Rostab 10

Generic

Rosuvastatin

 

Indications

Heterozygous Hypercholesterolemia (Familial and Non-Familial) Homozygous Hypercholesterolemia (Familial) Mixed Dyslipidemia (Fredrickson Type IIa and IIb) Primary prevention of cardiovascular disease are all indications for rosuvastatin.

 

Pharmacology

HMG-CoA reductase is the rate-limiting enzyme that transforms 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 altering lipid levels. To begin, it boosts the number of hepatic LDL receptors on the cell surface, which improves LDL absorption and degradation. Second, Rosuvastatin decreases the total quantity of VLDL and LDL particles by inhibiting VLDL formation in the liver.

 

Dosage & Administration

5-40 mg once daily is the dosage range. Only use the 40 mg dose if you haven't met your LDL-C goal with the 20 mg HoFH: start with 20 mg/day.

Patients with HeFH in pediatrics should take 5-10 mg per day if they are 8 to less than 10 years old, and 5-20 mg per day if they are 10 to 17 years old.

Patients from 7 to 17 years old who have HoFH should take 20 mg each day.

 

Interaction

The following are notable Rosuvastatin medication interactions: Cyclosporine: When used together, Rosuvastatin exposure is increased. The daily dose of rosuvastatin should be kept to 5 mg.

The combination should be avoided with gemfibrozil. If taken concurrently, the dose of rosuvastatin should be kept at 10 mg once a day.

The combination of coumarin anticoagulants increases the international normalized ratio (INR). Prior to commencing Rosuvastatin, make sure your INR is stable. When starting or stopping Rosuvastatin medication, the INR should be checked often until it is stable.

Concurrent lipid-lowering therapies: Using fibrates and niacin products at the same time may raise the risk of skeletal muscle side effects.

 

Contraindications

Rosuvastatin is contraindicated in the following situations: Known hypersensitivity to product ingredients Liver disease, including unexplained persistent increases in hepatic transaminase levels Pregnant women and women who may become pregnant Nursing mothers.

 

Side Effects

Rosuvastatin is well tolerated by most people. Headache, myalgia, constipation, asthenia, stomach 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 whether it is excreted in human milk.

 

Precautions & Warnings

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): The risk of myopathy and rhabdomyolysis increases with the use of the 40 mg dose, advanced age (>65 years), hypothyroidism, renal impairment, and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, or certain other lipid-lowering drugs. Patients should be encouraged to report any unexplained muscle discomfort, soreness, or weakness as soon as possible. If indications or symptoms arise, rosuvastatin can be stopped.

Abnormalities in liver enzymes and monitoring: Hepatic transaminases might be persistently elevated.

Before and during treatment, liver enzymes should be checked.

 

Therapeutic Class

Statins and other anti-anginal and anti-ischemic medications.

 

Storage Conditions

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

 

Pharmaceutical Name

ACME Laboratories Ltd.