Pravachol: Proven LDL Cholesterol Reduction for Cardiovascular Risk Management
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Synonyms | |||
Pravachol (pravastatin sodium) is an HMG-CoA reductase inhibitor, commonly known as a statin, specifically formulated to address dyslipidemia and reduce the risk of major cardiovascular events. It functions by competitively inhibiting the enzyme responsible for cholesterol synthesis in the liver, thereby lowering serum concentrations of low-density lipoprotein cholesterol (LDL-C) and triglycerides 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 outcomes data from landmark trials. Its hydrophilic properties contribute to a selective action on hepatic tissue, which may be associated with a favorable side effect profile compared to more lipophilic statins.
Features
- Active ingredient: Pravastatin sodium
- Available in tablet strengths: 10 mg, 20 mg, 40 mg, 80 mg
- Administration: Oral, once daily
- Mechanism: Competitive inhibition of HMG-CoA reductase
- Pharmacokinetics: Hydrophilic, minimal cytochrome P450 3A4 metabolism
- Half-life: Approximately 1.3 to 2.8 hours
Benefits
- Significantly reduces LDL cholesterol levels, a primary modifiable risk factor for ASCVD
- Lowers triglyceride levels and modestly raises HDL cholesterol, contributing to a improved overall lipid profile
- Demonstrated reduction in the risk of myocardial infarction, revascularization procedures, and cardiovascular mortality
- Slows the progression of coronary atherosclerosis and may promote plaque stabilization
- Effective for both primary prevention in individuals with multiple risk factors and secondary prevention in patients with established cardiovascular disease
- Generally well-tolerated with a established safety profile across diverse patient populations
Common use
Pravachol is primarily 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 to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures, and reduce the risk of cardiovascular mortality in patients with hypercholesterolemia without clinically evident coronary heart disease. Furthermore, it is indicated to slow the progression of coronary atherosclerosis in patients with clinically evident coronary heart disease and to reduce the risk of stroke or transient ischemic attack in patients with clinically evident coronary heart disease.
Dosage and direction
The recommended starting dose is 40 mg once daily. Dosing should be individualized according to patient response and established guidelines, with the range of usual doses being 10 mg to 80 mg once daily. Pravachol can be administered orally as a single dose at any time of day, with or without food. It is recommended to obtain a lipid profile prior to initiating therapy and periodically thereafter to assess therapeutic efficacy. For patients requiring less aggressive LDL-C reductions or who are predisposed to myopathy, a 10 mg starting dose may be considered. Dosage adjustments may be necessary in patients with renal impairment or those taking concomitant medications.
Precautions
Prior to initiating therapy, secondary causes of hypercholesterolemia should be excluded. Liver function tests should be performed before initiation and periodically thereafter. Patients should be advised to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, as these may be signs of myopathy. Caution is advised in patients with a history of liver disease or substantial alcohol consumption. Blood glucose levels should be monitored, as statins can increase HbA1c and fasting serum glucose levels. The product contains lactose; patients with rare hereditary problems of galactose intolerance should not take this medicine.
Contraindications
Pravachol is contraindicated in patients with hypersensitivity to pravastatin sodium or any component of the formulation. It is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases. Concomitant use with cyclosporine is contraindicated. It is contraindicated in pregnancy and in women who are breastfeeding, due to the potential for serious fetal harm and because statins may pass into breast milk.
Possible side effect
The most common adverse reactions (incidence >2% and greater than placebo) include musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache. Important serious side effects include myopathy, which may progress to rhabdomyolysis with renal dysfunction; hepatic enzyme abnormalities; and increases in HbA1c and fasting serum glucose levels. Rarely, immune-mediated necrotizing myopathy, an autoimmune myopathy, has been reported. Other reported side effects include cognitive impairment (e.g., memory loss, confusion), hemorrhagic stroke in certain populations, and hypersensitivity reactions.
Drug interaction
Concomitant use with cyclosporine is contraindicated. The risk of myopathy/rhabdomyolysis is increased with concomitant use of other fibrates, niacin (≥1 g/day), colchicine, or strong inhibitors of CYP450 enzymes (though pravastatin has minimal CYP450 metabolism, interactions can still occur via other pathways). Caution is advised with concomitant use of gemfibrozil, other fibrates, or erythromycin. Pravachol may increase the concentration of digoxin; monitoring is recommended. Bile acid sequestrants may decrease the bioavailability of pravastatin; administration should be separated by at least 4 hours.
Missed dose
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed one.
Overdose
There is no specific antidote for pravastatin overdose. In the event of an overdose, symptomatic and supportive measures should be instituted. The patient should be treated appropriately, and liver function and CK levels should be monitored. Due to extensive protein binding, pravastatin is not expected to be eliminated by hemodialysis.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from moisture and light. Keep out of the reach of children and pets.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Do not disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
(Note: As an expert medical document, this section summarizes clinical consensus and trial data rather than individual patient testimonials.) Pravachol has been extensively evaluated in large-scale, randomized controlled trials such as the West of Scotland Coronary Prevention Study (WOSCOPS) and the Cholesterol and Recurrent Events (CARE) trial. These studies demonstrated significant relative risk reductions in major coronary events and cardiovascular mortality in various patient populations. It is regarded by cardiologists and lipid specialists as an effective and well-tolerated statin, particularly valued for its evidence-based outcomes benefits and its hydrophilic properties which may be associated with a lower incidence of certain adverse effects compared to other statins. Its role in both primary and secondary prevention is firmly established in major international guidelines.