ROSUVOR FILM COATED TABLET 20MG [SIN16836P]

Product Info

ROSUVOR FILM COATED TABLET 20MG

[SIN16836P]

INDICATION:
Rosuvastatin is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type Ila, lIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate.
Rosuvastatin is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyperlipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate.
Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines.
Rosuvastatin also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-l ratios and increases ApoA-l.
Rosuvastatin is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis).
Primary prevention of cardiovascular disease: Rosuvastatin is indicated 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, Rosuvastatin is indicated to:

• reduce the risk of stroke

• reduce the risk of myocardial infarction

• reduce the risk of arterial revascularization procedures

RECOMMENDED DOSE
The dosage of Rosuvastatin should be individualised according to the goal of therapy and patient response. The recommended start dose is 5 or 10 mg once daily in both statin naive patients or patients switched from another HMG CoA reductase inhibitor. The choice of starting dose should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. A dose adjustment to the next dose level can be made after 4–6 weeks, if necessary. Increasing the dose to 40 mg should be reserved for patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg and should only be initiated under close specialist supervision. The physician who elects to use Rosuvastatin at doses higher than 20 mg should periodically re-evaluate the long-term risk/benefit of Rosuvastatin for the individual patient. Rosuvastatin should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis (see “Warning and Precautions” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Asian population
Increased plasma concentration of rosuvastatin has been observed in Asian subjects including subjects of Japanese, Chinese, Malay and Indian ancestry (See "Warnings and Precautions" & "Pharmacokinetics Properties" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.). Increased systemic exposure, which is considered a pre-disposing factor for myopathy, should be taken into consideration when making dose decisions for Asian patients. Initiation of Rosuvastatin therapy with 5 mg once daily should be considered for Asian patients. This should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. Doses exceeding 20 mg are not generally recommended and should only be considered for patients with high cardiovascular risk whose hypercholesterolaemia is not controlled with doses up to 20mg. In rare cases where Rosuvastatin at doses higher than 20mg is indicated, initiation of therapy should be under close specialist supervision. The physician who elects to use Rosuvastatin at doses higher than 20 mg should periodically re-evaluate the long-term risk/benefit of Rosuvastatin for the individual patient.

Use in the elderly
No dose adjustment is necessary.

Dosage in patients with renal insufficiency
No dose adjustment is necessary in patients with mild to moderate renal impairment.
The use of Rosuvastatin in patients with severe renal impairment is contraindicated.

Dosage in patients with hepatic insufficiency
The usual dose range applies in patients with mild hepatic impairment [Child-Pugh scores of ≤ 7].
Increased systemic exposure to rosuvastatin has been observed in patients with moderate hepatic impairment [Child-Pugh scores of 8 or 9]. There is no experience in patients with severe hepatic impairment. Rosuvastatin is contraindicated in patients with active liver disease. (see “Pharmacokinetic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Genetic polymorphisms
Genotypes of SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA have been shown to be associated with an increase in rosuvastatin exposure (AUC) compared to SLCO1B1 c.521TT and ABCG2 c.421CC. For patients known to have the c.521CC or c.421AA genotype, a maximum once daily dose of 20 mg of Rosuvastatin is recommended.

Concomitant therapy
Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Rosuvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. cyclosporin, ticagrelor and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Rosuvastatin. Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing Rosuvastatin therapy. In situations where co-administration of these medicinal products with Rosuvastatin is unavoidable, the benefit and the risk of concurrent treatment and Rosuvastatin dosing adjustments should be carefully considered.

CONTRAINDICATION
Rosuvastatin is contraindicated:

• in patients with hypersensitivity to any component of this product.

• in patients with active liver disease or unexplained, persistent elevations of serum transaminases.

• in patients receiving concomitant cyclosporin.

• in patients with severe renal impairment (creatinine clearance < 30 ml/min).