CHOLEROSE 10 MG 21 TAB; rosuvastatin, cardiovascular agents .
ACTIVE-INGREDIENT OF CHOLEROSE 10 MG 21 TAB
Each tablet contains: 10.4 mg rosuvastatin calcium (eq. to rosuvastatin 10 mg).
INDICATION OF CHOLEROSE 10 MG 21 TAB
Treatment of hypercholesterolaemia. Adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia (type Iia including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. LDL apheresis) or if such treatments are 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 event, as an adjunct to correction of other risk factors.
DOSAGE OF CHOLEROSE 10 MG 21 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Before treatment initiation the patient should be placed on a standard cholesterol-loweing diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidlines. Cholerose may be given at any time of day, with or without food. Treatment of hypercholesterolaemia: The recommended start dose is 5 or 10 mg orally once daily in both statin native or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk of adverse reactions. A dose adjustment to the next dose level can be made after 4 weeks, if necessary. In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses, a final titration to the maximum dose of 40 mg should only be considered in 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 in whom routine follow-up will be performed. Specialist supervision is recommended when the 40 mg dose is initiated. Prevention of cardiovascular events. In the cardiovascular events risk reduction study, the dose used was 20 mg daily. Pediatric population: Pediatric use should only be carried out by specialists. Children and adolescents 10 to 17 years of age (boys tanner stage II and asbove, and girls who are at least 1 year post-menarche). In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily. The usual dose range is 5-20 mg orally once daily. Titration should be conducted according to the individual response and tolerability in pediatric patients , as recommended by the pediatric treatment recommendations. children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment inintiation; this diet should be continued during rosuvastatin treatment. Saftey and effiicacy of doses greater than 20 mg have not been studied in this population. The 40 mg tablet is not suitable for use in pediatric patients. Children younger than 10 years: Eperience in children younger than 10 years is limited to a small number of children (aged between 8 and 10 years) with homozygous familial hypercholesterolaemia. Therefore, cholerose is not recommended for use in children younger than 10 years. Use in the elderly: A start dose of 5 mg is recommended in patients > 70 years. No other dose adjustment is necessary in relation to age. Dosage in patients with renal insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment. The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance of OVER-DOSAGE OF CHOLEROSE 10 MG 21 TAB
There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomitically and supportive measures instituated as required. Liver function and Ck levels should be monitored. Haemodialysis is unlikely to be of benefit.
CONTRA-INDICATION OF CHOLEROSE 10 MG 21 TAB
Cholerose is contraindicated: In patients with hypersensitivity to rosuvastatin or 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 patients with severe renal impairment (creatinine clearance STORAGE OF CHOLEROSE 10 MG 21 TAB
Store at temperature not exceeding 30 °C, in dry place.
PACK OF CHOLEROSE 10 MG 21 TAB
Carton box containing 3 (Al/white opaque PVC) each of 7 tablets + insert leaflet.
CHOLEROSE 10 MG 21 TAB MANUFACTURED BY
Macryl Pharmaceutical Industries El Obour City – Egypt