Properties
What is it?
Ottadex Ear Drops Composition: Each 1 ml of solution contains: Active substances: 3 mg Ciprofloxacin (equivalent to 3.5 mg Ciprofloxacin hydrochloride), 1 mg Dexamethasone; Excipients: Benzalkonium chloride, Disodium edetate, Sodium chloride, Sodium phosphate dihydrate, Hydroxypropyl-beta-cyclodextrin, Polyvinyl alcohol, Hydrochloric acid/Sodium hydroxide (pH adjuster), Water for injection. Indicated in children with acute otitis media with tympanic membrane shunt, without otorrhea due to the presence of a tympanic membrane shunt. Systemic effects of ciprofloxacin are not expected in patients with acute external otitis. Ottadex Ear Drops, sterile solution International Nonproprietary Name: Ciprofloxacin/Dexamethasone Indications for use: For the treatment of the following infections in adults and children caused by strains of susceptible microorganisms: acute phase of chronic otitis media, chronic suppurative otitis media, acute bacterial external otitis. Contraindications: Hypersensitivity to ciprofloxacin, other quinolones, dexamethasone, or any of the excipients; viral (e.g., chickenpox, herpes simplex) and fungal infections of the ear, as well as mycobacterial infections caused by acid-fast bacilli and other mycobacteria, such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Dosage and administration: Unless otherwise recommended by a doctor, Ottadex ear drops are used in the acute phase of chronic otitis media and chronic suppurative otitis media, 4 drops 2-3 times a day for 7-10 days. For acute bacterial external otitis, use 3 drops 2 times a day for 7 days. Instructions for use: Remove the bottle cap as follows. Remove the cap. Remove the ring located under the cap. Replace the cap and tighten properly. This opens the dropper membrane and allows the liquid to be dispensed from the bottle. To avoid contamination of the tip and to limit the risk of bacterial entry, care must be taken not to touch the auricle or the external auditory canal and surrounding areas, or other surfaces with the dropper tip. The bottle must be kept tightly closed during storage. The suspension should be warmed by holding the bottle in hand for a few minutes to avoid dizziness caused by the instillation of cold suspension. Patients should be instructed to shake the bottle vigorously before use. The patient should lie down with the affected ear facing upwards, and the drops should be instilled by pulling the ear. For patients with acute otitis media with tympanic membrane shunt, press 5 times on the tragus of the ear inwards to facilitate the entry of drops into the middle ear. This position should be maintained for approximately 5 minutes to promote the entry of drops into the ear. If necessary, repeat the same in the other ear. Storage conditions: Store at room temperature not exceeding 25°C, out of reach of children!