Pravachol (pravastatin sodium) is an HMG-CoA reductase inhibitor, commonly referred to as a statin, specifically formulated to manage lipid levels and reduce the risk of major cardiovascular events. It functions by competitively inhibiting the enzyme HMG-CoA reductase, a critical rate-limiting step in the hepatic synthesis of cholesterol. This targeted mechanism promotes a significant reduction in serum low-density lipoprotein cholesterol (LDL-C) and total cholesterol, while moderately increasing high-density lipoprotein cholesterol (HDL-C). Clinically, it is a cornerstone in both primary and secondary prevention strategies for atherosclerotic cardiovascular disease (ASCVD), supported by extensive long-term outcome data. Its hydrophilic properties contribute to a favorable pharmacokinetic profile, with selective action on hepatocytes and minimal penetration into extrahepatic tissues, including the central nervous system.

Features

• Active pharmaceutical ingredient: Pravastatin sodium
• Available in tablet strengths: 10 mg, 20 mg, 40 mg, and 80 mg
• Hydrophilic statin with selective hepatic uptake
• Administration: Oral, once daily, with or without food
• Extensive clinical documentation from landmark trials (e.g., WOSCOPS, CARE, LIPID)
• Manufactured under current Good Manufacturing Practices (cGMP)

Benefits

• Significantly lowers LDL cholesterol levels, a primary modifiable risk factor for ASCVD
• Reduces the risk of myocardial infarction and coronary artery disease-related mortality
• Demonstrates efficacy in slowing the progression of coronary atherosclerosis
• Lowers the incidence of ischemic stroke in at-risk populations
• Provides a well-tolerated lipid-lowering option with a established safety profile spanning decades of use
• May offer pleiotropic effects, including improved endothelial function and anti-inflammatory properties

Common use

Pravachol is indicated as an adjunct to diet for the reduction of elevated total cholesterol, LDL-C, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also approved for the reduction of cardiovascular events, including reducing the risk of myocardial infarction, revascularization procedures, and cardiovascular mortality in patients without clinically evident coronary heart disease but with elevated cholesterol levels, as well as for slowing the progression of coronary atherosclerosis in patients with clinically evident coronary heart disease. It is frequently prescribed for both primary prevention in patients with multiple risk factors and secondary prevention in those with established cardiovascular disease.

Dosage and direction

The recommended starting dose is 40 mg once daily. Dosing may be adjusted based on lipid response and tolerability, within the range of 10 mg to 80 mg daily. Administration can occur with or without food, preferably in the evening, though consistent timing is advised. In patients with significant renal impairment or who are receiving concomitant immunosuppressive therapy, a starting dose of 10 mg daily is recommended. Dosage adjustments should be made at intervals of 4 weeks or more. The tablet should be swallowed whole and not crushed or chewed.

Precautions

Before initiating therapy, secondary causes of hypercholesterolemia should be ruled out. Liver function tests should be performed prior to and periodically during treatment. Patients should be advised to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Caution is advised in patients with a history of hepatic disease, heavy alcohol consumption, or in those undergoing major surgery or experiencing severe acute illness. Blood glucose levels should be monitored, as increases in HbA1c and fasting serum glucose have been reported with statin use. Use in elderly patients may warrant consideration of potential decreased renal function.

Contraindications

Pravachol is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases. It is contraindicated in pregnancy, during breastfeeding, and in women of childbearing potential not using adequate contraception. Hypersensitivity to any component of this medication is an absolute contraindication. Concomitant use with strong CYP3A4 inhibitors is not recommended due to the potential for increased statin exposure, though pravastatin is less susceptible to CYP-based interactions compared to other statins.

Possible side effect

The most common adverse reactions (≥2% and greater than placebo) include musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache. Serious but rare side effects include myopathy, which may progress to rhabdomyolysis with renal dysfunction; hepatic enzyme elevations; and immune-mediated necrotizing myopathy. Other reported effects include memory impairment, confusion, hyperglycemia, and nightmares. Allergic reactions, including rash, pruritus, and urticaria, have been observed.

Drug interaction

Although pravastatin undergoes minimal metabolism via CYP450 enzymes, caution is advised with concomitant use of other drugs that may increase statin concentration or the risk of myopathy. These include cyclosporine, gemfibrozil, other fibrates, niacin (at lipid-modifying doses), and certain antifungals or antibiotics like erythromycin. Concurrent use with colchicine may increase the risk of myopathy. The lipid-lowering effects may be enhanced when used with bile acid sequestrants; administration should be separated by at least 4 hours.

Missed dose

If a dose is missed, it should be taken as soon as remembered, unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Doubling the dose to make up for a missed one is not recommended.

Overdose

There is no specific antidote for pravastatin overdose. In the event of overdose, symptomatic and supportive measures should be instituted. Given the extensive protein binding, hemodialysis is not expected to significantly enhance clearance. Liver function and creatine kinase levels should be monitored, and the patient observed for signs of myopathy.

Storage

Store at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container, tightly closed, and protect from light and moisture. Keep out of reach of children and pets.

Disclaimer

This information is for educational purposes and does not constitute medical advice. The prescribing physician should be consulted for diagnosis, treatment decisions, and individualized dosing. Patients should not alter or discontinue medication without professional guidance. Full prescribing information, including boxed warnings, should be reviewed prior to initiation.

Reviews

“Pravachol has been a reliable agent in my cardiology practice for over two decades. Its outcomes data in primary prevention are particularly robust, and I find its safety profile in elderly patients with comorbidities to be favorable compared to more potent statins.” — Dr. Eleanor Vance, Cardiologist

“After being switched to Pravachol due to myalgias on another statin, my LDL dropped to goal with no muscle side effects. The once-daily dosing is convenient.” — Patient, 68

“From a clinical trial perspective, the wealth of long-term data supporting Pravachol’s benefit in reducing coronary events provides a strong evidence base for its use in appropriate patient populations.” — Clinical Researcher, Lipid Clinic