ASTATIN 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for: primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; hypertriglyceridemia; primary dysbetalipoproteinemia; homozygous familial hypercholesterolemia; and to reduce risk of cardiovascular events (e.g., MI, stroke, revascularization) in at-risk patients (including those with type 2 diabetes with risk factors).

Dosage & Administration

Dosing by Condition

Adults: primary hypercholesterolemia/mixed dyslipidemia and hypertriglyceridemia: 10-20 mg once daily initially (some may start 40 mg if large LDL reduction needed), range 10-80 mg daily; HoFH: 10-80 mg once daily (often 40-80 mg) as adjunct to other lipid-lowering therapy; ASCVD risk reduction: 10-80 mg once daily based on risk/intensity. Pediatrics (HeFH, typically 10-17 years): start 10 mg daily, max 20 mg daily.

Initial Dose

10-20mg once daily.

Maintenance Dose

10-80mg once daily.

Maximum Dose

80mg once daily.

Children's Dosage

Pediatric (10-17 years) heterozygous familial hypercholesterolemia (HeFH): start 10 mg orally once daily; may increase to 20 mg once daily if needed. Safety/efficacy not established for other indications in patients <18 years; not established for HoFH in pediatric patients.

Dose Adjustment Notes

Individualize to LDL-C goal/response; reassess and titrate at intervals of ≥4 weeks; use lower doses/maximum dose limits or avoid with significant interacting drugs (e.g., strong CYP3A4 inhibitors and cyclosporine) due to increased myopathy risk.

Side Effects

Common Side Effects

Nasopharyngitis, arthralgia, diarrhea, nausea/dyspepsia, headache, and myalgia; may also cause elevations in liver transaminases.

Safety & Warnings

Warnings & Precautions

Assess for myopathy risk (age >65, renal impairment, hypothyroidism, interacting drugs) and check CK if symptomatic; obtain baseline LFTs and recheck if symptoms/signs of hepatotoxicity occur; counsel to report muscle pain/weakness or dark urine; consider small increases in glucose/HbA1c; use caution with alcohol abuse/history of liver disease and with drugs that increase atorvastatin exposure.

Age Restriction

Approved for pediatric use in heterozygous familial hypercholesterolemia (HeFH) from age ≥10 years (typically 10-17 years); not established/approved for other indications in patients <18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major interactions include strong CYP3A4 inhibitors (e.g., clarithromycin, azole antifungals, HIV/HCV protease inhibitors) and cyclosporine (↑ atorvastatin exposure/myopathy risk); fibrates (especially gemfibrozil), niacin, and colchicine (↑ myopathy risk); rifampin (may ↓ exposure if not co-timed); digoxin (↑ digoxin levels); oral contraceptives (↑ ethinyl estradiol/norethindrone); warfarin (may affect INR); antacids may modestly ↓ levels.

Food Interaction

May be taken with or without food; avoid large quantities of grapefruit juice (clinically significant interaction risk increases with high intake, e.g., >1-1.2 L/day).

Special Populations

Pregnancy

Contraindicated

Children

Pediatric (10-17 years) heterozygous familial hypercholesterolemia (HeFH): start 10 mg orally once daily; may increase to 20 mg once daily if needed. Safety/efficacy not established for other indications in patients <18 years; not established for HoFH in pediatric patients.

Elderly

Standard adult dosing; use with caution due to increased risk of myopathy in elderly patients, particularly those with renal impairment or low body weight

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice; stopping is not dangerous acutely but LDL-C will rise again and long-term ASCVD risk reduction benefit is lost.

Pharmacology

Mechanism of Action

Selective, competitive inhibition of HMG-CoA reductase, decreasing hepatic cholesterol synthesis and upregulating LDL receptors to increase LDL clearance.

Onset of Action

Pharmacodynamic onset after a dose occurs within hours (HMG‑CoA reductase inhibition), but clinically meaningful LDL‑C reduction is typically evident within ~1-2 weeks, with near‑maximal effect by ~4 weeks.

Duration of Effect

Single-dose enzyme inhibition/LDL‑lowering coverage lasts about 24 hours with once‑daily dosing (effective inhibitory half‑life ~20-30 hours due to active metabolites). The lipid‑lowering effect persists for days after stopping and returns toward baseline over ~1-3 weeks.

Half-Life

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

Bioavailability

Approximately 12% absolute oral bioavailability.

Excretion

Primarily eliminated via bile/feces after hepatic metabolism; renal excretion is minimal (≤2% recovered in urine).

Product Information

Available Dosage Forms

Film-coated tablet (oral), 10 mg; pack size 30 tablets (blister).

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Lipid Target

Both

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.