ATORVA 40/MG FC TAB 30/FC TAB

Dosage & Administration

Initial Dose

10-20mg once daily. [6, 9]

Dose Adjustment Notes

Assess lipids about 2-4 weeks after initiation or dose change and titrate as needed; avoid/limit doses with interacting drugs-e.g., with cyclosporine avoid or do not exceed 10 mg/day; with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, some HIV/HCV antivirals) use the lowest necessary dose and follow specific maximum-dose recommendations (often ≤20 mg/day depending on agent).

Side Effects

Common Side Effects

Common: nasopharyngitis, myalgia, arthralgia, diarrhea, nausea/dyspepsia, headache; less commonly reported but possible: insomnia and urinary tract infection.

Safety & Warnings

Warnings & Precautions

Warnings/precautions: assess for myopathy risk (e.g., interacting drugs, renal impairment, hypothyroidism, older age) and check CK when clinically indicated; counsel to report muscle pain/weakness and stop/evaluate if severe symptoms or markedly elevated CK; obtain baseline LFTs and repeat if symptoms of liver injury occur; use caution with substantial alcohol use/history of liver disease; may increase blood glucose/HbA1c; consider rare cognitive effects and very rare interstitial lung disease if unexplained respiratory symptoms.

Age Restriction

Pediatrics: approved for heterozygous familial hypercholesterolemia (HeFH) in children/adolescents aged 10-17 years; not established/approved <10 years. Other indications (e.g., primary prevention/ASCVD risk reduction) are generally adult indications and not established/approved <18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: strong/moderate CYP3A4 inhibitors (e.g., clarithromycin, azole antifungals, HIV protease inhibitors) ↑ atorvastatin exposure/myopathy risk; cyclosporine markedly ↑ exposure (avoid/very limited dosing per labeling); fibrates (esp. gemfibrozil) and niacin (lipid-lowering doses) ↑ myopathy risk; colchicine ↑ myopathy risk; grapefruit juice (large amounts) ↑ exposure; digoxin levels may increase; warfarin-monitor INR when starting/stopping; antacids may reduce atorvastatin concentrations (usually not clinically significant).

Food Interaction

May be taken with or without food; avoid excessive grapefruit juice (large quantities) due to increased atorvastatin exposure and myopathy risk.

Special Populations

Elderly

Standard adult dosing; use with caution due to increased risk of myopathy in patients over 70 years

Storage & Patient Advice

Storage Conditions

Store below 25°C, in a dry place, protected from light

Stopping the Medicine

Do not stop atorvastatin without consulting the prescriber; stopping is not physiologically dangerous acutely, but LDL-C will rise and long-term cardiovascular risk may increase.

Pharmacology

Mechanism of Action

Competitive inhibition of HMG‑CoA reductase reduces hepatic cholesterol synthesis, upregulates LDL receptors, and increases clearance of circulating LDL (with modest TG lowering and HDL increase).

Onset of Action

LDL-C lowering begins within ~3-5 days, is evident by 1-2 weeks, and reaches near-maximal effect by ~4 weeks after starting or changing the dose.

Duration of Effect

LDL-C lowering persists for days to weeks after discontinuation; with once-daily dosing, HMG‑CoA reductase inhibition provides ~24-hour coverage (parent t½ ~14 hours; active metabolites contribute inhibitory activity ~20-30 hours).

Half-Life

Parent atorvastatin ~14 hours; HMG-CoA reductase inhibitory activity persists ~20-30 hours due to active metabolites.

Bioavailability

Approximately 14% (absolute oral bioavailability).

Excretion

Primarily biliary/fecal elimination after hepatic metabolism; <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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