IVARIN 20/MG FC TAB 30/FC TAB

Indications

Off-Label Uses

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

Dosage & Administration

Initial Dose

5-10mg once daily (10mg for most patients; 5mg for patients at risk of myopathy or Asian patients)

Dose Adjustment Notes

Assess lipids and titrate at intervals of ≥4 weeks; consider lower starting dose (e.g., 5 mg daily) in patients of Asian ancestry; in severe renal impairment (CrCl <30 mL/min/1.73 m², not on hemodialysis) start 5 mg and do not exceed 10 mg daily; avoid/contraindicated with cyclosporine; with interacting protease inhibitors, use the lowest effective dose and follow product-specific maximum dose limits (often not exceeding 10 mg daily with certain boosted regimens).

Side Effects

Common Side Effects

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

Safety & Warnings

Warnings & Precautions

Warnings/precautions: assess and counsel for muscle symptoms; check CK if symptomatic and discontinue if severe myopathy/rhabdomyolysis suspected; higher risk with high dose, age ≥65, renal impairment, hypothyroidism, interacting drugs, and certain ethnicities (e.g., Asian ancestry-use lower starting dose); obtain baseline LFTs and test if symptoms of liver injury occur; monitor for new-onset diabetes in at-risk patients; consider renal monitoring/proteinuria at higher doses; avoid/withhold with systemic fusidic acid due to rhabdomyolysis risk.

Age Restriction

Pediatric use: approved for heterozygous familial hypercholesterolemia (HeFH) in children and adolescents 8 to 17 years and for homozygous familial hypercholesterolemia (HoFH) in children and adolescents 7 to 17 years; safety and efficacy have not been established in patients <18 years for other indications.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: cyclosporine (contraindicated-markedly increases rosuvastatin exposure); gemfibrozil/other fibrates and niacin (↑ myopathy risk-avoid gemfibrozil and use caution/lowest dose with others); protease inhibitors (e.g., atazanavir/ritonavir, lopinavir/ritonavir-↑ levels-dose limits/avoid per labeling); warfarin (↑ INR-monitor); aluminum/magnesium antacids (↓ rosuvastatin exposure-separate dosing); colchicine and systemic fusidic acid (↑ myopathy/rhabdomyolysis risk-avoid/withhold statin with fusidic acid); oral contraceptives (↑ ethinyl estradiol/norgestrel exposure).

Food Interaction

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

Special Populations

Elderly

No dose adjustment required based on age alone; however, elderly patients (≥70 years) may have increased exposure - start at 5mg and titrate with caution, monitor for myopathy

Storage & Patient Advice

Stopping the Medicine

No taper is required; however, do not discontinue without prescriber advice because LDL-C will rise and cardiovascular risk management may be compromised.

Pharmacology

Mechanism of Action

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

Onset of Action

LDL-C lowering begins within ~1 week; near-maximal effect is typically achieved by ~4 weeks of continuous therapy.

Duration of Effect

Pharmacodynamic LDL-C lowering persists with once-daily dosing; the effect is maintained over the 24-hour dosing interval. After discontinuation, lipid levels gradually return toward baseline over several weeks.

Half-Life

Approximately 19 hours (often cited as ~19-20 hours).

Bioavailability

Approximately 20% oral bioavailability.

Excretion

Predominantly fecal/biliary excretion (~90%); urinary/renal excretion is minor (~10% or less).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

OTC Alternatives

No OTC alternative - statins require prescription. Dietary supplements such as plant sterols or omega-3 fatty acids may provide modest lipid-lowering effects but are not equivalent

Lipid Target

Both

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