Rozavel5 mg

Rozavel 5 mg is indicated in- Heterozygous Hypercholesterolemia (Familial and Non familial) Homozygous Hypercholesterolemia (Familial) Mixed Dyslipidemia (Fredrickson Type IIa and IIb) Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rozavel 5 mg is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. It produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, the solution inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mgHoFH: Starting dose 20 mg/day.Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rozavel 5 mg can be taken with or without food, at any time of day.

Remarkable drug interactions of Rozavel 5 mg are:

• Cyclosporine: Combining these medications increases its exposure. The recommended dose should not exceed 5 mg once daily.
• Gemfibrosil: It is advisable to avoid combining these drugs. If necessary, limit the dosage to 10 mg once daily when used together.
• Lopinavir/Ritonavir or atazanavir/ritonavir: When used in combination, these medications can elevate its exposure. The recommended dose should be limited to 10 mg once daily.
• Coumarin anticoagulants: Combining with coumarin anticoagulants can prolong the international normalized ratio (INR). Achieve a stable INR before initiating treatment and monitor it frequently until it remains stable during therapy.
• Concomitant lipid-lowering therapies: When used with fibrates and niacin products, there may be an increased risk of skeletal muscle effects.

Rozavel 5 mg is contraindicated if- Known hypersensitivity to product components Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels Pregnant women and women who may become pregnant Nursing mothers

Rozavel 5 mg is generally well tolerated. The most frequent adverse events thought to be related to the medicine were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

The safety in pregnant women has not been established. It is not known whether Rozavel 5 mg is excreted in human milk or not.

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rozavel 5 mg can be discontinued if signs or symptoms appear.Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Liver enzymes should be monitored before and during treatment

Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.

Use in children: The safety and effectiveness in pediatric patients have not been established.