LORVAST 10MG 30TAB

Indications

Approved Uses

Adjunct to diet for: primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; hypertriglyceridemia; primary dysbetalipoproteinemia; homozygous familial hypercholesterolemia; and to reduce risk of cardiovascular events (e.g., MI, stroke, revascularization, angina) in appropriate high-risk patients.

Dosage & Administration

Dosing by Condition

Adults (most indications): start 10-20 mg once daily (may start 40 mg if >45% LDL-C reduction needed); maintenance 10-80 mg once daily. Homozygous familial hypercholesterolemia: 10-80 mg once daily (often with other lipid-lowering therapy). Pediatrics (HeFH, typically ≥10 years): start 10 mg once daily; usual max 20 mg/day (per many labels/guidelines).

Initial Dose

10-20mg once daily. [6, 7]

Dose Adjustment Notes

Assess lipids 2-4 weeks (or up to 4-12 weeks per guidelines) after initiation or dose change and titrate accordingly; if myopathy is suspected, hold/discontinue and evaluate CK; with cyclosporine limit atorvastatin to 10 mg/day; avoid or use the lowest necessary dose with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors) and monitor closely for muscle toxicity.

Safety & Warnings

Contraindications

Hypersensitivity to atorvastatin/excipients; active liver disease or unexplained persistent elevations of hepatic transaminases; pregnancy; breastfeeding.

Warnings & Precautions

Myopathy/rhabdomyolysis risk (higher with interacting drugs and predisposing conditions such as hypothyroidism/renal impairment/older age); obtain baseline LFTs and check if symptoms of liver injury occur; counsel to report unexplained muscle pain/weakness and stop/evaluate if severe; may increase blood glucose/HbA1c (new-onset diabetes risk); use caution with heavy alcohol use or history of liver disease; rare reversible cognitive effects have been reported.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major interactions include strong CYP3A4 inhibitors (e.g., clarithromycin, azole antifungals, HIV/HCV protease inhibitors/cobicistat), cyclosporine (also OATP1B1 inhibition), gemfibrozil/other fibrates, niacin (lipid-lowering doses), colchicine; additional clinically relevant interactions: CYP3A4 inducers (reduced effect), digoxin (↑digoxin levels), warfarin (possible ↑INR), antacids (↓atorvastatin levels), and some oral contraceptives (↑ethinyl estradiol/norethindrone exposure).

Interaction Severity

MAJOR: cyclosporine; strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors); gemfibrozil (high myopathy/rhabdomyolysis risk). MODERATE: other fibrates, niacin (lipid-lowering doses), colchicine (myopathy risk); warfarin (INR changes-monitor); digoxin (increased levels). MINOR: antacids (lower Cmax without major LDL effect); oral contraceptives (increased hormone exposure).

Special Populations

Breastfeeding

Contraindicated

Elderly

Standard adult dosing; no routine dose adjustment required. Use with caution due to increased risk of myopathy in elderly patients.

Liver Impairment

Contraindicated in active liver disease or unexplained persistent transaminase elevations; no specific dose adjustment is provided for stable chronic hepatic impairment-use caution and the lowest effective dose with monitoring.

Storage & Patient Advice

Stopping the Medicine

Do not stop without consulting the prescriber; stopping will allow LDL-C to rise and may increase cardiovascular risk over time.

Pharmacology

Mechanism of Action

Competitive inhibition of HMG-CoA reductase reduces hepatic cholesterol synthesis, upregulates LDL receptors, and increases clearance of circulating LDL (also lowers VLDL/TG and modestly raises HDL).

Bioavailability

Approximately 14% (absolute oral bioavailability).

Metabolism

Extensive hepatic metabolism primarily via CYP3A4 to active ortho- and parahydroxylated metabolites (plus other metabolites including beta-oxidation products).

Excretion

Primarily biliary/fecal elimination; <2% excreted in urine.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

OTC Alternatives

No OTC alternative

Lipid Target

Both

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