ANAURAN * GTT OTO FL 25ML
Therapeutic indications
Acute and chronic otitis.
Dosage and method of use
- Adults 4-5 drops, 2-4 times a day. - Children 2-3 drops, 3-4 times a day. Instill, using the appropriate dropper, into the ear duct keeping the head tilted to the side for a few minutes. The treatment period is variable in relation to the rapidity of the therapeutic response, it is recommended not to use the medicine for more than 10 consecutive days.
Contraindications
ANAURAN is contraindicated: - in patients with hypersensitivity to Polymyxin B sulphate, Neomycin sulphate and Lidocaine hydrochloride and chemically closely related compounds or to any of the excipients; - in patients with perforated tympanic membrane, due to the risk of ototoxicity.
Side effects
Following administration of Anauran, the following adverse reactions have been reported. Frequency cannot be estimated from the available data.
| System and organ classification | Adverse reactions |
| Skin and subcutaneous tissue disorders | Allergic dermatitis, itching |
| General disorders and administration site conditions | Application site irritation |
| Injury, poisoning and procedural complications | Ototoxicity (see section 4.4) |
Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Special warnings
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, stop the treatment and consult your doctor to establish a suitable therapy. In the presence of deep or resistant infections it is advisable to integrate the local dressing with appropriate general antibiotic treatments. As with other antibiotic preparations, prolonged treatments can result in superinfections with resistant germs. Neomycin can induce permanent sensorineural hearing loss following damage to the cochlea, especially with the destruction of the hair cells of the organ of Corti. The risk of ototoxicity is greater in case of prolonged use, therefore a duration of therapy limited to 10 consecutive days is recommended. Cross-allergy and cross-resistance with other aminoglycoside derivatives may occur. ANAURAN is to be used exclusively in the otological field; applications in other locations are inappropriate. Important information about some of the ingredients: The medicine contains 0.001 mg benzalkonium chloride in each drop, which may irritate the skin. The medicine contains 11.6 mg of propylene glycol in each drop which may cause skin irritation.
Pregnancy and breastfeeding
Pregnancy: There are no adequate and well-controlled studies in pregnant women. The medicine should be used during pregnancy only in cases of real need and under direct medical supervision.Feeding time:Caution should be used when the medicine is used by breastfeeding women.
Expiration and retention
No particular precautions.
Interactions with other drugs
There are no known interaction studies with the active ingredients present in the medicinal product.
Overdose
No cases of overdose have been reported.
Active principles
100 ml of solution contain:Active principlesPolymyxin B sulphate IU 1,000,000; Neomycin sulfate 0.500 g (equal to base neomycin 0.375 g); Lidocaine hydrochloride 4 g. Excipients with known effects: benzalkonium chloride and propylene glycol. For the full list of excipients, see section 6.1.
Excipients
Benzalkonium chloride, Propylene glycol, Glycerol, Purified water.
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