Ofloxacin ear drops
قطره گوش افلوکساسین
👁️ Sensory OrgansTopical otic fluoroquinolone
Market / country: 🇺🇸 USA
Floxin Otic (US)
🧮 Dose calculator
Otitis externa · Regimen source: FDA Ofloxacin otic · Dosage and Administration
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to ofloxacin or other quinolones. FDA Ofloxacin otic · Contraindications
- ⛔ Not established under 6 months. FDA Ofloxacin otic · Pediatric Use
Formulations
- 0.3% otic solution — drops 🇺🇸 USA FDA Ofloxacin otic · Description
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Ofloxacin otic · Pregnancy
“Teratogenic Effects Pregnancy Category C.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Ofloxacin otic · Nursing Mothers
“Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Ofloxacin otic · Pediatric Use
“Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed indications: six months and older: otitis externa with intact tympanic membranes one year and older: acute otitis media with tympanostomy tubes twelve years and older: chronic suppurative otitis media with perforated …”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA076527
- DailyMed (FDA label)FDA Ofloxacin otic
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDS02AA16
- Darooyab (Iran)Ofloxacin
🇮🇷 Registered in Iran Darooyab · G-461/Ofloxacin
Dosage forms with Iranian generic codes, per Darooyab.
- 02446 · OFLOXACIN 0.30% OTIC DROP · قطره گوشی افلوکساسین ۰٫۳۰ درصد
- 00929 · OFLOXACIN 100MG TAB · قرص افلوکساسین ۱۰۰ میلیگرم
- 00930 · OFLOXACIN 200MG FC TAB · قرص روکشدار افلوکساسین ۲۰۰ میلیگرم
- 02009 · OFLOXACIN 300MG FC TAB · قرص روکشدار افلوکساسین ۳۰۰ میلیگرم
- 08636 · OFLOXACIN 400MG FC TAB · قرص روکشدار افلوکساسین ۴۰۰ میلیگرم
- 52369 · OFLOXACIN SOLUTION, DROPS OPHTHALMIC 3 mg/1mL 5 mL · قطره چشمی افلوکساسین ۳ میلیگرم / ۱ میلیلیتر ۵ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Ofloxacin otic · DescriptionFDA Ofloxacin otic · Dosage and AdministrationFDA Ofloxacin otic · ContraindicationsFDA Ofloxacin otic · Pediatric UseFDA Ofloxacin otic · PregnancyFDA Ofloxacin otic · Nursing MothersFDA Ofloxacin otic · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-461/Ofloxacin
- Clinical review⚠ Unverified