- Approval Id
- 3c55098e15faed8c
- Drug Name
- CETRAXAL EAR DROPS SOLUTION 2MG/ML
- Product Name
- CETRAXAL EAR DROPS SOLUTION 2MG/ML
- Approval Number
- SIN14596P
- Approval Date
- 2014-08-29
- Registrant
- HYPHENS PHARMA PTE. LTD.
- Licence Holder
- HYPHENS PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><em>Adults and children aged one year and older:</em><br>
Instill the contents of one single ampoule into the affected ear twice daily for seven days.</p>
<p><em>Paediatric patients less than one year</em><br>
The safety and efficacy of Cetraxal in children aged below 1 year of age have not been established. No data are available. See section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Instructions for correct use of the product:</p>
<ul>
<li>The solution should be warmed, by holding the ampoule in the hand for several minutes, to avoid the dizziness that may result from the instillation of a cold solution into the ear canal.</li>
<li>The patient should lie with the affected ear upward and then the drops should be instilled, pulling several times on the auricle. This position should be maintained for around 5 minutes to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.</li>
<li>The patient should be advised to discard the single-dose container after the use, and not keep it for subsequent use.</li>
<li>In case an otowick/tampon is used to facilitate administration, the first dose should be doubled (2 ampoules instead of 1).</li>
</ul>
<p><em><strong>Renal/ hepatic impairment</strong></em><br>
Since the drug plasma concentration is anticipated to be undetectable, no dosage adjustment for these patient groups is deemed necessary.</p>
- Route Of Administration
- AURICULAR (OTIC)
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Cetraxal 2 mg/ml ear drops solution is indicated for the treatment of acute otitis externa caused by ciprofloxacin susceptible microorganisms (see sections 4.4 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Consideration should be given to official guidance on the appropriate use of antibacterial agents.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance ciprofloxacin or any member of the quinolone class of antimicrobial agents or to any of the excipients.</p>
- Atc Code
- S02AA15
- Atc Item Name
- ciprofloxacin
- Pharma Manufacturer Name
- HYPHENS PHARMA PTE. LTD.
