal failure and a liver, alcohol intake, a decompensation of cordial activity, serious infectious diseases and catabolic states, and also interaction with other drugs.

Skin allergic reactions are seldom or never observed.

Against the background of treatment Forminum celebrated isolated cases of disturbance of absorption of B12 vitamin and folic acid.

At a combination therapy Forminum and drug of sulphonylurea to patients do not recommend driving of vehicles and control of mechanisms because of possible emergence of a hypoglycemia.

Interaction with other medicines:

Strengthening of hypoglycemic action of Forminum Pliva perhaps at a concomitant use with other hypoglycemic drugs (sulphonylurea derivatives, acarbose, insulin), and also with NPVS, MAO inhibitors, Oxytetracyclinum, APF inhibitors derivative of Clofibratum, cyclophosphamide and its derivatives, beta adrenoblockers.
 
Decrease in hypoglycemic effect of drug is possible at a concomitant use with GKS, peroral is oestrogenic-gestagennymi the contraceptives, Epinephrinum and other sympathomimetics, a glucagon, hormones of a thyroid gland, thiazide and "loopback" diuretics, diazoxide derivative of a fenotiazin, niacin derivatives.
 
At reception of Forminum Pliva against the background of use of indirect anticoagulants - derivatives of coumarin weakening of action of the last is possible.
 
At simultaneous use with ethanol the risk of development of heavy side reactions (a hypoglycemia, lactic acidosis) increases.
 
The concomitant use of Cimetidinum slows down Metforminum removal owing to what the risk of development of lactic acidosis increases.

Contraindications:

• diabetic coma, prekoma, ketoacidosis;
• serious infectious diseases, injuries, surgeries when performing insulin therapy is shown;
• a renal failure and a liver (because of the increased risk of development of a hypoglycemia and lactic acidosis);
• heart failure, an acute phase  of a myocardial infarction, respiratory insufficiency, dehydration, an alcoholism and other states which can promote development of lactic acidosis;
• pregnancy and lactation;
• children's age;
• diabetes mellitus of the I type (insulin-dependent);
• a diabetes mellitus of I I types (non-insulin-dependent) at inefficiency of drugs of sulphonylurea;
• hypersensitivity to drug components;
• use within not less than 2 days before and 2 days after the X-ray or radiologichesyoky inspection with use of contrast means;
• observance of a diet with restriction of caloric content of food (<1000 kcal a day).

Precautionary measures

Use of Forminum is possible at normal function of kidneys. At states which can cause development of molochyonokisly acidosis it is necessary to monitor  glomerular filtering carefully. Prior to treatment and in 4 weeks from the beginning of therapy it is necessary to determine by Forminum creatinine level in blood serum and to regularly control it 1-2 times a year.

At elderly people increase in level of creatinine in blood serum is not a reliable indicator of a renal failure therefore prior to therapy it is necessary to define clearance of creatinine.

Simultaneous use with drugs of sulphonylurea or insulin can cause a hypoglycemia therefore it is necessary to carry out control of level of glucose to blood. The combined treatment by Forminum and insulin should be carried out in a hospital before establishment of an adequate dose of each drug.

At patients on continuous therapy with Forminum it is necessary опреде­лять the content of B12 vitamin because of possible reduction of its absorption once a year.

At patients of advanced age (more than 65 years), owing to the slowed-down metabolism, it is necessary to estimate attentively a ratio between advantage and risk of drug use.

Overdose:

At overdose of Forminum development of lactic acidosis with a fatalyyony outcome is possible. Also accumulation of Forminum  owing to a renal failure can be the reason of development of lactic acidosis. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, temperature increase, abdominal pains, muscle pains, further to be noted breath increase, golovokruzheyony, disturbance of consciousness and development of a coma. In case of symptoms of lactic acidosis, treatment by Forminum  needs to be stopped immediately, bolyyony urgently to hospitalize and, having defined concentration of a lactate and Forminum, to confirm the diagnosis. The most effective meroyopriyatiy on removal from an organism of a lactate and Forminum is the hemodialysis. Carry out also symptomatic treatment. At a combination therapy of Forminum with drugs of sulphonylurea the hypoglycemia can develop.

Storage conditions:

To store at the room temperature (15-25C). To STORE IN the PLACE, UNAVAILABLE TO CHILDREN! Period of validity 3 years. Drug cannot be used on expiry date, specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, on 850 mg. In packaging of 30 or 60 tablets.