- Approval Id
- 8ba4fe942bac7796
- Drug Name
- CILODEX OTIC SUSPENSION
- Product Name
- CILODEX OTIC SUSPENSION
- Approval Number
- SIN13199P
- Approval Date
- 2006-04-18
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- NOVARTIS (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- **4 Dosage regimen and administration**
**Dosage regimen**
**Acute Otitis Media in pediatric patients with tympanostomy tubes:** 4 drops twice daily (BID) in the affected ear(s) for 7 days.
**Special populations**
**Renal and hepatic impairment**
When using Cilodex® Otic in patients with renal or hepatic impairment, dose adjustment is not necessary.
**Pediatric patients**
The safety and efficacy of Cilodex® Otic in pediatric patients below 6 months has not been established.
**Method of administration**
- For otic use only.
- The bottle must be shaken well before use.
- To avoid contamination, the dropper tip should not touch the ear or any other surface.
- The suspension should be warmed by holding the bottle in the hand for 1–2 minutes to avoid any unpleasant sensation 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 tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds.
- Route Of Administration
- AURICULAR (OTIC)
- Indication Info
- **3 Indications**
**Otic use**
Cilodex® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Acute otitis media in pediatric patients (age 6 months and older) with tympanostomy tubes (AOMT) due to _Staphylococcus aureus_, _Streptococcus pneumoniae_, _Haemophilus influenzae_, _Moraxella catarrhalis_, and _Pseudomonas aeruginosa_.
- Contraindications
- **5 Contraindications**
- Hypersensitivity to the active substance, any of the excipients or other quinolones.
- Viral, fungal, and untreated parasitic otic infections.
- Atc Code
- J01MA02
- Atc Item Name
- ciprofloxacin
- Pharma Manufacturer Name
- NOVARTIS (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/novartis-singapore-pte-ltd
