ATORVA 20/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for: primary hypercholesterolemia (including heterozygous familial and nonfamilial), mixed dyslipidemia (Fredrickson IIa/IIb), hypertriglyceridemia (type IV), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia; and to reduce risk of cardiovascular events in appropriate high‑risk patients.

Dosage & Administration

Dosing by Condition

Adults (hypercholesterolemia/mixed dyslipidemia/hypertriglyceridemia): 10-20 mg once daily initially (may start 40 mg if large LDL reduction needed), maintenance 10-80 mg once daily (max 80 mg/day). HoFH: 10-80 mg once daily as adjunct to other lipid-lowering therapy. Pediatric HeFH (≥10 years): 10 mg once daily initially; usual range 10-20 mg/day.

Initial Dose

10-20mg once daily. [8, 9]

Maintenance Dose

10-80mg once daily.

Maximum Dose

80mg once daily.

Children's Dosage

HeFH (10-17 years): start 10 mg orally once daily; may increase to 20 mg once daily if needed; maximum 20 mg/day. HoFH: safety/efficacy in pediatric patients not established.

Dose Adjustment Notes

Individualize dose to LDL-C goal and response; reassess lipids and titrate no sooner than 2-4 weeks after initiation or dose change; no routine dose adjustment is required in renal impairment; limit/avoid higher doses with strong CYP3A4 inhibitors and other myopathy-risk combinations.

How to Take

Swallow the film‑coated tablet whole with water; take once daily at any time of day, with or without food, preferably at the same time each day.

Side Effects

Common Side Effects

Common adverse effects include nasopharyngitis/upper respiratory symptoms, headache, gastrointestinal upset (dyspepsia, nausea, diarrhea), and musculoskeletal symptoms (myalgia/arthralgia).

Safety & Warnings

Warnings & Precautions

Key warnings/precautions: myopathy/rhabdomyolysis risk (higher with interacting drugs, higher doses, older age, hypothyroidism, renal impairment, frailty); obtain baseline LFTs and repeat if symptoms/signs of liver injury occur (routine periodic LFTs not required in asymptomatic patients); counsel to report muscle pain/weakness or dark urine and stop/evaluate if severe; consider diabetes risk (small increase in glucose) and monitor as clinically indicated; caution with heavy alcohol use or history of liver disease.

Age Restriction

Adults: indicated. Pediatrics: approved for heterozygous familial hypercholesterolemia (HeFH) in patients aged 10-17 years; safety/efficacy not established for <10 years. Other pediatric indications are not established.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major/clinically important interactions: strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole/azole antifungals, HIV/HCV protease inhibitors) and cyclosporine (↑ atorvastatin exposure/myopathy risk); systemic fusidic acid (avoid-↑ rhabdomyolysis risk); gemfibrozil and other fibrates and niacin (↑ myopathy risk); colchicine (↑ myopathy risk); grapefruit juice (↑ exposure, especially large amounts). Other notable: rifampin may ↓ exposure (timing-dependent); warfarin (monitor INR); digoxin (may ↑ digoxin levels).

Food Interaction

Can be taken with or without food; avoid large quantities of grapefruit juice (CYP3A4 inhibition may increase atorvastatin exposure).

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

HeFH (10-17 years): start 10 mg orally once daily; may increase to 20 mg once daily if needed; maximum 20 mg/day. HoFH: safety/efficacy in pediatric patients not established.

Elderly

Standard adult dosing; elderly patients (≥65 years) may be at higher risk for myopathy - monitor closely and use lowest effective dose

Storage & Patient Advice

Stopping the Medicine

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

Patient Counseling

Take 20 mg by mouth once daily, same time each day, with or without food; continue long-term alongside a heart‑healthy diet/exercise. Avoid large amounts of grapefruit juice and limit alcohol. Tell your prescriber/pharmacist about all other medicines (especially strong CYP3A4 inhibitors/inducers) and any liver disease. Seek medical advice urgently for unexplained muscle pain/weakness (especially with fever/malaise) or dark urine. Contraindicated in pregnancy-use effective contraception and stop if pregnant; do not breastfeed. Attend follow-up for lipid response and liver enzymes as clinically indicated.

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/triglycerides and modestly raises HDL).

Onset of Action

Lipid changes can be seen within several days; a clear effect is usually seen by ~2 weeks, with maximal LDL-lowering by ~2-4 weeks after starting or changing the dose. Clinical effect is maintained with continued once-daily dosing (~24-hour coverage).

Duration of Effect

LDL-lowering persists for ~24 hours with once-daily dosing (effective HMG‑CoA reductase inhibitory activity half-life ~20-30 hours due to active metabolites). Full lipid-lowering response develops over ~2-4 weeks and is maintained with continued daily therapy.

Half-Life

Approximately 14 hours for the parent drug; 20-30 hours for HMG-CoA reductase inhibitory activity due to active metabolites. [1, 30]

Bioavailability

Approximately 14% (systemic availability of HMG‑CoA reductase inhibitory activity is higher, ~30%).

Excretion

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

Product Information

Available Dosage Forms

Film‑coated tablet (this SFDA-registered product).

Composition per Dose

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

OTC Alternatives

No OTC alternative

Lipid Target

Both

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