ASTATIN 40/MG FC TAB 30/FC TAB

Indications

Approved Uses

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

Off-Label Uses

No routinely recommended off‑label use; while studied in conditions such as NAFLD/NASH or inflammatory states, these are not guideline-endorsed indications for prescribing atorvastatin.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: 10-20 mg once daily initially (or 40 mg if >45% LDL‑C reduction needed), maintenance 10-80 mg once daily; Homozygous familial hypercholesterolemia: 10-80 mg once daily (often 40-80 mg) as adjunct to other lipid‑lowering therapy; Hypertriglyceridemia/dysbetalipoproteinemia: 10-80 mg once daily; Cardiovascular risk reduction: 10-80 mg once daily based on risk/intensity.

Initial Dose

10-20mg once daily. [12, 15]

Maintenance Dose

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

Maximum Dose

80mg once daily. [6, 8]

Children's Dosage

Heterozygous Familial Hypercholesterolemia (10 years and older): Initially 10mg once daily, max 20mg daily. Homozygous Familial Hypercholesterolemia (10 years and older): Initially 10-20mg once daily, up to 80mg daily. [6, 7]

Dose Adjustment Notes

Titrate based on LDL‑C response at intervals of about 2-4 weeks; no adjustment is needed in renal impairment; avoid/use lowest necessary dose with strong CYP3A4 inhibitors and cyclosporine due to increased myopathy risk, and avoid in active liver disease.

How to Take

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

Side Effects

Common Side Effects

Myalgia, arthralgia, diarrhea, nausea, headache, and nasopharyngitis/upper respiratory tract symptoms; may also cause elevations in liver enzymes.

Side Effect Frequency

Common (≥1% to <10%): nasopharyngitis, arthralgia, diarrhea, pain in extremity, urinary tract infection, nausea, dyspepsia, myalgia, insomnia, headache, and increases in liver enzymes. Rare/very rare: myopathy, rhabdomyolysis, hepatitis.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key warnings/precautions: myopathy/rhabdomyolysis risk (higher with interacting drugs, older age, hypothyroidism, renal impairment, frailty)-evaluate muscle symptoms and CK when indicated; obtain baseline LFTs and check if symptoms of hepatotoxicity occur; use caution with substantial alcohol use or history of liver disease; may increase glucose/HbA1c (new-onset diabetes risk); temporarily withhold during serious acute illness/surgery/conditions predisposing to rhabdomyolysis/renal failure.

Age Restriction

Pediatrics: approved for heterozygous familial hypercholesterolemia (HeFH) in children/adolescents aged ≥10 years; not established/approved for <10 years, and pediatric use for other indications is generally not established.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors including ritonavir-boosted regimens) and cyclosporine (↑ atorvastatin exposure/myopathy risk); fibrates (especially gemfibrozil) and high-dose niacin (↑ myopathy/rhabdomyolysis risk); colchicine (↑ myopathy risk); warfarin (may alter INR); digoxin (↑ digoxin levels); certain HCV antivirals (e.g., glecaprevir/pibrentasvir-avoid/contraindicated per many labels); antacids may reduce atorvastatin concentrations.

Interaction Severity

MAJOR: cyclosporine; strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors); hepatitis C regimens containing glecaprevir/pibrentasvir; gemfibrozil (and other fibrates) due to myopathy/rhabdomyolysis risk. MODERATE: grapefruit juice (high intake), colchicine, niacin (high dose), warfarin (monitor INR), digoxin (monitor levels/clinical effect). MINOR: aluminum/magnesium antacids (reduced concentrations, usually not clinically significant).

Food Interaction

Can be taken with or without food; avoid large quantities of grapefruit juice (clinically, limit to no more than about 1 liter/day; smaller amounts are generally acceptable).

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Heterozygous Familial Hypercholesterolemia (10 years and older): Initially 10mg once daily, max 20mg daily. Homozygous Familial Hypercholesterolemia (10 years and older): Initially 10-20mg once daily, up to 80mg daily. [6, 7]

Elderly

Start at the lower end of the dosing range. For secondary prevention in patients >75 years, moderate-intensity therapy (10-20mg) is often initiated.

Kidney Impairment

No renal dose adjustment required.

Liver Impairment

Active liver disease or unexplained persistent transaminase elevations: contraindicated; otherwise no specific dose adjustment is defined, but exposure increases in hepatic impairment-use the lowest effective dose with close monitoring and avoid use in severe/decompensated hepatic impairment.

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 (e.g., >12 hours have passed or it is the next day), skip and resume the regular schedule-do not double doses.

Stopping the Medicine

No taper is required; do not stop without prescriber advice because LDL-C will rise and cardiovascular risk reduction benefit is lost.

Overdose

No specific antidote; manage with supportive care and monitoring (CK, renal function, liver enzymes) and treat complications (e.g., rhabdomyolysis); hemodialysis is unlikely to be effective due to high protein binding-seek urgent medical attention for significant overdose.

Patient Counseling

Take ASTATIN (atorvastatin) once daily at the same time each day, with or without food. Continue therapy long-term unless your prescriber advises otherwise. Seek medical advice promptly for unexplained muscle pain/tenderness/weakness (especially with fever or dark urine). Avoid large amounts of grapefruit juice. Limit alcohol due to liver risk. Do not use in pregnancy; use effective contraception and inform your prescriber immediately if pregnancy occurs. Breastfeeding is not recommended while taking atorvastatin. Maintain a cholesterol-lowering diet/exercise plan and attend follow-up lipid and liver tests as directed.

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 myopathy risk; consider glucose/HbA1c monitoring in patients at risk for diabetes.

Pharmacology

Mechanism of Action

Selective, competitive inhibition of HMG‑CoA reductase, reducing hepatic cholesterol synthesis and upregulating LDL receptors to increase clearance of circulating LDL.

Onset of Action

HMG‑CoA reductase inhibition begins after the first dose; measurable LDL‑C reduction is typically seen within ~3-7 days, with substantial effect by ~2 weeks and near‑maximal lipid lowering by ~4 weeks of continuous daily dosing.

Duration of Effect

Each dose provides ~24‑hour lipid‑lowering activity (effective half‑life ~20-30 hours due to active metabolites). LDL‑C lowering is maintained with continued once‑daily therapy over weeks to months; after discontinuation, lipid levels generally return toward baseline over ~2-4 weeks.

Half-Life

Approximately 14 hours for the parent drug; 20-30 hours for HMG-CoA reductase inhibitory activity due to active metabolites. [1, 29]

Bioavailability

Approximately 14% (systemic availability) due to extensive first-pass metabolism.

Metabolism

Extensive hepatic metabolism via CYP3A4 to active ortho- and parahydroxylated metabolites. [3, 22]

Excretion

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

Protein Binding

Highly protein bound: ≥98%.

Product Information

Available Dosage Forms

Film‑coated tablet (this product).

Composition per Dose

Each film-coated tablet: 40mg atorvastatin as atorvastatin calcium.

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

Both

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