Source: Health Products Regulatory Authority (ZA) Revision Year: 2017 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
BETADEXAMINE is indicated as a second-line therapy when antihistamines are not effective for the treatment of:
Dosage should be individualised and adjusted according to the condition under treatment and the response obtained.
BETADEXAMINE is only to be used for short-term treatment (less than 5 days).
BETADEXAMINE should only be used for well-defined indications.
BETADEXAMINE should not be mixed with other mixtures.
Recommended initial dose: Take 5 ml to 10 ml four times daily, after meals and at bedtime.
The dose should not exceed 40 ml daily.
The dose should be tapered off and discontinued as improvement occurs.
Treatment should not exceed 5 days.
The course should not be repeated within 28 days unless specifically indicated by a medical practitioner.
Not for use in children under 12 years of age.
Shake bottle before use.
(see SIDE EFFECTS).
Overdosage with sedating antihistamines is associated with antimuscarinic, extrapyramidal, and CNS effects. When CNS stimulation predominates over CNS depression, which is more likely in children or the elderly, it causes ataxia, excitement, tremors, psychoses, hallucinations, and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. In adults, CNS depression is more common with drowsiness, coma, and convulsions, progressing to respiratory failure and cardiovascular collapse.
Treatment is symptomatic and supportive.
Store at or below 25°C, in well-closed containers.
Protect from light.
Keep in original package until required for use.
KEEP OUT OF REACH OF CHILDREN.
100 ml round, amber, glass bottle with white, tamper-evident, polypropylene screw cap. The bottle is placed in an outer cardboard carton together with a leaflet.
100 ml, high density polyethylene, brown bottle with a white, low density polyethylene, snap-cap closure. The bottle is placed in an outer cardboard carton together with a leaflet.
Not all packs are necessarily marketed.
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