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Pravachol

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Pravachol

Indications
Dosage
How Supplied

INDICATIONS

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

Prevention of Cardiovascular Disease

In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), PRAVACHOL (pravastatin sodium) is indicated to:

  • reduce the risk of myocardial infarction (MI).
  • reduce the risk of undergoing myocardial revascularization procedures.
  • reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.

In patients with clinically evident CHD, PRAVACHOL is indicated to:

  • reduce the risk of total mortality by reducing coronary death.
  • reduce the risk of MI.
  • reduce the risk of undergoing myocardial revascularization procedures.
  • reduce the risk of stroke and stroke/transient ischemic attack (TIA).
  • slow the progression of coronary atherosclerosis.

Hyperlipidemia

PRAVACHOL is indicated:

  • as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).1
  • as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).
  • for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
  • as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
    1. LDL-C remains ≥ 190 mg/dL or
    2. LDL-C remains ≥ 160 mg/dL and:
  • there is a positive family history of premature cardiovascular disease (CVD) or
  • two or more other CVD risk factors are present in the patient.

Limitations of Use

PRAVACHOL has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

DOSAGE AND ADMINISTRATION

General Dosing Information

The patient should be placed on a standard cholesterol-lowering diet before receiving PRAVACHOL and should continue on this diet during treatment with PRAVACHOL [see NCEP Treatment Guidelines for details on dietary therapy].

Adult Patients

The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with significant renal impairment, a starting dose of 10 mg daily is recommended. PRAVACHOL can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient's response to therapy and established treatment guidelines.

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.

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].

Concomitant Lipid-Altering Therapy

PRAVACHOL may be used with bile acid resins. 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 CLINICAL PHARMACOLOGY.]

Dosage in Patients Taking Cyclosporine

In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin sodium 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 sodium dose of 20 mg/day. In patients taking cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once daily [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Dosage in Patients Taking Clarithromycin

In patients taking clarithromycin, therapy should be limited to 40 mg of pravastatin sodium once daily [see DRUG INTERACTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

PRAVACHOL® 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.

20 mg tablets: Yellow, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 20” engraved on the opposite side.

40 mg tablets: Green, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 40” engraved on the opposite side.

80 mg tablets: Yellow, oval-shaped tablet with “BMS” on one side and “80” on the other side.

Storage And Handling

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 contain a desiccant canister.

40 mg tablets: Green, rounded, rectangular-shaped, biconvex with a “P” embossed on one side and “PRAVACHOL 40” engraved on the opposite side. They are supplied in bottles of 90 (NDC 0003-5194-10). Bottles contain a desiccant canister.

80 mg tablets: Yellow, oval-shaped tablet with “BMS” on one side and “80” on the other side. They are supplied in bottles of 90 (NDC 0003-5195-10). Bottles contain a desiccant canister.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

REFERENCES

1. Fredrickson DS, Levy RI, Lees RS. Fat transport in lipoproteins - An integrated approach to mechanisms and disorders. N Engl J Med. 1967;276: 34-44, 94-103, 148-156, 215-225, 273-281.

Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA.

Last reviewed on RxList: 3/14/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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