Janumet 500
Endocrinology

Janumet 500

Janumet 500

Janumet (500 mg) is recommended for lowering blood sugar levels and for the treatment of type II diabetes. Assign both as an independent tool or in combination with others. Metformin and sitagliptin – the active components – complement and enhance the action of each other, have good absorption. Read more about the dosage and features of the reception in the instructions.

Information

Indications for use (instruction)

For the treatment of adult patients with type II diabetes mellitus:

  • Janumet is indicated as an addition to the diet and exercise regimen to improve glycemic control in patients who have not achieved adequate control on the background of metformin monotherapy at the maximum tolerated dose, as well as in patients who are already receiving treatment with a combination of sitagliptin and metformin.
  • Janumet is indicated in combination with sulfonylurea derivatives (a combination of three drugs) as an addition to the diet and exercise regimen for patients who have not achieved adequate control during metformin therapy at the maximum tolerated dose and sulfonylurea.
  • Janumet is indicated in combination with peroxisome proliferator-activated receptor agonists (PPAR-γ) (e.g., thiazolidinediones) (a combination of three drugs) as a supplement to diet and exercise regimen for patients who have not achieved adequate control during metformin therapy at the maximum tolerated dose and agonist of PPAR-γ.
  • Janumet is also indicated for patients taking insulin (a combination of three drugs), as an addition to the diet and exercise regimen to improve glycemic control in patients who have not achieved adequate control during treatment with a stable dose of insulin and metformin.

How to use

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

Adults with normal renal function (GFR> 90 ml/min).

For patients who have not achieved adequate control with metformin monotherapy at the maximum tolerated dose.

An initial recommended dose of Janumet for patients who have not adequately controlled with metformin monotherapy should provide a daily recommended dose of sitagliptin 100 mg (50 mg 2 times daily) plus the current dose of metformin.

For patients switching from simultaneous administration of sitagliptin and metformin.

When switching from sitagliptin and metformin as monopreparations, the starting dose of Janumet should be equivalent to the one in which sitagliptin and metformin were used separately.

For patients who have not achieved adequate control in the treatment of the maximum tolerated dose of metformin and a sulfonylurea derivative.

The Janumet dose should provide the daily recommended dose of sitagliptin 100 mg (50 mg 2 times daily) plus close to the current dose of metformin. Patients using Janumet in combination with a sulfonylurea may need a lower dose of a sulfonylurea to reduce the risk of hypoglycemia.

For patients who have not been adequately controlled on treatment with the maximum tolerated dose of metformin and the PPAR-γ agonist.

The dose of Janumet should provide a daily dose of sitagliptin 100 mg (50 mg 2 times a day) plus close to the current dose of metformin.

For patients who have not been adequately controlled on treatment with the maximum tolerated dose of insulin and metformin.

The dose of Janumet should provide a daily dose of sitagliptin 100 mg (50 mg 2 times a day) plus close to the current dose of metformin. When using Janumet with insulin, it may be advisable to reduce the current dose of insulin to reduce the risk of hypoglycemia.

Patients should continue to follow a special diet with an adequate distribution of carbohydrate intake throughout the day. Overweight patients should continue to maintain a low calorie diet.

Individual patient groups

Renal insufficiency.

Patients with moderate renal dysfunction (glomerular filtration rate [GFR] ≥ 60 ml/min) do not require dose adjustment. GFR should be evaluated prior to treatment with metformin containing drugs at least once a year thereafter. Patients at increased risk of further progression of renal failure and the elderly should have their kidney function evaluated more frequently, for example, every 3–6 months.

It is better to divide the maximum daily dose of metformin into 2–3 doses. Factors that may increase the risk of lactic acidosis should be considered before the administration of metformin to patients with GFR <60 ml/min.

Dysfunction of the liver. Janumet should not be given to patients with hepatic impairment.

Elderly patients. Because metformin and sitagliptin are excreted by the kidneys, Janumet should be used with caution in elderly patients. To prevent metformin-related lactic acidosis, renal function should be monitored, especially in elderly patients.

Children. The safety and efficacy of Janumet for children and adolescents (under 18 years of age) have not been studied.

Contraindications

  • Hypersensitivity to sitagliptin phosphate, metformin hydrochloride or to any other component of the drug.
  • Any type of acute metabolic acidosis (e.g. lactic acidosis, diabetic ketoacidosis, diabetic coma).
  • Severe renal failure (rCGF <30 ml/min).
  • Acute conditions that can affect kidney function: dehydration, severe infections, shock, intravascular administration of iodinated contrast agents.
  • Acute or chronic diseases that can lead to tissue hypoxia, such as heart or lung failure, recent myocardial infarction, shock.
  • Impaired liver function.
  • Acute alcohol intoxication, alcoholism.
  • The period of breastfeeding.
  • Type I diabetes.

Composition

Active ingredients: sitagliptin, metformin hydrochloride;

1 coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg sitagliptin and 500 mg metformin hydrochloride.

Excipients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium stearyl fumarate.

Shell tablets: dye Opadry II 85F94203 pink.

The composition of the dye: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 3350, talc, black iron oxide (E172), red iron oxide (E 172).

Release form

14 tablets in a blister; 4 blisters per carton. Tablets coated with a film sheath.

Basic physical and chemical properties:

50/500 mg tablets: film coated tablets, light pink with 575 engraving on one side and smooth on the other.

Storage conditions

Store in the original package at a temperature not exceeding 25 °C, out of the reach of children.

Manufacturer

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, the Netherlands.

Sanitary and hygienic conclusion

№ 1772 dated 08/12/2019

Registration certificate

UA/11003/01/01