CREVAST 10 MG 30 TAB

Indications

Approved Uses

Adjunct to diet for treatment of primary hypercholesterolemia (including heterozygous familial) and mixed dyslipidemia; adjunct to diet for hypertriglyceridemia; adjunct to diet for homozygous familial hypercholesterolemia; to slow the progression of atherosclerosis; and to reduce risk of major cardiovascular events (e.g., MI, stroke, revascularization) in appropriate primary/secondary prevention populations per statin guidelines.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: start 5-10 mg once daily (some patients may start 10-20 mg), usual 5-20 mg, max 40 mg; Homozygous familial hypercholesterolemia: start 20 mg once daily, max 40 mg; Hypertriglyceridemia: 5-40 mg once daily; Cardiovascular risk reduction: 10-20 mg once daily (higher-intensity regimens may be used per guideline risk category).

Maintenance Dose

5-20 mg once daily

Maximum Dose

40 mg once daily

Children's Dosage

Heterozygous Familial Hypercholesterolemia (HeFH): 5-10mg daily for ages 8 to <10 years; 5-20mg daily for ages 10 to 17 years. Homozygous Familial Hypercholesterolemia (HoFH): 20mg daily for ages 7 to 17 years.

Dose Adjustment Notes

Adjust dose based on LDL-C response at intervals of ≥4 weeks; consider a 5 mg starting dose in Asian patients and in those with higher myopathy risk or relevant interacting drugs; reserve 40 mg only for patients not at goal on 20 mg and without predisposing risk factors.

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, nausea, constipation, asthenia/weakness (± dizziness).

Side Effect Frequency

Common (1-10%): headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia; proteinuria can occur (usually transient). Rare/very rare: myopathy/rhabdomyolysis, hepatitis/jaundice, pancreatitis, thrombocytopenia, peripheral neuropathy, and memory/mood effects.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key precautions: assess/monitor for muscle symptoms and check CK when indicated (higher risk with age >65, renal impairment, hypothyroidism, interacting drugs); obtain baseline LFTs and repeat if clinically indicated; manage diabetes risk (may raise HbA1c/glucose); avoid in pregnancy/breastfeeding and stop if pregnancy occurs; consider renal monitoring/proteinuria at higher doses; rare ILD-evaluate unexplained dyspnea/cough.

Drug Interactions

Drug Interactions

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

Interaction Severity

MAJOR: Cyclosporine (avoid/contraindicated due to large exposure increase), gemfibrozil (avoid if possible; markedly increases exposure/myopathy risk), certain HIV protease inhibitor regimens (increase levels-dose limits/avoid depending on regimen). MODERATE: Warfarin (↑INR-monitor), other fibrates and 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

May be taken with or without food; grapefruit juice is not a clinically significant interaction for rosuvastatin.

Alcohol Interaction

Avoid excessive alcohol

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Heterozygous Familial Hypercholesterolemia (HeFH): 5-10mg daily for ages 8 to <10 years; 5-20mg daily for ages 10 to 17 years. Homozygous Familial Hypercholesterolemia (HoFH): 20mg daily for ages 7 to 17 years.

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; mild-moderate impairment: no adjustment; hemodialysis: exposure is increased-use the same low-dose approach and avoid higher doses (do not exceed 10 mg/day).

Liver Impairment

Active liver disease/unexplained persistent transaminase elevations: contraindicated; mild hepatic impairment: no routine adjustment; moderate hepatic impairment (Child-Pugh B): increased exposure-use caution and start low (e.g., 5 mg) with close monitoring; severe hepatic impairment (Child-Pugh C): not recommended/avoid.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Overdose

No specific antidote; manage with supportive care and monitoring (CK, renal function, LFTs) for myopathy/rhabdomyolysis and hepatic enzyme elevation; consider GI decontamination if very recent ingestion; hemodialysis is unlikely to be beneficial.

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; do not use in pregnancy (stop immediately if pregnant) and avoid breastfeeding; keep follow-up for lipid monitoring and clinically indicated liver tests.

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; CK only if muscle symptoms/risk factors; consider glucose/HbA1c monitoring in patients at risk for diabetes; consider urinalysis/proteinuria assessment when using high-dose (e.g., 40 mg) or if clinically indicated.

Pharmacology

Mechanism of Action

Selective, competitive inhibition of HMG‑CoA reductase leading to reduced hepatic cholesterol synthesis and upregulation of LDL receptors, increasing LDL clearance.

Half-Life

Approximately 19 hours.

Bioavailability

Oral bioavailability approximately 20% (systemic exposure can be higher in some Asian populations).

Metabolism

Minimal metabolism; ~10% is metabolized (primarily by CYP2C9, with minor CYP2C19), and most circulating drug is unchanged rosuvastatin.

Excretion

Renal tubular secretion is responsible for >90% of total renal clearance; fecal/biliary excretion accounts for the remainder.

Protein Binding

Approximately 88-90%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

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

Generic Availability

Yes

Lipid Target

Both

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 07-05-2026