ROSWIN TABLETS 10MG

Indications

• Primary hyperlipidemia
• Mixed dyslipidemia
• Familial hypercholesterolemia
• Cardiovascular disease prevention
• Hypertriglyceridemia

Dosage

Children: Refer to the BNF for Children for appropriate pediatric dosing guidelines.

Adults: Refer to the BNF for specific dosing recommendations based on the condition being treated and patient factors.

Mechanism of action

Rosuvastatin selectively inhibits HMG-CoA reductase, leading to a decrease in cholesterol synthesis. This inhibition results in the upregulation of LDL receptors on hepatocyte surfaces, enhancing the clearance of LDL-C from the bloodstream. Additionally, rosuvastatin may have anti-inflammatory and plaque-stabilizing effects, contributing to cardiovascular protection.

Pharmacodynamics

The pharmacodynamic effects of rosuvastatin include a significant reduction in LDL-C levels, an increase in high-density lipoprotein cholesterol (HDL-C), and a decrease in triglyceride levels. The extent of LDL-C reduction is dose-dependent, with higher doses yielding greater reductions. Rosuvastatin also demonstrates pleiotropic effects, which include improvements in endothelial function and anti-inflammatory properties.

Pharmacokinetics

Rosuvastatin is well absorbed following oral administration, with peak plasma concentrations occurring within 3 to 5 hours. It has a bioavailability of approximately 20%. The drug is primarily metabolized in the liver via CYP2C9 and CYP2C19 pathways, although it is less dependent on cytochrome P450 than other statins. Its elimination half-life is approximately 19 hours, allowing for once-daily dosing. Rosuvastatin is excreted predominantly in the feces, with a smaller fraction eliminated in urine.

Contra-indications

• Hypersensitivity to rosuvastatin or any of the excipients
• Active liver disease or unexplained persistent elevations of serum transaminases
• Severe renal impairment
• Pregnancy and breastfeeding

Adverse effects

• Myopathy
• Rhabdomyolysis
• Hepatic impairment
• Gastrointestinal disturbances (nausea, constipation, abdominal pain)
• Headache
• Dizziness
• Allergic reactions (rash, pruritus)

Interactions

• Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase rosuvastatin levels
• Antacids may reduce absorption of rosuvastatin
• Warfarin may have increased anticoagulant effect when used concurrently
• Other lipid-lowering therapies (e.g., fibrates) may increase risk of myopathy

Precautions

• Monitor liver function tests before and during treatment
• Use caution in patients with a history of liver disease
• Assess for muscle pain or weakness, especially in the elderly or those on concurrent therapy with other statins or fibrates
• Consider dose adjustments in patients with moderate renal impairment

Pregnancy

Rosuvastatin is contraindicated in pregnancy due to potential for harm to the fetus.

Breast-feeding

Rosuvastatin is not recommended during breastfeeding as it may pass into breast milk.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

• Tablets (5 mg, 10 mg, 15 mg, 20 mg, 40 mg)