MSD-ERTUGLIFLOZIN-SITAGLIPTIN 5/100 ertugliflozin/sitagliptin (as phosphate monohydrate) 5 mg/100 mg film-coated tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin phosphate monohydrate, Quantity: 128.5 mg (Equivalent: sitagliptin, Qty 100 mg); ertugliflozin pyroglutamic acid, Quantity: 6.48 mg (Equivalent: ertugliflozin, Qty 5 mg)

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; sodium stearylfumarate; microcrystalline cellulose; calcium hydrogen phosphate; Carnauba Wax; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black

Administration route:

Oral

Units in package:

7, 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MSD-ERTUGLIFLOZIN-SITAGLIPTIN (ertugliflozin and sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE]

Product summary:

Visual Identification: Beige, almond-shaped, film-coated tablets debossed with '554' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2018-05-17