Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2020 Publisher: Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland
To reduce the frequency of moderate to severe attacks of angina pectoris due to coronary artery disease in patients who have not responded to other conventional therapy or in whom such therapy may be contraindicated.
Note: Because of the serious nature of potential side effects, perhexiline maleate should be reserved for use in patients with intractable angina who are refractory or intolerant to other agents and are not suitable candidates for coronary bypass surgery.
Commence therapy with 100 mg daily. Adjust progressively, up or down, at 2 to 4 weekly intervals based on the results of plasma level monitoring. It is generally advised not to administer more than 300 mg per day, in divided doses, but in certain cases it may be necessary to use 400 mg per day. The maintenance dose must be the minimum dose that is effective and well tolerated.
As for adults – see section 4.3 Contraindications.
Not recommended for use in children as safety and efficacy in this age group has not been established.
Plasma perhexiline concentrations should be maintained between 0.15 and 0.60 mcg/mL. Because of perhexiline’s slow and variable clearance, the marked inter-subject variability in metabolism of the medicine and the potential for serious toxicity, regular monitoring of plasma levels of perhexiline is essential commencing at the end of the first week of use.
Dosage should not be increased unless the plasma concentrations are sub-therapeutic and at least two to four weeks have elapsed since commencement, or last increase in dose, of perhexiline. If facilities for determining plasma levels are not available, Pexsig should not be prescribed.
Reported symptoms following overdosage are nausea and vomiting. Other symptoms that have not been reported but would be anticipated are ataxia and headache. Hepatic damage and cardiac arrhythmias may possibly occur.
Treatment should be symptomatic and supportive. Acute perhexiline overdose should result in careful monitoring of drug levels, continuous cardiac monitoring and serial blood glucose recordings in diabetic patients. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. Adequate urinary output should also be maintained.
Dialysis is not indicated because of the high degree of protein and tissue binding.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
Shelf life: 24 months from the date of manufacture when stored below 30°C.
Store in cool dry place below 30°C.
Bottles (glass) containing 100 tablets.
No data available.
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