Polydex

Active material: Dexamethasone, Neomycin, polymyxin B
When ATH: S02CA06
CCF: The preparation with antimicrobial and anti-inflammatory action for local application in an ENT-practice
ICD-10 codes (testimony): H60
When CSF: 04.04.01
Manufacturer: Laboratoires Bouchara-RECORDATI (France)

Pharmaceutical form, composition and packaging

Excipients: tïomersal, lemon acid, Sodium hydroxide (1N sodium), macrogol 400, polysorbate 80, Purified water.

10.5 ml – vials of dark glass (1) complete with dosing pipette – packs cardboard.

Pharmacological action

Combined preparation for local application in otorhinolaryngology. The therapeutic effect of the drug Polydex caused by anti-inflammatory effect of dexamethasone, and antibacterial action of antibiotics neomycin and polymyxin B. With the combination of these antibiotics extended spectrum antimicrobial effect on most gram-positive and gram-negative microorganisms, causing infectious-inflammatory diseases of the outer and middle ear.

Neomycin active against Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae.

Полимиксин B active against gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Pseudomonas aeruginosa.

By the action of these antibiotics resistant Streptococcus spp. (incl. Streptococcus pneumoniae) and anaérobnıe bakterïï.

In the absence of damage eardrum Polydex has no systemic effect.

Pharmacokinetics

Systemic absorption is absent, except in cases of perforation of the eardrum.

Testimony

- Otitis externa (in particular, infected eczema of the external auditory passage).

Dosage regimen

The drug is prescribed for 1-5 drops in each ear 2 times / day for 6-10 days.

Before using ear drops it is recommended to warm the bottle, holding it in your hand, in order to avoid unpleasant sensations, related to exposure to the cold fluid in the ear. After instillation of the drug in one ear must tilt the head in the opposite direction for several minutes, and then drip into the other ear.

Side effect

Allergic reactions: rarely – cutaneous manifestations.

Contraindications

- Infectious or traumatic injury of the tympanic membrane;

- Hypersensitivity to the drug.

Pregnancy and lactation

Adequate and well-controlled clinical studies safety of the drug Polydex during pregnancy and lactation (breast-feeding) not performed.

Cautions

Before treatment is necessary to examine the condition of the eardrum. If perforation of the tympanic membrane is unacceptable to use the drug due to the risk of toxic effects on the vestibular and hearing aids.

If an allergy to neomycin possible cross-allergy to antibiotics, aminoglycosides.

Overdose

Due to the low degree of absorption into the systemic circulation overdose is unlikely.

Drug Interactions

No clinically significant drug interactions Polydex with other drugs have been identified.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored at temperatures above 25 ° C. Shelf life – 3 year.