"The European Medicines Agency (EMA) is alerting doctors and other healthcare professionals to the possibility of atypical cases of diabetic ketoacidosis (DKA) associated with use of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a relatively "...
Monotherapy and Combination Therapy
Important Limitations of Use
ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
DOSAGE AND ADMINISTRATION
Recommendations for All Patients
ACTOS should be taken once daily and can be taken without regard to meals.
The recommended starting dose for patients without congestive heart failure is 15 mg or 30 mg once daily.
The recommended starting dose for patients with congestive heart failure (NYHA Class I or II) is 15 mg once daily.
The dose can be titrated in increments of 15 mg up to a maximum of 45 mg once daily based on glycemic response as determined by HbA1c.
After initiation of ACTOS or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating ACTOS. Routine periodic monitoring of liver tests during treatment with ACTOS is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of ACTOS or who are found to have abnormal liver tests while taking ACTOS should be managed as described under WARNINGS AND PRECAUTIONS [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Concomitant Use with an Insulin Secretagogue or Insulin
If hypoglycemia occurs in a patient co-administered ACTOS and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response.
Concomitant Use with Strong CYP2C8 Inhibitors
Coadministration of ACTOS and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of ACTOS is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
Round tablet contains pioglitazone as follows:
- 15 mg: White to off-white, debossed with “ACTOS” on one side and “15” on the other
- 30 mg: White to off-white, debossed with “ACTOS” on one side and “30” on the other
- 45 mg: White to off-white, debossed with “ACTOS” on one side and “45” on the other
Storage And Handling
ACTOS is available in 15 mg, 30 mg, and 45 mg tablets as follows:
15 mg tablet: White to off-white, round, convex, nonscored tablet with “ACTOS” on one side, and “15” on the other, available in:
NDC 64764-151-04 Bottles of 30
NDC 64764-151-05 Bottles of 90
NDC 64764-151-06 Bottles of 500
30 mg tablet: White to off-white, round, flat, nonscored tablet with “ACTOS” on one side, and “30” on the other, available in:
NDC 64764-301-14 Bottles of 30
NDC 64764-301-15 Bottles of 90
NDC 64764-301-16 Bottles of 500
45 mg tablet: White to off-white, round, flat, nonscored tablet with “ACTOS” on one side, and “45” on the other, available in:
NDC 64764-451-24 Bottles of 30
NDC 64764-451-25 Bottles of 90
NDC 64764-451-26 Bottles of 500
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.
Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Revised: November 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/25/2013
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