Pravachol

[Pravastatin]

Pediatric Patients

Children (Ages 8 to 13 Years, Inclusive) The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.

Adolescents (Ages 14 to 18 Years) The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population.

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Children and adolescents treated with pravastatin should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C (see INDICATIONS AND USAGE, Hyperlipidemia, NCEP Treatment Guidelines).

In patients taking immunosuppressive drugs such as cyclosporine (see WARNINGS: Skeletal Muscle) concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin once-a-day at bedtime and titration to higher doses should be done with caution. Most patients treated with this combination received a maximum pravastatin dose of 20 mg/ day.

Concomitant Therapy

The lipid-lowering effects of PRAVACHOL on total and LDL cholesterol are enhanced when combined with a bile-acid-binding resin. When administering a bile-acid-binding resin (e. g., cholestyramine, colestipol) and pravastatin, PRAVACHOL should be given either 1 hour or more before or at least 4 hours following the resin. (See also ADVERSE REACTIONS: Concomitant Therapy.)

HOW SUPPLIED

PRAVACHOL ® (pravastatin sodium) Tablets are supplied as:

10 mg tablets:

Pink to peach, rounded, rectangular-shaped, biconvex with a P embossed on one side and PRAVACHOL 10 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5154-05). Bottles contain a desiccant canister.

20 mg tablets:

Yellow, rounded, rectangular-shaped, biconvex with a P embossed on one side and PRAVACHOL 20 engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5178-05), bottles of 1000 (NDC 0003-5178-75), and hospital unit-dose packages of 100 tablets (NDC 0003-5178-06). Bottles contain a desiccant canister.

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