Rocovas 5

Generic

Rosuvastatin

 

Indications

Rosuvastatin is a statin drug that is recommended by doctors.

• Hypercholesterolemia Heterozygous is a term that refers to a person who is (Familial and Non familial)
• In a homozygous condition, hypercholesterolemia occurs (Familial)
• Dyslipidemia caused by a mixture of lipids (Fredrickson Type IIa and IIb)
• Preventing cardiovascular disease in the first place

 

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 amount of hepatic LDL receptors on the cell surface, which improves LDL absorption and degradation. Second, Rosuvastatin lowers the overall amount of VLDL and LDL particles by inhibiting VLDL production in the liver.

 

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.

Rosuvastatin can be taken with or without food, at any time of day.

 

Interaction

Before starting niacin treatment, try to control hyperlipidemia through proper diet, exercise, and weight reduction in obese patients, and treat other potential medical problems. Patients with a history of jaundice, hepatobiliary disease, or peptic ulcer should be closely observed during niacin treatment. Liver function tests and blood sugar should be monitored frequently to ensure that the drug does not adversely affect these organ systems. Diabetes patients may experience increased dose-related glucose intolerance, the clinical significance of which is unclear. Patients with diabetes or potential diabetes should be closely monitored. May need to adjust diet and/or hypoglycemic therapy.

Caution should also be exercised when using niacin in patients with unstable angina or acute MI, especially when these patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blockers. Niacin treatment can cause uric acid levels to rise, so it should be used with caution in patients prone to gout. Niacin was associated with a small but statistically significant dose-related decrease in platelet count and increase in prothrombin time. Caution should be exercised when niacin is administered with anticoagulants; the prothrombin time and platelet count of these patients should be closely monitored. Niacin is associated with a small but statistically significant dose-related reduction in phosphorus levels (an average reduction of 13% at 2000 mg). Therefore, phosphorus levels in high-risk patients should be monitored regularly.

 

Contraindications

If you have a known hypersensitivity to any of the product's ingredients, you should avoid taking rosuvastatin.

• Unexplained chronic increases in hepatic transaminase values are a sign of liver illness.
• 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, stomach discomfort, 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

Effects on skeletal muscle (e.g., myopathy and rhabdomyolysis): Usage of the 40 mg dosage, advanced age (>65 years), hypothyroidism, renal impairment, and use of cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, or some other lipid-lowering medications all enhance the risks. Patients should be encouraged to report any unexplained muscular discomfort, soreness, or weakness as soon as possible. If indications or symptoms occur, rosuvastatin can be stopped.

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

Before and throughout therapy, liver enzymes should be checked.

 

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins

 

Storage Conditions

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

 

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.