Janumet, 1000 mg+50 mg 56 pcs.

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

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

Indications

Janumet is indicated as an adjunct to diet and exercise regimen to improve glycemic control in patients with type II diabetes who have not achieved adequate control on monotherapy with metformin or sitagliptin, or after unsuccessful combination treatment with both drugs.

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

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

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

Active ingredient

Composition

1 film-coated tablet contains:

Active substances:

Sitagliptin phosphate monohydrate 64.25 mg (equivalent to 50 mg 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 Opadray II Pink tablet sheath, 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 %.

How to take, the dosage

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

Janumet is usually administered as a twice-daily regimen with meals, with gradual dose increases to minimize possible gastrointestinal (GI) side effects typical of metformin. The initial dose of the drug Janumet depends on the current hypoglycemic therapy.

Interaction

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

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

Special Instructions

Application in elderly Janumet: Since the kidneys are the main route of excretion of sitagliptin and metformin, and since renal excretory function decreases with age, the precautions for administration of Janumet increase in proportion to age. In elderly patients, careful dose selection and regular monitoring of renal function are performed.

Contraindications

Side effects

Headaches;

Drowsiness;

Cough;

Nausea;

Abdominal pain;

Overdose

When taking an overdose of Janumet, standard measures are recommended first: remove residual unabsorbed drug from the GI tract, monitor vital signs (ECG), perform hemodialysis, and prescribe supportive therapy if necessary.

Pregnancy use

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

Limited data suggest that metformin use in pregnant women is not associated with an increased risk of congenital malformations.

Janumet should not be used during pregnancy. If a patient plans to become pregnant or becomes pregnant, treatment with Janumet should be stopped and insulin should be prescribed as soon as possible.

Metformin passes into human milk in small amounts. It is not known whether sitagliptin is excreted with milk in humans. For this reason, Janumet should not be used in women who are breastfeeding.

Similarities