ROZAVI 10MG 28TAB

Indications

Approved Uses

Adjunct to diet for treatment of primary hypercholesterolemia (including heterozygous familial and non‑familial) and mixed dyslipidemia; adjunct to diet for hypertriglyceridemia; adjunct to other lipid‑lowering therapies for homozygous familial hypercholesterolemia; reduction of risk of major cardiovascular events in appropriate high‑risk patients (primary and secondary prevention per guideline-defined risk).

Off-Label Uses

No routine, guideline-endorsed off-label indication; may be used in selected patients for pleiotropic/adjunctive purposes (e.g., NAFLD/NASH or CKD risk reduction) but evidence does not constitute a standard labeled indication.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: start 5-10 mg once daily (some patients may start 10-20 mg), usual range 5-20 mg, max 40 mg/day (40 mg reserved for severe hypercholesterolemia not at goal on lower doses); hypertriglyceridemia: 5-20 mg once daily; homozygous familial hypercholesterolemia: start 20 mg once daily, max 40 mg/day; cardiovascular risk reduction: dose intensity per guideline risk (commonly 20-40 mg for high-intensity when indicated).

Initial Dose

5-10 mg once daily

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

Titrate at intervals of ≥4 weeks based on lipid response; 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; Asian patients: consider starting at 5 mg; cyclosporine: avoid/contraindicated; with protease inhibitors (e.g., atazanavir/ritonavir, lopinavir/ritonavir): limit to 10 mg/day; with gemfibrozil: avoid if possible-if used, limit to 10 mg/day and monitor closely.

How to Take

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

Side Effects

Common Side Effects

Headache, myalgia, abdominal pain, nausea, asthenia/weakness; constipation can also occur.

Side Effect Frequency

Common (1-10%): myalgia, constipation, asthenia, abdominal pain, nausea; headache is also commonly reported in labeling.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Monitor/educate for muscle symptoms (higher risk with age >65, renal impairment, hypothyroidism, interacting drugs); check LFTs at baseline and if symptoms of liver injury occur; use lower starting dose in severe renal impairment and in patients with higher exposure risk (e.g., some Asian patients per labeling); consider IMNM if weakness persists despite stopping; manage proteinuria/hematuria if noted (more with higher doses).

Age Restriction

Approved in pediatrics ≥7 years for heterozygous familial hypercholesterolemia (HeFH); ≥8 years for HeFH in many labels; ≥7 years for HoFH in some labels-use only for specific indications, not for general primary prevention.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: cyclosporine (contraindicated); gemfibrozil/other fibrates (↑ myopathy risk; avoid gemfibrozil if possible); protease inhibitors (↑ rosuvastatin exposure-dose limits/avoid depending on regimen); warfarin (↑ INR-monitor); aluminum/magnesium antacids (↓ absorption-separate dosing); niacin (↑ myopathy risk); colchicine (↑ myopathy risk); fusidic acid (avoid/temporarily stop statin due to rhabdomyolysis risk).

Interaction Severity

MAJOR: Cyclosporine (avoid/contraindicated); protease inhibitors (e.g., atazanavir/ritonavir, lopinavir/ritonavir-dose limit/avoid depending on regimen); gemfibrozil (avoid if possible; if unavoidable, use lowest dose with strict limit and monitoring). MODERATE: Warfarin (monitor INR), other fibrates/niacin (↑ myopathy risk), colchicine (↑ myopathy risk), fusidic acid (avoid-risk of severe myopathy/rhabdomyolysis). MINOR: Aluminum/magnesium antacids (separate by ≥2 hours).

Food Interaction

May be taken with or without food; no clinically meaningful grapefruit juice interaction.

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.

Elderly

No specific dose adjustment required; however, elderly patients (≥70 years) may have higher plasma concentrations - start at 5 mg and titrate with caution, monitor for myopathy

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: start 5 mg and do not exceed 10 mg/day.

Liver Impairment

Contraindicated in active liver disease; in chronic stable liver disease use with caution-no adjustment in mild impairment, avoid in severe hepatic impairment (Child-Pugh C) and exposure increases in moderate impairment (Child-Pugh B) so start low (e.g., 5 mg) and monitor.

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.

Stopping the Medicine

Do not stop without consulting the prescriber; stopping is not medically dangerous acutely but will remove LDL-C/CV risk protection.

Overdose

Overdose: no specific antidote; provide supportive care, monitor CK/renal function and liver enzymes, treat rhabdomyolysis if present; 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 pregnancy (stop before conception) and discuss breastfeeding; limit excessive alcohol and report symptoms of liver injury; check with a clinician before new medicines (notably cyclosporine, protease inhibitors, fibrates/niacin, colchicine, and fusidic acid); if using Al/Mg antacids, take them ≥2 hours after rosuvastatin.

Monitoring Requirements

Fasting (or nonfasting per local practice) lipid panel at baseline and 4-12 weeks after initiation or dose change, then every 3-12 months; baseline liver enzymes and repeat if symptoms/signs of hepatotoxicity occur; CK only if muscle symptoms or high-risk history; assess for secondary causes and drug interactions; consider urinalysis/proteinuria evaluation if using 40 mg or if clinically indicated.

Pharmacology

Mechanism of Action

Competitive inhibition of HMG‑CoA reductase → decreased hepatic cholesterol synthesis → upregulation of LDL receptors → increased clearance of circulating LDL (and reduced VLDL/apoB).

Onset of Action

LDL-C lowering begins within ~1 week; near-maximal effect by ~4 weeks.

Duration of Effect

LDL-C lowering is sustained with once-daily dosing; measurable effect within ~1 week and near-maximal by ~4 weeks. After discontinuation, lipid levels gradually return toward baseline over several weeks.

Half-Life

Approximately 19 hours.

Bioavailability

Approximately 20% oral bioavailability.

Metabolism

Limited hepatic metabolism; ~10% is metabolized (primarily via CYP2C9, minor CYP2C19) to N-desmethyl rosuvastatin (active).

Excretion

Eliminated mainly in feces (~90%) and to a lesser extent in urine (~10%).

Protein Binding

Approximately 88% protein bound (mainly to albumin).

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

OTC Alternatives

No OTC alternative

Lipid Target

Both

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