Actos 30 mg/1

pioglitazone · TABLET · Takeda Pharmaceuticals America, Inc.

No Recall History

Plain English

Actos is a tablet containing pioglitazone at 30 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..

Key Facts

Brand Name: Actos
Generic Name: pioglitazone
NDC Code (Product): 64764-301
Manufacturer: Takeda Pharmaceuticals America, Inc.
Strength: 30 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA021073
Marketing Start: 07/15/1999

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

bladder cancer8,737 reports

blood glucose increased3,389 reports

nausea2,944 reports

weight decreased2,088 reports

diarrhoea1,714 reports

death1,546 reports

fatigue1,493 reports

drug ineffective1,480 reports

vomiting1,450 reports

dyspnoea1,412 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ] . Important Limitations of Use ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS 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 (5.3) ] . ACTOS is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ( 1 , 14 ) Important Limitations of Use: • Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Initiate ACTOS at 15 mg or 30 mg once daily. Limit initial dose to 15 mg once daily in patients with NYHA Class I or II heart failure. ( 2.1 ) • If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily. ( 2.1 ) • Obtain liver tests before starting ACTOS. If abnormal, use caution when treating with ACTOS, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on ACTOS is not recommended in patients without liver disease. ( 5.3 ) 2.1 Recommendations for All Patients ACTOS should be taken once daily and can be taken without regard to meals. The recommended starting dose for patients without congestive heart failure is 15 mg or 30 mg once daily. The recommended starting dose for patients with congestive heart failure (NYHA Class I or II) is 15 mg once daily. The dose can be titrated in increments of 15 mg up to a maximum of 45 mg once daily based on glycemic response as determined by HbA1c. After initiation of ACTOS or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema,…

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 or any other component of ACTOS. • 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 or any other component of ACTOS. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit ACTOS 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 ) 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 dose of ACTOS is 15 mg daily if used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ]. 7.2 CYP2C8 Inducers An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with ACTOS, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for ACTOS [see Clinical Pharmacology (12.3) ] . 7.3 Topiramate A decrease in the exposure of pioglitazone and its active metabolites were noted w…

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) ] • Edema [see Warnings and Precautions (5.5) ] • Fractures [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥5%) are upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis. ( 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. Over 8500 patients with type 2 diabetes have been treated with ACTOS in randomized, double-blind, controlled clinical trials, including 2605 patients with type 2 diabetes and macrovascular disease treated with ACTOS in the PROactive clinical trial. In these trials, over 6000 patients have been treated with ACTOS for six mont…

Frequently Asked Questions

What is Actos used for?

Actos contains pioglitazone. It is a tablet taken oral. Consult your doctor for specific uses.

Is Actos a controlled substance?

Actos is not classified as a controlled substance by the DEA.

What is the generic name for Actos?

The generic name for Actos is pioglitazone. There are 12 other brand versions of pioglitazone.

What is the NDC code for Actos 30 mg/1?

The NDC (National Drug Code) for Actos 30 mg/1 is 64764-301, listed by Takeda Pharmaceuticals America, Inc..

Product NDC

64764-301

Package NDC

64764-301-02

Other Pioglitazone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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