Ciprofloxacin with dexamethasone auricular
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Ear drops of ciprofloxacin with dexamethasone
Drugs List
Therapeutic Indications
Uses
Acute otitis externa
Acute otitis media in patients with tympanostomy tubes
Dosage
Adults
Instil four drops in the affected ear(s) twice a day for 7 days.
Children
Children six months to 1 year
Acute otitis media in patients with tympanostomy tubes
Instil four drops in the affected ear(s) twice a day for 7 days.
Children over 1 year
Acute otitis media in patients with tympanostomy tubes
Instil four drops in the affected ear(s) twice a day for 7 days.
Acute otitis externa
Instil four drops in the affected ear(s) twice a day for 7 days.
Contraindications
Children under 6 months
Precautions and Warnings
Breastfeeding
Pregnancy
Consult national/regional policy on the use of anti-infectives
Exclude external ear canal viral infection before initiating treatment
Exclude fungal ear infection before initiating treatment
Contains benzalkonium chloride
Discontinue at first sign of pain/inflammation of limb(possible tendonitis)
Evaluate for other conditions if otorrhea persists/reoccurs after treatment
If visual disturbances occur, perform ophthalmic evaluation
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if drug-related rash or other hypersensitivity reactions occur
Not licensed for all indications in all age groups
Pregnancy and Lactation
Pregnancy
Use ciprofloxacin with dexamethasone with caution during pregnancy.
The manufacturer advises that ciprofloxacin with dexamethasone should not be used during pregnancy unless clearly necessary and only if the potential benefit justifies the potential risk to the foetus. At the time of writing, no animal reproduction studies and no adequate or well controlled studies in pregnant women have been conducted with the combination of ciprofloxacin and dexamethasone.
Ciprofloxacin
Briggs (2015) states that the use of ciprofloxacin during pregnancy does not appear to be associated with an increased risk of major congenital malformations. A number of birth defects have occurred in the offspring of women who have taken ciprofloxacin during pregnancy.
Dexamethasone
That use in the first trimester has a small absolute risk of oral clefts. However the benefit of therapy may outweigh the risk.
Lactation
Use ciprofloxacin with dexamethasone with caution during breastfeeding.
The manufacturer advises caution if ciprofloxacin with dexamethasone is used during breastfeeding. Ciprofloxacin and corticosteroids, as a class, appear in milk following oral administration. It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in breast milk. A risk to the suckling child cannot be excluded.
Ciprofloxacin
Ciprofloxacin is excreted into human milk. Data is limited, but the amount of ciprofloxacin in breast milk does not appear to represent a significant risk to an infant, especially if nursing is several hours after a dose.
Dexamethasone
There is no available data for the use of dexamethasone during breastfeeding, although the molecular weight is considered low enough for passage into breast milk.
Side Effects
Anaphylactic reaction
Auricular swelling
Blurred vision
Candidiasis
Crying
Dizziness
Dysgeusia
Ear congestion
Ear discomfort
Ear infection
Ear pain
Ear pruritus
Erythematous rash
Fatigue
Flushing
Headache
Hypersensitivity reactions
Hypoacusis
Irritability
Medication residue
Otorrhoea
Paraesthesia
Skin exfoliation
Tinnitus
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 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Cilodex ear drops, suspension. Consilient Health Ltd. Revised June 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Ciprofloxacin Last revised: 31 October 2018
Last accessed: 09 October 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Dexamethasone Last revised: 31 October 2018
Last accessed: 09 October 2020
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