POLYDEXA EAR DROPS.
active substances: 1 ml solution contains neomycin sulfate 10 mg (6500 IU), polymyxin b sulfate 10,000 IU, dexamethasone sodium metasulphobenzoate 1 mg;
excipients: thiomersal, citric acid monohydrate, sodium hydroxide, macrogol 400, Polysorbate 80, purified water.
Dosage form. Ear drops, solution.
Basic physical and chemical properties: clear yellow solution.
Combined preparations containing a corticosteroid and an antimicrobial agent.
Code ATC S02C A06.
The pharmacological properties.
The therapeutic effect due to anti-inflammatory effects of dexamethasone and antimicrobial action of neomycin and polymyxin B. the combination of these antibiotics extends the spectrum of antimicrobial activity against most gram-positive and gram-negative microorganisms that cause infectious-inflammatory diseases of the ear.
In polymyxin is active against Acinetobacter, Aeromonas, Alcaligenes, Citrobacter, Enterobacter, E. coli, Klebsiella, Moraxella, P. aeruginosa, Salmonella, Shigella, S. maltophilia.
To the action of polymyxin b resistant cocci and Bacillus, 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.
To the action of Neomycin resistant Enterococci, N. asteroides, Met-R, Staphylococcus, Streptococcus, A. denitrificans, Burkholderia, flavo sp. P. stuartii, P. aeruginosa, S. maltophilia, chlamydia, Mycoplasma, Rickettsiae, resistant anaerobes.
If there is no damage to the eardrum systemic absorption is not observed.
Local treatment of external otitis of bacterial origin with an intact eardrum, in particular infectious eczema of the external auditory canal.
Hypersensitivity (Allergy) to any component of the drug included in the drug, in particular to neomycin or other aminoglycosides, polymyxin b, dexamethasone; existing or suspected perforation of the tympanic membrane; the presence of a viral infection in the outer ear canal, including varicella and infection caused by Herpes simplex.
Interaction with other medicinal products and other forms of interaction.
It is not recommended to use the drug in conjunction with any other drugs for local use.
Features of the application.
Before treatment it is necessary to study the condition of the eardrum. In violation of the integrity of the tympanic membrane the drug is illegal because of possible serious complications (deafness, impaired balance).
Local application of antibacterial drugs may cause sensitisation to the active substances and lead to systemic reactions.
The presence of corticosteroids does not affect the signs of skin allergic reactions to antibiotics, but may modify the clinical picture of an allergic reaction.
You should immediately stop using the product if there is skin rash or other local or systemic manifestations of allergic reactions.
Athletes should be warned that this medicinal product contains an active substance (dexamethasone) that can give a positive reaction in doping control.
Do not swallow solution, do not use the injection.
In use, should avoid touching the edge of the drip as fingers and ear to reduce the risk of infection.
If symptoms persist after a 10-day course of treatment, the patient should contact the physician for review of the disease and treatment strategies.
Despite local application, should be aware that long-term treatment (more than the deadline), or at application doses, greatly exceeding recommended, the drug may cause systemic effects.
When treatment with this medicine must comply with the official recommendations on the appropriate use of antibiotics.
Use during pregnancy or breast-feeding.
There is clinical and experimental data on animals for use in pregnant women.
It is unlikely that the drug gets into the circulatory system, if not broken eardrum. The use of the drug during pregnancy or breast-feeding a valid physician's recommendation in the case of absolute necessity.
The ability to influence the reaction rate when driving motor transport or operating other mechanisms.
There were no cases of influence on velocity reactions while driving or operating other mechanisms.
Method of application and doses.
The drug is used topically in the form of instillation into the ear.
Drops instilled into the external auditory meatus of the affected ear each morning, repeat the procedure in the evening.
Adult dosage: 1-5 drops in the affected ear 2 times a day.
Dosage for children (depending on age of child): 1-2 drops in the affected ear 2 times a day.
The duration of treatment depends on the nature and severity of the disease and is determined individually. The average duration of treatment is 7 days.
Before applying the drops should warm the bottle by holding it in the palm of your hand to avoid the unpleasant sensation associated with contact with cold liquid in the ear. Tilt your head, put the right amount of drops in the ear several times to pull a little on your ear. Keep the head tilted for about 5 minutes to improve contact with the ear canal. If necessary, repeat the procedure for the second ear.
Do not inject the drug under pressure.
After completion of treatment the vial should be discarded, do not store the preparation for re-use in the future.
To apply for the appointment of a physician for the treatment of children of all ages.
No cases of overdose were noted.
The skin and subcutaneous tissues.
Local reactions (irritation).
From the immune system.
Possible allergic reaction and sensitization to antibiotics, the composition of the drug, which may hinder the reception of such of the following or related antibiotics.
Because the product contains thiomersal, there is a risk of contact dermatitis, allergic reactions and skin irritation.
Organs of hearing and balance.
Vestibular ototoxicity or kohlarn in case of violation of the integrity of the tympanic membrane (see section "Peculiarities of use").
Infections and invasions.
The formation of resistant microorganisms and fungal infections.
The expiration date. 3 years.
The storage conditions.
Keep at temperature not exceeding 25 °C. Keep out of reach of children.
Packing. 10.5 ml in bottle, 1 bottle with dropper in cardboard box.