"The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects about 24 million people and accounts for "...
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 m²or 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
|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||0003-1427-11|
|Bottles of 90||0003-1427-12|
|Bottles of 500||0003-1427-13|
|Hospital Unit Dose Cartons of 100||0003-1427-14|
|10 mg||yellow, biconvex, diamond-shaped||“10” engraved on one side and “1428” engraved on the other side||Bottles of 30||0003-1428-11|
|Bottles of 90||0003-1428-12|
|Bottles of 500||0003-1428-13|
|Hospital Unit Dose Cartons of 100||0003-1428-14|
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].
Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Marketed by: Bristol-Myers Squibb Company Princeton, NJ 08543 and AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Issued: January 2014
Last reviewed on RxList: 1/22/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Farxiga Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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