SITAGLIPTIN SANDOZ sitagliptin (as hydrochloride monohydrate) 100 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin hydrochloride monohydrate, Quantity: 113.37 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: iron oxide black; calcium hydrogen phosphate; purified talc; hyprolose; microcrystalline cellulose; titanium dioxide; macrogol 6000; sodium stearylfumarate; croscarmellose sodium; hypromellose; iron oxide red; iron oxide yellow; magnesium stearate

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SITAGLIPTIN SANDOZ 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: Light brown, round, biconvex film coated tablet debossed with ST 100 on one side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-11-10