Duetact 4 mg/1
pioglitazone and glimepiride · TABLET · Takeda Pharmaceuticals America, Inc.
Duetact is a tablet containing pioglitazone and glimepiride at 4 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..
Key Facts
- Brand Name
- Duetact
- Generic Name
- pioglitazone and glimepiride
- NDC Code (Product)
64764-304- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021925
- Drug Class
- Sulfonylurea [EPC]
- Marketing Start
- 07/28/2006
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 DUETACT is 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 )] . Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT 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 )] . DUETACT is 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Individualize the starting dose of DUETACT 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 ) • DUETACT should be given in a single dose once daily with meals. ( 2.1 ) • Obtain liver tests before starting DUETACT. If abnormal, use caution when treating with DUETACT, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on DUETACT is not recommended in patients without liver disease. ( 5.5 ) 2.1 Recommendations for All Patients DUETACT should be taken once daily with the first main meal. DUETACT 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 mg/2 mg or 30 mg/4 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, • for patients inadequately controlled on glimepir…
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 DUETACT [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 DUETACT. ( 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 DUETACT dose adjustment and close monitoring of blood glucose ( 7.4 ). • Miconazole: Severe hypoglycemia can occur when DUETACT 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. DUETACT 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 combination with gemfibrozil or other strong CYP2C8 inhibitors. Since th…
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 America, Inc. at 1-877-TAKEDA-7 (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 treatm…
Frequently Asked Questions
What is Duetact used for?
Duetact contains pioglitazone and glimepiride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Duetact a controlled substance?
Duetact is not classified as a controlled substance by the DEA.
What is the generic name for Duetact?
The generic name for Duetact is pioglitazone and glimepiride. There are 2 other brand versions of pioglitazone and glimepiride.
What is the NDC code for Duetact 4 mg/1?
The NDC (National Drug Code) for Duetact 4 mg/1 is 64764-304, listed by Takeda Pharmaceuticals America, Inc..