Tab. Rovast 5 mg

Indication: Rovast 5 mg is indicated for:

Reducing elevated total cholesterol, LDL-C, ApoB, non-HDL-C, and triglycerides.
Increasing HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.
Treating hypertriglyceridemia and primary dysbetalipoproteinemia (Type III hyperlipoproteinemia).
Managing homozygous familial hypercholesterolemia.
Slowing the progression of atherosclerosis.
Reducing the risk of myocardial infarction, stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with multiple risk factors.

Pharmacology, Dosage & Administration: Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the enzyme responsible for converting HMG-CoA to mevalonate, a precursor of cholesterol. It works by increasing hepatic LDL receptors, enhancing LDL uptake and catabolism, and inhibiting hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.

Dosage:

Adults: The usual starting dose is 5 mg once daily, which may be adjusted based on individual response and risk factors. The maximum recommended dose is 40 mg daily.

Pediatric Patients (10 to 17 years): The recommended starting dose is 5 mg once daily, with a maximum of 20 mg daily.

Administration: Rovast 5 mg can be taken with or without food, at any time of day. Swallow each tablet whole with water. Try to take it at the same time every day to maintain consistency.

Interaction:

Cyclosporine: Increases rosuvastatin exposure; limit dose to 5 mg once daily.
Gemfibrozil: Avoid combination; if necessary, limit rosuvastatin dose to 10 mg once daily.
Protease Inhibitors (e.g., Lopinavir/Ritonavir, Atazanavir/Ritonavir): May increase rosuvastatin exposure; limit dose to 10 mg once daily.
Coumarin Anticoagulants: May prolong INR; monitor INR frequently until stable.
Other Lipid-Lowering Therapies: Combination with fibrates or niacin may increase the risk of skeletal muscle effects.

Contraindications:

Known hypersensitivity to rosuvastatin or any component of the formulation.
Active liver disease, including unexplained persistent elevations of hepatic transaminase levels.
Pregnancy and lactation.

Side Effects: Common side effects include headache, myalgia, constipation, asthenia, abdominal pain, and nausea. Serious adverse reactions may include myopathy and rhabdomyolysis.

Pregnancy & Lactation: Rosuvastatin is contraindicated during pregnancy and lactation due to potential harm to the fetus and the possibility of serious adverse reactions in nursing infants. Women of childbearing potential should use effective contraception during therapy.

Precautions & Warnings:

Skeletal Muscle Effects: Monitor for signs of myopathy, especially in patients with predisposing factors.
Liver Enzyme Abnormalities: Perform liver function tests before initiating therapy and as clinically indicated thereafter.
Renal Impairment: Use with caution in patients with severe renal impairment; starting dose should be 5 mg once daily, not exceeding 10 mg daily.

Overdose Effects: In case of overdose, provide symptomatic and supportive treatment as needed. Hemodialysis is unlikely to be beneficial due to extensive drug binding to plasma proteins.

Therapeutic Class: Rovast 5 mg belongs to the therapeutic class of HMG-CoA reductase inhibitors, commonly known as statins.

Storage Conditions: Store below 30°C, protected from light and moisture. Keep out of reach of children.