CREVAST 20/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for primary hypercholesterolemia (including heterozygous familial and non‑familial) and mixed dyslipidemia; adjunct to diet for hypertriglyceridemia; adjunct to diet for homozygous familial hypercholesterolemia; and to reduce risk of major cardiovascular events (primary prevention in appropriate high‑risk patients and secondary prevention in established ASCVD).

Off-Label Uses

No single universally accepted off-label indication; rosuvastatin has been studied off-label in conditions such as NAFLD/NASH and prevention of contrast-associated AKI, but these are not established standard indications.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: start 5-10 mg once daily (or 10-20 mg if larger LDL reduction needed), titrate to 5-40 mg once daily; Homozygous familial hypercholesterolemia: start 20 mg once daily, max 40 mg once daily; Hypertriglyceridemia: 5-20 mg once daily (titrate as needed, max 40 mg); Cardiovascular risk reduction: 10-20 mg once daily (intensity-based; 20-40 mg for high-intensity when appropriate).

Initial Dose

10-20mg once daily.

Maintenance Dose

5-20 mg once daily, adjusted at 4-week intervals based on lipid response

Maximum Dose

40 mg once daily

Children's Dosage

Approved for children ≥6 years for heterozygous familial hypercholesterolemia (5-20 mg/day) and homozygous familial hypercholesterolemia (≥6 years, 5-20 mg/day); pediatric dosing should be supervised by a specialist

Dose Adjustment Notes

Adjust dose based on LDL-C response at intervals of ≥4 weeks; consider lower starting dose (e.g., 5 mg) in patients of Asian ancestry and in those with myopathy risk factors; renal impairment: no adjustment for mild-moderate, but in severe renal impairment (CrCl <30 mL/min, not on dialysis) start 5 mg and do not exceed 10 mg/day; interacting drugs: cyclosporine-avoid or if unavoidable do not exceed 5 mg/day; gemfibrozil-avoid, or if used do not exceed 10 mg/day; protease inhibitors (e.g., atazanavir/ritonavir, lopinavir/ritonavir)-limit to 10 mg/day.

How to Take

Swallow tablet whole with water, once daily, with or without food. Can be taken at any time of day, but should be taken at the same time each day.

Side Effects

Common Side Effects

Headache, myalgia, nausea, constipation, abdominal pain, asthenia, dizziness, proteinuria (dose-dependent)

Side Effect Frequency

Common (≥1% to <10%): myalgia, headache, abdominal pain, asthenia; constipation and nausea are also commonly reported (generally in the ~1-10% range depending on dataset).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to rosuvastatin/excipients; active liver disease (including unexplained persistent transaminase elevations); pregnancy; breastfeeding; concomitant cyclosporine use.

Warnings & Precautions

Key warnings/precautions: myopathy/rhabdomyolysis risk (higher dose, age ≥65, renal impairment, hypothyroidism, interacting drugs); check baseline LFTs and repeat if symptoms of liver injury occur; consider CK if muscle symptoms and stop if severe myopathy/marked CK; risk of new-onset diabetes; proteinuria/hematuria can occur (more at higher doses); counsel on pregnancy avoidance and to report muscle pain/weakness or dark urine promptly.

Age Restriction

Pediatric use: approved for HeFH in children 8-17 years; approved for HoFH in children 7-17 years; not established/approved below these ages.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: cyclosporine (contraindicated/avoid); gemfibrozil (avoid); other fibrates and niacin (↑ myopathy risk); protease inhibitors (e.g., atazanavir/ritonavir, lopinavir/ritonavir) (↑ rosuvastatin exposure-dose limits/avoid depending on regimen); warfarin (↑ INR-monitor); aluminum/magnesium antacids (↓ rosuvastatin exposure-separate dosing); colchicine (↑ myopathy risk); fusidic acid (systemic) (↑ rhabdomyolysis risk-avoid/temporarily stop statin).

Interaction Severity

MAJOR: Cyclosporine (markedly increases rosuvastatin exposure-avoid or strict max 5 mg/day), gemfibrozil (increases exposure/myopathy risk-avoid or max 10 mg/day), certain HIV protease inhibitor regimens (increase exposure-dose limit, typically max 10 mg/day). MODERATE: Warfarin (↑INR-monitor), other fibrates/niacin (↑myopathy risk), colchicine (↑myopathy risk), fusidic acid (avoid combination due to rhabdomyolysis risk). MINOR: Aluminum/magnesium antacids (↓absorption-separate by ~2 hours).

Food Interaction

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

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Approved for children ≥6 years for heterozygous familial hypercholesterolemia (5-20 mg/day) and homozygous familial hypercholesterolemia (≥6 years, 5-20 mg/day); pediatric dosing should be supervised by a specialist

Elderly

Standard adult dosing; however, start at 5 mg in patients over 70 years due to increased risk of myopathy; titrate cautiously

Kidney Impairment

Severe renal impairment (CrCl <30 mL/min/1.73 m², not on hemodialysis): start 5 mg once daily and do not exceed 10 mg/day; CrCl ≥30 mL/min: no adjustment generally required (use caution with higher doses).

Liver Impairment

Active liver disease: contraindicated; mild hepatic impairment: no routine dose adjustment; moderate hepatic impairment (Child-Pugh B): increased exposure-use with caution and generally avoid high doses; severe hepatic impairment (Child-Pugh C): not recommended/avoid.

Storage & Patient Advice

Storage Conditions

Store below 30°C, in a dry place, protected from light

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 rosuvastatin without consulting the prescriber; stopping may increase cardiovascular risk.

Overdose

No specific antidote; manage with supportive care and monitoring (CK, renal function, LFTs) for myopathy/rhabdomyolysis; hemodialysis is unlikely to be effective.

Patient Counseling

Take once daily at the same time, with or without food; continue diet/exercise; report unexplained muscle pain/weakness or dark urine promptly; avoid excessive alcohol; avoid pregnancy-contraindicated in pregnancy and breastfeeding and use effective contraception if of childbearing potential; separate aluminum/magnesium antacids by ~2 hours; do not stop without clinician advice and attend follow-up lipid testing.

Monitoring Requirements

Lipid panel at baseline and 4-12 weeks after initiation or dose change, then every 3-12 months; liver enzymes at baseline and thereafter if clinically indicated (symptoms/signs of hepatotoxicity); CK only if muscle symptoms or high myopathy risk; assess renal function in patients at risk and consider urinalysis/proteinuria monitoring if clinically indicated (especially with higher doses).

Pharmacology

Mechanism of Action

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

Onset of Action

LDL-C reduction begins within ~1 week; substantial effect by 2 weeks; maximal effect typically by 4 weeks.

Duration of Effect

LDL-C lowering begins within ~1 week; substantial effect by 2 weeks; maximal effect typically by 4 weeks, and is maintained with continued once-daily dosing. After discontinuation, lipid levels gradually return toward baseline over several weeks.

Half-Life

Approximately 19 hours.

Bioavailability

Approximately 20% oral bioavailability.

Metabolism

Minimal hepatic metabolism; ~10% of an oral dose is metabolized, mainly via CYP2C9 (minor CYP2C19), forming N-desmethyl rosuvastatin (active) and a lactone metabolite.

Excretion

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

Protein Binding

Approximately 88% (often reported as ~88-90%), mainly bound to albumin.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 20 mg rosuvastatin (as rosuvastatin calcium)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

Both

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