Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Gauteng, 1601
VASTOR 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.
VASTOR 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 aphaeresis) or if such treatments are unavailable.
Therapy with lipid-lowering medicines should be a component of multiple-risk-factor intervention in individuals at increased risk of atherosclerotic vascular disease due to hypercholesterolaemia. Lipid-altering medicines 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 VASTOR, 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 majority of patients are controlled with 10 mg VASTOR 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 VASTOR 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 VASTOR.
In a compassionate-use, uncontrolled study of 29 patients with homozygous familial hypercholesterolaemia, most patients responded to a dose of 80 mg of VASTOR, with a mean reduction in LDL-C of 20% (range 7% - 53%), although in some patients an increase of LDL-C occurred.
Renal disease has no influence on the plasma concentrations or lipid effects of VASTOR; therefore, no dosage adjustment is necessary (see section 4.4).
In patients with moderate to severe hepatic dysfunction, the therapeutic response to VASTOR 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 approximately 16-fold and 11-fold increased, respectively, in patients with Child-Pugh B disease.
Caution with dosage should be exercised in patients who consume substantial quantities of alcohol and/or have a history of liver disease (see section 4.3 and 4.4).
Treatment experience in the homozygous familial hypercholesterolaemia paediatric population with VASTOR is limited.
For oral use.
In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).
There is no specific treatment for VASTOR overdosage.
In the event of overdosage, the patient should be treated symptomatically, and supportive measures instituted as required.
Due to extensive binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
36 months.
Store in a cool and dry place at or below 25ºC.
The HDPE bottles must be kept tightly closed.
Do not remove blisters from carton until required for use.
HDPE bottle pack (without stabilox):
High-density polyethylene (HDPE) bottle pack comprises of white opaque HDPE bottle provided along with a polypropylene (PP) screw cap.
The HDPE bottle is placed in a carton (excl. Tender).
Pack sizes: 28’s, 30’s, 90’s and 500’s.
HDPE bottle pack (with activated carbon):
High-density polyethylene (HDPE) bottle pack comprises of white opaque HDPE bottle with desiccant (activated Carbon Minipax) sachet provided with a polypropylene (PP) screw cap.
The HDPE bottle is placed in a carton (exc. Tender).
Pack sizes: 28’s, 30’s 90’s and 500’s.
Cold Form Blister Pack:
Cold form blister pack (marketable pack) comprises of cold form laminate on one side [aluminium foil laminated to oriented polyamide on one side and laminated to PVC on other side, (i.e. OPA/AI/PVC)] and hard tempered aluminium foil coated with heat seal lacquer on the other side.
The blisters are placed in a carton. 7 or 10 tablets per blister strip packed as 28’s or 30’s.
PVC/Aclar Blister Pack:
PVC/Aclar blister pack comprises of clear, transparent, PVC laminated with Aclar on one side and hard tempered aluminium foil coated with VMCH heat seal lacquer on the other side.
The blisters are placed in a carton. 7, 10 or 15 tablets per blister strip packed as 28’s or 30’s.
Not all packs may be marketed.
No special requirements.
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