Pioglitazone HCL and Metformin HCL 500 mg/1
Pioglitazone HCL and Metformin HCL · TABLET · Torrent Pharmaceuticals Limited
Pioglitazone HCL and Metformin HCL is a tablet containing pioglitazone hcl and metformin hcl at 500 mg/1, taken oral. Manufactured by Torrent Pharmaceuticals Limited.
Key Facts
- Brand Name
- Pioglitazone HCL and Metformin HCL
- Generic Name
- Pioglitazone HCL and Metformin HCL
- NDC Code (Product)
13668-280- Manufacturer
- Torrent Pharmaceuticals Limited
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202001
- Marketing Start
- 09/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Pioglitazone and metformin hydrochloride tablets, are 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 ) Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Pioglitazone and metformin hydrochloride tablets are not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Obtain liver tests before initiation. If abnormal, use caution when treating with pioglitazone and metformin hydrochloride tablets, investigate the probable cause, treat (if possible), and follow appropriately. ( 2.1 ) • Take orally with meals to reduce gastrointestinal adverse reactions with metformin ( 2.1 ) • 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 ) o Contraindicated in patients with eGFR below 30 mL/min o Initiation is not recommended in patients with eGFR between 30 to 45 mL/min o Assess risk/benefit of continuing pioglitazone and metformin hydrochloride tablets if eGFR falls below 45 mL/min o Discontinue if eGFR falls below 30 mL/min • Monitor patien…
Contraindications
4 CONTRAINDICATIONS • In patients with established New York Heart Association (NYHA) Class III or IV heart failure at the time of pioglitazone and metformin hydrochloride tablets 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 pioglitazone and metformin hydrochloride tablets. ( 4 ) • In patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis. ( 4 ) Pioglitazone and metformin hydrochloride tablets are contraindicated in patients with: • Established NYHA Class III or IV heart failure at the time of pioglitazone and metformin hydrochloride tablets 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 pioglitazone and metformin hydrochloride tablets. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis [see Warnings and Precautions (5.2)] .
Drug Interactions
7 DRUG INTERACTIONS • Strong CYP2C8 inhibitors (e.g., gemfibrozil): Limit pioglitazone and metformin hydrochloride tablets 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 (t1/2) of pioglitazone. Therefore, the maximum recommended dosage of pioglitazone and metformin hydrochloride tablets is 15 mg of pioglitazone and 850 mg of metformin HCl once daily if used in combinati…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (>5%) are upper respiratory tract infection, edema, diarrhea, headache and weight gain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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] 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 compared to rates in the clinical trials of another drug and may not refl…
Frequently Asked Questions
What is Pioglitazone HCL and Metformin HCL used for?
Pioglitazone HCL and Metformin HCL contains Pioglitazone HCL and Metformin HCL. It is a tablet taken oral. Consult your doctor for specific uses.
Is Pioglitazone HCL and Metformin HCL a controlled substance?
Pioglitazone HCL and Metformin HCL is not classified as a controlled substance by the DEA.
What is the generic name for Pioglitazone HCL and Metformin HCL?
The generic name for Pioglitazone HCL and Metformin HCL is Pioglitazone HCL and Metformin HCL. There are no other listed brand versions of Pioglitazone HCL and Metformin HCL.
What is the NDC code for Pioglitazone HCL and Metformin HCL 500 mg/1?
The NDC (National Drug Code) for Pioglitazone HCL and Metformin HCL 500 mg/1 is 13668-280, listed by Torrent Pharmaceuticals Limited.
Other Pioglitazone HCL and Metformin HCL Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)