Rhea Dapagliflozin

Rhea Dapagliflozin Dosage/Direction for Use

Manufacturer:

AstraZeneca

Distributor:

Philusa
Full Prescribing Info
Dosage/Direction for Use
The recommended dose of Dapagliflozin is 10 mg 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 is 10 mg 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 metformin), 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 and metformin when used as initial combination therapy are 10 mg Dapagliflozin plus 500 mg 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: Patients with Renal Impairment: No dosage adjustment is required based on renal function.
The glucose lowering efficacy of dapagliflozin is reduced in patients with eGFR <45 mL/min/1.73 m2 (see Precautions and Pharmacology: Pharmacodynamics under Actions). Therefore, if eGFR falls below 45 mL/min/1.73 m2, additional glucose lowering treatment should be considered in patients with diabetes mellitus.
Patients with Hepatic Impairment: No dosage adjustment for Dapagliflozin is necessary for patients with mild, moderate, or severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Pediatric and Adolescent Patients: Safety and effectiveness of Dapagliflozin in pediatric and adolescent patients have not been established.
Geriatric Patients: No dosage adjustment for Dapagliflozin is required based on age (see Pharmacology: Pharmacodynamics: Special populations under Actions). Older patients are more likely to have impaired renal function. The renal function recommendation provided for all patients also apply to elderly patients (see Use in Patient with Renal Impairment under Precautions).
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