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Rolip (Rosuvastatin)

Tablets

Description

Rosuvastatin Calcium, a synthetic lipid-lowering agent, is an inhibitor of HMG-CoA reductase.

Composition

Rolip 5mg Tablets: Each film coated tablet contains Rosuvastatin (as Rosuvastatin calcium)  ……… 5mg.
Rolip 10mg Tablets: Each film coated tablet contains Rosuvastatin (as Rosuvastatin calcium)…… 10mg.
Rolip 20mg Tablets: Each film coated tablet contains Rosuvastatin (as Rosuvastatin calcium) …… 20mg.

Pharmacology: Mode of action

Rolip (Rosuvastatin), a competitive selective inhibitor of HMG-CoA reductase (the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol), increases the number of hepatic LDL receptors thus increasing catabolism of LDL.It also prevents hepatic synthesis of VLDL. As a result, It decreases total cholesterol, LDL-C, ApoB, and nonHDL-C, and TG,and increases HDL-C

Indications and usage

Indications of Rosuvastatin Calcium Tablets are as follows: Elevated total-Cholesterol,LDL-C, ApoB, and nonHDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Type lla and Hb), as an adjunct to diet. • Elevated serum TG levels (Fredrickson Type IV), as an adjunct to diet. . Homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Contraindications

: Rosuvastatin Calcium tablets are contraindicated in: 
• Patients with a known hypersensitivity to any component of this product. 
• Patients with active liver disease or with unexplained persistent elevations of serum transaminases.
 • Pregnant women: Rosuvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued immediately.
 • Nursing mothers.

Side Effects

Rosuvastatin is generally well tolerated. Side effects reported are mild and transient. Frequent reports are myalgia, constipation, asthenia, abdominal pain, and nausea. Less frequent are UTI, Sinusitis, Flu syndrome. Pharyngitis, Headache, Dyspepsia, Nausea, Asthenia, Back Pain and Rhinitis.

Precautions

elevated transaminases /Abnormal Hepatic Function, Myopathy / Rhabdomyolysis, Carcinogenesis, Mutagenesis, Impairment of Fertility.

Pregnancy

There are no adequate and well-controlled studies of Rosuvastatin in pregnant women. Hence it is contraindicated in women who are or may become pregnant.

Nursing mothers

It is not known whether Rosuvastatin is excreted in human milk. Hence administration of Rosuvastatin in nursing mothers should be taken on the basis of risk against benefit.

Use in children

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

Use in old age

The efficacy of Rosuvastatin in patients • 65 years of age is comparable to the efficacy observed in the nonelderly.

Overdose

 There is no specific treatment in the event or overdose. In the event of overdose the patient should be treated symptomatically and supportive measures instituted as required like maintenance of airways, monitoring of vital signs etc. Hemodialysis does not significantly enhance clearance of  Rosuvastatin.

Drug interactions 

Co-administration of Rosuvastatin and cyclosporine causes no significant changes in cyclosporine plasma concentrations. However, Cmax and AUC of Rosuvastatin increase 11 and 7 times, respectively.These increases are clinically insignificant. Rosuvastatin does not change warfarin plasma concentrations but increases the International Normalized Ratio (INR). Administration of Ketoconazole,Itraconazole, Fluconazole, Erythromycin. Gemfibrozil, Digoxin, and Fenofibrate do alter Cmax and AUC but these changes are not significant clinically. Co-administered Rosuvastatin increases the plasma concentrations of ethinyl estradiol and norgestrel by 26% and 34%, respectively. 
Co-administration of an antacid (aluminum and magnesium hydroxide combination) reduces plasma concentrations of Rosuvastatin by 54%. However, when given 2 hours after Rosuvastatin, it causes no clinically significant changes in plasma concentrations of Rosuvastatin.

Dosage and administration

 A standard cholesterol-lowering diet should be started before starting Rosuvastatin and continued during treatment. 
Rosuvastatin can be administered as a single dose irrespective of time and food. Dosage of Rosuvastatin should be adjusted as per the following table:
Rolip dose 
In Heterozygous Familial and Nonfamilial Hypercholesterolemia and Mixed Dyslipidemia (Fredrickson Type lla and Ilb)*
 For patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy,
5-10 mg once daily
For patients with marked hypercholesterolemia (LDL-C> 190 mg/dl) and aggressive lipid targets20 mg once daily
For the patients who do not achieve the target LDL-C with ROSUVASTATIN 20mg40 mg once daily
In Homozygous Familial Hypercholesterolemia **
Starting dose    20 mg once daily
Maximum dose40 mg once daily
Combined with other drugs
Combined with Cyclosporine5 mg once daily
Combined with Gemfibrozil10 mg once daily
In Renal Dysfunction***
Severe5-10 mg once daily
• Dose of Rosuvastatin should be re-adjusted after analyzing lipid levels in 2 to 4 weeks.
 • Rosuvastatin can be combined with other lipid-lowering treatments or used alone. Dose of Rosuvastatin should be titrated according to the response to therapy. .
 • In mild to moderate renal dysfunction, it is not necessary to modify the dose of Rosuvastatin 

Storage:

 Store in a cool, dry place and protect from sunlight. Keep away from the reach of children. Presentations: Rolip 5mg Tablets :Pack of 10’s. Rolip 10mg Tablets :Pack of 10’s. Rolip 20mg Tablets :Pack of 10’S.
Manufactured by: Hilton Pharma (Pvt.) Ltd.

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