Rosumax 10

Generic

 

Indications

• Heterozygous Hypercholesterolemia is treated with rosuvastatin (Familial and Non familial)
• Hypercholesterolemia Homozygous (Familial)
• Dyslipidemia (Mixed) (Fredrickson Type IIa and IIb)
• Primary cardiovascular disease prevention

 

Pharmacology

HMG-CoA reductase is the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase. Rosuvastatin has two mechanisms for modifying lipid levels. To begin, it boosts the number of hepatic LDL receptors on the cell surface, which improves LDL uptake and catabolism.

 

Dosage & Administration

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: 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.

 

Interaction

The following are notable Rosuvastatin drug interactions: Cyclosporine: When used together, Rosuvastatin exposure is increased. The daily dose of rosuvastatin should be kept to 5 mg.
Combination should be avoided with gemfibrosil. If taken together, the dose of rosuvastatin should be kept to 10 mg once a day.
The combination of lopinavir/ritonavir or atazanavir/ritonavir increases Rosuvastatin exposure.

 

Contraindications

• If you have a known hypersensitivity to any of the product's ingredients, you should avoid taking rosuvastatin.
• Unexplained persistent elevations in hepatic transaminase levels are a sign of liver disease.
• Women who are pregnant or may become pregnant
• Mothers who are breastfeeding

 

Side Effect

Rosuvastatin is well tolerated by most people. Headache, myalgia, constipation, asthenia, abdominal pain, and nausea were the most common side effects linked to Rosuvastatin.

 

Pregnancy & Lactation

The safety of the drug in pregnant women has yet to be determined. Rosuvastatin is not known whether or not it is excreted in human milk.
Warnings and Precautions.

 

Precautions & Warnings

Depending on the severity of the disease, the drug should be used in the smallest amount possible. Patients who are elderly, have renal failure, or have hepatic disorders should be given the drug with caution.

 

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins

 

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children's reach.

 

Pharmaceutical Name