Rosetor 10mg

Tablet
Rosuvastatin
ACI Pharmaceuticals

Other Strength:
- Rosetor 5mg
- Rosetor 20mg

Alternative:
- Rosutin 10mg
- ROSTAB 10mg
- RosuvaTM 10mg
- Rovast 10mg
- Rosu 10mg
- Cholcut 10mg
- Rosvin 10mg
- Ruvastin 10mg
- Rolip 10mg



Rosetor
Description
Rosetor®is a preparation of Rosuvastatin which is a lipid-lowering agent. It's a selective & competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to Mevalonate, a precursor of sterols, including cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Indications
(a)Hyperlipidemia and Mixed dyslipidemia

Rosetor®is indicated as an adjunctive therapy to diet to reduce elevated Total-C, LDL-C, Apo B, nonHDL-C and TG and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

(b)Hypertriglyceridemia
(c)Primary prevention of cardiovascular disease

In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age 50 years old in men and 60 years old in women, hsCRP 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, Rosetor®is indicated to:

reduce the risk of stroke
reduce the risk of myocardial infarction
reduce the risk of arterialrevascularization procedures

(d)Slowing the progression of atherosclerosis
(e)Primary dysbetalipoproteinemia (Type III hyperlipoproteinemia)
(f)Heterozygous familial hypercholesterolemia (Pediatric patients 10 to 17 years of age)

As an adjunct to dietto reduce Total-C, LDL-C, and Apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with an adequate trial of diet therapy the following findings are present:

–LDL-C remains 190 mg/dL or
–LDL-C remains 160 mg/dL and:
There is a positive family history of premature cardiovascular disease or
Two or more other CVD risk factors are present in the pediatric patient

(g)Homozygous familial hypercholesterolemia

Dosage and administration
The dose range for Rosetor®is 5 to 40 mg orally once daily. The usual starting dose is 5-10 mg. Rosetor®can be administered as a single dose at any time of the day, with or without food. When initiating Rosetor®therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate Rosetor®starting dose first be utilized, and only then titrated according to the patients' response and individualized goals of therapy. After initiation or upon titration of Rosetor®lipid level should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

Specific Populations
Heterozygous familial hypercholes-terolemia in pediatric patients(10 to 17 years of age)
Homozygous familial hypercholes-terolemia
With Cyclosporine therapy
With Lopinavir/ Ritonavir or Atazanavir/ Ritonavir therapy
With mild to moderate renal impairment (CLcr ³ 30 mL/ min/ 1.73 m2)
With severe renal impairment (CLcr < 30 mL/ min/ 1.73 m2) not on hemodialysis

Dose
Usual dose range: 5-20 mg/ day
Maximum recommended dose: 20 mg/ day
Starting dose: 20 mg/ day
Maximum dose: 5 mg/ day
Maximum dose: 10 mg/ day
No dosage adjustment required
Starting dose: 5 mg/ day
Maximum dose: 10 mg/ day

Patients with hepatic impairment:Rosuvastatin is contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. Chronic alcohol liver disease is known to increase Rosuvastatin exposure. Rosuvastatin should be used with caution in these patients.

Geriatric Use:No overall differences in safety or effectiveness wereobserved between elderly and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out. Since advanced age is a predisposing factor for myopathy, Rosuvastatin should be prescribed with caution in the elderly.

Children and adolescents: Safety and effectiveness in patients 10-17 years of age with heterozygous familial hypercholesterolemia have been evaluated in a controlled clinical trial of 12 weeks duration followed by 40 weeks of open-label exposure. Patients treated with Rosuvastatin had an adverse experience profile generally similar to that of patients treated with placebo. There was no detectable effect of Rosuvastatin on growth, weight, BMI, or sexual maturation. Doses greater than 20 mg have not been studied in this patient population. Rosuvastatin has not been studied in controlled clinical trials involving pre-pubertal patients or patients younger than 10 years of age.

Use in pregnancy and lactation
Pregnancy Category X. Rosuvastatin is contraindicated in women who are or may become pregnant. It is not known whether Rosuvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Statins have a potential to cause serious adverse reactions in nursing infants, women requiring Rosuvastatin treatment should be advised not to nurse their infants.

Side effects
The most commonly reported adverse reactions in patients treated with Rosuvastatin in placebo-controlled trials were: headache, myalgia, abdominal pain, asthenia and nausea.

Contraindications
Rosuvastatin is contraindicated in patients who are hypersensitive to any component of this product or to any of its ingredients. It is also contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.

Precautions
Caution should be exercised when anticoagulants are given in conjunction with Rosuvastatin. It should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. This drug should be prescribed with caution in patients with predisposing factors for myopathy (e.g.,age 65 years, inadequately treated hypothyroidism, renal impairment).

Drug interactions
Concomitant use of Rosuvastatin with some drugs like Cyclosporine, Gemfibrozil and other lipid-lowering products, protease inhibitors and Itrakonazole may be resulted in increased AUC. However, no clinically relevant interactions have been observed between Rosuvastatin and either Fluconazole or Ketoconazole. On the contrary, concomitant use of Rosuvastatin with Antacid or Erythromycin results in decreased AUC. Adverse effects caused by simultaneous use of Rosuvastatin and Ezetimibe cannot be ruled out. As with other HMG-CoA reductase inhibitors, the initiation of treatment or dosage up-titration of Rosuvastatin in patients treated concomitantly with vitamin K antagonists (e.g. warfarin or another coumarin anticoagulant) may result in an increase in International Normalised Ratio (INR). Discontinuation or down-titration of Rosuvastatin may result in a decrease in INR. In such situations, appropriate monitoring of INR is desirable.

Over dosage
There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function and Creatine Kinase levels should be monitored. Haemodialysis is unlikely to be of benefit.

Pharmaceutical precautions
Store in a cool and dry place. Protect from light.

Presentation
Rosetor®5 tablet: Each coated tablet contains Rosuvastatin 5 mg as Calcium INN.
Rosetor®10 tablet: Each coated tablet contains Rosuvastatin 10 mg as Calcium INN.

Package quantities
Rosetor®5 tablet: Carton of 30 tablets in blister pack.
Rosetor®10 tablet: Carton of 20 tablets in blister pack.

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