pioglitazone and glimepiride 4 mg/1
pioglitazone and glimepiride · TABLET · Prasco Laboratories
This medication combines two diabetes drugs—pioglitazone (a thiazolidinedione) and glimepiride (a sulfonylurea)—to help lower blood sugar in people with type 2 diabetes. It works by improving insulin sensitivity and stimulating the pancreas to release more insulin.
Key Facts
- Brand Name
- pioglitazone and glimepiride
- Generic Name
- pioglitazone and glimepiride
- NDC Code (Product)
66993-822- Manufacturer
- Prasco Laboratories
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021925
- Drug Class
- Sulfonylurea [EPC]
- Marketing Start
- 08/04/2015
Recall History
Sandoz Inc
Failed Dissolution Specifications
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 Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14) ] . Pioglitazone and glimepiride tablets are a thiazolidinedione and a sulfonylurea 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 glimepiride is appropriate. ( 1 ) Important Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 ) Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone and glimepiride tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.5) ].
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Individualize the starting dose of pioglitazone and glimepiride tablets based on the patient's current regimen. ( 2.1 ) May adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of pioglitazone 45 mg and glimepiride 8 mg. ( 2.1 ) Pioglitazone and glimepiride tablets should be given in a single dose once daily with meals. ( 2.1 ) Obtain liver tests before starting pioglitazone and glimepiride tablets. If abnormal, use caution when treating with pioglitazone and glimepiride tablets, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on pioglitazone and glimepiride tablets is not recommended in patients without liver disease. ( 5.5 ) 2.1 Recommendations for All Patients Pioglitazone and glimepiride tablets should be taken once daily with the first main meal. Pioglitazone and glimepiride tablets are available as a 30 mg pioglitazone plus 2 mg glimepiride or a 30 mg pioglitazone plus 4 mg glimepiride tablet. If therapy with a combination tablet containing pioglitazone and glimepiride is considered appropriate the recommended starting dose is: 30 …
Contraindications
4 CONTRAINDICATIONS Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning ] . Use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of pioglitazone and glimepiride tablets [see Warnings and Precautions (5.3) ] . Use in patients with known history of an allergic reaction to sulfonamide derivatives. Reported hypersensitivity reactions with glimepiride include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [see Warnings and Precautions (5.3) and Adverse Reactions (6.2) ] Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see Boxed Warning ] . ( 4 ) Use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of pioglitazone and glimepiride tablets. ( 4 ) Hypersensitivity to sulfonamide derivatives. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit pioglitazone dose to 15 mg daily. ( 2.3 , 7.1 ) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ( 7.2 ) Topiramate may decrease pioglitazone concentrations. ( 7.3 ) Certain medications may affect glucose metabolism, requiring pioglitazone and glimepiride tablet dose adjustment and close monitoring of blood glucose. ( 7.4 ) Miconazole: Severe hypoglycemia can occur when pioglitazone and glimepiride tablets and oral miconazole are used concomitantly. ( 7.5 ) CYP2C9 interactions: Inhibitors and inducers may affect glycemic control by altering glimepiride plasma concentrations. ( 7.6 ) Colesevelam: Coadministration may reduce glimepiride absorption. Pioglitazone and glimepiride tablets should be administered at least 4 hours prior to colesevelam. ( 2.4 , 7.7 ) 7.1 Strong CYP2C8 Inhibitors Pioglitazone 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 dose of pioglitazone is 15 mg daily if used in …
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) ] Hypoglycemia [see Warnings and Precautions (5.2) ] Edema [see Warnings and Precautions (5.7) ] Fractures [see Warnings and Precautions (5.8) ] Hemolytic Anemia [see Warnings and Precautions (5.9) ] Most common adverse reactions (≥5%) are upper respiratory tract infection, accidental injury, and combined edema/peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 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 reflect the rates observed in practice. The adverse events reported in at least 5% of patients in the controlled 16 week clinical studies between placebo plus a sulfonylurea and pioglitazone (15 mg and 30 mg combined) plus sulfonylurea treatment arms were upper respiratory tract infectio…
Frequently Asked Questions
What is pioglitazone and glimepiride used for?
This medication combines two diabetes drugs—pioglitazone (a thiazolidinedione) and glimepiride (a sulfonylurea)—to help lower blood sugar in people with type 2 diabetes. It works by improving insulin sensitivity and stimulating the pancreas to release more insulin.
Is pioglitazone and glimepiride a controlled substance?
pioglitazone and glimepiride is not classified as a controlled substance by the DEA.
What is the generic name for pioglitazone and glimepiride?
The generic name for pioglitazone and glimepiride is pioglitazone and glimepiride. There are 2 other brand versions of pioglitazone and glimepiride.
What is the NDC code for pioglitazone and glimepiride 4 mg/1?
The NDC (National Drug Code) for pioglitazone and glimepiride 4 mg/1 is 66993-822, listed by Prasco Laboratories.