Varostin

VAROSTIN 10 mg: Each film-coated tablet contains: Rosuvastatin (as Calcium) 10 mg.
VAROSTIN 20 mg: Each film-coated tablet contains: Rosuvastatin (as Calcium) 20 mg.

HMG CoA Reductase Inhibitor.
Pharmacology: Pharmacokinetics: Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol. It also lowers ApoB, nonHDL-C, VLDL-TG and increases ApoA-L. Rosuvastatin also lowers the LDL-C/HDL-C, total C/HDL-C and nonHDL-C/HDL-C and the ApoB/ApoA-I ratios.
A therapeutic effect is obtained within 1 week following treatment initiation and 90% of maximum response is achieved in 2 weeks. The maximum response is usually achieved by 4 weeks and is maintained after that.

Treatment of hypercholesterolemia: Adults, adolescent and children aged 10 years or older with primary hypercholesterolemia (type II A including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type II B) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Homozygous familial hypercholesterolemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatment is not appropriate.
Prevention of Cardiovascular Events: Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular events as an adjunct to correction of other risk factors.

The dose of this medicine will be different for different patients. Follow the doctor's orders or the directions on the label. The following information include only the average dose of this medicine. If the dose is different, do not change it unless the doctors tell to do so.
For atherosclerosis: Adults: 5 to 40 milligrams (mg) once a day.
Children: Use and dose must be determined by the doctor.
For heterozygous familial hypercholesterolemia: Adults: 5 to 40 milligrams (mg) once a day.
Children 10 to 17 years of age: 5 to 20 mg per day.
Children 8 to 9 years of age: 5 to 10 mg per day.
Children younger than 8 years of age: Use and dose must be determined by the doctor.
For homozygous familial hypercholesterolemia: Adults: At first, 20 milligrams (mg) once a day. The doctor may adjust the dose as needed.
Children 7 to 17 years of age: 20 mg once a day.
Children younger than 7 years of age: Use and dose must be determined by the doctor.
Missed Dose: If the patient misses a dose of this medicine, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.
However, do not take 2 doses of this medicine within 12 hours of each other.

There is no specific treatment in the event of overdosage. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored. Hemodialysis is unlikely to be of benefit.

It is contraindicated in patient with hypersensitivity to Rosuvastatin or to any of the excipients, in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN), in patient with severe renal impairment (creatinine clearance < 30 ml/min), in patients with myopathy, in patients receiving concomitant cyclosporin, it is also contraindicated during pregnancy and lactation and in women of childbearing potential not using  appropriate contraceptive measures.

Renal Effects: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with higher doses of Rosuvastatin, in particular 40 mg, where it was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. The reporting rate for serious renal events in post-marketing use is higher at the 40 mg dose. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg.
Skeletal Muscle Effects: Effects on skeletal muscle e.g. myalgia, myopathy and, rarely, rhabdomyolysis have been reported in Rosuvastatin-treated patients with all doses and in particular with doses > 20 mg. Very rare cases of rhabdomyolysis have been reported with the use of ezetimibe in combination with HMG CoA reductase inhibitors. A pharmacodynamic interaction cannot be excluded and caution should be exercised with their combined use.
Creatinine Kinase Measurement: Creatinine Kinase (CK) should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase which may be confound interpretation of the result. If CK levels are significantly elevated at baseline (>5 x ULN) a confirmatory test should be carried out within 5-7 days. If the repeat test confirms a baseline CK >5 x ULN, treatment should not be started.
Race: Pharmacokinetic studies show an increase in exposure in Asian subject with Caucasians.
Protease Inhibitors: The concomitant use with protease inhibitors is not recommended. Lactose intolerance patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.
Interstitial Lung Disease: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy. Presenting features can include dyspnea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Diabetes Mellitus: In patients with fasting glucose 5.6 to 6.9 mmol/L, treatment with Rosuvastatin has been associated with an increased risk of diabetes mellitus.

Most frequent adverse reactions are headache, myalgia, abdominal pain, asthenia, and nausea.

Store at temperatures not exceeding 30°C.
Keep away from direct heat and sunlight exposure.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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