Januvia® 25 mg film-coated tablets
Januvia® 50 mg film-coated tablets
Januvia® 100 mg film-coated tablets
Each 25 mg tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Each 50 mg tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Each 100 mg tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
For the full list of excipients, see section 6.1.
Film-coated tablet (tablet).
25 mg tablet: Round, pink film-coated tablet with “221” on one side.
50 mg tablet: Round, light beige film-coated tablet with “112” on one side.
100 mg tablet: Round, beige film-coated tablet with “277” on one side.
For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
as monotherapy
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
as triple oral therapy in combination with
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ
