Ciprofloxacin Hydrochloride and Dexamethasone
Drug Details
- Generic Name
- Ciprofloxacin Hydrochloride and Dexamethasone
- Brand Names
- Ciprofloxacin and Dexamethasone
- Application Number
- ANDA216487
- Sponsor
- Upsher-Smith Laboratories, LLC
- NDC Codes
- 1
- Dosage Forms
- SUSPENSION
- Routes
- AURICULAR (OTIC)
- Active Ingredients
- CIPROFLOXACIN HYDROCHLORIDE, DEXAMETHASONE
Indications and Usage
1 INDICATIONS AND USAGE Ciprofloxacin and dexamethasone, otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition 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 (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . Ciprofloxacin and dexamethasone, 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 condition 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 (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . ( 1 )