PIOGLITAZONE 30 mg/1
Pioglitazone · TABLET · Solco Healthcare LLC
PIOGLITAZONE is a tablet containing pioglitazone at 30 mg/1, taken oral. Manufactured by Solco Healthcare LLC.
Key Facts
- Brand Name
- PIOGLITAZONE
- Generic Name
- Pioglitazone
- NDC Code (Product)
43547-427- Manufacturer
- Solco Healthcare LLC
- Strength
- 30 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207806
- Drug Class
- Peroxisome Proliferator Receptor alpha Agonist [EPC]; Peroxisome Proliferator Receptor gamma Agonist [EPC]
- Marketing Start
- 05/20/2018
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Takeda Development Center Americas, Inc.
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Sandoz Inc
Failed Dissolution Specifications
Aidapak Services, LLC
Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg, NDC 49884072703, Pedigree: AD52778_25, EXP: 5/20/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: W003263, EXP: 6/17/2014.
Macleods Pharma Usa Inc
Superpotent
Teva Pharmaceuticals USA
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Aurobindo Pharma USA Inc.
Superpotent and Failed Tablet/Capsule Specifications
Aidapak Services, LLC
Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD21846_31, EXP: 5/1/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD25452_7, EXP: 5/3/2014; ARIPiprazole, Tablet, 15 mg, NDC 59148000913, Pedigree: AD28322_1, EXP: 5/6/2014.
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 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 used for?
PIOGLITAZONE contains Pioglitazone. It is a tablet taken oral. Consult your doctor for specific uses.
Is PIOGLITAZONE a controlled substance?
PIOGLITAZONE is not classified as a controlled substance by the DEA.
What is the generic name for PIOGLITAZONE?
The generic name for PIOGLITAZONE is Pioglitazone. There are 10 other brand versions of Pioglitazone.
What is the NDC code for PIOGLITAZONE 30 mg/1?
The NDC (National Drug Code) for PIOGLITAZONE 30 mg/1 is 43547-427, listed by Solco Healthcare LLC.
Other PIOGLITAZONE Dosages
Other Pioglitazone Brands
See all →- PIOGLITAZONE HYDROCHLORIDE30 mg/150090-6393
- PIOGLITAZONE HYDROCHLORIDE30 mg/150090-7846
- Duetact2 mg/164764-302
- Pioglitazone30 mg/168071-2373
- Pioglitazone30 mg/168788-7514
- Pioglitazone15 mg/171610-495
- Pioglitazone HCL and Metformin HCL500 mg/113668-280
- Pioglitazone30 mg/116714-646
- Pioglitazone and metformin hydrochloride500 mg/133342-176
- Pioglitazone15 mg/142291-959
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)