Properties
What is it?
DIALYPTIN-M 850 Composition: DIALYPTIN-M 850 film-coated tablets Each film-coated tablet contains: Metformin Hydrochloride USP 850 mg and Vildagliptin INN 50 mg. Excipients: Hydroxypropyl methylcellulose, Polyvinylpyrrolidone, Magnesium stearate, Purified talc, Microcrystalline cellulose; Coating agents: Sheff coat PVA (Polyvinyl alcohol, Lecithin, Purified talc, Titanium dioxide, PB 86620 Brown color). Indications: DIALYPTIN-M 850 film-coated tablets are indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control: • As initial therapy when diabetes is not adequately controlled by diet and exercise alone; • As therapy in patients who have not achieved adequate control with metformin hydrochloride or vildagliptin alone, or who are already being treated with a combination of vildagliptin and metformin hydrochloride as monotherapy; • As combination therapy – with other drugs, including insulin, when they do not provide adequate glycemic control. Important limitations on use DIALYPTIN-M 850 should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it will not be effective in these cases. Dosage and administration: Route of administration: For oral use DIALYPTIN-M 850 should be taken during meals to reduce gastrointestinal side effects associated with metformin hydrochloride. If a dose of the drug is missed, DIALYPTIN-M 850 should be taken as soon as the patient remembers. Do not take a double dose on the same day. Dosage: Adults The use of antihyperglycemic therapy in the treatment of type 2 diabetes should be individualized based on efficacy and tolerability. When using DIALYPTIN-M 850, do not exceed the maximum daily dose of vildagliptin (100 mg). The recommended starting dose of DIALYPTIN-M 850 should be based on the patient's condition and/or the current regimen of vildagliptin and/or metformin hydrochloride. Pregnancy and lactation: Pregnancy: The experience of using the drug DIALYPTIN-M 850 in pregnant women has not been sufficiently studied. Embryo-fetal development (teratology) studies were conducted in rats and rabbits using a 1:10 combination of vildagliptin and metformin hydrochloride and showed no evidence of teratogenicity in either species. DIALYPTIN-M 850 should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Animal studies do not always predict human response to a drug. Lactation: Animal studies have shown excretion of metformin and vildagliptin in milk. No studies have been conducted on the combined components of DIALYPTIN-M 850. Metformin is excreted in breast milk. It is unknown whether vildagliptin is excreted in breast milk. The drug should not be prescribed to nursing mothers.