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Fixed-dose combination

Ciprofloxacin and Dexamethasone

Also known as ciprofloxacin hydrochloride, dexamethasone
Available on request
Presentations
1
Brands
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Manufacturers
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Available from stock
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Ciprofloxacin and Dexamethasone is a fixed-dose combination of a corticosteroid and a fluoroquinolone antibacterial indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. MedsAcross supplies Ciprofloxacin and Dexamethasone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Corticosteroid, Fluoroquinolone Antibacterial, Corticosteroid Hormone Receptor Agonists, Cytochrome P450 1A2 Inhibitors
US FDA first approval
18 July 2003
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Otic
Dosage forms
Otic suspension
Fixed-dose combination of
Ciprofloxacin, Dexamethasone
Identifiers
RxCUI 465397CAS 130244-48-3Q48566651

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • Acute Otitis Media (AOM) 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.

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

Ciprofloxacin and dexamethasone 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.

Source: US FDA prescribing information

Contraindications

• Ciprofloxacin and dexamethasone 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. • Ciprofloxacin and dexamethasone 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.

Source: US FDA prescribing information

Warnings and precautions

• Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin and dexamethasone otic suspension. • Prolonged use may result in overgrowth of non-susceptible bacteria and fungi.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions • Potential for Microbial Overgrowth with Prolonged Use Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%).

Source: US FDA prescribing information

Storage

Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid freezing. Protect from light.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Ciprofloxacin and Dexamethasone, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Ciprofloxacin and Dexamethasone 3 mg/1 mg per mL otic suspensionOticGeneric nameCiprofloxacin and Dexamethasone—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 18 July 2003Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Ciprofloxacin and Dexamethasone available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Ciprofloxacin and Dexamethasone and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Ciprofloxacin and Dexamethasone approved by the US FDA?

Yes. The US FDA first approved Ciprofloxacin and Dexamethasone on 18 July 2003, according to Drugs@FDA.

Does Ciprofloxacin and Dexamethasone need cold chain shipping?

No listed presentation of Ciprofloxacin and Dexamethasone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Ciprofloxacin and Dexamethasone prescribing information (Sandoz). U.S. National Library of Medicine, DailyMed. Retrieved 31 January 2025

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