pioglitazone hydrochloride


Also found in: Dictionary.
Related to pioglitazone hydrochloride: Glimepiride, Metformin hydrochloride

pioglitazone hydrochloride

Actos, Apo-Pioglitazone (CA), Co Pioglitazone (CA), Gen-Pioglitazone (CA), Novo-Pioglitazone (CA), PMS-Pioglitazone (CA), Ratio-Pioglitazone (CA), Sandoz Pioglitazone (CA)

Pharmacologic class: Thiazolidinedione

Therapeutic class: Hypoglycemic

Pregnancy risk category C

FDA Box Warning

• Drug may cause or exacerbate heart failure. After starting therapy or increasing dosage, observe patient carefully for signs and symptoms of heart failure. If these develop, manage patient according to current standards of care and consider discontinuing drug or reducing dosage.

• Drug isn't recommended in patients with symptomatic heart failure. In patients with established New York Heart Association Class III or IV heart failure, drug initiation is contraindicated.

Action

Enhances insulin sensitivity in muscle and adipose tissue; inhibits hepatic gluconeogenesis

Availability

Tablets: 15 mg, 30 mg, 45 mg

Indications and dosages

Adjunct to diet and exercise to improve glycemic control in type 2 (non-insulin-dependent) diabetes mellitus

Adults: 15 to 30 mg/day; may increase to 45 mg/day if needed

Contraindications

• Hypersensitivity to drug, its components, or rosiglitazone
• Established New York Heart Association Class III or IV heart failure

Precautions

Use cautiously in:
• edema, hepatic impairment
• symptomatic heart failure (use not recommended)
• female patients of childbearing age
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Give with or without food.
• Know that drug may be used with sulfonylureas, metformin, or insulin when combination of diet, exercise, and monotherapy doesn't achieve adequate glycemic control.

Adverse reactions

CNS: headache

CV: congestive heart failure (CHF) or exacerbation of CHF

EENT: sinusitis, pharyngitis

Hematologic: anemia

Metabolic: aggravation of diabetes mellitus, hypoglycemia, hyperglycemia

Musculoskeletal: myalgia

Respiratory: upper respiratory infection

Other: tooth disorders, pain, edema

Interactions

Drug-drug.

Hormonal contraceptives: decreased contraceptive efficacy

Ketoconazole: increased pioglitazone effects

Drug-diagnostic tests.Creatine kinase: transient increase

Hematocrit, hemoglobin: decreased values (usually during first 4 to 12 weeks of therapy)

Drug-herbs.Chromium, coenzyme Q10, fenugreek: additive hypoglycemic effects

Glucosamine: poor glycemic control

Patient monitoring

Monitor patient carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and edema) after initiation and after dosage increases. Consider discontinuation or dosage reduction if these symptoms appear.
• Assess patient's weight and compliance with diet and exercise program.
• Monitor liver function tests before and during therapy.
• Monitor glycosylated hemoglobin, hemoglobin, hematocrit, and blood glucose levels.
• Assess for signs and symptoms of hypoglycemia or hyperglycemia.

Patient teaching

• Instruct patient to take exactly as prescribed. Tell him he may take drug without regard to food.
• Tell patient drug may increase his risk for EENT and respiratory infections. Instruct him to contact prescriber if symptoms occur.

Advise patient to immediately report unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, fever, trauma, infection, rapid weight gain, edema, or shortness of breath.
• Tell premenopausal anovulatory patient that drug may cause ovulation. Recommend use of reliable contraception.
• Advise female of childbearing age to contact prescriber promptly if pregnancy occurs.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

Mentioned in ?
References in periodicals archive ?
Accurately weighed quantities of Pioglitazone hydrochloride, SBC, various concentrations of retardant material (HPMC grades i.
Composition of floating matrix tablets of Pioglitazone hydrochloride with different PEO grades (WSR 301 and WSR coagulant) were shown in Table 1.
Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study.
The company's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets are the generic versions of Takeda Pharmaceutical Company's Actos Tablets and Actoplus Met Tablets, respectively, and are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
7bn, and Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg, had US sales of about USD413m, for the 12 months ending 30 June 2012.
Figures from IMS Health indicated that Pioglitazone Tablets USP, 15mg, 30mg and 45mg, and Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg, achieved US sales of approximately USD2.
and Takeda Pharmaceuticals North America, resolving patent litigation related to Pioglitazone hydrochloride 15 mg, 30 mg and 45 mg tablets, a generic equivalent version of Actos.
On Thursday, Aurobindo Pharma, a pharmaceutical production unit in India announced securing tentative approval from the US Food & Drug Administration (USFDA) for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg (base)/500mg and 15mg (base)/850mg.
and Andrx Labs in connection with the filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration for pioglitazone hydrochloride and extended-release metformin hydrochloride tablets, 15 mg/1,000 mg and 30 mg/1,000 rag.
Headquartered at Hyderabad, India, Aurobindo Pharma Ltd has received tentative approval from the US Food & Drug Administration for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg (base)/500mg and 15mg (base)/850mg.
says it entered into a settlement with Takeda for Actoplus Met, 15 mg/500 mg and 15 mg/850 mg, known generically as pioglitazone hydrochloride (HCl) and metformin HCl tablets, and Actos, 15 mg, 30 mg and 45 mg, known generically as pioglitazone HCl tablets.
The largest pharmaceutical company in Japan and one of the leaders in the world, Takeda is committed to making a difference in people's lives by creating innovative and effective ways to alleviate disease and promote good health -- Takeda markets its original products such as candesartan cilexetil (marketed as Blopress(R), Kenzen(R) and Amias(R)), pioglitazone hydrochloride, leuprolide acetate and lansoprazole from Japan and 14 overseas bases in the US, Europe and Asia.