Ciprofloxacin and Dexamethasone 3 mg/mL
Ciprofloxacin Hydrochloride and Dexamethasone · SUSPENSION · Upsher-Smith Laboratories, LLC
This ear drop suspension combines an antibiotic (ciprofloxacin) to fight bacterial infections and a corticosteroid (dexamethasone) to reduce inflammation in the ear. It is used to treat bacterial ear infections and related ear inflammation.
Key Facts
- Brand Name
- Ciprofloxacin and Dexamethasone
- Generic Name
- Ciprofloxacin Hydrochloride and Dexamethasone
- NDC Code (Product)
0832-1430- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 3 mg/mL
- Dosage Form
- SUSPENSION
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- ANDA216487
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 01/06/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ciprofloxacin 0.3% and dexamethasone 0.1% 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 . Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, 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. ( 1 ) • Acute Otitis Externa (AOE) in pediatric (…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is for otic use (ears) only, not for ophthalmic use, or for injection. ( 2.1 ) • Shake well immediately before use. (2.1 ) • Instill four drops into the affected ear twice daily, for seven days. ( 2 ) 2.1 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. 2.2 Dosage For the Treatment of Acute Otitis Media in Pediatric Patients (age 6 months and older) With Tympanostomy Tubes The recommended dosage regimen through tympanostomy tubes is as follows: • Four drops [equivalent to 0.14 mL of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension, (consisting of 0.42 mg of ciprofloxacin and 0.14 mg of dexamethasone)] instilled into the affected ear twice daily for seven days. • 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 tr…
Contraindications
4 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. • 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. ( 4 ) • Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. (4)
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions ( 5.2)] Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). (6) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar RxLLC, at 1-800-206- 7821or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phases II and III clinical trials, a total of 937 patients were treated with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE. The reported adverse reactions are listed below: Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes The following adverse reactions occurred …
Frequently Asked Questions
What is Ciprofloxacin and Dexamethasone used for?
This ear drop suspension combines an antibiotic (ciprofloxacin) to fight bacterial infections and a corticosteroid (dexamethasone) to reduce inflammation in the ear. It is used to treat bacterial ear infections and related ear inflammation.
Is Ciprofloxacin and Dexamethasone a controlled substance?
Ciprofloxacin and Dexamethasone is not classified as a controlled substance by the DEA.
What is the generic name for Ciprofloxacin and Dexamethasone?
The generic name for Ciprofloxacin and Dexamethasone is Ciprofloxacin Hydrochloride and Dexamethasone. There are no other listed brand versions of Ciprofloxacin Hydrochloride and Dexamethasone.
What is the NDC code for Ciprofloxacin and Dexamethasone 3 mg/mL?
The NDC (National Drug Code) for Ciprofloxacin and Dexamethasone 3 mg/mL is 0832-1430, listed by Upsher-Smith Laboratories, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)