Januvia

Adult patients with type 2 diabetes, Januvia is indicated to improve glycemic control:

as monotherapy:

• when the patient's condition is not properly controlled by diet and exercise alone and when metformin cannot be used due to contraindications or intolerance;

as dual oral therapy in combination with:

• metformin when diet and exercise in combination with metformin alone do not provide adequate glycemic control;
• sulfonylurea when diet and exercise combined with the maximum tolerated dose of sulfonylurea alone do not provide adequate glycemic control and when metformin cannot be used due to contraindications or intolerance;
• peroxisome proliferator activator gamma receptor agonist (PPARγ) (ie thiazolidinedione) when the use of a PPARγ agonist is appropriate and when diet and exercise alone in combination with the PPARγ agonist alone do not provide adequate glycemic control;

as triple oral therapy in combination with:

• sulfonylurea and metformin when diet and exercise in combination with dual therapy with these drugs do not provide adequate glycemic control;
• the PPARγ agonist and metformin when the use of the PPARγ agonist is appropriate and when diet and exercise combined with dual therapy with these drugs do not provide adequate glycemic control.

Januvia is also indicated as an insulin supplement (with or without metformin) when diet and exercise combined with a stable dose of insulin do not provide adequate glycemic control.

It is recommended that you take 100 mg of Januvia once a day as monotherapy or in combination with a metformin and / or PPARγ agonist (such as thiazolidinedione).

When administered in combination with Sulfonylurea or insulin, a lower dose of Sulfonylurea or insulin is considered to reduce the risk of hypoglycaemia.

If the patient has missed the dose, the dose should be taken as soon as possible after the patient has mentioned a missed dose. It is unacceptable to take a double dose of Januvia on the same day.

Januvia can be taken irrespective of food intake.

Patients with impaired renal function

As the dose depends on the function of the kidneys, it is recommended to evaluate the function of the kidneys before taking the drug and periodically during treatment.

Patients with mild renal failure (glomerular filtration rate [GFR] from ≥60 to <90 ml/min) do not require a dose adjustment of Januvia.

Patients with moderate renal insufficiency (GFR of ≥45 to <60 ml/min) do not require a dose adjustment of Januvia.

For patients with moderate renal insufficiency (GFR of ≥30 to <45 ml/min), the dose of Januvia is 50 mg once daily.

For patients with severe renal insufficiency (GFR ≥15 to <30 ml/min) or with terminal renal failure (GFR <15 ml/min), including those requiring hemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once a day.

Patients with hepatic insufficiency

No dosage adjustment is needed for patients with mild or moderate hepatic impairment. The use of the drug has not been studied in patients with severe hepatic impairment, therefore caution should be exercised.

Elderly patients

No dosage adjustment is required for the elderly.

Children

The efficacy and safety of administration of the drug to patients under the age of 18 have not been sufficiently studied, so the drug should not be assigned to this age group.

• Hypersensitivity to any of the components of the drug.
• Type 1 diabetes.
• Diabetic ketoacidosis.

Active ingredient: sitagliptin;

1 film-coated tablet contains sitagliptin phosphate hydrate equivalent to 25 mg, 50 mg or 100 mg sitagliptin.

Excipients: microcrystalline cellulose, calcium hydrophosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate.

Tablet shell: Opadray® II dye pink or light beige or beige.

14 tablets in a blister. 2 blisters in a carton.

Store in a dark place at a temperature not exceeding 30 °C.

Keep out of the reach of children.

Manufacturer responsible for the series release:

Merck Sharp and Dohme BV, Vaarderweg 39, 2031 BN Haarlem, The Netherlands.

Full cycle manufacturer:

Merck Sharp & Dohme Limited, Shotton Lane, Cramlington, Northumberland NE23 3JU, United Kingdom.

No.1772 of 08/12/2019
Registration certificate (for dosage of 25 mg): UA/9432/01/01
Registration certificate (for a dosage of 50 mg): UA/9432/01/02
Registration certificate (for a dosage of 100 mg): UA/9432/01/03