Rosutin 5 mg Tablet contains Rosuvastatin, a potent HMG-CoA reductase inhibitor (statin), designed to manage elevated cholesterol levels and reduce cardiovascular risk. By selectively inhibiting the rate-limiting enzyme in cholesterol synthesis, Rosutin 5 mg effectively lowers LDL cholesterol, total cholesterol, and triglycerides, while modestly increasing HDL cholesterol. It is suitable for adults and selected pediatric patients for the treatment of familial and non-familial hypercholesterolemia, mixed dyslipidemia, and for primary prevention of cardiovascular disease.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Indications

Rosutin 5 mg is indicated for:

• Heterozygous Hypercholesterolemia (Familial and Non-familial)

• Homozygous Hypercholesterolemia (Familial)

• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)

• Primary prevention of cardiovascular disease in high-risk patients

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins

Pharmacology

Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, the enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. Its lipid-lowering effects are mediated by:

1. Upregulation of hepatic LDL receptors, enhancing clearance and catabolism of LDL particles.

2. Reduction of VLDL synthesis in the liver, decreasing the total number of VLDL and LDL particles.

This dual action leads to significant improvements in lipid profiles and reduction in cardiovascular risk.

Dosage and Administration

Adults:

• Typical dose range: 5–40 mg once daily

• Use 40 mg only in patients not reaching LDL-C goals on 20 mg

Homozygous familial hypercholesterolemia (HoFH):

• Starting dose: 20 mg/day

Pediatric patients:

• Heterozygous familial hypercholesterolemia (HeFH, 8–10 years): 5–10 mg/day

• HeFH (10–17 years): 5–20 mg/day

• HoFH (7–17 years): 20 mg/day

Administration:

• Can be taken with or without food, at any time of day.

Drug Interactions

• Cyclosporine: Limit to 5 mg/day due to increased exposure

• Gemfibrozil: Avoid; if necessary, limit to 10 mg/day

• Lopinavir/ritonavir or atazanavir/ritonavir: Limit to 10 mg/day

• Coumarin anticoagulants: May prolong INR; monitor closely

• Other lipid-lowering therapies: Increased risk of muscle toxicity

Contraindications

• Hypersensitivity to Rosuvastatin or components

• Active liver disease or unexplained persistent elevations in hepatic enzymes

• Pregnancy and women who may become pregnant

• Nursing mothers

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Side Effects

Common adverse effects include:

• Headache, myalgia (muscle pain)

• Constipation, abdominal pain, nausea

• Asthenia (fatigue)

Serious:

• Rare cases of myopathy or rhabdomyolysis, especially with high doses or in combination with interacting drugs

Precautions and Warnings

• Muscle effects: Report unexplained muscle pain, tenderness, or weakness immediately

• Liver monitoring: Assess hepatic enzymes before and during treatment

• High-risk populations: Older adults, renal impairment, hypothyroidism, or combination therapy increase risk of skeletal muscle effects

Pregnancy and Lactation

• Safety in pregnancy is not established; avoid use

• Excretion in breast milk is unknown; breastfeeding should be avoided during therapy

Storage Conditions

• Store below 30°C, protected from light and moisture

• Keep out of reach of children

Mode of Action

Rosuvastatin inhibits HMG-CoA reductase, decreasing cholesterol synthesis in the liver. The resultant upregulation of LDL receptors enhances clearance of LDL cholesterol from the bloodstream, while inhibition of VLDL synthesis reduces circulating lipids, improving overall lipid profile and reducing cardiovascular risk.