Pravastatin

The label includes primary hyperlipidemia, hypertriglyceridemia and primary dysbetalipoproteinemia as diet adjuncts. It also includes reducing myocardial infarction, revascularization and cardiovascular mortality in adults with elevated LDL-C without clinically evident coronary heart disease, and reducing coronary death, MI, revascularization, stroke/TIA and atherosclerosis progression in adults with evident coronary disease. Selection depends on the patient’s lipid and cardiovascular risk assessment.

As an adjunct to diet, pravastatin reduces LDL-C in children age 8 and older with HeFH. This is not approval for every childhood lipid disorder. The current indication/dosing sections and original FDA pediatric approval support age 8; an inconsistent age-10 sentence in current section 8.4 is not used to override those sections.

Current recommended adult starting dose: 40–80 mg orally once daily, at any time, with or without food. Assess LDL-C as early as four weeks and adjust to response. If a high-intensity statin is needed or LDL goals remain unmet at 80 mg/day, use alternative LDL-lowering treatment rather than exceeding that dose.

Age 8–13: 20 mg once daily; age 14–18: recommended starting dose 40 mg once daily. The original pediatric studies evaluated no more than 20 mg in the younger group and 40 mg in adolescents; do not extrapolate the adult 80-mg dose. Reassess treatment at transition to adult care.

Severe renal impairment: start 10 mg/day, maximum 40 mg/day. Mild/moderate impairment uses the usual regimen. With cyclosporine: start 10 mg/day, maximum 20 mg/day. With clarithromycin or erythromycin: maximum 40 mg/day. Give at least one hour before or four hours after a bile acid sequestrant. Apply the most restrictive relevant limit.

Current formal contraindications are acute liver failure or decompensated cirrhosis, and hypersensitivity to pravastatin or its excipients. Pregnancy is no longer a blanket formal contraindication: most pregnant patients should stop, with individualized decisions for exceptional cardiovascular risk. Do not reuse superseded pregnancy or broad “active liver disease” wording.

The selected current label has no boxed warning. Its muscle, liver, pregnancy and interaction precautions still apply.

Trials report nausea/vomiting, diarrhea, headache, rash, muscle symptoms and liver/CK elevations. Rare spontaneous reports include serious allergy/skin reactions, hepatic failure, cognitive complaints, and new or worsened myasthenia gravis; these reports cannot establish frequency or causation. Severe allergy or serious weakness needs urgent assessment. No specific antidote is known; suspected overdose requires Poison Control/medical evaluation.

Avoid gemfibrozil. Cyclosporine requires a 10-mg start and 20-mg maximum; clarithromycin/erythromycin a 40-mg maximum. Other macrolides can also increase exposure. Niacin, other fibrates and colchicine require weighing benefit against muscle injury and monitoring during initiation/titration. Pravastatin is an OATP1B1 substrate; review other transporter inhibitors rather than assuming absence of CYP-based metabolism means no interactions.

Cholestyramine/colestipol can lower pravastatin exposure. Give pravastatin at least one hour before or at least four hours after a bile acid sequestrant. Recheck lipid response after relevant regimen changes.

Discontinue when pregnancy is recognized in most patients; the prescriber may consider continued therapy in a small group with very high cardiovascular risk. FDA removed the all-pregnancy contraindication in 2021; this does not make routine gestational use appropriate. Available observational data do not establish a major-malformation increase, but miscarriage evidence is insufficient. Pravastatin is present in milk; current labeling advises against breastfeeding during treatment. Discuss temporary interruption or alternative feeding according to maternal need.

The approved pediatric scope is HeFH age ≥8, with the two age-specific regimens above; no regimen is established below age 8 or for other pediatric lipid disorders. The current label’s contrary age-10 sentence is an internal inconsistency reconciled against indication/dosage and original approval evidence. Older age increases muscle risk; choose doses cautiously with organ dysfunction and polypharmacy.

Renal impairment increases muscle risk; monitor for myopathy. Severe impairment starts at 10 mg/day with a 40-mg maximum; mild/moderate impairment needs no special labeled reduction. Acute liver failure/decompensated cirrhosis is contraindicated. Other liver disease or substantial alcohol use calls for assessment and clinically indicated liver testing; the label gives no universal compensated-cirrhosis dose algorithm.

Pravastatin reversibly inhibits HMG-CoA reductase, increases hepatic LDL-receptor expression and uptake, and lowers LDL/total cholesterol and VLDL production. Maximal LDL reduction is usually achieved by four weeks.

It is administered in active form; peak plasma concentrations occur around 1–1.5 hours. Absolute oral bioavailability is about 17% with extensive first-pass hepatic extraction; approximately 50% is protein bound. Elimination includes renal and nonrenal pathways; the parent elimination half-life is about 1.8 hours. Food lowers plasma exposure but not the label’s lipid response, supporting administration with or without food.

Assess LDL-C when clinically appropriate, as early as four weeks after initiation. Review muscle symptoms and risk factors, obtain CK when clinically warranted by suspected injury, and consider liver enzymes before treatment and thereafter when indicated. Persistent weakness after withdrawal needs evaluation for IMNM. Monitor glucose/HbA1c as clinically appropriate and review pregnancy and interacting drugs.

Continue the diet/activity plan. Report unexplained muscle pain/tenderness/weakness, especially with fever or malaise; jaundice or dark urine; serious allergy; or new/worsening weakness or eye symptoms. Notify the prescriber about pregnancy or breastfeeding and before starting antibiotics, cyclosporine, colchicine or another lipid medicine. Take consistently and do not exceed the prescribed regimen.

Cipla 40-mg tablets are green, rounded-rectangular and biconvex, marked “G5” and “40”; the 90-tablet bottle is NDC 69097-791-05 and contains a desiccant canister. Other strengths have different shapes/colors and generic manufacturers differ.

The selected oral tablets supply 10, 20, 40 and 80 mg pravastatin sodium. A 10-mg generic enables renal/cyclosporine initiation; do not assume every brand currently supplies all four strengths. This record does not establish a commercial oral liquid.

Store at 20–25°C; excursions 15–30°C permitted. Keep tightly closed, protected from moisture and light; retain the bottle’s desiccant appropriately and keep medicines out of children’s reach.