"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.
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Important Limitations of Use
- Due to its mechanism of action, AVANDIA is active only in the presence of endogenous insulin. Therefore, AVANDIA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
- The coadministration of AVANDIA and insulin is not recommended [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
AVANDIA may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8 mg daily. Increases in the dose of AVANDIA should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. AVANDIA may be taken with or without food.
The total daily dose of AVANDIA should not exceed 8 mg.
Specific Patient Populations
No dosage adjustment is necessary when AVANDIA is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and AVANDIA is also contraindicated in patients with renal impairment.
Liver enzymes should be measured prior to initiating treatment with AVANDIA. Therapy with AVANDIA should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of AVANDIA, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]
Data are insufficient to recommend pediatric use of AVANDIA [see Use In Specific Populations].
Dosage Forms And Strengths
Pentagonal film-coated TILTAB® tablet contains rosiglitazone as the maleate as follows:
- 2 mg - pink, debossed with GSK on one side and 2 on the other
- 4 mg - orange, debossed with GSK on one side and 4 on the other
- 8 mg - red-brown, debossed with GSK on one side and 8 on the other
Storage And Handling
Each pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows: 2 mg-pink, debossed with GSK on one side and 2 on the other; 4 mg-orange, debossed with GSK on one side and 4 on the other; 8 mg-red-brown, debossed with GSK on one side and 8 on the other.
2 mg bottles of 60: NDC 0173-0861-18
4 mg bottles of 30: NDC 0173-0863-13
8 mg bottles of 30: NDC 0173-0864-13
Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, lightresistant container.
GlaxoSmithKline, Research Triangle Park, NC 27709. May 2014
Last reviewed on RxList: 5/27/2014
This monograph has been modified to include the generic and brand name in many instances.
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