RESOVA 10/MG TAB 30/TAB

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: start 5-10 mg PO once daily (some patients may start 10-20 mg based on LDL-C reduction needed), usual 10-20 mg, max 40 mg daily. Hypertriglyceridemia: 5-10 mg daily initially, titrate; max 40 mg daily. Homozygous familial hypercholesterolemia: start 20 mg once daily, max 40 mg once daily. Primary prevention/risk reduction: 10-20 mg once daily (dose individualized to risk and LDL-C goal).

Initial Dose

The usual starting dose is 10 to 20 mg once daily.

Maintenance Dose

10-20mg once daily

Maximum Dose

40mg 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

Assess lipids and titrate at intervals of about 4 weeks; consider lower starting dose (e.g., 5 mg) in patients with higher exposure risk (e.g., Asian ancestry) and in those with renal impairment; 40 mg is reserved only for patients not at goal on 20 mg with careful monitoring; adjust/limit dose with interacting drugs (e.g., avoid with cyclosporine; limit dose with certain HIV protease inhibitors).

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.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to rosuvastatin/excipients; active liver disease including unexplained persistent elevations of serum transaminases; pregnancy; breastfeeding; concomitant use with cyclosporine.

Age Restriction

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Drug Interactions

Drug Interactions

Clinically important interactions include: cyclosporine (contraindicated/avoid); gemfibrozil (avoid if possible; increases exposure and myopathy risk); protease inhibitors (e.g., atazanavir/ritonavir, lopinavir/ritonavir-dose limit/avoid high doses); warfarin (may increase INR-monitor); aluminum/magnesium antacids (reduce rosuvastatin absorption-separate dosing); niacin and fibrates (incl. fenofibrate) (additive myopathy risk); colchicine (myopathy risk); fusidic acid (avoid/temporarily stop statin due to rhabdomyolysis risk).

Interaction Severity

MAJOR: Cyclosporine (markedly increases rosuvastatin exposure-avoid/contraindicated per many labels); Gemfibrozil (increases exposure and myopathy risk-avoid). MODERATE: Warfarin (may increase INR-monitor), HIV protease inhibitors (e.g., lopinavir/ritonavir, atazanavir/ritonavir-limit rosuvastatin dose), other fibrates (e.g., fenofibrate) and niacin (additive myopathy risk-use caution/monitor), colchicine (myopathy risk-monitor), fusidic acid (serious myopathy risk-avoid combination/temporarily stop statin). MINOR: Aluminum/magnesium antacids (reduce 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

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 once daily; mild-moderate impairment: no adjustment; hemodialysis: start 5 mg once daily and do not exceed 10 mg once daily.

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.

Patient Counseling

Take once daily at the same time, with or without food; continue long-term alongside diet/exercise. Report unexplained muscle pain/weakness or dark urine promptly. Avoid use in pregnancy; inform provider if pregnant/planning pregnancy or breastfeeding. Limit excessive alcohol and report symptoms of liver injury. Tell clinicians about all medicines (notably cyclosporine, gemfibrozil, warfarin, HIV antivirals, and antacids-separate antacids by ~2 hours). Attend follow-up lipid tests and any symptom-triggered labs.

Pharmacology

Metabolism

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

Protein Binding

Approximately 88% protein bound (primarily to albumin).

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

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

Generic Availability

Yes

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.