Monotherapy and Combination Therapy

AVANDIA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. [See Clinical Studies]

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.
• The use of AVANDIA with nitrates is not recommended.

The management of antidiabetic therapy should be individualized. All patients should start AVANDIA at the lowest recommended dose. Further increases in the dose of AVANDIA should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING and WARNINGS and PRECAUTIONS].

AVANDIA may be administered either at a starting dose of 4 mg 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 FPG, the dose may be increased to 8 mg daily as monotherapy or in combination with metformin, sulfonylurea, or sulfonylurea plus metformin. Reductions in glycemic parameters by dose and regimen are described under Clinical Studies. AVANDIA may be taken with or without food.

The total daily dose of AVANDIA should not exceed 8 mg.

Monotherapy

The usual starting dose of AVANDIA is 4 mg administered either as a single dose once daily or in divided doses twice daily. In clinical trials, the 4-mg twice-daily regimen resulted in the greatest reduction in FPG and HbA1c.

Combination With Sulfonylurea or Metformin

When AVANDIA is added to existing therapy, the current dose(s) of the agent(s) can be continued upon initiation of AVANDIA therapy.

Sulfonylurea: When used in combination with sulfonylurea, the usual starting dose of AVANDIA is 4 mg administered as either a single dose once daily or in divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.

Metformin: The usual starting dose of AVANDIA in combination with metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with AVANDIA.

Combination With Sulfonylurea Plus Metformin

The usual starting dose of AVANDIA in combination with a sulfonylurea plus metformin is 4 mg administered as either a single dose once daily or divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.

Specific Patient Populations

Renal Impairment: 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.

Hepatic Impairment: 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) [see WARNINGS and PRECAUTIONS and CLINICAL PHARMACOLOGY]. Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with AVANDIA and periodically thereafter [see WARNINGS and PRECAUTIONS].

Pediatric: Data are insufficient to recommend pediatric use of AVANDIA [see Use in Specific Populations].

Dosage forms and Strength

Pentagonal film-coated TILTAB® tablet contains rosiglitazone as the maleate as follows:

• 2 mg - pink, debossed with SB on one side and 2 on the other
• 4 mg - orange, debossed with SB on one side and 4 on the other
• 8 mg - red-brown, debossed with SB 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 SB on one side and 2 on the other; 4 mg–orange, debossed with SB on one side and 4 on the other; 8 mg–red-brown, debossed with SB on one side and 8 on the other.

2 mg bottles of 60: NDC 0029-3158-18
4 mg bottles of 30: NDC 0029-3159-13
4 mg bottles of 90: NDC 0029-3159-00
8 mg bottles of 30: NDC 0029-3160-13
8 mg bottles of 90: NDC 0029-3160-59

Store at 25° C (77° F); excursions 15° –30° C (59° –86° F). Dispense in a tight, light-resistant container.

GlaxoSmithKline., Research Triangle Park, NC 27709, FDA revision date: 11/14/2007

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