Apo-Pravastatin Dosage/Direction for Use

Prior to initiating APO-PRAVASTATIN (pravastatin sodium), the patient should be placed on at least an equivalent of the American Heart Association (AHA) Step 1 diet, which should be continued during treatment. If appropriate, a program of weight control and physical exercise should be implemented.
Hypercholesterolemia and Coronary Heart Disease: The recommended starting dose is 10 to 20 mg once daily at bedtime. If serum cholesterol is markedly elevated [e.g. Total Cholesterol greater than 7.75 mmol/L (300 mg/dL)] dosage may be initiated at 40 mg per day. APO-PRAVASTATIN may be taken without regard to meals.
Since the maximal effect of a given dose is seen within four weeks, periodic lipid determinations should be performed and dosage adjusted according to the patient's response to therapy. Consideration should be given to reducing the dosage of APO-PRAVASTATIN if cholesterol levels fall below the targeted range, such as that recommended by the Second Report of the U.S. National Cholesterol Education Program (NCEP), as well as the Canadian Working Group on Hypercholesterolemia and Other Dyslipidemias. The recommended dosage range is 10 to 40 mg administered once a day at bedtime.
Concomitant Therapy: Some patients may require combination therapy with one or more lipid-lowering agents. Pharmacokinetic interaction with pravastatin administered concurrently with nicotinic acid, probucol, or gemfibrozil did not statistically significantly affect the bioavailability of pravastatin. The combined use of pravastatin and fibrates should however generally be avoided (see Warnings). No results are available from clinical studies involving the concomitant administration of pravastatin with probucol.
In patients taking cyclosporine, with or without other immunosuppressive drugs, concomitantly with pravastatin, therapy should be initiated with 10 mg per day and titration to higher doses should be performed with caution. Most patients treated with this combination received a maximum pravastatin dose of 20 mg/day.
The lipid-lowering effects of pravastatin on Total and Low Density Lipoprotein Cholesterol are additive when combined with a bile acid-binding resin. However, when administering a bile acid-binding resin (e.g. cholestyramine, colestipol) and pravastatin, APO-PRAVASTATIN should not be administered concomitantly, but should be given either one hour or more before or at least four hours following the resin (see Interactions).