Finished product reference
Ciprofloxacin / Dexamethasone
Suspension, Drops Auricular ( · Otic · ) 0.3 %/0.1 %
- List code
- 12972
- Pharmacologic class
- Corticosteroid
What it is and how it works
Mechanism of Action Ciprofloxacin is a fluoroquinolone antibacterial . Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
Mechanism class: Corticosteroid Hormone Receptor Agonists
Indications
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension USP is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • Acute Otitis Media (/\OM) in pediatric patients (age 6 months and older with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa .
Dosage and administration (summary)
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is for otic use (ears) only, not for ophthalmic use, or for injection. Shake well immediately before use. Instill four drops into the affected ear twice daily, for seven days. Important Administration Instructions Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is for otic use (ears) only, and not for ophthalmic use, or for injection. Shake well immediately before use.
Contraindications
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections.
Warnings and precautions
Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. Hypersensitivity Reactions Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
Pregnancy
Pregnancy Risk Summary There are no available data on ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Storage and supply
How Supplied: Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension, USP is a white-to off-white suspension supplied as follows: 7.5 mL fill in a system consisting of a natural polyethylene bottle and natural plug, with a white HDPE closure. Tamper evidence is provided with a tamper-evident ring around the closure and neck area of the package.
Source: Ciprofloxacin And Dexamethasone (Ciprofloxacin And Dexamethasone) — US FDA prescribing information, 2026-04-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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