Pioglitazone and metformin hydrochloride 850 mg/1
Pioglitazone and metformin hydrochloride · TABLET · Macleods Pharmaceuticals Limited
Pioglitazone and metformin hydrochloride is a prescription tablet that combines two medications to help lower blood sugar levels in people with type 2 diabetes. This combination works by improving how your body uses insulin and reducing glucose production in the liver.
Key Facts
- Brand Name
- Pioglitazone and metformin hydrochloride
- Generic Name
- Pioglitazone and metformin hydrochloride
- NDC Code (Product)
33342-177- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 850 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA204802
- Drug Class
- Biguanide [EPC]; Biguanides [CS]
- Marketing Start
- 11/06/2015
Recall History
Macleods Pharma Usa Inc
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & 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 is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. Pioglitazone and metformin hydrochloride tablets are a thiazolidinedione and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate. ( 1 , 14 ) Limitations of Use : • Not 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 ( 2.1 ) • 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 if eGFR falls below 45 mL/min o Discontinue if eGFR falls below 30 mL/min • Monitor patients for adverse e…
Contraindications
4 CONTRAINDICATIONS 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)]. Pioglitazone and metformin hydrochloride tablets is 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 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 tablets is 15 mg of pioglitazone and 850 mg of metformin HCl once daily if used in combination wit…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Congestive heart failure [see Boxed Warning, and Warnings and Precautions ( 5.1 )] • Lactic acidosis [see Boxed Warning and Warnings, and Precautions ( 5.2 )] • Edema [see Warnings and Precautions ( 5.3 )] • Fractures [see Warnings and Precautions ( 5.7 )] • 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 Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 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 trial…
Frequently Asked Questions
What is Pioglitazone and metformin hydrochloride used for?
Pioglitazone and metformin hydrochloride is a prescription tablet that combines two medications to help lower blood sugar levels in people with type 2 diabetes. This combination works by improving how your body uses insulin and reducing glucose production in the liver.
Is Pioglitazone and metformin hydrochloride a controlled substance?
Pioglitazone and metformin hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Pioglitazone and metformin hydrochloride?
The generic name for Pioglitazone and metformin hydrochloride is Pioglitazone and metformin hydrochloride. There are 1 other brand versions of Pioglitazone and metformin hydrochloride.
What is the NDC code for Pioglitazone and metformin hydrochloride 850 mg/1?
The NDC (National Drug Code) for Pioglitazone and metformin hydrochloride 850 mg/1 is 33342-177, listed by Macleods Pharmaceuticals Limited.