"The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called keto"...
AVANDARYL® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
- Due to its mechanism of action, rosiglitazone is active only in the presence of endogenous insulin. Therefore, AVANDARYL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
- Coadministration of AVANDARYL with insulin is not recommended [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
Therapy with AVANDARYL should be individualized for each patient. The risk-benefit of initiating monotherapy versus dual therapy with AVANDARYL should be considered.
No studies have been performed specifically examining the safety and efficacy of AVANDARYL in patients previously treated with other oral hypoglycemic agents and switched to AVANDARYL. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur. [See INDICATIONS AND USAGE]
The recommended starting dose is 4 mg/1 mg administered once daily with the first meal of the day. For adults already treated with a sulfonylurea or rosiglitazone, a starting dose of 4 mg/2 mg may be considered.
All patients should start the rosiglitazone component of AVANDARYL at the lowest recommended dose. Further increases in the dose of rosiglitazone should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
When switching from combination therapy of rosiglitazone plus glimepiride as separate tablets, the usual starting dose of AVANDARYL is the dose of rosiglitazone and glimepiride already being taken.
Dose increases should be individualized according to the glycemic response of the patient. Patients who may be more sensitive to glimepiride [see WARNINGS AND PRECAUTIONS], including the elderly, debilitated, or malnourished, and those with renal, hepatic, or adrenal insufficiency, should be carefully titrated to avoid hypoglycemia. If hypoglycemia occurs during up-titration of the dose or while maintained on therapy, a dosage reduction of the glimepiride component of AVANDARYL may be considered. Increases in the dose of rosiglitazone should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
To switch to AVANDARYL for adults currently treated with rosiglitazone, dose titration of the glimepiride component of AVANDARYL is recommended if patients are not adequately controlled after 1 to 2 weeks. The glimepiride component may be increased in no more than 2 mg increments. After an increase in the dosage of the glimepiride component, dose titration of AVANDARYL is recommended if patients are not adequately controlled after 1 to 2 weeks.
To switch to AVANDARYL for adults currently treated with sulfonylurea, it may take 2 weeks to see a reduction in blood glucose and 2 to 3 months to see the full effect of the rosiglitazone component. Therefore, dose titration of the rosiglitazone component of AVANDARYL is recommended if patients are not adequately controlled after 8 to 12 weeks. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to AVANDARYL due to potential overlapping of drug effect. After an increase in the dosage of the rosiglitazone component, dose titration of AVANDARYL is recommended if patients are not adequately controlled after 2 to 3 months.
The maximum recommended daily dose is 8 mg rosiglitazone and 4 mg glimepiride.
Specific Patient Populations
Elderly and Malnourished Patients and Those With Renal, Hepatic, or Adrenal Insufficiency
In elderly, debilitated, or malnourished patients, or in patients with renal, hepatic, or adrenal insufficiency, the starting dose, dose increments, and maintenance dosage of AVANDARYL should be conservative to avoid hypoglycemic reactions. [See WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]
Liver enzymes should be measured prior to initiating treatment with AVANDARYL. Therapy with AVANDARYL 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 AVANDARYL, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]
Pregnancy and Lactation
AVANDARYL should not be used during pregnancy or in nursing mothers.
Safety and effectiveness of AVANDARYL in pediatric patients have not been established. AVANDARYL and its components, rosiglitazone and glimepiride, are not recommended for use in pediatric patients.
Dosage Forms And Strengths
Each rounded triangular tablet contains rosiglitazone maleate and glimepiride as follows:
- 4 mg/1 mg - yellow, gsk debossed on one side and 4/1 on the other.
- 4 mg/2 mg - orange, gsk debossed on one side and 4/2 on the other.
- 4 mg/4 mg - pink, gsk debossed on one side and 4/4 on the other.
- 8 mg/2 mg - pale pink, gsk debossed on one side and 8/2 on the other.
- 8 mg/4 mg - red, gsk debossed on one side and 8/4 on the other.
Storage And Handling
Each rounded triangular tablet contains rosiglitazone as the maleate and glimepiride as follows:
4 mg/1 mg - yellow, gsk debossed on one side and 4/1 on
4 mg/2 mg - orange, gsk debossed on one side and 4/2 on the other.
4 mg/4 mg - pink, gsk debossed on one side and 4/4 on the other.
8 mg/2 mg - pale pink, gsk debossed on one side and 8/2 on the other.
8 mg/4 mg - red, gsk debossed on one side and 8/4 on the other.
4 mg/1 mg bottles of 30: NDC 0173-0841-13
4 mg/2 mg bottles of 30: NDC 0173-0842-13
4 mg/4 mg bottles of 30: NDC 0173-0843-13
8 mg/2 mg bottles of 30: NDC 0173-0844-13
8 mg/4 mg bottles of 30: NDC 0173-0845-13
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.
GlaxoSmithKline, Research Triangle Park, NC 27709. May 2014
Last reviewed on RxList: 5/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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