ROZINUS 10 mg Tablets

ROZINUS 10 mg Tablets
Generic Name:
Rosuvastatin 10 mg
Therapeutic Group:
Lipid-Lowering Agent
Drug Category:
HMG-CoA Reductase Inhibitor (Statin)
Content / Composition:
Each film-coated tablet contains:
Rosuvastatin …………………………… 10 mg
Excipients ……………………………… q.s.
Indications:
ROZINUS is indicated for:
Primary hypercholesterolemia
Mixed dyslipidemia
Prevention of cardiovascular events (heart attack, stroke)
Atherosclerotic cardiovascular disease (ASCVD)
Reduction of LDL cholesterol, total cholesterol, and triglycerides
Increase of HDL cholesterol
Dosage:
Initial dose: 5–10 mg once daily
Maintenance dose: 10–20 mg once daily
Maximum dose: 40 mg/day (under specialist supervision)
Dose adjustment required in renal impairment
As directed by the physician
Contraindications:
Hypersensitivity to rosuvastatin
Active liver disease
Severe renal impairment (without dose adjustment)
Pregnancy and breastfeeding
History of statin-induced muscle disorders
Administration:
Administer orally with water
Can be taken at any time of the day, with or without food
Swallow whole; do not crush or chew
Drug Interactions:
Increased risk of myopathy with fibrates, cyclosporine, or certain antivirals
Warfarin (monitor INR)
Antacids may reduce absorption (administer separately)
Alcohol increases risk of liver toxicity
Compatibility:
Suitable for combination with antihypertensive and antidiabetic medications
Compatible with comprehensive cardiovascular management plans
Stability / Storage:
Store below 25°C
Protect from light, heat, and moisture
Keep out of reach of children
Precautions:
Monitor liver function before and during treatment
Assess muscle symptoms (risk of myopathy/rhabdomyolysis)
Use cautiously in elderly patients
Lifestyle modification (diet, exercise) should be continued
Not to be used during pregnancy
Side Effects:
Common:
Headache
Muscle pain (myalgia)
Abdominal pain
Nausea
Uncommon:
Elevated liver enzymes
Fatigue
Constipation
Serious (Rare):
Rhabdomyolysis
Severe liver injury
Hypersensitivity reactions
Important Note:
ROZINUS is a potent statin used for cholesterol control and cardiovascular risk reduction. It should be used under medical supervision. This information is intended for healthcare professionals and educational purposes only.