Velmetia, 1000 mg+50 mg 56 pcs.

Pharmacotherapeutic group:
Hypoglycemic agent for oral administration combined (dipeptidyl peptidase-4-inhibitor + biguanide)
ATC:
A.10.B.D Combination of biguanides and sulfonylurea derivatives
A.10.B.D.07 Metformin and sitagliptin

Pharmacodynamics:
The drug Velmetia® 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 enzyme dipeptidyl peptidase-4 (DPP-4), and metformin, a representative of the class of biguanides.

Indications

Monotherapy
Velmetia® is indicated as initial therapy in patients with type 2 diabetes mellitus to improve glycemic control if diet and exercise do not achieve adequate control.

Velmetia® is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate control with metformin or sitagliptin monotherapy, or after unsuccessful combination treatment with two drugs.

Combination therapy
Velmetia® is indicated for patients with type 2 diabetes mellitus to improve glycemic control in combination with a sulfonylurea (triple combination: metformin + sitagliptin + sulfonylurea) when diet and exercise regimen in combination with two of these three drugs: metformin, sitagliptin or sulfonylurea do not lead to adequate glycemic control.

Velmetia® is indicated for patients with type 2 diabetes mellitus to improve glycemic control in combination with thiazolidinediones (peroxisome proliferator-activated receptor agonists) when diet and exercise regimen in combination with two of these three drugs: metformin, sitagliptin or thiazolidinedione do not lead to adequate glycemic control.
Velmetia® is indicated for patients with type 2 diabetes mellitus to improve glycemic control in combination with insulin when diet and exercise regimen in combination with insulin do not lead to adequate glycemic control.

Pharmacological effect

Pharmacotherapeutic group:
Combined hypoglycemic agent for oral administration (dipeptidyl peptidase-4 inhibitor + biguanide)
ATX:
A.10.B.D Combination of biguanides and sulfonylureas
A.10.B.D.07 Metformin and sitagliptin

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

Special instructions

Velmetia®

Active ingredient

Metformin, Sitagliptin

Composition

Active ingredients:

sitagliptin phosphate monohydrate 64.25 mg (equivalent to 50 mg sitagliptin) and metformin hydrochloride 1000 mg.

Excipients:

microcrystalline cellulose 112.3 mg,

povidone K-29/32 91.00 mg,

sodium stearyl fumarate 26.00 mg,

sodium lauryl sulfate 6,500 mg.

Opadry® II red tablet coating, 85F15464 (32.50 mg) contains:

polyvinyl alcohol 48.300%,

titanium dioxide (E 171) 6.000%,

Macrogol 3350 (polyethylene glycol) 24.380%,

talc 17.870%,

iron oxide black (E 172) 0.150%,

iron oxide red (E 172) 3.300%.

Pregnancy

Velmetia®

Contraindications

– Known hypersensitivity to sitagliptin, metformin or any of the components of Velmetia®.
– Diabetes mellitus type 1.
– Kidney disease or decreased renal function (with serum creatinine concentrations ≥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 a risk of developing renal dysfunction:
– dehydration (with diarrhea, vomiting), fever, severe infectious diseases,
– hypoxia conditions (shock, sepsis, kidney infections, bronchopulmonary diseases).
– Acute or chronic metabolic acidosis, including diabetic ketoacidosis (with or without coma).
– Clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including cardiac or respiratory failure, acute myocardial infarction).
– Major surgical operations and injuries, when insulin therapy is indicated (see section “Special instructions”).
– Liver failure, liver dysfunction.
– Chronic alcoholism, acute alcohol poisoning.
– Pregnancy, breastfeeding period.
– Lactic acidosis (including history).
– Use for at least 48 hours before and 48 hours after radioisotope or x-ray studies with the introduction of an iodine-containing contrast agent (see section “Interaction with other drugs”).
– Following a hypocaloric diet (less than 1000 kcal/day).
– Children under 18 years of age.

Side Effects

In studies, combination treatment with sitagliptin and metformin was generally well tolerated by patients with type 2 diabetes mellitus. The incidence of side effects with combination treatment with sitagliptin and metformin was comparable to the incidence with metformin in combination with placebo.

Combination treatment with sitagliptin and metformin

Initial therapy

In a study of initial combination therapy with sitagliptin and metformin (sitagliptin 50 mg + metformin 500 mg or 1000 mg x twice daily), the following drug-related adverse reactions were observed in the combination therapy group compared with metformin (500 mg or 1000 mg x twice daily), sitagliptin (100 mg once daily) or placebo monotherapy groups: observed with a frequency of ≥1% in the combination treatment group and more often than in the placebo group: diarrhea (sitagliptin + metformin – 3.5%, metformin – 3.3%, sitagliptin – 0.0%, placebo – 1.1%), nausea (1.6%, 2.5%, 0.0% and 0.6%), dyspepsia (1.3%, 1.1%, 0.0% and 0.0%), flatulence (1.3%, 0.5%, 0.0% and 0.0%), vomiting (1.1%, 0.3%, 0.0% and 0.0%), headache (1.3%, 1.1%, 0.6% and 0.0%) and hypoglycemia (1.1%, 0.5%, 0.6% and 0.0%).
Adding sitagliptin to current metformin therapy

Interaction

Sitagliptin and metformin

Overdose

Sitagliptin

Storage conditions

Store at a temperature not exceeding 25 °C.

Shelf life

2 years.

Manufacturer

Berlin-Pharma/Berlin-Chemie AG, Russia