APO-SITAGLIPTIN sitagliptin 25 mg (as phosphate monohydrate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin phosphate monohydrate, Quantity: 32.125 mg (Equivalent: sitagliptin, Qty 25 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

sitagliptin phosphate monohydrate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: iron oxide red; purified talc; titanium dioxide; hyprolose; croscarmellose sodium; hypromellose; macrogol 8000; microcrystalline cellulose; magnesium stearate; iron oxide yellow; calcium hydrogen phosphate

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sitagliptin is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:,- as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used.,- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.,- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control.,- as add-on combination therapy with insulin (with or without metformin).

Product summary:

Visual Identification: Pink, round biconvex coated tablet. Engraved "SIT" over "25" on one side and "APO" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-04-15