Instructions for Polydex ear drops solution bottle 10.5 ml
Composition
active ingredients: 1 ml of solution contains neomycin sulfate 10 mg (6500 IU), polymyxin B sulfate 10,000 IU, dexamethasone sodium metasulfobenzoate 1 mg;
excipients: thiomersal, citric acid monohydrate, sodium hydroxide, macrogol 400, polysorbate 80, purified water.
Dosage form
Ear drops, solution.
Main physicochemical properties: clear yellow solution.
Pharmacotherapeutic group
Combination drugs containing corticosteroids and antimicrobials.
ATX code S02C A06.
Pharmacological properties
Pharmacodynamics
The therapeutic effect is due to the anti-inflammatory effect of dexamethasone and the antimicrobial effect of neomycin and polymyxin B. The combination of these antibiotics expands the spectrum of antimicrobial action against most gram-positive and gram-negative microorganisms that cause infectious and inflammatory diseases of the ear.
Polymyxin B is active against Acinetobacter, Aeromonas, Alcaligenes, Citrobacter, Enterobacter, E.coli, Klebsiella, Moraxella, P.aeruginosa, Salmonella, Shigella, S.maltophilia.
Cocci and bacilli resistant to Polymyxin B, B.catarrhalis, Brucella, B.cepacia, B.pseudomallei, Campylobacter, C.meningosepticum, Legionella, Morganella, Neisseria, Proteus, Providencia, Serratia, V.cholera El Tor, Mycobacteria.
Neomycin is active against Corynebacterium, Listeria monocytogenes, Met-S Staphylococcus, Acinetobacter, B.catarrhalis, Campylobacter, Citrobacter, Enterobacter, E.coli, H.influenzae, Klebsiella, Morganella, Proteus, Providencia, Salmonella, Serratia, Shigella, Yersinia, Pasteurella.
Enterococci, N.asteroides, Met-R Staphylococcus, Streptococcus, A.denitrificans, Burkholderia, Flavobacterium sp., P.stuartii, P.aeruginosa, S.maltophilia, Chlamidia, Mycoplasma, Rickettsiae, and resistant anaerobes are resistant to Neomycin.
Pharmacokinetics
In the absence of damage to the eardrum, systemic absorption is not observed.
Indication
Topical treatment of external otitis of bacterial origin with an intact eardrum, in particular infectious eczema of the external auditory canal.
Contraindication
Hypersensitivity (allergy) to any of the components of the drug, including neomycin or other aminoglycosides, polymyxin B, dexamethasone; existing or suspected perforation of the eardrum; presence of viral infection in the external auditory canal, including chickenpox and infection caused by Herpes simplex.
Interaction with other medicinal products and other types of interactions
It is not recommended to use the drug simultaneously with any other medications for topical use.
Application features
Before starting treatment, it is necessary to examine the condition of the eardrum. If the integrity of the eardrum is impaired, the use of the drug is unacceptable, as serious complications are possible (deafness, balance disorders).
Topical use of antibacterial drugs may cause sensitization to the active substances and lead to systemic reactions.
The presence of a corticosteroid does not affect the manifestations of cutaneous allergic reactions to antibiotics, but may change the clinical picture of the allergic reaction.
It is necessary to immediately discontinue use of the drug if skin rashes or other local or systemic manifestations of allergic reactions occur.
Athletes should be warned that this medicine contains an active substance (dexamethasone) which may give a positive reaction during doping control.
Do not swallow the solution, do not use as an injection.
During use, avoid touching the edge of the dropper with either your fingers or your ear to reduce the risk of infection.
If symptoms persist after a 10-day course of treatment, the patient should consult a doctor for a review of the disease and treatment strategy.
Despite topical application, it should be noted that with long-term treatment (beyond the prescribed period) or when using a dose significantly exceeding the recommended one, the drug may cause systemic effects.
When treating with this medicine, official recommendations for the appropriate use of antibiotics should be followed.
Use during pregnancy or breastfeeding
There are no clinical or experimental animal data on use in pregnant women.
It is unlikely that the drug will enter the circulatory system unless the integrity of the eardrum is compromised. Use of the drug during pregnancy or breastfeeding is permissible on the recommendation of a doctor if absolutely necessary.
Ability to influence reaction speed when driving vehicles or other mechanisms
No cases of impact on reaction speed when driving vehicles or other mechanisms were identified.
Method of administration and doses
The drug should be applied topically as an ear drop.
Drops should be instilled into the external auditory canal of the affected ear every morning, and the procedure should be repeated in the evening.
Dosage for adults: 1-5 drops in the affected ear, 2 times a day.
Dosage for children (depending on the child's age): 1-2 drops in the affected ear, 2 times a day.
Before using the drops, warm the bottle by holding it in your palm to avoid the unpleasant sensation associated with getting cold liquid into the ear. Tilt your head, drop the required number of drops into the ear, slightly pull the earlobe back several times. Keep your head tilted for about 5 minutes to improve the penetration of the solution into the ear canal. If necessary, repeat the procedure for the other ear.
Do not administer the drug under pressure.
After completion of treatment, the vial should be discarded; the drug should not be stored for future use.
Children
Use as prescribed by a doctor for the treatment of children without age restrictions.
Overdose
No cases of overdose were noted.
Adverse reactions
On the skin and subcutaneous tissue.
Local reactions (irritation).
From the immune system.
Allergic reactions and sensitization to the antibiotics included in the preparation are possible, which may complicate subsequent administration of such or related antibiotics.
Because the drug contains thiomersal, there is a risk of contact dermatitis, allergic reaction, and skin irritation.
On the part of the organs of hearing and balance.
Vestibular or cochlear ototoxicity in case of disruption of the integrity of the tympanic membrane (see section "Special instructions").
Infections and invasions.
The formation of resistant microorganisms and the development of fungal infections are possible.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10.5 ml in a bottle, 1 bottle with a pipette in a cardboard box.
Vacation category
According to the recipe.
Producer
Bouchard Recordate Laboratories.
Location of the manufacturer and its business address
Le Wilson Building, 70 Avenue du General de Gaulle, 92800 Puteaux, France.
