Vogdia Special Precautions

Endocrine and metabolic: Reduced cholesterol synthesis as a result of therapy could theoretically lead to reduced adrenal or gonadal steroid hormone production. Patients with signs/symptoms of endocrine dysfunction should be evaluated as clinically indicated. Use caution with concomitant medications (eg. spironolactone, cimetidine, ketoconazole) that may reduce steroid hormone levels/activity.
Hepatic: Liver function abnormalities have been reported. Use caution in patients who have a recent (less than 6 months) history of hepatic disease, signs of suspected hepatic disease (unexplained aminotransferase elevations, jaundice), or are heavy users of alcohol. Liver enzyme tests should be obtained at baseline and as clinically indicated, routine periodic monitoring of liver enzymes is not necessary. Hepatic failure, some cases fatal, has been reported. Prompt interruption of therapy may be required.
Musculoskeletal: Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported. Patients should be monitored closely. This risk is dose-related and is increased with concurrent use of erythromycin, cyclosporine, fibric acid derivatives (eg. gemfibrozil), or niacin (doses ≥1 g/day). Temporarily withhold therapy in patients experiencing conditions predisposing to the development of renal failure secondary to rhabdomyolysis (eg. sepsis, hypotension, major surgery, trauma, uncontrolled epilepsy, severe metabolic, endocrine, or electrolyte disorders). Discontinue therapy in any patient in which CPK levels are markedly elevated (>10 times ULN) or if myopathy is suspected/diagnosed. Use caution in patients with inadequately treated hypothyroidism and those taking other drugs associated with myopathy (eg. colchicine). These patients are predisposed to myopathy. Patients should be instructed to report unexplained muscle pain, tenderness, weakness, or brown urine. Immune-mediated necrotizing myopathy (IMNM), an autoimmune mediated myopathy, has been rarely reported. Discontinue use if suspected. Supportive therapy may be required.
Neurologic: Use caution in patients with preexisting amyotrophic lateral sclerosis (ALS). Rate of ALS functional decline may increase with statin therapy.
Renal: Acute or serious conditions that predispose patients to the development of renal failure secondary to rhabdomyolysis (eg. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders, or uncontrolled epilepsy). Dosage interruption is required.