Velmetia, 850 mg+50 mg 56 pcs.

Active ingredient

Metformin, Sitagliptin

Composition

Active ingredients:

Sitagliptin phosphate monohydrate 64.25 mg (equivalent to 50 mg sitagliptin) and metformin hydrochloride 850 mg.

Auxiliary substances:

Microcrystalline cellulose 96.64 mg,

povidone K-29/32 78.19 mg,

sodium stearyl fumarate 22.34 mg,

sodium lauryl sulfate 5.585 mg;

the tablet sheath Opadray® II pink, 85F94182 (27.93 mg) contains:

Polyvinyl alcohol 49.950%,

Titanium dioxide (E 171) 6.000%,

Macrogol 3350 (polyethylene glycol) 25.210%,

talc 18.470%,

iron oxide black (E 172) 0.020%,

iron oxide red (E 172) 0.350%.

How to take, the dosage

General information
The dosing regimen of Velmetia® should be selected individually, based on the current therapy, efficacy and tolerability, but not exceeding the maximum recommended daily dose of sitagliptin 100 mg.
Velmetia® is usually administered in a twice-daily regimen with meals, with gradual dose increase to minimize possible gastrointestinal (GI) side effects characteristic of metformin.

Dosing recommendations
The starting dose of Velmetia® depends on current hypoglycemic therapy. Velmetia® is taken twice daily with meals.
The following dosages of the drug are suggested:
850 mg metformin + 50 mg sitagliptin,
1000 mg metformin + 50 mg sitagliptin.

Start therapy
Patients with type 2 diabetes with inadequate glycemic control against a background of diet and exercise regime, the recommended starting dose is 500 mg metformin + 50 mg sitagliptin* twice daily. Subsequently, the dose may be increased to 1000 mg metformin + 50 mg sitagliptin twice daily.

For patients not achieving adequate control on metformin monotherapy
The recommended starting dose of Velmetia® for patients not achieving adequate control on metformin monotherapy should provide the recommended therapeutic daily dose of sitagliptin 100 mg, i.e.i.e., 50 mg sitagliptin twice daily plus the current dose of metformin.

For patients not achieving adequate control on sitagliptin monotherapy
The recommended starting dose for patients not achieving adequate control on sitagliptin monotherapy is 500 mg metformin + 50 mg sitagliptin* twice daily. Subsequently, the dose may be increased to 1000 mg metformin + 50 mg sitagliptin 2 times daily. In patients taking a dose of sitagliptin adjusted for renal failure, treatment with Velmetia® is contraindicated (see section “Contraindications”).
For patients taking a combination of sitagliptin and metformin

When changing from the combination treatment of sitagliptin and metformin, the starting dose of Velmetia® may be equivalent to the doses of sitagliptin and metformin taken separately.

For patients taking two of the above three hypoglycemic drugs – sitagliptin, metformin or sulfonylurea derivatives

The starting dose of Velmetia® should provide the recommended therapeutic daily dose of sitagliptin 100 mg, ie, 50 mg sitagliptin twice daily. The starting dose of metformin should be determined based on the level of glycemic control and the current (if the patient is taking this medication) dose of metformin.

Increasing the dose of metformin should be gradual to minimize the associated gastrointestinal side effects. In patients taking a sulfonylurea derivative, it would be reasonable to reduce the current dose to reduce the risk of sulfonyl-induced hypoglycemia (see section “Special Precautions”).

For patients taking two of the above three hypoglycemic drugs – sitagliptin, metformin or PPARy-receptor agonists (thiazolidinediones)

The starting dose of Velmetia® should correspond to the daily dose of sitagliptin 100 mg, i.e.i.e., 50 mg sitagliptin twice daily and the previously taken metformin dose. If it is necessary to increase the metformin dose, gradual titration of the drug is recommended to avoid gastrointestinal side effects.

For patients taking two of the above three hypoglycemic drugs – sitagliptin, metformin or insulin
The starting dose of Velmetia® should correspond to the daily dose of sitagliptin 100 mg, i.e. 50 mg sitagliptin twice daily and the previously taken metformin dose. If it is necessary to increase the dose of metformin, gradual titration of the drug is recommended to avoid gastrointestinal side effects. Patients may need to reduce the dose of insulin to prevent the risk of hypoglycemia (see section “Cautions”).

Special studies to evaluate the safety and effectiveness of switching from treatment with other hypoglycemic drugs to treatment with the combination drug Velmetia have not been conducted. Any changes in treatment of type 2 diabetes mellitus should be performed with caution and under control of appropriate parameters, taking into account possible changes in glycemic control.

Administration in children
Safety of Velmetia® in children and adolescents under 18 years of age has not been studied.
* – When prescribing the starting therapy, it should be noted that Velmetia® in dosage 500 mg metformin + 50 mg sitagliptin is not registered in the Russian Federation.

Contraindications

– Known hypersensitivity to sitagliptin, metformin or any of the components of Velmetia®.
– Type 1 diabetes mellitus.
– Renal disease or decreased renal function (with serum creatinine concentration ≥1.5 mg/dL and ≥1.4 mg/dL in men and women respectively or decreased creatinine clearance (< 60 ml/min), including due to cardiovascular collapse (shock), acute myocardial infarction or septicemia.
– Acute conditions with risk of renal dysfunction:
– Dehydration (during diarrhea, vomiting), fever, severe infectious diseases,
– Hypoxic conditions (shock, sepsis, renal infections, bronchopulmonary diseases).
– Acute or chronic metabolic acidosis, including diabetic ketoacidosis (with or without coma).
– Clinically pronounced manifestations of acute and chronic diseases that may lead to the development of tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction).
– Extensive surgical operations and injuries when insulin therapy is indicated (see section “Special indications”).
– Liver failure, liver dysfunction.
– Chronic alcoholism, acute alcohol poisoning.
– Pregnancy, breast-feeding.
– Lactoacidosis (including in anamnesis).
– Administration for at least 48 hours before and for 48 hours after radioisotopic and X-ray studies with iodine contrast agent administration (see section “Interaction with other medicinal products”).
– Compliance with a hypocaloric diet (less than 1000 kcal/day).