Pioglitazone

A to Z Drug Facts

 Actions Increases insulin sensitivity.

 Indications Type 2 diabetes, as an adjunct to diet and exercise; also may be used in conjunction with a sulfonylurea, metformin, or insulin.

 Contraindications Standard considerations.

 Route/Dosage

Initially, PO 15 or 30 mg/day, up to 45 mg/day. If monotherapy is inadequate, consider combinations using same starting dose and adjust accordingly. May be given without regard to meals.

 Interactions

Contraceptives, oral: Oral contraceptives may decrease both hormone components about 30%, potentially reducing contraceptive effectiveness. P450 system: Cytochrome P450 isoform CYP3A4 is partially responsible for pioglitazone metabolism; therefore, other drugs affected by or affecting this system may interact.

 Lab Test Interferences Mean hemoglobin values may decline 2% to 4%, usually in first 4 to 12 wk of therapy, then stabilize; not associated with hemotologic clinical effects.

 Adverse Reactions

CNS: Headache. METABOLIC: Diabetes mellitus aggravated. RESPIRATORY: Upper respiratory tract infection, sinusitis, pharyngitis. OTHER: Myalgia, tooth disorder, edema.

 Precautions

Pregnancy: Category C. LACTATION: Undetermined. CHILDREN: Safety and efficacy not established. Ovulation: May result in ovulation in premenopausal anovulatory women; recommend contraception. Edema: Use caution. Hepatic function: Related drugs have reported rare hepatotoxicity; monitor liver enzymes and symptoms.

 Administration/Storage

• Do not administer to patients with clinical evidence of active liver disease or elevated liver enzymes (ALT above 2.5 × upper limit of normal) or to patients with type 1 diabetes mellitus.
• Administer dose qd, usually in the morning, with or without food.
• Store at controlled room temperature. Protect from moisture and humidity.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of liver disease or CHF.
• Ensure that liver enzymes are determined before starting therapy and periodically during therapy (eg, q 2 mo for first year, then periodically thereafter).
• Check blood sugar frequently and observe for signs of hypoglycemia and hyperglycemia; report to health care provider.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to take qd without regard to meals.
• Educate patient, family, or caregiver regarding type 2 diabetes and its management.
• Instruct patient that this drug is not a substitute for diet and exercise and to follow prescribed regimens.
• Emphasize the importance of regular daily blood glucose monitoring and periodic glycosylated hemoglobin (HbA_1c) tests.
• Advise diabetic patient to carry medical identification (eg, Medi-Alert).
• Advise patient to report any of the following to the health care provider immediately: nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, yellowing of the skin or eyes.
• Review symptoms of hypoglycemia and hyperglycemia and action plans to undertake in the event either occur. Instruct patient to report hypoglycemic or hyperglycemic episodes to the health care provider.
• Advise patient that blood will be drawn to check liver function prior to starting therapy and about every 2 mo for the first year and periodically thereafter. Remind patient to keep appointments.
• Caution women that drug can cause resumption of ovulation in premenopausal, anovulatory women with insulin resistance. Address adequate contraceptive measures for these women.
• Advise women to inform health care provider if pregnant, planning on becoming pregnant, or are breastfeeding.
• Instruct patient not to take prescription or OTC drugs or dietary supplements without consulting health care provider.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts