ofloxacin
ofloxacin is listed in the FDA National Drug Code directory with 20 NDC codes, marketed under brand names including Ofloxacin, OCUFLOX, ofloxacin. Available dosage forms: solution, solution/ drops.
Drug Details
- Generic Name
- ofloxacin
- Brand Names
- Ofloxacin, OCUFLOX, ofloxacin
- Application Number
- ANDA076513
- Sponsor
- A-S Medication Solutions
- NDC Codes
- 20
- Dosage Forms
- SOLUTION, SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- OFLOXACIN
Indications and 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 (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . ( 1 )