NOVOFORMIN®

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

DOSAGE FORM, COMPOSITION AND PACKAGING

Pills, Film-coated from white to white with a yellowish tint, round, lenticular, with Valium on one side; of presentations – core from white to light yellow in color.

Excipients: povidone, polyethylene glycol 6000, sorbitol (E420), magnesium stearate.

The composition of the coating film: Opadry Y-1-7000 (hydroxypropyl, polyethylene glycol 400, Titanium dioxide (E171), solid paraffin).

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

Pharmacological action

Oral hypoglycemic agents from the group of biguanides. NovoFormin^® inhibits hepatic gluconeogenesis, reduces glucose absorption from the intestine, increases peripheral glucose utilization, and improves the sensitivity of tissues to insulin. When this has no effect on insulin secretion from the beta cells of the pancreas, It does not cause hypoglycemic reactions. It reduces the level of triglycerides and cholesterol in the blood. 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 plasma levels achieved after 2.5 hours after ingestion.

Distribution

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

Deduction

T_1/2 is about 6.5 no. Excreted by the kidneys unchanged.

Pharmacokinetics in special clinical situations

If the kidney function possible drug accumulation.

Testimony

- Diabetes mellitus type 2 no inclination to ketoacidosis (especially in patients with obesity) the poor diet;

- In combination with insulin – diabetes mellitus type 2, especially when expressed with a degree of obesity of secondary insulin resistance.

Dosage regimen

Dose set individually depending on the level of glucose in the blood.

Coated tablets 500 mg. The initial dose is 500-1000 mg / day (1-2 tab.). Through 10-15 days may further gradual increase in the dose depending on blood glucose. Maintenance dose is usually 1.5-2 g / day (3-4 tab.). The maximum dose - 3 g / day (6 tab.).

Coated tablets 850 mg. The initial dose is 850 mg / day. Through 10- 15 days may further gradual increase in the dose depending on blood glucose. Maintenance dose is usually 1.7 g / day. The maximum dose - 2.55 g / day.

To elderly patients The recommended daily dose should not exceed 1 g (2 tab.).

Tablets should be taken as a whole during or immediately after a meal, drinking a small amount of liquid (glass of water). To reduce side effects of the digestive system of the daily dose be divided into 2-3 admission.

Due to the increased risk of lactic acidosis, the dose should be reduced in severe metabolic disorders.

Side effect

From the digestive system: nausea, vomiting, “metal” taste in the mouth, anorexia, diarrhea, flatulence, stomach ache. These symptoms often occur especially at the beginning of the treatment and, usually, are themselves. These symptoms can be reduced by the appointment of antacids, derivatives of atropine or antispasmodics.

Metabolism: rarely – Lactic acidosis (require discontinuation of treatment); long-term treatment – In gipovitaminoz₁₂ (malabsorption).

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

On the part of the endocrine system: gipoglikemiâ.

Allergic reactions: skin rash.

Contraindications

- Diabetic ketoacidosis;

- Diabetic precoma, coma;

- Renal dysfunction;

- Acute diseases, proceeding with the risk of renal dysfunction: degidratatsiya (diarrhea, rvote), fever, serious infectious disease, state hypoxia (shock, sepsis, kidney infections, bronchopulmonary diseases);

- Symptomatic manifestations of acute and chronic diseases, which can lead to the development of tissue hypoxia (incl. cardiac or respiratory failure, acute myocardial infarction);

- Major surgery or injury (when it is shown holding insulin);

- Abnormal liver function;

- Alcoholism, acute alcohol poisoning;

- Pregnancy;

- Lactation (breast-feeding);

- Lactic acidosis (incl. history);

- Application for at least 2 days prior to and during 2 days after the radioisotope or radiological examinations with administration of iodinated contrast agents;

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

- Hypersensitivity to the drug.

It is not recommended to use the drug in patients over 60 years, performing heavy physical work, which it is associated with an increased risk of developing lactic acidosis.

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breast-feeding).

When planning a pregnancy, and in the case of pregnancy while taking the drug NovoFormin^®, it should be withdrawn and insulin.

Data on the allocation of metformin in breast milk is not available. If necessary, use NovoFormin^® lactation, Breastfeeding should be discontinued.

Cautions

During the period of treatment is necessary to monitor renal function.

At least 2 once a year, and when a myalgia should be determined in plasma lactate.

Besides, 1 once every 6 months requires monitoring of serum creatinine (especially in elderly patients). It should appoint a drug NovoFormin^®, if the content of serum creatinine above 135 mmol / L in men and 110 mmol / L in women.

Perhaps NovoFormin drug application in combination with sulfonylureas. In this case, you need particularly careful monitoring of blood glucose.

For 48 hours prior to and during 48 hours after the application of X-ray contrast agents (at urography, I / angiography) should stop taking the drug NovoFormin^®.

When bronchopulmonary infection or infectious disease urinary organs the patient should immediately notify the doctor.

During treatment should refrain from drinking alcohol and drugs, containing ethanol.

Effects on ability to drive vehicles and operate machinery

Use of the drug as a single agent did not affect the ability to drive the truck and to the mechanisms.

With the combination of the drug NovoFormin^® with other hypoglycemic agents incl. (sulfonylureas, insulinom) may develop hypoglycaemia, where the deteriorating ability to drive vehicles and occupation of other potentially hazardous activities, requiring increased attention and rapid psychomotor 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 include nausea, vomiting, diarrhea, declination of fever, stomach ache, muscle aches, in the future there may be a shortness of breath, dizziness, impaired consciousness and coma.

Treatment: in case of signs of lactic acidosis, treatment with NovoFormin^® you must immediately stop, and the patient hospitalized immediately, determine the concentration of lactate, confirm the diagnosis. The most effective measure for the excretion of lactate and metformin is hemodialysis. Spend as symptomatic treatment.

In combination therapy with NovoFormin^® with sulfonylureas may develop hypoglycemia.

Drug Interactions

Not recommended simultaneous reception of danazol to avoid hyperglycemic action last. If necessary, treatment with danazol and after discontinuation of the last requires correction of the dose NovoFormin under the control of blood glucose levels.

Chlorpromazine when taken in high doses (100 mg / day) It increases the blood glucose level, reducing the release of insulin. When neuroleptic treatment and after discontinuation of the last requires correction of the dose NovoFormin under the control of blood glucose levels.

While the use of sulfonylureas, akarʙozoj, insulinom, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, clofibrate derivatives, tsiklofosfamida, β-blockers may increase the hypoglycemic effect of the drug NovoFormin^®.

At simultaneous application with Valium, oral contraceptives, epinephrine, simpatomimetikami, glucagon, thyroid hormone, and thiazide “loop” Diuretics, phenothiazine derivatives, nicotinic acid may reduce the hypoglycemic effect of the drug NovoFormin^®.

Cimetidine slows down metformin, Because of this increased risk of lactic acidosis.

The drug NovoFormin^® could weaken the effects of anticoagulants (coumarin derivatives).

Drinking alcohol increases the risk of lactic acidosis in acute alcohol intoxication, especially in cases of starvation or low calorie diet compliance, and liver failure.

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 at or above 25 ° C. Store in the original package. Shelf life – 3 year.