Actoplus Met 850 mg/1
pioglitazone and metformin hydrochloride · TABLET, FILM COATED · Takeda Pharmaceuticals America, Inc.
Actoplus Met is a tablet, film coated containing pioglitazone and metformin hydrochloride at 850 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..
Key Facts
- Brand Name
- Actoplus Met
- Generic Name
- pioglitazone and metformin hydrochloride
- NDC Code (Product)
64764-158- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Strength
- 850 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021842
- Marketing Start
- 08/29/2005
Recall History
Takeda Development Center Americas, Inc.
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Teva Pharmaceuticals USA
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ACTOPLUS MET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ACTOPLUS MET is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. ACTOPLUS MET is a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Obtain liver tests before initiation. If abnormal, use caution when treating with ACTOPLUS MET, investigate the probable cause, treat (if possible), and follow appropriately. ( 2.1 ) Take orally with meals to reduce gastrointestinal adverse reactions with metformin ( 2.10 ) Individualize the starting dose based on the patient’s current regimen and titrate the dosage gradually, as needed after assessing therapeutic response and tolerability. The maximum recommended total daily dosage is pioglitazone 45 mg and metformin 2,550 mg. ( 2.2 ) Recommended starting dosage in patients with NYHA Class I or Class II congestive heart failure is 15 mg of pioglitazone and 850 mg of metformin HCl orally once daily. ( 2.4 ) Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR). ( 2.2 ) Contraindicated in patients with eGFR below 30 mL/min Initiation is not recommended in patients with eGFR between 30 to 45 mL/min Assess risk/benefit of continuing ACTOPLUS MET if eGFR falls below 45 mL/min Discontinue if eGFR falls below 30 mL/min Monitor patients for adverse events related to fluid retention after initiation and dose increases. ( 2.4…
Contraindications
4 CONTRAINDICATIONS ACTOPLUS MET is contraindicated in patients with: Established NYHA Class III or IV heart failure at the time of ACTOPLUS MET initiation [see Boxed Warning ] . Severe renal impairment (eGFR below 30 mL/min) [see Warnings and Precautions (5.2) ] . A history of serious hypersensitivity to pioglitazone, metformin HCl, or any of the excipients in ACTOPLUS MET. Acute or chronic metabolic acidosis, including diabetic ketoacidosis [see Warnings and Precautions (5.2) ] . In patients with established New York Heart Association (NYHA) Class III or IV heart failure at the time of ACTOPLUS MET initiation [see Boxed Warning ]. ( 4 ) In patients with severe renal impairment: (eGFR below 30 mL/min). ( 4 ) In patients with a history of serious hypersensitivity to pioglitazone, metformin HCl, or any of the excipients in ACTOPLUS MET. ( 4 ) In patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP2C8 inhibitors (e.g., gemfibrozil): Limit ACTOPLUS MET dose to 15 mg/850 mg daily. ( 7.1 ) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ( 7.2 ) Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring. ( 7.3 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. ( 7.4 ) Alcohol: Warn patients against excessive alcohol intake. ( 7.5 ) Use of insulin secretagogues or insulin use may increase the risk for hypoglycemia and may require dose reduction. ( 7.6 ) Topiramate may decrease pioglitazone concentrations. ( 7.8 ) 7.1 Strong CYP2C8 Inhibitors An inhibitor of CYP2C8 (e.g., gemfibrozil) significantly increases the exposure (area under the serum concentration-time curve or AUC) and half-life (t ½ ) of pioglitazone. Therefore, the maximum recommended dosage of ACTOPLUS MET is 15 mg of pioglitazone and 850 mg of metformin HCl once daily if used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Dosage and Administration (…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Congestive heart failure [see Boxed Warning , Warnings and Precautions (5.1) ] Lactic acidosis [see Boxed Warning , Warnings and Precautions (5.2) ] Edema [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.4) ] Hepatic Effects [see Warnings and Precautions (5.5) ] Urinary Bladder Tumors [see Warnings and Precautions (5.6) ] Fractures [see Warnings and Precautions (5.7) ] Macular Edema [see Warnings and Precautions (5.8 ] Vitamin B 12 Levels [see Warnings and Precautions (5.9 ] Most common adverse reactions (>5%) are upper respiratory tract infection, edema, diarrhea, headache and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-825-3327 and the ACTOPLUS MET website at: www.actoplusmet.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compare…
Frequently Asked Questions
What is Actoplus Met used for?
Actoplus Met contains pioglitazone and metformin hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Actoplus Met a controlled substance?
Actoplus Met is not classified as a controlled substance by the DEA.
What is the generic name for Actoplus Met?
The generic name for Actoplus Met is pioglitazone and metformin hydrochloride. There are 4 other brand versions of pioglitazone and metformin hydrochloride.
What is the NDC code for Actoplus Met 850 mg/1?
The NDC (National Drug Code) for Actoplus Met 850 mg/1 is 64764-158, listed by Takeda Pharmaceuticals America, Inc..