Rocovas 10

Indications

Rocovas Tablet is indicated for the following conditions:

• Primary Hyperlipidemia & Mixed Dyslipidemia: As an adjunct to diet, it helps lower total cholesterol (total-C), LDL cholesterol (LDL-C), ApoB, non-HDL cholesterol, and triglycerides (TG), while increasing HDL cholesterol.
• Hypertriglyceridemia: As an adjunct to diet to reduce elevated triglyceride levels.
• Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): Used with diet for lipid reduction.
• Homozygous Familial Hypercholesterolemia (HoFH): Helps reduce LDL-C, total-C, and ApoB levels.
• Slowing Atherosclerosis Progression: Used to lower total-C and LDL-C, as part of a treatment plan alongside diet.
• Pediatric Use (Ages 10-17): For children with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated cholesterol levels after inadequate diet therapy.
• Risk Reduction of Cardiovascular Events: Helps reduce the risk of Myocardial Infarction (MI), stroke, and arterial revascularization procedures in patients with multiple cardiovascular risk factors but without clinically evident coronary heart disease (CHD).

Consult a registered healthcare provider for proper dosage and usage.

Pharmacology

Rosuvastatin, the active ingredient in Rocovas, is a selective and competitive HMG-CoA reductase inhibitor. It works by blocking the enzyme responsible for cholesterol production, which helps reduce total cholesterol levels. Additionally, Rocovas increases the number of LDL receptors in the liver, enhancing the uptake and breakdown of LDL cholesterol. It also inhibits the synthesis of VLDL cholesterol, lowering both VLDL and LDL particle levels.

Dosage & Administration

• Heterozygous Familial Hypercholesterolemia (Ages 10-17):
  Usual dose: 5-20 mg/day; maximum dose is 20 mg/day. Adjust dosage every 4 weeks as needed.
• Very High Cholesterol & High Risk of MI or Stroke:
  Usual dose: 40 mg once daily.
• Homozygous Familial Hypercholesterolemia (HoFH):
  Start with 20 mg once daily, adjusting based on LDL-C levels before apheresis.
• Asian Patients:
  Initiate treatment with 5 mg once daily due to potentially higher exposure.
• Patients on Cyclosporine, Lopinavir/Ritonavir, or Atazanavir/Ritonavir:
  Limit Rocovas dosage to 5 mg/day for Cyclosporine and 10 mg/day for the latter combinations.
• Patients on Concomitant Lipid-Lowering Therapy:
  Niacin or Fenofibrate may increase muscle-related side effects. Consider dose reduction.
  Gemfibrozil: Avoid combination use due to increased Rocovas exposure.
• Severe Renal Impairment (CrCl < 30 mL/min/1.73 m²):
  Start with 5 mg/day, with a maximum dose of 10 mg/day for non-dialysis patients.

Always follow the doctor’s prescribed regimen for optimal results.

Drug Interactions

• Cyclosporine: Increases Rocovas exposure. Limit dose to 5 mg/day.
• Gemfibrozil: Avoid co-administration. If used, limit Rocovas to 10 mg/day.
• Lopinavir/Ritonavir or Atazanavir/Ritonavir: Increases exposure. Limit Rocovas to 10 mg/day.
• Coumarin Anticoagulants: Increases INR. Regular INR monitoring is essential.
• Other Lipid-Lowering Drugs (Fibrates, Niacin): Use with caution as they may elevate the risk of muscle effects.

Contraindications

Rocovas is contraindicated in:

• Known hypersensitivity to Rosuvastatin or any component of the product.
• Liver disease, including unexplained persistent elevations in liver enzymes.
• Pregnancy and breastfeeding women.
• Women who may become pregnant.

Side Effects

Most patients tolerate Rocovas well. However, some common side effects include:

• Headache
• Myalgia (muscle pain)
• Constipation
• Asthenia (weakness)
• Abdominal pain
• Nausea

Pregnancy & Lactation

• Pregnancy: Rocovas should only be used in women of childbearing age when it is unlikely they will conceive. If pregnancy occurs during treatment, stop the medication immediately.
• Lactation: The safety of Rosuvastatin during breastfeeding is not known. Discontinue the drug if breastfeeding.

Precautions & Warnings

• Myopathy Risk: Patients with risk factors for muscle-related side effects (e.g., age >65 years, hypothyroidism, renal impairment) should use Rocovas cautiously.
• Concomitant Therapies: Using Rocovas with Fibrates, Niacin, or Gemfibrozil increases the risk of muscle damage.
• Liver Monitoring: Perform liver function tests at baseline, after 12 weeks of therapy, after dose increases, and periodically thereafter.
• Renal Concerns: Rocovas may need to be adjusted or discontinued in patients with symptoms suggestive of muscle damage or rhabdomyolysis.

Overdose Effects

In case of overdose, there is no specific antidote. Symptomatic treatment should be provided, and hemodialysis is not effective in enhancing clearance of Rocovas.

Therapeutic Class

• Statins
• Anti-anginal & Anti-ischaemic Drugs

Storage Conditions

Store Rocovas below 30°C, in a cool, dry place, away from light and moisture. Keep out of the reach of children.