Source: Web Search Publisher: Pharmacia South Africa (Pty) Limited, 85 Bute Lane, Sandton, 2196, South Africa
ASPAVOR is indicated as an adjunct to diet for reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein-B, and triglyceride levels in patients with primary hypercholesterolaemia; mixed dyslipidaemia; and heterozygous familial hypercholesterolaemia.
ASPAVORis also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Therapy with lipid-lowering agents should be a component of multiple-risk-factor intervention in individuals at increased risk of atherosclerotic vascular disease due to hypercholesterolaemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other non-pharmacological measures has been inadequate.
Prior to initiating therapy with ASPAVOR, secondary causes for hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total-C, LDL-C, HDL-C, and TG.
The patient should be placed on a standard cholesterol-lowering diet before receiving ASPAVOR and should continue on this diet during treatment with ASPAVOR.
The usual starting dose is 10 mg once a day. Doses should be individualised according to the baseline LDL-C levels, the goal of therapy, and patient response. Adjustment of dosage should only be made after an interval of 4 weeks or more. The maximum recommended dose is 40 mg once a day. Doses may be given at any time of day with or without food.
The majority of patients are controlled with 10 mg ASPAVOR once a day. A therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 4 weeks. The response is maintained during chronic therapy.
Patients should be started with ASPAVOR 10 mg daily. Doses should be individualised and adjusted every 4 weeks to 40 mg daily. Thereafter, a bile acid sequestrant (e.g. colestipol) may be combined with 40 mg ASPAVOR.
In a compassionate-use, uncontrolled study of 29 patients with homozygous familial hypercholesterolaemia, most patients responded to a dose of 80 mg of ASPAVOR, with a mean reduction in LDL-C of 20% (range 7% - 53%), although in some patients an increase of LDL-C occurred.
Treatment experience in the homozygous familial hypercholesterolaemia paediatric population with ASPAVOR is limited.
Renal disease has no influence on the plasma concentrations or lipid effects of ASPAVOR; thus, no adjustment of dose is required.
In patients with moderate to severe hepatic dysfunction, the therapeutic response to ASPAVOR is unaffected but serum levels of the drug are greatly increased. In patients with chronic alcoholicliver disease, plasma concentrations of atorvastatin are markedly increased. Cmax and AUC are each 4-fold greater in patients with Child-Pugh A disease. Cmax and AUC are approximately 16-fold and 11-fold increased, respectively, in patients with Child-Pugh B disease. Therefore, caution with dosage should be exercised in patients who consume substantial quantities of alcohol and/or have a history of liver disease (See CONTRA-INDICATIONS and WARNINGS).
There is nospecific treatment for atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
Store in a cool (below 25°C), dry place.
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
Silver colouredpolyamide/aluminium foil/PVC blister (foil blister) that are packed in an outer cardboard carton with a package insert. ASPAVOR tablets are available in pack sizes of 28, 30, 56, 60, 84, 90, 100 or 500 tablets.
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