Label Changes for:
Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride) Tablets
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.10 Monitoring of Renal Function
- Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Therefore, ACTOPLUS MET is contraindicated in patients with renal impairment
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
- In the 24-week ACTOPLUS MET trial, edema was reported in 3.0% of patients in the ACTOPLUS MET group, 4.2% in the pioglitazone monotherapy group and 1.4% in the metformin monotherapy group. In a double-blind clinical study of metformin in patients with type 2 diabetes, a total of 141 patients .....
- added: In this trial, diarrhea led to discontinuation of study medication in 6% of patients treated with metformin.
8 USE IN SPECIFIC POPULATIONS
8.4 Pediatric Use
- ACTOPLUS MET is not recommended for the treatment of diabetes in pediatric patients based on adverse effects observed with pioglitazone in adults, including fluid retention and congestive heart failure, fractures, and urinary bladder tumors
The most common side effects of ACTOPLUS MET include:
- added ..... diarrhea, swelling (edema), increased weight
- conversion of the approved patient package insert to a Medication Guide