Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aspire Pharma Limited, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Cetraxal Plus is indicated in adults and in children aged 6 months and older for the following infections:
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Acute otitis externa and acute otitis media with tympanostomy tubes: Instil the contents of one single-dose container into the affected ear canal every 12 hours for 7 days.
No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
No dosage adjustment is deemed necessary.
The dosage in children aged 6 months and older is the same as for adults for both indications.
Auricular use.
The solution should be warmed before its use, by holding the bottle in the hand for several minutes. This will avoid the discomfort that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then for patients with otitis externa the drops should be instilled pulling several times on the auricle. For patients with acute otitis media with tympanostomy tubes, the tragus should be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for around 1 minute to facilitate penetration of the drops into the ear.
Repeat, if necessary, for the opposite ear.
No case of overdose has been reported.
Due to negligible plasma levels observed after application in the ear, it is unlikely that topically applied ciprofloxacin or fluocinolone acetonide may show clinically meaningful systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear.
The limited holding capacity of the ear canal for topical otic products practically precludes overdosing via the ototopical route. However, oral ingestion of Cetraxal Plus resulting in overdose or long-term ototopical therapy may produce suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Although decreases in paediatric growth velocity and/or suppression of cortisol plasma concentrations may be more pronounced after substantial overdose or prolonged treatment (e.g. several months) with Cetraxal Plus, the effect is expected to be transient (days to weeks) and easily reversible with no long-term sequelae.
If the preparation is accidentally swallowed, treatment will include gastric emptying by induced vomiting or gastric lavage, the administration of activated charcoal and antacids containing magnesium or calcium.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
2 years.
Shelf-life after first opening of the pouch: 7 days.
Store below 30°C. Store the single-dose containers in the pouch in order to protect from light.
After first opening of the single-dose container: use immediately and discard the single-dose container after use.
The solution is contained within a formed low-density polyethylene (LDPE) single-dose container. Each single-dose container delivers 0.25 ml.
The single-dose containers are contained in an aluminium foil overwrap pouch for protection. Each pack contains 15 single-dose containers.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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