Pioglitazone Hydrochloride and Metformin Hydrochloride 500 mg/1
Pioglitazone Hydrochloride and Metformin Hydrochloride · TABLET, FILM COATED · Aurobindo Pharma Limited
Pioglitazone Hydrochloride and Metformin Hydrochloride is a tablet, film coated containing pioglitazone hydrochloride and metformin hydrochloride at 500 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Pioglitazone Hydrochloride and Metformin Hydrochloride
- Generic Name
- Pioglitazone Hydrochloride and Metformin Hydrochloride
- NDC Code (Product)
65862-525- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 500 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA200823
- Marketing Start
- 02/13/2013
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 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. Pioglitazone and metformin hydrochloride tablets are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride, 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 pioglitazone and metformin hydrochloride, 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 500 mg of metformin hydrochloride or 15 mg of pioglitazone and 850 mg of metformin hydrochloride 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 pioglitazone and metformin hydrochloride if eGFR falls below 45 mL/min Discontinue if eGFR …
Contraindications
4 CONTRAINDICATIONS Pioglitazone and metformin hydrochloride are contraindicated in patients with: Established NYHA Class III or IV heart failure at the time of pioglitazone and metformin hydrochloride 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 hydrochloride, 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) ]. In patients with established New York Heart Association (NYHA) Class III or IV heart failure at the time of pioglitazone and metformin hydrochloride 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 hydrochloride, or any of the excepients in pioglitazone and metformin hydrochloride tablets. ( 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 pioglitazone and metformin hydrochloride 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 1/2 ) of pioglitazone. Therefore, the maximum recommended dosage of pioglitazone and metformin hydrochloride is 15 mg of pioglitazone and 850 mg of metformin hydrochloride once daily if used in combination with gemfibrozi…
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 compared to rates in the clinical trials of another drug and may not re…
Frequently Asked Questions
What is Pioglitazone Hydrochloride and Metformin Hydrochloride used for?
Pioglitazone Hydrochloride and Metformin Hydrochloride contains Pioglitazone Hydrochloride and Metformin Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Pioglitazone Hydrochloride and Metformin Hydrochloride a controlled substance?
Pioglitazone Hydrochloride and Metformin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Pioglitazone Hydrochloride and Metformin Hydrochloride?
The generic name for Pioglitazone Hydrochloride and Metformin Hydrochloride is Pioglitazone Hydrochloride and Metformin Hydrochloride. There are no other listed brand versions of Pioglitazone Hydrochloride and Metformin Hydrochloride.
What is the NDC code for Pioglitazone Hydrochloride and Metformin Hydrochloride 500 mg/1?
The NDC (National Drug Code) for Pioglitazone Hydrochloride and Metformin Hydrochloride 500 mg/1 is 65862-525, listed by Aurobindo Pharma Limited.
Other Pioglitazone Hydrochloride and Metformin Hydrochloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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