Instructions for use Anauran ear drops, bottle with dropper cap 25 ml
Composition
active ingredients: 100 ml of the drug contain: polymyxin B sulfate – 1,000,000 IU, neomycin sulfate – 0.5 g (equivalent to 375,000 IU), lidocaine hydrochloride – 4.0 g;
Excipients: benzalkonium chloride, propylene glycol, glycerin, purified water.
Dosage form
Ear drops.
Main physicochemical properties: transparent, slightly viscous, odorless liquid.
Pharmacotherapeutic group
Means acting on the sense organs. Drugs used in otology. Antimicrobial drugs, combinations.
ATX code S02A AZ0.
Pharmacological properties
Pharmacodynamics.
The drug Anauran, thanks to its active ingredients, has antibacterial and anesthetic properties.
The components – neomycin sulfate and polymyxin B sulfate – effectively act against the etiological factors of infectious inflammation of the auditory organs.
Lidocaine, thanks to its anesthetic effect, relieves pain symptoms characteristic of most otological diseases.
When using the drug Anauran, signs of inflammation, such as pain and itching, stop mucopurulent discharge, and the drug prevents the development of possible complications of existing inflammation (mycotic superinfections, wound infection, etc.).
Pharmacokinetics.
The active ingredients of the drug are not absorbed into the systemic bloodstream in active doses.
Indication
Acute or chronic otitis media.
Contraindication
Hypersensitivity to any component of the drug and to other compounds with a related chemical structure.
Perforation of the eardrum (risk of developing ototoxicity).
Hypersensitivity to amide local anesthetic drugs.
Interaction with other medicinal products and other types of interactions
There are no known studies of interactions with the active substances present in the medicinal product.
Application features
The use of topical preparations, especially long-term, may cause sensitization. In this case, it is necessary to suspend treatment and consult a doctor.
In severe and persistent infections, local treatment must be supplemented with adequate systemic antibacterial therapy.
Prolonged use of the drug, like other antibiotics, may lead to the development of superinfection with microorganisms resistant to the drug, including fungi.
Neomycin may cause permanent sensorineural hearing loss, especially if the hair cells of the organ of Corti are affected. The risk of ototoxicity increases with prolonged use, so it is recommended to limit treatment to 10 consecutive days.
Cross-allergy and cross-resistance with other aminoglycoside derivatives may occur.
Neomycin and polymyxin B sulfate are potentially nephrotoxic substances.
Anauran is intended for otological use only; application to other areas of the body is not permitted.
Before prescribing the drug, the integrity of the eardrum should be checked.
Important information about the components of the drug
The drug contains benzalkonium chloride and propylene glycol, which may cause skin reactions and skin irritation.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding, as adequate and strictly controlled studies in pregnant women have not been conducted.
Ability to influence reaction speed when driving vehicles or other mechanisms
Anauran does not affect the ability to drive vehicles and other mechanisms.
Method of administration and doses
Locally into the external auditory canal using a special pipette. After instillation, keep the head tilted for several minutes.
Adults use 4–5 drops 2–4 times a day, children over 6 years old use 2–3 drops 3–4 times a day, depending on the severity of the disease.
The duration of treatment is determined by the doctor and depends on the speed of response to therapy. The course of treatment should not exceed 10 days.
Children.
There is insufficient experience with the use of Anauran in children under 6 years of age, therefore it is not recommended to prescribe the drug to this age group of patients.
Overdose
Cases of overdose have not been described.
Side effects
The following adverse reactions have been reported with the use of Anauran (the frequency of adverse reactions cannot be estimated from the available data).
| Organ system | Adverse reactions |
| Diseases of the skin and subcutaneous tissue | Allergic dermatitis, itching, hypersensitivity reactions including rash, redness. The product contains benzalkonium chloride and propylene glycol, which may cause skin reactions and skin irritation. |
| General complications and injection site reactions | Irritation at the site of application. |
| Injury, poisoning and procedural complications | Ototoxicity (see section "Special warnings and precautions for use"). |
Reporting adverse reactions after registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua/.
Expiration date
3 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
After opening the bottle, the drug can be used for 3 months.
Packaging
25 ml in a bottle with a dropper cap; 1 bottle in a pack.
Vacation category
According to the recipe.
Producer
Zambon SPA/Zambon SPA
Location of the manufacturer and address of its place of business
Via della Chimica, 9 - 36100 Vicenza (province of Vicenza), Italy / Via della Chimica, 9 - 36100 Vicenza (VI), Italy.
