Clinical Pharmacology Details


PITVASTATIN


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Indications & Dose:

Hypercholesterolamia, familial Hypercholesterolamia



Adult


1-2mg once daily may be increased to max; 2mg


Children


not recommended


 


 


 

Contraindications:

Active liver disease, unexplained persistent elevated liver function tests 

Side Effects:

Cautions:

Precautions:

History of liver disease, renal function impairment, elderly, children < 18 yr, alcoholism; risk factors predisposing to the development of renal failure secondary to rhabdomyolysis (severe acute infection, trauma, hypotension, uncontrolled seizure disorder, severe metabolic disorders, electrolyte imbalance)


PREGNANCY AND LACTATION: Pregnancy category X: small amounts excreted in breast milk; should probably not be used by women who are nursing


 

Interaction:

Drugs 


Azole antifungals (fluconazole, itraconazole, ketoconazole, miconazole): Increased plasma pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis


Cholestyramine: Reduced bioavailability of pravastatin


Clarithromycin: Increased plasma pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis


Clofibrate: Small increased risk of myopathy with combination


Colestipol: Reduced bioavailability of pravastatin


Cyclosporine: Concomitant administration increases risk fo severe myopathy or rhabdomyolysis


Danazol: Increased plasma pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis


Erythromycin: Increased pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis


Fluoxetine: Increased pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis


Gemfibrozil: Small increased risk of myopathy with combination, especially at high doses of statin


Isradipine: May decrease pravastatin plasma concentrations


Niacin: Concomitant administration increases risk of severe myopathy or rhabdomyolysis


Nefazodone: May inhibit hepatic metabolism of pravastatin with risk of rhabdomyolysis 


Troleandomycin: Increased pravastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis


 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Dizziness, headache


CV: Chest pain


GI: Abdominal pain, anorexia, cholestatic jaundice, cirrhosis, constipation, fatty changes in liver, flatulence, heartburn, hepatitis, increased serum transaminase levels, nausea, pancreatitis, vomiting


GU: Erectile dysfunction, loss of libido


MS: Arthralgia, localized pain, myalgia, myopathy, rhabdomyolysis


SKIN: Alopecia, photosensitivity, pruritus, rash


MISC: Fatigue, gynecomastia


 

Patient And Carer Advice: