ATORLIP 10/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 to reduce risk of cardiovascular events in appropriate high‑risk patients (primary and secondary prevention).

Off-Label Uses

No single off‑label use is universally recommended; atorvastatin has been studied off‑label in conditions such as NAFLD/NASH and contrast‑associated AKI prevention, but these are not standard indications and should be individualized.

Dosage & Administration

Dosing by Condition

Adults (oral, once daily): primary hypercholesterolemia/mixed dyslipidemia: 10-20 mg initial, range 10-80 mg; hypertriglyceridemia: 10-80 mg; primary dysbetalipoproteinemia: 10-80 mg; heterozygous familial hypercholesterolemia: 10-80 mg; homozygous familial hypercholesterolemia: 10-80 mg (adjunct to other lipid‑lowering therapy); cardiovascular risk reduction: 10-80 mg based on required LDL‑C lowering.

Initial Dose

10-20mg once daily. [6, 7, 10, 16]

Maintenance Dose

10-80mg once daily. [6, 7, 10]

Maximum Dose

80mg per day. [6, 7, 8]

Children's Dosage

For heterozygous familial hypercholesterolemia (HeFH) ages 10-17 years: Start 10 mg once daily; may increase to 20 mg once daily if needed; maximum 20 mg/day. Safety/efficacy not established for <10 years; pediatric dosing for homozygous familial hypercholesterolemia is not established.

Dose Adjustment Notes

Assess lipids and titrate dose based on response/tolerability, typically at intervals of about 2-4 weeks; no dosage adjustment is required in renal impairment; limit/avoid higher doses with strong CYP3A4 inhibitors and in other myopathy‑risk situations.

How to Take

Oral: swallow the film‑coated tablet whole with water; may be taken with or without food; take once daily at the same time each day.

Side Effects

Common Side Effects

Common: nasopharyngitis, diarrhea, nausea, dyspepsia, myalgia, arthralgia, pain in extremity, headache, insomnia, urinary tract infection.

Side Effect Frequency

Common (≥1% to <10%): nasopharyngitis, myalgia, arthralgia, diarrhea, nausea, dyspepsia, headache; elevations in liver enzymes can occur. Serious but rare/uncommon: myopathy/rhabdomyolysis, hepatitis, pancreatitis, immune‑mediated necrotizing myopathy.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key precautions: counsel to report unexplained muscle pain/weakness and check CK if severe symptoms; myopathy/rhabdomyolysis risk increases with higher doses, older age, hypothyroidism, and interacting drugs (CYP3A4 inhibitors, cyclosporine, fibrates/niacin, colchicine); assess liver enzymes before initiation and evaluate if symptoms of hepatic injury occur; may increase blood glucose/new-onset diabetes risk; use caution with substantial alcohol use or prior liver disease.

Age Restriction

Pediatric use: approved for heterozygous familial hypercholesterolemia (HeFH) in ages 10-17 years; not established/approved for <10 years; other indications generally not established in <18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: strong/moderate CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, azole antifungals, HIV protease inhibitors/cobicistat) and grapefruit juice (large amounts) ↑ atorvastatin exposure/myopathy risk; cyclosporine ↑ exposure (avoid/very low max dose per labeling); fibrates (especially gemfibrozil) and high-dose niacin ↑ myopathy risk; colchicine ↑ myopathy risk; warfarin (may alter INR-monitor); digoxin (may ↑ digoxin levels); some oral contraceptives (may ↑ ethinyl estradiol/norethindrone); antacids may ↓ atorvastatin concentrations (separate if needed).

Interaction Severity

MAJOR/avoid or strict limits: cyclosporine; strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors/boosters); certain antivirals (e.g., telaprevir; tipranavir/ritonavir) - markedly increase exposure/myopathy risk. MODERATE: gemfibrozil and other fibrates, niacin (lipid‑lowering doses), colchicine (additive myotoxicity); warfarin (INR changes-monitor); digoxin (levels may increase); grapefruit juice (exposure increase). MINOR: antacids (reduced absorption-separate if needed).

Food Interaction

May be taken with or without food; avoid or limit grapefruit juice (especially large quantities) due to CYP3A4 inhibition increasing atorvastatin exposure and myopathy risk.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

For heterozygous familial hypercholesterolemia (HeFH) ages 10-17 years: Start 10 mg once daily; may increase to 20 mg once daily if needed; maximum 20 mg/day. Safety/efficacy not established for <10 years; pediatric dosing for homozygous familial hypercholesterolemia is not established.

Elderly

Standard adult dosing. Use with caution due to an increased risk of myopathy. [10, 22]

Kidney Impairment

No renal dose adjustment required.

Liver Impairment

Active liver disease or unexplained persistent transaminase elevations: contraindicated; otherwise no specific dose-adjustment algorithm-use caution in history of liver disease/heavy alcohol use and monitor clinically (and LFTs if symptoms).

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.

Stopping the Medicine

Do not stop atorvastatin without consulting the prescriber; stopping can lead to loss of LDL-C control and increased cardiovascular risk over time.

Overdose

No specific antidote; manage with symptomatic/supportive care, consider decontamination if early after ingestion, monitor CK/LFTs/renal function; hemodialysis is unlikely to be effective due to high protein binding; seek urgent medical attention/poison center guidance.

Patient Counseling

Take 1 tablet (atorvastatin 10 mg) by mouth once daily, at the same time each day, with or without food; continue long-term as prescribed alongside diet/exercise. Avoid large amounts of grapefruit juice and check with your clinician/pharmacist before starting new medicines (notably strong CYP3A4 inhibitors) due to interaction risk. Seek medical advice promptly for unexplained muscle pain/weakness/tenderness (especially with fever or dark urine) and for symptoms of liver injury; limit excessive alcohol. Contraindicated in pregnancy-use effective contraception and stop/notify your prescriber immediately if pregnancy occurs; generally avoid during breastfeeding. Attend follow-up lipid monitoring (and liver enzymes if clinically indicated).

Monitoring Requirements

Baseline: lipid panel and liver enzymes (ALT/AST). Follow‑up: lipid panel about 4-12 weeks after initiation or dose change, then every 3-12 months; liver enzymes only if clinically indicated (symptoms/signs of hepatotoxicity); CK only if muscle symptoms or high myopathy risk; consider periodic glucose/HbA1c in patients at risk for diabetes.

Pharmacology

Mechanism of Action

Competitive inhibition of HMG‑CoA reductase in the liver, decreasing cholesterol synthesis and upregulating hepatic LDL receptors to increase clearance of circulating LDL‑C.

Onset of Action

LDL‑C lowering begins within ~1-2 weeks; near‑maximal effect is typically achieved by ~2-4 weeks (often ~4 weeks).

Duration of Effect

Pharmacodynamic lipid‑lowering effect persists for several days after a dose; with once‑daily dosing, HMG‑CoA reductase inhibitory activity provides ~24‑hour coverage (inhibitory activity half‑life ~20-30 hours due to active metabolites).

Half-Life

Approximately 14 hours for the parent drug; 20-30 hours for HMG-CoA reductase inhibitory activity due to active metabolites. [1, 26, 27]

Bioavailability

Approximately 12% (systemic availability) due to extensive first-pass metabolism.

Metabolism

Extensively hepatic metabolism via CYP3A4 to active ortho- and parahydroxylated metabolites (and beta-oxidation products).

Excretion

Primarily biliary/fecal elimination; renal excretion is minimal (about <2% in urine).

Protein Binding

Highly protein bound: ≥98%.

Product Information

Available Dosage Forms

Film‑coated tablet.

Composition per Dose

Each film-coated tablet: 10 mg atorvastatin as atorvastatin calcium

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

LDL

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