ROZAVI 20/MG FC TAB 28/FC TAB

Indications

Approved Uses

Adjunct to diet for treatment of primary hypercholesterolemia (including heterozygous familial) and mixed dyslipidemia; hypertriglyceridemia; primary dysbetalipoproteinemia (Type III); homozygous familial hypercholesterolemia; and to reduce risk of cardiovascular events in appropriate high‑risk patients (primary/secondary prevention per guideline-based risk assessment).

Dosage & Administration

Dosing by Condition

Adults (most indications): start 5-10 mg once daily (or 10-20 mg if higher-intensity needed), titrate to 5-40 mg once daily; primary hypercholesterolemia/mixed dyslipidemia and hypertriglyceridemia: 5-40 mg once daily; homozygous familial hypercholesterolemia: 20 mg once daily, may increase to 40 mg; pediatric HeFH: 5-10 mg (6-9 years) and 5-20 mg (10-17 years) once daily; pediatric HoFH: 20 mg once daily (7-17 years).

Maintenance Dose

5-20 mg once daily

Maximum Dose

40 mg once daily

Children's Dosage

Not applicable for this 20 mg tablet presentation; pediatric dosing requires individualized titration and may require lower-strength tablets. Use only if specifically prescribed by a specialist for approved pediatric indications.

How to Take

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

Side Effects

Side Effect Frequency

Very common (>10%): none established. Common (1-10%): headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia, increased ALT/AST, proteinuria. Uncommon (0.1-1%): pruritus, rash, urticaria. Rare (<0.1%): myopathy, rhabdomyolysis, pancreatitis, hepatitis/jaundice, angioedema/serious hypersensitivity.

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to rosuvastatin/excipients; active liver disease including unexplained persistent transaminase elevations; pregnancy; breastfeeding.

Drug Interactions

Interaction Severity

MAJOR: Cyclosporine (avoid/contraindicated); systemic fusidic acid (avoid-myopathy/rhabdomyolysis risk); gemfibrozil (avoid if possible; if unavoidable, strict low-dose limit). MODERATE: Warfarin (INR increase-monitor); HIV protease inhibitor regimens (exposure increase-dose limits); other fibrates/niacin (myopathy risk-caution); colchicine (myopathy risk-caution). MINOR: Aluminum/magnesium antacids (reduced absorption-separate by ≥2 hours); oral contraceptives (increased hormone exposure-usually not clinically limiting).

Alcohol Interaction

Use caution; increased risk of hepatotoxicity with excessive alcohol consumption

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Not applicable for this 20 mg tablet presentation; pediatric dosing requires individualized titration and may require lower-strength tablets. Use only if specifically prescribed by a specialist for approved pediatric indications.

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 once daily; hemodialysis: start 5 mg once daily and do not exceed 10 mg once daily.

Liver Impairment

Avoid/contraindicated in active liver disease; in chronic liver disease without active hepatitis, exposure increases-use caution and generally avoid in Child-Pugh B/C (moderate/severe impairment), with no adjustment typically needed in mild impairment if clinically appropriate.

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, liver enzymes) and treat suspected myopathy/rhabdomyolysis promptly; consider decontamination if very recent ingestion and clinically appropriate; seek urgent medical attention.

Patient Counseling

Take once daily at the same time, with or without food; continue diet/exercise; report unexplained muscle pain/weakness (especially with fever, malaise, or dark urine); avoid use in pregnancy and stop if pregnant; limit alcohol and report symptoms of liver injury; separate aluminum/magnesium antacids by ≥2 hours; inform clinicians about interacting drugs (e.g., cyclosporine, protease inhibitors, fibrates/niacin, warfarin, fusidic acid).

Monitoring Requirements

Fasting lipid panel at baseline and 4-12 weeks after initiation or dose change, then every 3-12 months; liver enzymes at baseline and if symptoms of hepatotoxicity occur; CK only if muscle symptoms or high-risk features; consider glucose/HbA1c monitoring in patients at risk for diabetes; renal function/urinalysis as clinically indicated (especially with higher doses or renal disease).

Pharmacology

Metabolism

Minimal hepatic metabolism (~10%); primarily via CYP2C9 (minor contribution from CYP2C19), forming N-desmethyl rosuvastatin (less active) and a lactone metabolite.

Protein Binding

Approximately 88-90%, mainly to albumin.

Product Information

Composition per Dose

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

Generic Availability

Yes

Lipid Target

Both

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