Ciprofloxacin and fluocinolone acetonide auricular
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Ear drops containing ciprofloxacin and fluocinolone acetonide.
Drugs List
Therapeutic Indications
Uses
Acute otitis externa
Acute otitis media in patients with tympanostomy tubes
Dosage
Adults
Instil the contents of 1 dose unit into the affected ear(s) every 12 hours for 7 days.
Children
Children over 6 months
Instil the contents of 1 dose unit into the affected ear(s) every 12 hours for 7 days.
Children under 6 months
This medication may used under exceptional circumstances if the expected benefit to the child is greater than any risk.
Contraindications
None known
Precautions and Warnings
Children under 6 months
Breastfeeding
Pregnancy
Exclude external ear canal viral infection before initiating treatment
Exclude fungal ear infection before initiating treatment
Evaluate for other conditions if otorrhea persists/reoccurs after treatment
If visual disturbances occur, perform ophthalmic evaluation
Hypersensitivity reactions may be masked by the presence of the steroid
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if drug-related rash or other hypersensitivity reactions occur
Pregnancy and Lactation
Pregnancy
Use the combination of ciprofloxacin and fluocinolone acetonide with caution during pregnancy.
The manufacturer notes that systemic exposure will be very low but consideration should be given to the expected benefit to the mother outweighing any risk to the foetus.
No malformative or foetal/neonatal toxicity is indicated in human pregnancy.
Lactation
Use the combination of ciprofloxacin and fluocinolone acetonide with caution during breastfeeding.
The manufacturer notes that ciprofloxacin is excreted in breast milk but systemic exposure to it will be very low.
Side Effects
Auricular swelling
Blurred vision
Candidiasis
Crying
Dizziness
Dysgeusia
Ear congestion
Ear discomfort
Ear fungal infection
Ear pain
Ear pruritus
Erythematous rash
Fatigue
Flushing
Headache
Hypertrophic granulation
Hypoacusis
Irritability
Medication residue
Otitis externa
Otitis media
Otorrhoea
Paraesthesia
Rash
Skin exfoliation
Tinnitus
Tympanic membrane disorder
Tympanostomy tube obstruction
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2018
Reference Sources
Summary of Product Characteristics: Cetraxal Plus 3mg/ml + 0.25mg/ml ear drops solution in single-dose container.. Aspire Pharma Limited. Revised May 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.