Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Unicorn Pharmaceuticals (Pty) Ltd, Corner Searle & Pontac Streets, Cape Town, 8000 enquires@unicornpharma.co.za
DEZZOLIP is indicated:
DEZZOLIP is indicated as an adjunct to diet to reduce total-C, LDL-C, and apolipoprotein B levels in boys and postmenarchal girls between 10 to 17 years old, with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present:
In patients without clinically evident cardiovascular disease, and with or without dyslipidaemia, but with multiple risk factors for coronary heart disease, DEZZOLIP is indicated to reduce the risk of ischaemic cardiovascular and cerebrovascular diseases.
DEZZOLIP is indicated in the prevention of cardiovascular events in patients with clinically evident coronary heart disease and increased cholesterol levels.
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 DEZZOLIP, secondary causes for hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other medicine 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 DEZZOLIP and should continue on this diet during treatment with DEZZOLIP.
The usual starting dose is 10 mg once a day and should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum recommended dose will depend on the indication (see below). Doses may be given any time of the day with or without food.
The majority of patients are controlled with 10 mg DEZZOLIP once a day. A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The response is maintained during chronic therapy.
Patients should be started with 10 mg DEZZOLIP daily, the maximum recommended dose is 20 mg/day.
In a compassionate-use, uncontrolled study of patients with homozygous familial hypercholesterolaemia most patients responded to a dose of 80 mg of DEZZOLIP, with a greater than 15% reduction in LDL-C (18%-45%).
The dosage range is 10 to 80 mg once daily.
Renal disease has no influence on the plasma concentrations or on the lipid effects of DEZZOLIP; thus, no adjustment of dose is required.
In patients with moderate to severe hepatic dysfunction, the therapeutic response to DEZZOLIP is unaffected but serum levels of the medicine are greatly increased. In patients with chronic alcoholic liver 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 each 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 4.3 and 4.4).
There is no specific treatment available for DEZZOLIP overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
2 years.
Store at or below 25°C. Protect from moisture. Keep the blisters in the outer carton until required for use.
DEZZOLIP 10/20/40/80:
Pack size: 28 tablets or 30 tablets.
Tablets are packed in Alu-Alu blister composed of silver opaque Alu-Alu cold form laminate & silver opaque Aluminium foil. Each blister strip contains 7 tablets or 10 tablets. Four blister strips of 7’s or three blister strips of 10’s are packed in an outer carton.
No special requirements.
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