"Miriam E. Tucker
Medscape Medical News
The US Food and Drug Administration has approved the empagliflozin/linagliptin combination Glyxambi (Boehringer Ingelheim/Eli Lilly) as adjunctive treatment to diet and "...
FARXIGA (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies].
Limitation Of Use
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
DOSAGE AND ADMINISTRATION
The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.
Patients With Renal Impairment
Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter.
FARXIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m².
No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m² or greater).
Dosage Forms And Strengths
- FARXIGA 5 mg tablets are yellow, biconvex, round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side.
- FARXIGA 10 mg tablets are yellow, biconvex, diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side.
FARXIGA (dapagliflozin) tablets have markings on both sides and are available in the strengths and packages listed in Table 14.
Table 14: FARXIGA Tablet Presentations
|Tablet Strength||Film-Coated Tablet Color/Shape||Tablet Markings||Package Size||NDC Code|
|5 mg||yellow, biconvex, round||“5” engraved on one side and “1427” engraved on the other side||Bottles of 30||0310-6205- 30|
|10 mg||yellow, biconvex, diamond-shaped||“10” engraved on one side and “1428” engraved on the other side||Bottles of 30||0310-6210- 30|
Storage And Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Distributed by: AstraZeneca Pharmaceuticals LP W ilmington, DE 19850 Product of Ireland. Revised Dec 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/18/2015
Additional Farxiga Information
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