Source: Marketing Authorisation Holder Revision Year: 2020 Publisher: Activo Health (Pty) Ltd. Block B, Arena Office Park, 272 West Avenue, Centurion, 0157
LESTAVOR is indicated, in combination with diet, to decrease elevated total cholesterol, LDL-cholesterol, apolipoprotein-B and triglyceride levels in patients with:
LESTAVOR is 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 not available. 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.
Secondary causes for hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, nephrotic syndrome, hypothyroidism, obstructive liver disease, dysproteinaemias, alcoholism and therapy with other medicines) should be excluded prior to initiating therapy with LESTAVOR, and a lipid profile performed to measure total-C, LDLC, HDL-C and triglycerides.
The patient must follow a cholesterol-lowering diet before initiation of, and while on LESTAVOR therapy.
LESTAVOR can be taken at any time of the day with meals or on an empty stomach.
LESTAVOR should not be taken with grapefruit juice.
Heterozygous familial hypercholesterolaemia and mixed dyslipidaemia
The usual starting dose is 10 mg of LESTAVOR daily. The dose may be adjusted at intervals of 4 weeks up to a maximum of 80 mg daily.
Children: Treatment experience in the paediatric population is limited.
10 to 80 mg LESTAVOR once per day. LESTAVOR should be used in these patients as an adjunct to other lipidlowering treatments such as LDL apheresis, or if such treatments are unavailable.
The usual dose is 10 mg LESTAVOR once per day.
Dosage adjustment in patients with renal dysfunction is not necessary because renal disease does not affect the plasma concentrations nor LDL-C reduction (however, see WARNINGS).
In patients with moderate to severe hepatic dysfunction, the therapeutic response to LESTAVOR is unaffected, but serum levels of the medicine are significantly increased. In patients with chronic alcoholic liver disease, plasma concentrations of atorvastatin are markedly increased. Both Cmax and AUC are 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 dosing should be exercised in patients who take substantial quantities of alcohol and/or have a history of liver disease (see CONTRA-INDICATIONS and WARNINGS).
General measures should be adopted and liver function should be monitored. Treatment is symptomatic and supportive. Haemodialysis is not expected to significantly increase atorvastatin (as in LESTAVOR) clearance, due to extensive plasma protein binding.
Store in the original packaging (in the carton) at or below 30°C.
KEEP OUT OF REACH OF CHILDREN.
Packs of 28 (4 blisters of 7 tablets) or 30 (3 blisters of 10 tablets) film-coated tablets packed in Aluminium/Aluminium blister strips in a cardboard carton. Not all pack sizes are necessarily marketed.
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