Duglimax (metformin hydrochloride) tablets 500 mg/1 mg. №60

Description

Duglimax №60 Storage
active substances: metformin hydrochloride (metformin hydrochloride), glimepiride (glimepiride);

1 tablet contains metformin hydrochloride (prolonged action) 500 mg and glimepiride 1 mg or metformin hydrochloride (prolonged action) 500 mg and glimepiride 2 mg;

Excipients (tablets 500 mg / 1 mg): sodium carboxymethylcellulose, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, iron oxide red (E 172);

Excipients (tablets 500 mg / 2 mg): sodium carboxymethylcellulose, hypromellose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, Pigment Blend PB-51323 green.

Duglimax №60 Dosage form
Tablets.

Basic physical and chemical properties:

Douglimax® (500 mg / 1 mg): two-layer, capsule-shaped biconvex tablets on one side pink, on the other – white, smooth on both sides; marbling is allowed;

Douglimax® (500 mg / 2 mg): two-layer, capsule-shaped biconvex tablets on one side green, on the other – white, smooth on both sides; marbling is allowed.

Pharmacotherapeutic group
Antidiabetic drugs. Combination of oral hypoglycemic drugs.

ATX code A10B D02.

Duglimax №60 Pharmacological properties

Pharmacodynamics.

Glimepiride is a substance that has hypoglycemic activity when administered orally and belongs to the group of sulfonylureas. It can be used in non-insulin dependent diabetes mellitus.

The effect of glimepiride is realized by stimulating the release of insulin from β-cells of the pancreas. Like other sulfonylurea derivatives, it increases the sensitivity of pancreatic β-cells to physiological glucose stimulation. In addition, glimepiride, like other sulfonylurea derivatives, is likely to have a pronounced extrapancreatic effect.

Insulin release.

Sulfonylurea regulates insulin secretion by closing ATP-sensitive potassium channels on the β-cell membrane. This closure leads to depolarization of the cell membrane, as a result of which calcium channels open and a large amount of calcium enters the cell.

This stimulates the release of insulin by exocytosis.

Indication
As a supplement to diet and exercise for patients with non-insulin dependent diabetes mellitus type II:

if monotherapy with sulfonylureas or metformin does not provide an adequate level of glycemic control;
when replacing combination therapy with sulfonylureas and metformin.

Contraindication
Insulin-dependent type I diabetes mellitus (eg history of ketonemia diabetes), diabetic ketonemia, diabetic coma and precoma.
Hypersensitivity to any of the excipients that are part of this drug, or derivatives of sulfonylureas, sulfonamides or biguanide.
Hepatic failure, severe hepatic impairment or hemodialysis patients. In case of severe hepatic and renal impairment, the patient should be switched to insulin to achieve proper control of blood sugar.
Renal failure, renal disease, or impaired renal function (as evidenced, for example, by an increase in plasma creatinine ≥ 1.5 mg / dL in men and ≥ 1.4 mg / dL in women, or impaired creatinine clearance), which may also be caused by conditions such as cardiovascular collapse (shock), acute myocardial infarction and septicemia.
Congestive heart failure that requires medical treatment; recent myocardial infarction; cardiovascular collapse or respiratory disorder.
Examination using radiological methods using intravascular administration of iodine-containing contrast agents (eg, intravenous urography, intravenous cholangiography, angiography, and computed tomography (CT) using intravascular administration of contrast agents). The use of methods of examination with intravascular administration of iodine-containing contrast agents may lead to acute renal impairment and be accompanied by the development of lactic acidosis in patients receiving metformin. Therefore, the use of Douglimax® in patients scheduled for any of these examinations should be temporarily discontinued 48 hours before the procedure and resumed no earlier than 48 hours after the procedure and only after re-evaluation of renal function and confirmation that it within normal limits.
Severe infections, conditions before and after surgery. Douglimax® should be temporarily discontinued during any surgical procedure (except for minor procedures that are not accompanied by restriction of food and fluid intake). The drug should not be resumed until the patient’s ability to take orally is restored and the results of the assessment of renal function show that it is within normal limits.
Malnutrition, starvation or exhaustion, as well as hypofunction of the pituitary or adrenal glands.
Hepatic impairment (because hepatic impairment is associated with isolated cases of lactic acidosis, this drug should be avoided in patients with clinical or laboratory signs of liver disease), pulmonary infarction, severe pulmonary dysfunction and other conditions that are likely to be accompanied by hypoxemia ( such as heart or respiratory failure, recent myocardial infarction, shock), excessive alcohol consumption, dehydration, gastrointestinal disorders, including diarrhea and vomiting.