ATORLIP 20/MG FC TAB 30/FC TAB

Indications

Approved Uses

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

Off-Label Uses

No routine/standard off‑label indication should be listed for this product; any off‑label uses (e.g., NAFLD or contrast nephropathy prevention) are not established as standard of care and should not be presented as typical indications.

Dosage & Administration

Dosing by Condition

Adults (hypercholesterolemia/mixed dyslipidemia, hypertriglyceridemia, and ASCVD risk reduction): 10-20 mg once daily initially (may start 40 mg if >45% LDL‑C reduction needed), maintenance 10-80 mg once daily; Homozygous familial hypercholesterolemia: 10-80 mg once daily (often higher end as adjunct to other therapies). Pediatric (heterozygous familial hypercholesterolemia, ≥10 years): 10 mg once daily, usual range 10-20 mg once daily.

Initial Dose

10-20mg once daily. [5, 16]

Maintenance Dose

10-80 mg once daily, adjusted at 4-week intervals based on lipid response

Maximum Dose

80mg once daily. [5, 7]

Children's Dosage

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

Dose Adjustment Notes

Assess lipids about 2-4 weeks after initiation or dose change and titrate as needed; no routine dose adjustment is required in renal impairment; limit/avoid higher doses with interacting drugs that increase exposure (e.g., cyclosporine and strong CYP3A4 inhibitors) and reduce dose/stop if myopathy is suspected.

How to Take

Swallow the film‑coated tablet whole with water once daily; may be taken at any time of day, with or without food, and taking it at the same time each day is recommended for adherence.

Side Effects

Common Side Effects

Common adverse effects include myalgia, arthralgia, diarrhea, nausea/dyspepsia, headache, and nasopharyngitis/upper respiratory tract symptoms; liver transaminase elevations can occur.

Side Effect Frequency

Common (1-10%): nasopharyngitis, myalgia, arthralgia, diarrhea, nausea/dyspepsia, pain in extremity, urinary tract infection, insomnia; transaminase elevations and hyperglycemia can occur (typically uncommon-common depending on population). Serious events (rare): rhabdomyolysis, hepatitis, pancreatitis, angioedema

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: assess for muscle symptoms and stop/evaluate if myopathy/rhabdomyolysis suspected (higher risk with interacting drugs, older age, hypothyroidism, renal impairment); check liver enzymes before initiation and if symptoms of hepatotoxicity occur; use caution with substantial alcohol use or prior liver disease; counsel on diabetes/hyperglycemia risk and lifestyle measures; advise prompt reporting of unexplained muscle pain/weakness or dark urine.

Age Restriction

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

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors) and cyclosporine (↑ atorvastatin exposure/myopathy risk); fibrates (esp. gemfibrozil) and niacin (↑ myopathy risk); colchicine (↑ myopathy risk); rifampin (↓ exposure if not timed appropriately); warfarin (may affect INR); digoxin (↑ digoxin levels); oral contraceptives (↑ ethinyl estradiol/norethindrone); antacids (↓ atorvastatin concentrations).

Interaction Severity

MAJOR: Cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors/cobicistat) and gemfibrozil (high myopathy/rhabdomyolysis risk). MODERATE: Other fibrates, niacin (lipid-lowering doses), colchicine, warfarin (INR changes), digoxin (level increase). MINOR: Antacids (reduced levels), rifampin (variable-can reduce exposure if not co-administered).

Food Interaction

May be taken with or without food; avoid large quantities of grapefruit juice (practically, avoid >1 quart/≈1 liter daily) due to increased atorvastatin exposure and myopathy risk.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

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

Elderly

Start at lower dose, titrate slowly. Geriatric patients may have higher plasma concentrations and are at an increased risk of myopathy. [2, 12]

Kidney Impairment

No renal dose adjustment required, including in renal impairment; monitor for myopathy risk in severe renal dysfunction or with interacting drugs.

Liver Impairment

Active liver disease or unexplained persistent transaminase elevations: contraindicated; otherwise no specific dose adjustment is defined for mild hepatic impairment but use caution and monitor, and avoid/use extreme caution in moderate-severe hepatic impairment due to markedly increased exposure.

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., the next day), skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop without prescriber advice; no taper is required, but discontinuation can lead to rebound elevation of LDL-C and increased cardiovascular risk over time.

Overdose

No specific antidote; manage with symptomatic/supportive care, consider GI decontamination if early, monitor CK/LFTs/renal function, and hemodialysis is unlikely to be effective due to high protein binding-seek urgent medical care.

Patient Counseling

Take once daily consistently (with or without food); continue diet/exercise; avoid large amounts of grapefruit juice; report unexplained muscle pain/weakness (especially with fever/malaise) and symptoms of liver injury; avoid in pregnancy (and generally avoid breastfeeding) and use effective contraception; limit alcohol; attend follow-up lipid testing (and LFTs if symptomatic).

Monitoring Requirements

Lipid panel at baseline and 4-12 weeks after initiation or dose adjustment, then periodically (e.g., every 3-12 months); ALT/LFTs at baseline and thereafter only if clinically indicated; 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, decreasing hepatic cholesterol synthesis and upregulating LDL receptors to increase LDL‑C clearance.

Onset of Action

Approximately 24 hours for HMG‑CoA reductase inhibition (supports once‑daily dosing); clinically meaningful LDL‑C reduction is typically seen within ~2 weeks, with near‑maximal effect by ~4 weeks.

Duration of Effect

LDL‑C lowering effect begins within ~2 weeks and reaches near‑maximal effect by ~4 weeks; lipid‑lowering effect is maintained with continued once‑daily therapy.

Half-Life

Approximately 14 hours for the parent drug; 20-30 hours for active metabolites.

Bioavailability

Approximately 12% (systemic absolute bioavailability); HMG‑CoA reductase inhibitory activity ~30% due to active metabolites

Metabolism

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

Excretion

Primarily biliary/fecal elimination after hepatic metabolism; <2% excreted in urine

Protein Binding

>98% (highly protein bound)

Product Information

Available Dosage Forms

Film‑coated tablet (oral), 20 mg; blister pack of 30 tablets.

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

Both

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