pioglitazone hydrochloride


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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.

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References in periodicals archive ?
AtT20 cells were cultured to 60% confluence in regular medium in 24-multiwell plates and then incubated either without or with at appropriate concentrations of MEKT1, rosiglitazone, and pioglitazone hydrochloride in DMEM added with 1% stripped FBS for 24 hours.
In the normal chow diet (Purina irradiated laboratory chow 38057, Purina Korea, Seoul, Korea) and high-fat diet (60kcal % fat diet, D12492, Research Diets, Inc., New Brunswick, NJ, USA) feeding condition, 8-10-week-old male [CAR.sup.+/+] (control and TCPOBOP-treated) and [CAR.sup.-/-] mice were assigned to vehicle or treatment groups according to the administration of pioglitazone hydrochloride (Takeda Chemical Industries, Osaka, Japan).
market introduction of its first-to-file pioglitazone hydrochloride and glimepiride tablets, the first generic version of Takeda Pharmaceuticals' Duetact.
Previously, the company had announced the receipt of final approval from the FDA for its ANDA for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg.
-- The Food and Drug Administration last month approved the first generic version of Actos (pioglitazone hydrochloride) tablets.
The FDA had already approved the company's application for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg.
Pioglitazone hydrochloride was obtained from Jiangsu Hengrui Medicine Co., Ltd.
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.
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.
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.