Expiration date: 02/2025

Structure and Composition:

Eye drops. 1 ml contains:

neomycin sulphate 3500 IU

polymyxin B sulfate 6,000 IU

Dexamethasone 1 mg

Other ingredients: hydroxypropyl - 0.5%, polysorbate 20, neutral additive distilled water

preservative: benzalkonium chloride - 0.004%

in bottles of 5 ml (with a metering device «Drop Tainer ™») in the paper cartons 1 bottle.

Characteristic:

Combined preparation for local application in ophthalmology.

Pharmacokinetics:

When applied topically, systemic absorption is low.

Description of the pharmacological actions:

Neomycin - bactericidal effect, disrupting bacterial protein synthesis in the cell. It is active against Staphylococcus aureus, Corynebacterium diphtheriae, Streptococcus viridans, Escherichia coli, Klersiella pneumoniae, Proteus vulgaris, Aerobacter aerogenes, Haemophilus influenzae. Not effective against and streptococci. No effect on pathogenic fungi, viruses, anaerobic flora. Resistance to neomycin microorganisms develops slowly and to a small extent.

Polymyxin B. The mechanism of action is mainly due to the blockade of the permeability of the cytoplasmic membrane of bacterial cells. It is active against P. aeruginosa, Aerobacter aerogenes, Escherichia coli, Klersiella pneumoniae, Koch-Weeks bacillus.

Dexamethasone - GCS. Has anti-inflammatory, anti-allergic and desensitizing effect. It has antiexudativ effect. Dexamethasone is effective in suppressing inflammatory processes.

The combination of dexamethasone with antibiotics to reduce the risk of infection.

Testimony:

Eye infections and its appendages:

• blepharitis,
  
• conjunctivitis
  
• keratoconjunctivitis
  
• keratitis
  
• iridocyclitis
  
• prevention of post-operative inflammation of the anterior eye.
  

Contraindications:

• individual hypersensitivity to any component of the preparation
  
• viral diseases eyes (including keratitis caused by herpes simplex, chicken pox)
  
• mycobacterial infection of the eye
  
• tubercular diseases of the eye
  
• acute herpes zoster
  
• fungal diseases of the eye
  
• condition after the removal of corneal foreign body
  
• purulent infection of the eye and eyelid mucosa caused by resistant to neomycin microorganisms, purulent corneal ulcer.
  

With caution is prescribed for glaucoma, cataract.

Application of pregnancy and breastfeeding:

Sufficient experience of use of the drug during pregnancy and lactation is not. It can be used to treat pregnant women to destination the attending physician, if the expected therapeutic effect is greater than the risk of possible side effects. It is necessary to interrupt the use of the drug for a period of lactation.

USE IN PEDIATRICS. At present, the safety and efficacy of the drug for children have not been established.

Side effect:

Local. Allergic reaction, accompanied by itching and swelling of the eyelids, and redness of the conjunctiva. Side effects due to the steroid component: increased intraocular pressure with possible subsequent development of glaucoma, optic nerve damage and visual field (when using the drug more than 10 days must be monitoring of intraocular pressure) posterior subcapsular cataracts, slowing down the process of wound healing. Topical steroid use in diseases which cause thinning of the cornea or sclera, may result in their perforations.

consecutive infection

The development of secondary infection may occur after use of combined preparations containing steroids in combination with antibiotics. Prolonged use of steroids may develop fungal infections of the cornea. The emergence of non-healing ulcers on the cornea after long-term treatment of steroids may indicate the development of fungal infestation. Secondary bacterial infection may occur as a consequence of the suppression of the protective reaction of the patient.

Drug Interactions:

Interactions with other drugs are not currently known.

In the case of use with other topical ophthalmic drugs interval between their application should be at least 10 minutes.

Dosage and administration:

In the conjunctival sac.

In non-severe infectious process - 1-2 drops of the drug is instilled every 4-6 hours in the case of severe infection preparation process is dug every hour, decreasing inflammation phenomena decreases the frequency of instillations of the drug.. Before use, the vial should be shaken with drops.

Special instructions:

The vial must be closed after each use. Before use, shake the bottle.

MANUFACTURER

sa Alcon-Couvreur NV, B-2870 Puurs, Belgium.

Storage conditions: (Upright)

Shelf life: 4 weeks after opened.