LESCOL XL 28TAB; fluvastatin, cardiovascular agents .
ACTIVE-INGREDIENT OF LESCOL XL 28TAB
Each prolonged release tablet contains: 84.24 mg fluvastatin sodium which corresponds to 80 mg Fluvastatin free acid.
INDICATION OF LESCOL XL 28TAB
Dyslipidaemia: Adults: Reduction of elevated levels of total cholesterol, LDL cholesterol, apolipoprotein B and tri-glycerides, and increase in HDL cholesterol, in adults with primary hypercholesterolemia and primary mixed dyslipidaemia (Fredrickson types IIa and IIb) in whome dietry measures have proved insufficiently effective. Children and adolescents: Reduction of elevated levels of total cholesterol, LDL cholesterol, apolipoprotein B and tri-glycerides, and increase in HDL cholesterol, in boys (9 to 16 years of age) and postmenarchal girls (10 to 16 years of age) with heterozygous familial hypercholesterolaemia, in whom dietry measures have proved insufficiently effective. Other indications: To reduce the need for additional coronary revascularisation procedures in adults with coronary heart disease.
DOSAGE OF LESCOL XL 28TAB
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 : –
Lescol XL may be taken as a single dose at any time of the day. Lescol XL tablets must be swallowed whole with a glass of water, but may be taken with or without food. Usual dosage recommendations: Adults: Prior to initiating treatment, the patient should be placed on a cholesterol-lowering diet, which should be continued during treatment. The recommended dose is 20 mg/day, 40 mg/day , or 80 mg/day (1 Lescol XL prolonged release tablet). The starting dose should be individualised according to baseline LDL cholesterol (LDL-C) and the therapeutic goal. The appropriate dose following precutaneous coronary intervention in patients with coronary heart disease is 80 mg/day. The maximum lipid-lowering effect with a give dose is achieved within 4 weeks. Doses should be adjusted according to the patient’s response, with dose adjustments made at intervals of 4 weeks or more. The therapeutic effect of Lescol is maintained with long-term administration. Lescol is efficacious in monotherapy. Studies have demonstrated the efficacy and tolerability of fluvastatin in combination with nicotinic acid, colestyramine or fibrates. Patients should, however, be monitored closely due to the risk of myopathy. Special dosage recommendations: Dosage recommendations: Dosage in children and adolescents with heterozygous familial hypercholesterolaemia boys (9 to 16 years of age). Postmenarchal girls (10 to 16 years of age): Prior ro initiating treatment, the patient should be placed on a cholesterol-lowering diet for 6 months, which should be continued during treatment. The starting dose should be individualised according to baseline LDL cholesterol (LDL-C) and the therapeutic goal. In clinical studies, a starting dose of 20 mg/day was administered. The recommended dose is 20 mg/day, mg/day or 80 mg/day (1 Lescol XL prolonged release tablet). The use of fluvastatin in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents has been investigated. Renal impairment: Fluvastatin in cleared almost exclusively by the liver, with only about 6% of the administered dose excreted into the urine. The pharmacokinetics of fluvastatin remain unchanged in patients with mild to severe renal insufficiency. No dose adjustments are therefore necessary in these patients. Hepatic impairment: Lescol is contraindicated in patients with active liver disease, or unexplained, persistent elevations in serum transaminases. Elderly patients: In clinical studies, the efficacy and tolerability of Lescol were demonstrated in patients both above and below 65 years of age. Response to treatment tended to be enhanced in elderly patients (> 65 years), but with no reduction in tolerability. Dose adjustment is therefore not necessary.
OVER-DOSAGE OF LESCOL XL 28TAB
In a placebo-controlled study including 40 hypercholesterolaemic patients, doses of up to 320 mg/day (n= 7 per dose group) administered as Lescol XL ( 80 mg prolonged release tablets) over two weeks were well tolerated. No specific recommendations can be made regarding the management of overdose. Should an overdose occur, it should be treated symptomatically and necessary suporting measures should be taken. Liver function tests and serum CK levels should be monitored.
CONTRA-INDICATION OF LESCOL XL 28TAB
Known hypersensitivity to fluvastatin or any of the excipients. Active liver disease or persistent, unexplained elevation of serum transaminase levels. Pregnancy and breast-feeding.
STORAGE OF LESCOL XL 28TAB
Do not store above 30 °C. Keep out of the reach of children.
PACK OF LESCOL XL 28TAB
Box of 2 strips each of 14 tablets.
LESCOL XL 28TAB MANUFACTURED BY
Novartis Pharma AG, Basle, Switzerland.