Source: Health Products and Food Branch (CA) Revision Year: 2017
CIPRODEX (ciprofloxacin/dexamethasone otic suspension) is indicated for the treatment of infections caused by most strains of the designated microorganisms in the specific conditions listed below:
Acute Otitis Media with Otorrhea through tympanostomy tubes in pediatric patients ≥6 months of age due to:
Aerobic, Gram-Positive:
Streptococcus pneumoniae
Staphylococcus aureus
Aerobic, Gram-Negative:
Haemophilus influenza
Moraxella catarrhalis
Pseudomonas aeruginosa
Acute Otitis Externa in adults and pediatric patients ≥1 year of age due to:
Aerobic, Gram-Positive:
Staphylococcus aureus
Aerobic, Gram-Negative:
Pseudomonas aeruginosa
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRODEX and other antibacterial drugs, CIPRODEX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
Geriatrics (>65 years of age): Elderly patients may be at a higher risk of developing tendon inflammation and rupture (see WARNINGS AND PRECAUTIONS, General).
Pediatrics (<6 months of age): The safety and effectiveness of CIPRODEX have not been evaluated in pediatric patients <6 months of age.
Acute Otitis Media in pediatric patients (≥6 months of age) with tympanostomy tubes: Four drops instilled into the affected ear twice daily for seven days.
Acute Otitis Externa in adult patients and pediatric patients (≥1 year of age): Four drops instilled into the affected ear twice daily for seven days.
If a dose is missed, it should be given as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
SHAKE WELL IMMEDIATELY BEFORE USING.
Acute Otitis Media in pediatric patients (≥6 months of age) with tympanostomy tubes: The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
Acute Otitis Externa in adult patients and pediatric patients (≥1 year of age): The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.
There is no known treatment of overdosage since overdosage in the use of topical otic preparations is a remote possibility. Discontinue medication when heavy or protracted use is suspected.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
Store at room temperature (15°C to 30°C). Avoid freezing. Protect from light. Keep out of reach and sight of children.
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