LORVAST 20/MG TAB 30/TAB

Indications

Approved Uses

Adjunct to diet for primary hypercholesterolemia and mixed dyslipidemia; hypertriglyceridemia; primary dysbetalipoproteinemia; heterozygous and homozygous familial hypercholesterolemia; and prevention of cardiovascular events in at‑risk patients.

Dosage & Administration

Dosing by Condition

Adults (primary hypercholesterolemia/mixed dyslipidemia, hypertriglyceridemia, dysbetalipoproteinemia, ASCVD risk reduction): 10-80 mg PO once daily (typical start 10-20 mg; may start 40 mg if large LDL‑C reduction needed). Homozygous familial hypercholesterolemia: 10-80 mg PO once daily (often higher doses as adjunct). Pediatric HeFH (≥10 years): start 10 mg once daily; usual range 10-20 mg once daily.

Maintenance Dose

10-80mg once daily, adjusted at intervals of 4 weeks or more based on lipid response

Maximum Dose

80mg once daily. [5, 6]

Children's Dosage

For children aged 10 years and older with Heterozygous or Homozygous Familial Hypercholesterolemia, the starting dose is 10mg once daily, with a usual range of 10-20mg daily for HeFH and 10-80mg for HoFH. [5, 6]

How to Take

Swallow the film‑coated tablet whole with water; take once daily at the same time each day, with or without food; avoid/limit grapefruit juice (especially large quantities).

Side Effects

Side Effect Frequency

Common (1-10%): nasopharyngitis, arthralgia, diarrhea, nausea/dyspepsia, pain in extremity, urinary tract infection, headache; Uncommon (0.1-1%): insomnia, dizziness, dysgeusia, urticaria/rash, hepatitis, pancreatitis, myopathy; Rare (<0.1%): rhabdomyolysis, cholestasis, severe cutaneous reactions (e.g., Stevens-Johnson syndrome).

Safety & Warnings

Contraindications

Contraindicated in: active liver disease or unexplained persistent elevations of hepatic transaminases; pregnancy; breastfeeding; hypersensitivity to atorvastatin or excipients.

Drug Interactions

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors/cobicistat) and gemfibrozil (markedly increased myopathy/rhabdomyolysis risk). MODERATE: Cyclosporine (substantially increases exposure-avoid or use very low dose with close monitoring), other fibrates, niacin (lipid‑lowering doses), colchicine (myopathy risk), digoxin (increased digoxin levels). MINOR: Antacids (↓ atorvastatin levels), St. John’s wort (↓ levels/efficacy), grapefruit juice (exposure increase-clinically relevant with large intake).

Alcohol Interaction

Use caution; limit alcohol due to potential increased risk of hepatotoxicity.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

For children aged 10 years and older with Heterozygous or Homozygous Familial Hypercholesterolemia, the starting dose is 10mg once daily, with a usual range of 10-20mg daily for HeFH and 10-80mg for HoFH. [5, 6]

Kidney Impairment

No renal dose adjustment required.

Liver Impairment

Hepatic impairment: contraindicated in active liver disease or unexplained persistent transaminase elevations; avoid/use extreme caution in severe hepatic impairment (e.g., decompensated cirrhosis); no specific dose adjustment defined for mild-moderate impairment but monitor clinically and with LFTs as indicated.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered on the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Overdose

No specific antidote; manage with symptomatic/supportive care and monitor (e.g., LFTs, CK, renal function if rhabdomyolysis suspected); hemodialysis is unlikely to be effective due to high protein binding; seek urgent medical attention.

Patient Counseling

Take once daily at the same time with or without food; continue long term with diet/exercise; avoid/limit grapefruit juice and limit alcohol; report unexplained muscle pain/weakness (especially with fever or dark urine); inform clinicians about all medicines (interaction risk); contraindicated in pregnancy-stop and contact prescriber if pregnant (avoid breastfeeding).

Monitoring Requirements

Lipid panel at baseline and 4-12 weeks after initiation or dose change, then every 3-12 months; ALT/AST at baseline and thereafter only if clinically indicated (symptoms/signs of hepatotoxicity); CK only if muscle symptoms or high risk; monitor for new-onset diabetes risk (periodic glucose/HbA1c in at‑risk patients).

Pharmacology

Metabolism

Extensive hepatic metabolism via CYP3A4 to active ortho- and parahydroxylated metabolites. [1, 2, 9]

Protein Binding

Highly protein bound: ≥98% (often reported as >98%).

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 20mg atorvastatin as atorvastatin calcium.

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

Both

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