Pravastatin

Pravastatin is a statin used to manage cholesterol disorders and to lower the risk of serious cardiovascular events. Here is the full range of conditions it is approved to treat:

• Reducing the risk of heart attack, need for revascularization procedures (to restore blood flow), and cardiovascular death in adults with high LDL cholesterol but no diagnosed coronary heart disease (CHD)
• Reducing the risk of coronary death, heart attack, stroke, transient ischemic attack (TIA), and revascularization procedures — and slowing the progression of coronary artery disease — in adults with established CHD
• Lowering total cholesterol, LDL (bad cholesterol), triglycerides (blood fats), and apolipoprotein B, while raising HDL (good cholesterol), in adults with primary hypercholesterolemia (high cholesterol) or mixed dyslipidemia (multiple abnormal blood fat levels)
• Lowering elevated triglyceride levels in adults with hypertriglyceridemia
• Treating adults with primary dysbetalipoproteinemia (a specific inherited cholesterol disorder) who do not respond adequately to diet alone
• Lowering LDL cholesterol in children and adolescents ages 8 and older with heterozygous familial hypercholesterolemia (HeFH), used alongside diet and lifestyle changes, when LDL remains too high after a trial of diet therapy

Pravastatin works by blocking HMG-CoA reductase, the enzyme that drives the liver's production of cholesterol. With less cholesterol being made internally, the liver responds by increasing the number of LDL receptors on its surface — proteins that grab LDL (bad cholesterol) from the bloodstream and bring it into the liver to be cleared. The result is lower LDL, lower total cholesterol, lower triglycerides and VLDL (very-low-density lipoprotein), and higher HDL (good cholesterol). Maximum LDL reduction is typically reached within 4 weeks of starting treatment.

Pravastatin Sodium tablets are taken once daily by mouth at any time of day — morning or evening — with or without food, since food does not meaningfully affect the cholesterol-lowering benefit. Dosing is different for adults, children ages 8–13, and adolescents ages 14–18, and lower starting doses are used for people with severe kidney disease or those taking certain interacting medications like cyclosporine. Children and adolescents should have their treatment reassessed when they reach adulthood.

• If you also take a bile acid sequestrant (like cholestyramine or colestipol), take pravastatin at least 1 hour before or at least 4 hours after that medicine to avoid reduced absorption
• Your prescriber will check your cholesterol as early as 4 weeks after starting to see if the dose needs adjusting
• Always follow your prescriber's exact instructions — do not change your dose on your own

Pravastatin is generally well tolerated, and most side effects are mild and temporary. Common ones include:

• Muscle or joint pain
• Nausea or vomiting
• Diarrhea
• Headache
• Fatigue
• Rash
• Upper respiratory infections (cold-like symptoms)
• Dizziness

More serious reactions to watch for include unexplained muscle pain, weakness, or tenderness (especially with fever or dark urine), which could signal muscle breakdown (rhabdomyolysis), and signs of liver problems such as yellowing of the skin or eyes, severe fatigue, or upper abdominal pain — contact your doctor immediately if any of these occur.

• Muscle damage (myopathy and rhabdomyolysis): This is the most important risk. In rare cases, pravastatin can cause serious muscle breakdown that may lead to kidney failure. Risk is higher in older adults (65+), people with kidney disease, and those taking certain other drugs. Report any unexplained muscle pain, tenderness, or weakness to your doctor right away.
• Immune-mediated necrotizing myopathy (IMNM): A rare autoimmune muscle condition associated with statins. Unlike ordinary muscle side effects, IMNM causes persistent proximal (upper arm and leg) muscle weakness even after stopping the statin, and requires immunosuppressive treatment.
• Liver enzyme elevations: Pravastatin can cause liver enzyme abnormalities. Your doctor will check liver function before you start and as needed during treatment. Do not take pravastatin if you have active liver disease or unexplained persistent liver enzyme elevations.
• Pregnancy: Pravastatin must not be used during pregnancy — it can harm the developing baby. Stop it immediately and call your doctor if you become pregnant while taking it.
• Breastfeeding: Pravastatin passes into breast milk and is not recommended during breastfeeding due to potential harm to the infant.

Several medications can interact with pravastatin, most by raising pravastatin levels and increasing the risk of muscle damage. Tell your prescriber and pharmacist about everything you take.

• Gemfibrozil (a cholesterol-lowering fibrate): avoid combining — significantly raises the risk of serious muscle damage
• Cyclosporine (immune-suppressing drug): greatly increases pravastatin exposure; dose must be started very low and kept within a strict limit
• Clarithromycin and erythromycin (macrolide antibiotics): raise pravastatin levels; the daily dose must be capped — other macrolides like azithromycin may also carry risk
• Niacin (high-dose vitamin B3): cases of myopathy and rhabdomyolysis reported; weigh the benefit-risk with your doctor
• Other fibrates (e.g., fenofibrate): increased muscle risk; use together only if your doctor determines the benefit outweighs the risk
• Colchicine (gout medicine): cases of muscle damage reported with combination use; monitor carefully
• Bile acid sequestrants (cholestyramine, colestipol): reduce pravastatin absorption by roughly half if taken at the same time; separate doses by at least 1 hour before or 4 hours after

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not take pravastatin if you have active liver disease or unexplained, persistent abnormal liver enzyme levels
• Do not take pravastatin if you are pregnant — it can harm a developing baby; use effective contraception if you are of childbearing age and discuss this with your doctor
• Do not breastfeed while on pravastatin; it passes into breast milk and may harm a nursing infant
• Tell your doctor if you have kidney disease — people with severe kidney impairment need a lower starting dose and careful monitoring
• Older adults (age 65 and over) have a higher risk of muscle problems and should be monitored more closely
• Pravastatin is approved in children only ages 8 and older, and only for hereditary familial hypercholesterolemia (HeFH) — it has not been studied in younger children or in other types of cholesterol problems in children
• Tell your doctor about all prescription and over-the-counter medicines, vitamins, and supplements you take — especially cyclosporine, certain antibiotics, fibrates, niacin, or colchicine
• Caution is needed if you have a history of liver disease; discuss this with your prescriber before starting

There is limited experience with pravastatin overdose. If you or someone else takes too much, seek medical attention or call Poison Control right away. Treatment focuses on managing symptoms and monitoring, with supportive care as needed.

By blocking the liver's cholesterol-making enzyme, pravastatin causes the liver to increase LDL receptors on its surface, which pull LDL cholesterol out of the bloodstream more efficiently. This leads to measurable drops in LDL (bad cholesterol), total cholesterol, triglycerides, and VLDL, along with an increase in HDL (good cholesterol). The full cholesterol-lowering effect is typically reached by 4 weeks and is maintained with continued treatment.

Pravastatin is taken as an already-active drug (not a prodrug) and is absorbed quickly — peak blood levels are reached within about 1 to 1.5 hours of taking a dose. Food can reduce the amount absorbed, but this does not meaningfully affect how well it lowers cholesterol, so it can be taken with or without meals. The drug is heavily processed by the liver on its first pass through (about 66% is extracted), and roughly half the drug circulating in the blood is bound to proteins. Pravastatin is eliminated through both urine (about 20%) and feces (about 70%), with a short half-life of about 1.8 hours for the parent drug. People with severe liver disease or severe kidney disease may have notably higher drug exposure and need dose adjustments; older adults also tend to have moderately higher drug levels compared to younger adults.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . protect from moisture). Protect from light.