Velmetia, 850 mg+50 mg 56 pcs.

Indications

Monotherapy

Pharmacological effect

Pharmacotherapeutic group:

Special instructions

Velmetia®

Active ingredient

Metformin, Sitagliptin

Composition

Active ingredients:

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

Excipients:

microcrystalline cellulose 96.64 mg,

povidone K-29/32 78.19 mg,

sodium stearyl fumarate 22.34 mg,

sodium lauryl sulfate 5.585 mg;

tablet shell Opadry® 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%.

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.

Interaction

Sitagliptin and metformin

Overdose

Sitagliptin

In clinical studies in healthy volunteers, single doses of sitagliptin up to 800 mg were generally well tolerated. Minimal changes in the QT interval, not considered clinically significant, were noted in one study of sitagliptin at a daily dose of 800 mg (see section “Pharmacodynamics. Effect on cardiac electrophysiology”). Doses above 800 mg per day have not been studied in humans.
In clinical studies of multiple doses of the drug (Phase I), no adverse reactions associated with treatment with sitagliptin were observed when taking the drug in a daily dose of up to 400 mg for 28 days.

In case of overdose, it is necessary to begin standard supportive measures: removal of the unabsorbed drug from the gastrointestinal tract, monitoring vital signs, including ECG, and prescribing symptomatic therapy if necessary.
Sitagliptin is poorly dialyzed: according to clinical studies, only 13.5% of the dose was excreted during a 3-4 hour dialysis session. If clinically necessary, prolonged hemodialysis is prescribed. There are no data on the effectiveness of peritoneal dialysis with sitagliptin.

Metformin
There have been cases of metformin overdose, including doses exceeding 50 g (50,000 mg). Hypoglycemia was observed in approximately 10% of all overdose cases, but a clear connection with metformin overdose has not been established. The development of lactic acidosis accompanied approximately 32% of all cases of metformin overdose (see section “Special instructions. Metformin”). Emergency hemodialysis is possible (metformin is dialyzed at a rate of up to 170 ml/min under conditions of good hemodynamics) to accelerate the removal of excess metformin if an overdose is suspected.

Storage conditions

Store at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

2 years.

Manufacturer

Berlin-Pharma/Berlin-Chemie AG, Russia