Pravachol

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Pravachol Information

Brand Name: Pravachol

Generic Name: Pravastatin Sodium

Other Common Names: Pravastatina

Pravachol is used to lower cholesterol and to prevent heart attacks.

Pravachol Indications

Therapy with lipid-altering agents such as Pravachol should be considered a component of multiple risk factor intervention in those individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate.

Primary Prevention of Coronary Events

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

Atherosclerosis

In hypercholesterolemic patients with clinically evident coronary artery disease, including prior MI, Pravachol is indicated to:

Pravachol is indicated to:

Pravastatin sodium is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, and TG levels in patients with primary hypercholesterotemia and Pravachol (Frederickson Type IIa and IIb)

Prior to initiating therapy with Pravachol, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure Total-C, HDL-C, and TG. For patients with triglycerides (TG) <400 mg/dl (<4.5 mmol/l), LDL-C can be estimated using the following equation:

LDL-C = Total-C - HDL-C - 1/5 TG

For TG levels >400 mg/dl (>4.5 mmol/l), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In many hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases, HMG-CoA reductase inhibitors are not indicated.

Lipid determinations should be performed at intervals of no less than four weeks and Pravachol dosage adjusted according to the patient's response to therapy.

Pravachol Ingredients and Composition

How Does Pravachol Work?

Pravachol Clinical Pharmacology

Cholesterol and triglycerides in the bloodstream circulate as party of lipoprotein complexes. These complexes can be separated by density ultracentrifugation into high (HDL), intermediate (IDL), low (LDL), and very low (VLDL) density lipoprotein fractions. Triglycerides (TG) and cholesterol synthesized in the liver are incorporated into very low density lipoproteins (VLDLs) and released into the plasma for delivery to peripheral tissues. In a series of subsequent steps, VLDLs are transformed into intermediate density lipoproteins (IDLs), and cholesterol-rich low density lipoproteins (LDLs). High density lipoproteins (HDLs), containing apolipoprotein A, are hypothesized to participate in the reverse transport of cholesterol from tissues back to the liver.

Pravachol produces its lipid-lowering effect in two ways. First, as a consequence of its reversible inhibition of HMG-CoA reductase activity, it effects modest reductions in intracellular pools of cholesterol. This results in an increase in the number of LDL-receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL. Second, pravastatin inhibits LDL production by inhibiting hepatic synthesis of VLDL, the LDL precursor.

Clinical and pathologic Pravachol studies have shown that elevated levels of total cholesterol (Total-C), low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (a membrane transport complex for LDL) promote human atherosclerosis. Similarly, decreased levels of HDL-cholesterol (HDL-C) and its transport complex, apolipoprotein A, are associated with the development of atherosclerosis. Epidemiologic investigations have established that cardiovascular morbidity and mortality vary directly with the level of Total-C and LDL-C and inversely with the level of HDL-C. In multicenter clinical trials, those pharmacologic and/or non-pharmacologic interventions that simultaneously lowered LDL-C and increased HDL-C reduced the rate of cardiovascular events (both fatal and nonfatal myocardial infarctions). In both normal volunteers and patients with hypercholesterolemia, treatment with pravastatin sodium reduced Total-C, LDL-C, and apolipoprotein B. Pravastatin also modestly reduced VLDL-C and TG while producing increases of variable magnitude in HDL-C and apolipoprotein A. The effects of Pravachol on Lp (a), fibrinogen, and certain other independent biochemical risk markers for coronary heart disease are unknown. The effect of Pravachol-induced changes in lipoprotein levels, including reduction or serum cholesterol, on cardiovascular morbidity or mortality has not been established. Although pravastatin is relatively more hydrophilic than other HMG-CoA reductase inhibitors, the effect of relative hydrophilicity, if any, on either efficacy or safety has not been established.

How To Take Pravachol and Pravachol Dosage and Administration

The patient should be placed on a standard cholesterol-lowering diet before receiving Pravachol and should continue on this diet during treatment with Pravachol.

The recommended starting Pravachol dose is 10 or 20 mg once daily at bedtime. In primary hypercholesterolemic patients with a history of significant renal or hepatic dysfunction, and in the elderly, a starting dose of 10 mg daily at bedtime is recommended. Pravastatin may be taken without regard to meals.

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. The recommended dosage range is generally 10 to 40 mg administered once a day at bedtime. In the elderly, maximum reductions in LDL-cholesterol may be achieved with daily doses of 20 mg or less.

In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of Pravachol 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 Pravachol, Pravachol should be given either 1 hour or more before or at least 4 hours following the resin.

If you suspect a Pravachol Overdose

To date, there are two reported cases of overdosage with Pravachol, both of which were asymptomatic and not associated with clinical laboratory abnormalities. If a Pravachol overdose occurs, it should be treated symptomatically and supportive measures should be instituted as required.

Pravachol Pill Identification / ID and Appearance

Pravachol 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.

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

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

Pravachol Side Effects

Pravachol Warnings

Pravachol Precautions and Contraindications

Pravachol is contraindicated in patients with a known hypersensitivity to any component of this medication.

Acute liver disease or unexplained, persistent elevations in liver function tests.

Taking Pravachol during Pregnancy or Breast-feeding

Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Pravachol should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus.

Pravachol Clinical Trials and Studies

Pravachol Drug Interactions

Immunosuppressive Drugs

Gemfibrozil, Niacin (Nicotinic Acid), Erythromycin

Antipyrine

Since concomitant administration of Pravachol had no effect on the clearance of antipyrine, interactions with other drugs metabolized via the same hepatic cytochrome isozymes are not expected.

Cholestyramine/Colestipol

Concomitant administration resulted in an approximately 40 to 50% decrease in the mean AUC of pravastatin. However, when Pravachol was administered 1 hour before or 4 hours after cholestyramine or 1 hour before colestipol and a standard meal, there was no clinically significant decrease in bioavailability or therapeutic effect.

Warfarin

In a study involving 10 healthy male subjects given pravastatin and warfarin concomitantly for 6 days, bioavailability parameters at steady state for pravastatin (parent compound) were not altered. Pravachol did not alter the plasma protein-binding of warfarin. Concomitant dosing did increase the AUC and Cmax of warfarin but did not produce any changes in its anticoagulant action (i.e., no increase was seen in mean prothrombin time after 6 days of concomitant therapy). However, bleeding and extreme prolongation of prothrombin time has been reported with another drug in this class. Patients receiving warfarin-type anticoagulants should have their prothrombin times closely monitored when pravastatin is initiated or the dosage of pravastatin is changed.

Cimetidine

The AUC0-12hr for Pravachol when given with cimetidine was not significantly different from the AUC for Pravachol when given alone. A significant difference was observed between the AUCs for Pravachol when given with cimetidine compared to when administered with antacid.

Digoxin

In a crossover trial involving 18 healthy male subjects given Pravachol and digoxin concurrently for 9 days, the bioavailability parameters of digoxin were not affected. The AUC of Pravachol tended to increase, but the overall bioavailability of pravastatin plus its metabolites SQ 31,906 and SQ 31,945 was not altered.

Cyclosporine

Some investigators have measured cyclosporine levels in patients on Pravachol, and to date, these results indicate no clinically meaningful elevations in cyclosporine levels. In one single-dose study, Pravachol levels were found to be increased in cardiac transplant patients receiving cyclosporine.

Gemfibrozil

In a crossover study in 20 healthy male volunteers given concomitant single doses of Pravachol and gemfibrozil, there was a significant decrease in urinary excretion and protein binding of pravastatin. In addition, there was a significant increase in AUC, Cmax, and Tmax for the pravastatin metabolite SQ 31,906. Combination therapy with Pravachol and gemfibrozil is generally not recommended.

Aspirin, Antacids, Cimetidine, Nicotinic Acid, Probucol

In interaction studies with aspirin, antacids (1 hour prior to pravastatin), cimetidine, nicotinic acid, or probucol, no statistically significant differences in bioavailability were seen when Pravachol was administered.

Other Drugs

During clinical trials, no noticeable drug interactions were reported when Pravachol was added to: diuretics, antihypertensives, digitalis, ACE inhibitors, calcium channel blockers, beta-blockers, or nitroglycerin.

Storing Pravachol

Do not store Pravachol above 86° F (30° C). Keep tightly closed (protect from moisture). Protect from light.

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