Cetraxal plus ear drops solution bottle 10 ml

• active ingredients: ciprofloxacine; fluocinolone acetonide;
• 1 ml contains ciprofloxacin 3 mg (as ciprofloxacin hydrochloride monohydrate 3.49 mg), fluocinolone acetonide 0.25 mg;
• excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), povidone, diethylene glycol monoethyl ether, glycereth-26, diluted hydrochloric acid (adjustment to pH 4.6 – 4.7), purified water.

Hypersensitivity to fluocinolone, ciprofloxacin or other quinolones, or to any of the other ingredients of the drug.

Viral infections of the external auditory canal, including chickenpox, herpes simplex, and fungal ear infections.

Infections and infestations – uncommon: candidiasis, ear fungal infection, contralateral otitis media.

Nervous system disorders – common: dysgeusia. Uncommon: paresthesia (tingling in the ears), dizziness, headache, tearfulness

Hearing and labyrinth disorders – common: ear pain, ear congestion, ear itching. Uncommon: hypoacusis, tinnitus, otorrhea, ear plug, tympanic membrane damage, auricular (ear) edema

Visual disturbances – frequency unknown: blurred vision.

Vascular disorders – uncommon: hot flashes.

Gastrointestinal disorders – uncommon: vomiting.

For instillation into the ear canal.

Adults, including elderly patients.

Acute otitis externa and acute otitis media in patients with tympanostomy tubes: instill 6–8 drops into the affected external ear canal every 12 hours for 7 days.

It is recommended to warm the bottle before use by holding it in the palms of your hands for a few minutes. This will help to avoid discomfort due to the cold solution getting into the ear canal. The patient should tilt their head to one side so that the affected ear is on top. Drops should be placed in the affected ear and the earlobe should be pulled several times.

Patients with acute otitis media with tympanostomy tubes should press the tragus inward 4 times to facilitate the penetration of the drops into the middle ear. This position should be maintained for approximately 1 minute to facilitate the penetration of the drops into the ear.

Repeat steps, if necessary, for the opposite ear.

To prevent contamination of the dropper tip and reduce the risk of bacterial contamination, care should be taken not to touch the auricle or external auditory canal and surrounding areas with the dropper tip. The bottle should be kept tightly closed when not in use.

Use during pregnancy or breastfeeding

Before administering the drug, the benefits of treatment should be assessed against the possible risks.

Given that most drugs are excreted in breast milk, caution should be exercised when Cetraxal Plus is administered to women during breastfeeding.

Children

Use in children aged 6 months and older is the same as for adults for both indications.

Ability to influence reaction speed when driving vehicles or other mechanisms

There is no data on the effect of ear drops on the ability to drive or use other mechanisms.

Given the method of administration, conditions of use and safety profile of Cetraxal Plus, the drug does not affect the ability to drive a car or operate other mechanisms.

No cases of overdose have been described.

Drug interaction studies with Cetraxal Plus have not been conducted. However, given the predicted low plasma levels after instillation into the ear, it is unlikely that ciprofloxacin or fluocinolone would cause clinically significant systemic interactions with other drugs.

Systemic administration of some quinolones has been shown to enhance the effects of the oral anticoagulant warfarin and its derivatives and has been associated with a transient increase in serum creatinine in patients receiving concomitant cyclosporine.

Oral ciprofloxacin has been shown to inhibit cytochromes P450 CYP1A2 and CYP3A4 and to alter the metabolism of methylxanthine compounds (caffeine, theophylline). Following topical application of Cetraxal Plus, plasma concentrations of ciprofloxacin are low and interactions involving P450 effects on the metabolism of Cetraxal Plus and concomitant medications are unlikely to result in clinically significant changes in methylxanthine plasma levels.

Simultaneous use in the ear canal with other medications is not recommended. If more than one medication needs to be administered into the ear canal, it is recommended to administer them at intervals.

Store at a temperature not exceeding 30 °C.

Keep out of reach of children.