Drugplain

PIOGLITAZONE HYDROCHLORIDE 30 mg/1

pioglitazone hydrochloride · TABLET · A-S Medication Solutions

1 Recall on Record
Plain English

PIOGLITAZONE HYDROCHLORIDE is a tablet containing pioglitazone hydrochloride at 30 mg/1, taken oral. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
PIOGLITAZONE HYDROCHLORIDE
Generic Name
pioglitazone hydrochloride
NDC Code (Product)
50090-7846
Manufacturer
A-S Medication Solutions
Strength
30 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA200268
Marketing Start
02/13/2013

Recall History

1 Recall on Record
Class II09/23/2019

Macleods Pharma Usa Inc

Superpotent

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dyspnoea88 reports
nausea70 reports
drug ineffective69 reports
pain in extremity65 reports
hypoglycaemia60 reports
diarrhoea57 reports
fatigue56 reports
condition aggravated55 reports
blood glucose increased54 reports
pneumonia53 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Monotherapy and Combination Therapy Pioglitazone tablets are 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 Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone 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 (5.3) ] . Pioglitazone 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 pioglitazone tablets 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 pioglitazone tablets. If abnormal, use caution when treating with pioglitazone tablets, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on pioglitazone tablets are not recommended in patients without liver disease. ( 5.3 ) 2.1 Recommendations for All Patients Pioglitazone tablets 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 pioglitazone tablets or with dose increase, monitor patients caref…

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 pioglitazone tablets. 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 pioglitazone tablets. (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 ) 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 pioglitazone 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 pioglitazone, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for pioglitazone [see Clinical Pharmacology (12.3) ] . 7.3 Topiramate A decrease in the exposure of pioglitazone and its active metabo…

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 Quallent Pharmaceuticals Health LLC at 1-877-605-7243 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 pioglitazone in randomized, double-blind, controlled clinical trials, including 2605 patients with type 2 diabetes and macrovascular disease treated with pioglitazone in the PROactive clinical trial. In these trials, over 6000 patients have been treated with pioglitazone for six months o…

Frequently Asked Questions

What is PIOGLITAZONE HYDROCHLORIDE used for?

PIOGLITAZONE HYDROCHLORIDE contains pioglitazone hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is PIOGLITAZONE HYDROCHLORIDE a controlled substance?

PIOGLITAZONE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for PIOGLITAZONE HYDROCHLORIDE?

The generic name for PIOGLITAZONE HYDROCHLORIDE is pioglitazone hydrochloride. There are 1 other brand versions of pioglitazone hydrochloride.

What is the NDC code for PIOGLITAZONE HYDROCHLORIDE 30 mg/1?

The NDC (National Drug Code) for PIOGLITAZONE HYDROCHLORIDE 30 mg/1 is 50090-7846, listed by A-S Medication Solutions.

Product NDC

50090-7846

Package NDC

50090-7846-0

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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