RASTOR 10/MG FC TAB 28/FC TAB

Indications

Off-Label Uses

No routine/endorsed off-label use for this product; hsCRP reduction is a biomarker effect rather than an indication, and NAFLD use is investigational/not guideline-endorsed as a primary indication.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: start 5-10 mg once daily (or 10-20 mg if higher-intensity needed), usual 5-20 mg, max 40 mg; Homozygous familial hypercholesterolemia: start 20 mg once daily, max 40 mg; Cardiovascular risk reduction: 10-20 mg once daily (intensity individualized).

Initial Dose

5-10mg once daily

Maintenance Dose

5-40mg once daily.

Maximum Dose

40mg once daily.

Children's Dosage

Heterozygous familial hypercholesterolemia (10-17 years): 5-20mg once daily. Homozygous familial hypercholesterolemia (6-17 years): 5-20mg once daily under specialist supervision. Not approved under 6 years

Dose Adjustment Notes

Adjust dose at intervals of ≥4 weeks based on LDL-C response/tolerability; consider 5 mg starting dose in Asian patients and those at higher myopathy risk; 40 mg is reserved for severe hypercholesterolemia not at goal on 20 mg with close supervision; apply interaction-based maximum doses (e.g., cyclosporine: max 5 mg; gemfibrozil: avoid or max 10 mg if unavoidable; certain HIV protease inhibitors: limit to 10 mg).

How to Take

Swallow tablet whole with water. Can be taken at any time of day, with or without food. Take at the same time each day for consistency

Side Effects

Common Side Effects

Headache, myalgia, abdominal pain, asthenia, nausea (± constipation)

Safety & Warnings

Warnings & Precautions

Key warnings/precautions: assess/monitor for muscle symptoms and CK when indicated; higher myopathy risk with high dose, age ≥65, renal impairment, hypothyroidism, and interacting drugs (e.g., fibrates, ciclosporin, protease inhibitors); obtain baseline LFTs and repeat if symptoms of liver injury occur; caution with history of liver disease or heavy alcohol use; dipstick proteinuria/hematuria may occur (usually reversible-consider dose reduction if persistent); small increased risk of new-onset diabetes with statins in at-risk patients.

Age Restriction

Pediatric use: approved for heterozygous familial hypercholesterolemia (HeFH) in ages 8-17 years and for homozygous familial hypercholesterolemia (HoFH) in ages 7-17 years; not established/approved below these ages, and routine non-FH indications are generally adult-focused (≥18 years).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: ciclosporin (contraindicated-major ↑ rosuvastatin exposure); gemfibrozil (avoid/limit dose-↑ exposure and myopathy risk); other fibrates/niacin (↑ myopathy risk); HIV protease inhibitors such as atazanavir/ritonavir or lopinavir/ritonavir (↑ levels-dose limits/avoid depending regimen); warfarin (↑ INR-monitor); aluminum/magnesium antacids (↓ absorption-separate dosing); fusidic acid (avoid-rhabdomyolysis risk); colchicine (myopathy risk-caution/monitor).

Interaction Severity

MAJOR: Cyclosporine (marked exposure increase-limit rosuvastatin to 5 mg/day), gemfibrozil (avoid if possible; if used, do not exceed 10 mg/day), systemic fusidic acid (avoid/temporarily stop statin due to rhabdomyolysis risk). MODERATE: Protease inhibitors (e.g., atazanavir/ritonavir, lopinavir/ritonavir-limit to 10 mg/day), warfarin (INR increase-monitor), other fibrates/niacin/colchicine (myopathy risk-caution). MINOR: Al/Mg antacids (reduced absorption-separate by ≥2 hours); some oral contraceptives may increase hormone exposure.

Food Interaction

No clinically meaningful food restriction-may be taken with or without food.

Special Populations

Children

Heterozygous familial hypercholesterolemia (10-17 years): 5-20mg once daily. Homozygous familial hypercholesterolemia (6-17 years): 5-20mg once daily under specialist supervision. Not approved under 6 years

Elderly

Higher plasma concentrations of rosuvastatin in patients >65 years; consider risk of myopathy; no specific dose adjustment required but consider starting lower dose in Asian patients or those at higher risk.

Kidney Impairment

CrCl ≥30 mL/min: no adjustment; severe renal impairment (CrCl <30 mL/min, not on hemodialysis): start 5 mg once daily and do not exceed 10 mg/day; hemodialysis: use same severe-impairment limits (avoid high doses such as 40 mg).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose (e.g., within ~12 hours), skip and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop without prescriber advice; if discontinued, LDL-C typically returns toward baseline and cardiovascular risk reduction benefit is lost.

Patient Counseling

Take once daily at the same time, with or without food; continue lifestyle measures; report unexplained muscle pain/weakness (especially with dark urine) promptly; avoid use in pregnancy and breastfeeding; check with clinicians before new medicines (notably cyclosporine, fibrates, protease inhibitors, fusidic acid); separate Al/Mg antacids by ≥2 hours; attend follow-up lipid tests (and liver tests if symptomatic).

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 if symptoms of hepatotoxicity occur; CK only if high myopathy risk at baseline and/or if muscle symptoms develop; consider periodic glucose/HbA1c in patients at diabetes risk.

Pharmacology

Mechanism of Action

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

Onset of Action

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

Duration of Effect

Per-dose pharmacodynamic effect supports once-daily dosing (~24 hours). Clinically, lipid-lowering is maintained with continued daily therapy and wanes gradually over ~2-4 weeks after discontinuation.

Half-Life

Approximately 19 hours.

Bioavailability

Approximately 20% oral bioavailability.

Excretion

Primarily fecal (~90%) with a smaller renal component (~10%), largely as unchanged drug.

Product Information

Available Dosage Forms

Film-coated tablet (oral)

Composition per Dose

Each film-coated tablet: 10mg rosuvastatin (as rosuvastatin calcium)

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.