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CETRAXAL is a brand name for Ciprofloxacin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cetraxal 2 mg/ml ear drops solution is indicated for the treatment of acute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible microorganisms (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults and children aged one year and older Instil the contents of one single ampoule into the affected ear twice daily for seven days. Paediatric patients less than one year The safety and efficacy of Cetraxal in children aged below 1 year of age have not been established.
No data are available. See section
In a Phase III clinical trial, a total of 319 patients were treated with Cetraxal. 6 % of patients. All treatment related adverse reactions are uncommon (≥1/1000 to <1/100) and are listed below.
Ear and Labyrinth Disorders Uncommon:
Ear pruritus, tinnitus Nervous System Disorders Uncommon: Dizziness, headache Skin and subcutaneous disorders Uncommon: Dermatitis General Disorders and Administration Site Conditions Uncommon: Application Site Pain With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative, Stevens-Johnson syndrome, and urticaria occur very rarely.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
4. Method of administration Precautions to be taken before handling or administering the medicinal product. The solution should be warmed, by holding the ampoule in the hand for several minutes, to avoid the dizziness 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 the drops should be instilled, pulling several times on the auricle. This position should be maintained for around 5 minutes to facilitate penetration of the drops into the ear.
Repeat, if necessary, for the opposite ear. The patient should be advised to discard the single-dose container after the use, and not keep it for subsequent use. In case an otowick/tampon is used to facilitate administration, the first dose should be doubled (2 ampoules instead of 1).
Renal/ hepatic impairment Since the drug plasma concentration is anticipated to be undetectable, no dosage adjustment for these patient groups is deemed necessary. 1. 4 Special warnings and precautions for use This medicinal product is for auricular use, not for ophthalmic use, inhalation or injection.
In otic use meticulous medical monitoring is required in order to be able to determine in a timely manner the possible necessity of other therapeutic measures. Paediatric population The safety and efficacy of this product have been established in paediatric patients 1 year and older in controlled clinical trials.
Although very limited data are available in patients less than age 1 year treated for acute otitis externa, there are no differences in the disease process itself, in this patient population, which would preclude use of this product in patients less than one year of age.
Based upon the very limited data, the prescribing physician should weigh the clinical benefits of use against the known and possibly unknown risks when prescribing in patients less than age 1 year. The safety and efficacy of Cetraxal have not been studied in the presence of a perforated tympanic membrane.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Therefore, Cetraxal should be used with caution in patients with known or suspected perforation, or where there is a risk of perforation of the tympanic membrane. Cetraxal should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment.
As with other antibiotic preparation, the use of this product may result in overgrowth of non-susceptible organisms, including bacterial strains, yeast and fungi. If superinfection occurs, appropriate therapy should be initiated. If after one week of therapy some signs and symptoms persist, further evaluation is recommended to reassess the disease and the treatment.
Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to sun. Due to the site of administration, it is unlikely that this product may show photoallergic reactions.