Dapavid 10mg

INDICATIONS

Dapagliflozin (DAPAVID) is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

• As monotherapy when metformin is considered inappropriate due to intolerance.

• In addition to other medicinal products for the treatment of type 2 diabetes.

DOSAGE AND ADMINISTRATION

The recommended dose of Dapagliflozin (DAPAVID) is 10mg taken orally once daily at any time of the day regardless of meals.

Type 2 Diabetes Mellitus

Monotherapy and Add-On Combination Therapy

The recommended dose of Dapagliflozin (DAPAVID) is 10mg once daily as monotherapy or as add-on to combination therapy with metformin (with or without a sulfonylurea), a thiazolidinedione, a sulfonylurea, a DPP4 inhibitor (with or without metformin), a GLP-1 receptor agonist (prolonged-release exenatide), when initiated concomitantly with Dapagliflozin (with meformin), or insulin (with or without oral antidiabetic therapy, either metformin plus insulin dual therapy or metformin plus

sulfonylurea plus insulin triple therapy).

Initial Combination therapy

The recommended starting doses of Dapagliflozin (DAPAVID) and metformin when used as initial combination therapy are 10mg Dapagliflozin (DAPAVID) plus 500mg metformin once daily. Patients with inadequate glycemic control on this dose should further have their metformin dose increased according to approved local label guidelines.

Special populations

Renal impairment

Dapagliflozin should not be initiated in patients with a glomerular filtration rate [GFR] < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min.

No dose adjustment is required based on renal function.

Hepatic impairment

No dose adjustment is necessary for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg.

Elderly (≥ 65 years)

In general, no dose adjustment is recommended based on age. Renal function and risk of volume depletion should be taken into account.

Paediatric population

The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established. No data are available.

Note: The information given here is limited. For further information, kindly consult your doctor or pharmacist.

Caution: Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.