pioglitazone hydrochloride

pioglitazone hydrochloride Warning - High-alert drug!

Actos

Pharmacologic class: Thiazolidinedione

Therapeutic class: Hypoglycemic

Pregnancy risk category C

FDA Boxed 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.

Route	Onset	Peak	Duration
P.O.	30 min	2 hr	24 hr

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.