Generic Name

Pioglitazone Hydrochloride

---

Classification

FDA Approved Indications

• Type 2 diabetes mellitus to improve glycemic control

Mechanism of Action

Pioglitazone activates peroxisome proliferator-activated receptor gamma (PPARγ), which modulates insulin sensitivity in adipose tissue, muscle, and the liver, thereby improving insulin-mediated glucose utilization.

Dosage and Administration

Adult: Initially 15-30 mg once daily, titrated up to 45 mg based on response; administered with or without food.

Pediatric: Not approved for pediatric use.

Geriatric: Start at lower end of dosing; assess renal and hepatic function.

Renal Impairment: Use with caution; dose adjustments may be necessary.

Hepatic Impairment: Use with caution; contraindicated in active liver disease.

Pharmacokinetics

Absorption: Rapidly absorbed after oral administration.

Distribution: Highly protein-bound (~99%).

Metabolism: Primarily hepatic via CYP2C8 and CYP3A4 enzymes.

Excretion: Metabolites excreted in urine and feces.

Half Life: Approximately 3-7 hours (not directly proportional to duration of action; active metabolites may have longer half-lives).

Contraindications

• Active liver disease, including elevated liver enzymes of unknown etiology.
• Heart failure (NYHA Class III or IV).

Precautions

• History of bladder cancer, edema, or congestive heart failure; monitor liver function periodically.

Adverse Reactions - Common

• Upper respiratory tract infection (Occasional)
• Headache (Common)
• Sinusitis (Occasional)

Adverse Reactions - Serious

• Heart failure worsening (Uncommon)
• Hepatotoxicity (Rare)
• Bladder cancer risk (Controversial, ongoing research)

Drug-Drug Interactions

• Insulin - increased risk of edema and heart failure; risk of hypoglycemia with sulfonylureas.
• CYP2C8 inhibitors (e.g., gemfibrozil) - increase pioglitazone levels.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication as directed, with or without food.
• Report swelling, weight gain, jaundice, or unusual tiredness.
• Maintain regular blood glucose and liver function tests.
• Avoid alcohol and hepatotoxic medications unless directed by healthcare provider.

Special Considerations

Black Box Warnings:

• Congestive heart failure: May cause or exacerbate heart failure; use with caution.
• Heart failure warning related to fluid retention.],
• genetic_factors":"Research ongoing regarding genetic predisposition to adverse effects.","lab_test_interference":"May cause elevations in liver enzymes and rare cases of hepatic failure."},
• overdose_management
• signs_symptoms":"Hypoglycemia (if combined with other antidiabetics), fluid retention, edema, weight gain, signs of hepatic toxicity.",
• treatment":"Supportive care; monitor blood glucose and liver function; manage edema and heart failure symptoms as needed."},
• storage_and_handling
• storage_conditions":"Store at room temperature in a tight, light-resistant container.
• stability":"Stable for at least 2 years if stored properly."},
• references
• FDA Labeling for Actos (pioglitazone hydrochloride).
• Clinical pharmacology reviews and prescribing information from manufacturer.

Genetic Factors: Ongoing research on genetic predispositions affecting metabolism and adverse effects.

Lab Test Interference: May elevate liver enzymes; monitor periodically.

Overdose Management

Signs/Symptoms: Hypoglycemia, fluid retention, weight gain, hepatic toxicity symptoms such as jaundice.

Treatment: Supportive care; monitor vital signs, blood glucose, and liver function; symptomatic treatment as necessary.

Storage and Handling

Storage: Store at room temperature, 20-25°C (68-77°F).

Stability: Stable for at least 2 years when stored properly.