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Pioglitazone (Pioglitazone)

Trade Name : Pioglitazone

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 15 mg/1

PIOGLITAZONE HYDROCHLORIDE Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pioglitazone (Pioglitazone) which is also known as Pioglitazone and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 15 mg/1 per ml. Read more

Pioglitazone (Pioglitazone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: CONGESTIVE HEART FAILURE
  • See full prescribing information for complete boxed warning.
  • Thiazolidinediones, including pioglitazone hydrochloride, cause or exacerbate congestive heart failure in some patients. ()
  • After initiation of pioglitazone hydrochloride, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone hydrochloride must be considered. ()
  • Pioglitazone hydrochloride is not recommended in patients with symptomatic heart failure. ()
  • Initiation of pioglitazone hydrochloride in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. (, )
  • 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 [].
  • Important Limitations of Use
  • Pioglitazone tablets exert their 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 [].
  • Pioglitazone tablets are 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. (, )
  • Important Limitations of Use:
  • Not for treatment of type 1 diabetes or diabetic ketoacidosis. ()
  • No data
  • 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. ()
  • If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily. ()
  • 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 is not recommended in patients without liver disease. ()
  • Round tablet contains pioglitazone as follows:
  • Tablets: 15 mg, 30 mg, and 45 mg ()
  • No data
  • Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [n ]. ()
  • Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. ()
  • No data
  • Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. ()
  • Hypoglycemia: When used with insulin or an insulin secretagogue, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. ()
  • Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt pioglitazone hydrochloride and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart pioglitazone hydrochloride if liver injury is confirmed and no alternate etiology can be found. ()
  • Bladder cancer: May increase the risk of bladder cancer. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. ()
  • Edema: Dose-related edema may occur. ()
  • Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. ()
  • Macular edema: Postmarketing reports. Recommend regular eye exams in all patients with diabetes according to current standards of care with prompt evaluation for acute visual changes. ()
  • Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with pioglitazone hydrochloride. (5.8)
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • Most common adverse reactions (u2265 5%) are upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit pioglitazone dose to 15 mg daily. (, )
  • CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ()
  • Topiramate may decrease pioglitazone concentrations. ()
  • No data
  • Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3)
  • Pediatrics: Not recommended for use in pediatric patients. (8.4)
  • During controlled clinical trials, one case of overdose with pioglitazone hydrochloride was reported. A male patient took 120 mg per day for four days, then 180 mg per day for seven days. The patient denied any clinical symptoms during this period.
  • In the event of overdosage, appropriate supportive treatment should be initiated according to the patientu2019s clinical signs and symptoms.
  • Pioglitazone Hydrochloride Tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone.
  • Pioglitazone [(u00b1)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert . No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:
  • CHNOSu2022HCl M.W. 392.90
  • Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in ,-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.
  • Pioglitazone Tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol.
  • No data
  • No data
  • No data
  • Pioglitazone Tablets USP are available as follows:
  • 15 mg: white to off-white, round convex tablets, debossed with u201cTEVAu201d on one side of the tablet and u201c7271u201d on the other side, available in bottles of 30 (NDC 0093-7271-56), 90 (NDC 0093-7271-98), and 500 (NDC 0093-7271-05).
  • 30 mg: white to off-white, round flat tablets, debossed with u201cTEVAu201d on one side of the tablet and u201c7272u201d on the other side, available in bottles of 30 (NDC 0093-7272-56), 90 (NDC 0093-7272-98), and 500 (NDC 0093-7272-05).
  • 45 mg: white to off-white, round flat tablets, debossed with u201cTEVAu201d on one side of the tablet and u201c7273u201d on the other side, available in bottles of 30 (NDC 0093-7273-56), 90 (NDC 0093-7273-98), and 500 (NDC 0093-7273-05).
  • See FDA-Approved Patient Labeling (Medication Guide).
  • Manufactured In Czech Republic By:n Opava-Komarov, Czech Republic
  • Manufactured For:n North Wales, PA 19454
  • Rev. H 5/2019
  • Pioglitazone (pye oh gliu2032 ta zone) Tabletsu00a0
  • What is the most important information I should know about pioglitazone tablets?
  • Pioglitazone tablets can cause serious side effects, including new or worse heart failure.
  • Call your doctor right away if you have any of the following:
  • Pioglitazone tablets can have other serious side effects. See u201cu201d
  • What are pioglitazone tablets?
  • Pioglitazone tablets are a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Pioglitazone tablets are a diabetes medicine called pioglitazone that may be taken alone or with other diabetes medicines.
  • It is not known if pioglitazone tablets are safe and effective in children under the age of 18. Pioglitazone tablets are not recommended for use in children.
  • Pioglitazone tablets are not for people with type 1 diabetes.
  • Pioglitazone tablets are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
  • Who should not take pioglitazone tablets?
  • See u201cu201d
  • Do not take pioglitazone tablets if you:
  • Talk to your doctor before taking pioglitazone tablets if you have either of these conditions.
  • What should I tell my doctor before taking pioglitazone tablets?
  • Before you take pioglitazone tablets, tell your doctor if you:
  • Tell your doctor about all the medicines you take
  • Pioglitazone tablets and some of your other medicines can affect each other. You may need to have your dose of pioglitazone tablets or certain other medicines changed.
  • Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take pioglitazone tablets with other medicines.
  • How should I take pioglitazone tablets?
  • What are the possible side effects of pioglitazone tablets?
  • Pioglitazone tablets may cause serious side effects including:
  • The most common side effects of pioglitazone tablets include:
  • Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of pioglitazone tablets. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store pioglitazone tablets?
  • General information about the safe and effective use of pioglitazone tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pioglitazone tablets for a condition for which they were not prescribed. Do not give pioglitazone tablets to other people, even if they have the same symptoms you have. They may harm them.
  • This Medication Guide summarizes the most important information about pioglitazone tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about pioglitazone tablets that is written for healthcare professionals. For more information, call 1-888-838-2872.
  • What are the ingredients in pioglitazone tablets?
  • Active Ingredient: pioglitazone hydrochloride
  • Inactive Ingredients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Czech Republic By:n Opava-Komarov, Czech Republic
  • Manufactured For:n North Wales, PA 19454
  • Rev. C 5/2019
  • NDCn- 7271
  • Pioglitazone
  • Tablets USP
  • 15 mg
  • PHARMACIST: Dispense the
  • accompanying Medication Guide
  • to each patient.
  • Rx only
  • 90 TABLETS
  • TEVA
  • Arrayn- Array
  • NDCn- 7272
  • Pioglitazone
  • Tablets USP
  • 30 mg
  • PHARMACIST: Dispense the
  • accompanying Medication Guide
  • to each patient.
  • Rx only
  • 90 TABLETS
  • TEVA
  • Arrayn- Array
  • NDCn- 7273
  • Pioglitazone
  • Tablets USP
  • 45 mg
  • PHARMACIST: Dispense the
  • accompanying Medication Guide
  • to each patient.
  • Rx only
  • 90 TABLETS
  • TEVA
  • Arrayn- Array

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