Janumet pills 1000mg+50mg, 56pcs

Composition

1 film coated tablet contains:

Active ingredients:

Sitagliptin Phosphate monohydrate 64.25 mg (equivalent to 50 mg of sitagliptin);

Metformin hydrochloride 1000 mg.

Auxiliary substances:

Microcrystalline cellulose 59.30 mg;

Povidone 48.23 mg;

Sodium stearyl fumarate 13.78 mg;

Sodium Lauryl sulfate 3,445 mg.

The shell of the Opadray II Pink tablet,85 F 94203 (17.23 mg) contains:

Polyvinyl alcohol 47,800%;

Titanium dioxide (E 171) 6,000%;

Macrogol – 3350 23,500%;

Talc 22.590%;

Iron oxide black (E 172) 0.005%;

Iron oxide red (E 172) 0.105%.

Pharmacological action

Yanumet is a combination of two hypoglycemic drugs with a complementary mechanism of action designed to improve glycemic control in patients with type 2 diabetes: sitagliptin, an inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4), and metformin, a representative of the biguanide class.

Sitagliptin is an orally active, highly selective DPP-4 inhibitor intended for the treatment of type 2 diabetes mellitus.

Indications

• Yanumet is indicated as an adjunct to diet and exercise regimen to improve glycemic control in patients with type II diabetes mellitus who have not achieved adequate control during metformin or sitagliptin monotherapy, or after unsuccessful combined treatment with the two drugs.

• Yanumet is indicated in combination with sulfonylurea derivatives (a combination of three drugs) as an adjunct to diet and exercise regimen to improve glycemic control in patients with type II diabetes who have not achieved adequate control after treatment with two of the following three medications: metformin, sitagliptin, or sulfonylurea derivatives.

• Yanumet is indicated in combination with PPAR-α agonists (e. g. thiazolidinediones) as an adjunct to diet and exercise regimen to improve glycemic control in patients with type II diabetes who have not achieved adequate control after treatment with two of the following three medications: metformin, sitagliptin, or a PPAR-A agonist.

• Yanumet is indicated for patients with type II diabetes mellitus (a combination of three drugs) as an adjunct to diet and exercise regimen to improve glycemic control in combination with insulin.

Use during pregnancy and lactation

There are no relevant data on the use of sitagliptin in pregnant women.

Limited evidence suggests that the use of metformin in pregnant women is not associated with an increased risk of developing birth defects.

Yanumet should not be used during pregnancy. If the patient is planning pregnancy or becomes pregnant, treatment with Yanumet should be discontinued and insulin should be prescribed as early as possible.

Metformin passes into human milk in small amounts. It is not known whether sitagliptin is excreted in human milk. For this reason, Yanumet should not be used in women who are breast-feeding.

Contraindications

• Hypersensitivity to sitagliptin phosphate, metformin hydrochloride or any other component of the drug;wbr>Acute conditions that may affect kidney function: dehydration, severe infections, shock;
• Acute or chronic diseases that can lead to tissue hypoxia, such as heart or respiratory failure, a recent myocardial infarction, or shock.
• Moderate or severe renal impairment (creatinine clearance
• Impaired liver function;
• Acute alcohol intoxication, alcoholism;
• Breast-feeding period;
• Type I diabetes mellitus;
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis (with or without coma);
• Radiological studies (intravascular use of iodine-containing contrast agents).
• Side effects

Headaches.

• Drowsiness.

• Cough.

• Nausea;

• Abdominal pain;

• Diarrhea, constipation;

• Dry mouth;

• Vomiting;

• Pancreatitis.

• Peripheral edema.

• Interaction

The effect of metformin is weakened by thiazide and other diuretics, corticosteroids, phenothiazines, glucagon, thyroid hormones, estrogens, including as part of oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium antagonists, isoniazid. In a single dose in healthy volunteers, nifedipine increased the absorption, Cmax (by 20%), AUC (by 9%) of metformin, Tmax and T1/2 did not change.

Hypoglycemic effect is enhanced by insulin, sulfonylurea derivatives, acarbose, NSAIDs, MAO inhibitors, oxytetracycline, ACE inhibitors, clofibrate derivatives, cyclophosphamide, beta-blockers.

How to take it, course of use and dosage

The dosage regimen of Yanumet should be selected individually, based on current therapy, efficacy and tolerability, but not exceeding the maximum recommended daily dose of sitagliptin 100 mg.

The drug Yanumet is usually prescribed 2 times a day with meals, with a gradual increase in the dose, in order to minimize possible side effects from the gastrointestinal tract (GIT), characteristic of metformin. The initial dose of Yanumet depends on the current hypoglycemic therapy.

Overdose

When taking over the dose of Yanumet, it is first recommended to carry out standard measures: remove the remains of the unabsorbed drug from the gastrointestinal tract, monitor vital signs (ECG), conduct hemodialysis, and prescribe maintenance therapy if necessary.

Special instructions

Use in the elderly of Yanumet: since the main route of elimination of sitagliptin and metformin is the kidneys, and since the excretory function of the kidneys decreases with age, precautions for prescribing Yanumet increase in proportion to age. Elderly patients should be carefully selected for the dose and regularly monitored for renal function.

Form of production

Pills.

Storage conditions

At a temperature not exceeding 25 °C

Shelf

life is 2 years.

Active ingredient

Metformin, Sitagliptin

Conditions of release from pharmacies

By prescription

Dosage form

of the tablet

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes