NELADEX EYE AND EAR DROPS
- International Name: NELADEX
- Pharmacological group: Antimicrobial preparation with glucocorticosteroids.
- Manufacturer: Vold Medicine Ilach San Ve
- Country: Turkey
- Issuance form: Group III over-the-counter
Drug form
eye/ear drops
Description: Odorless, white microdisperse suspension.
Composition
Eye/ear drops
1 ml of the drug contains:
active substances: dexamethasone 1.0 mg
neomycin (in sulfate form) 3.5 mg
polymyxin B sulfate 6000 IU
auxiliary substances: hydroxypropylmethylcellulose, benzalkonium chloride, disodium edetate, sodium chloride, sodium hydroxide or hydrochloric acid, polysorbate 80, Water for injection.
Pharmacotherapeutic group
Dexamethasone in combination with antimicrobial drugs.
Pharmacological properties
. Combined drug with antimicrobial and anti-inflammatory action.
Dexamethasone is a glucocorticoid. Does not have mineralocorticoid activity. It has pronounced anti-inflammatory, anti-allergic and desensitizing action. Actively inhibits inflammatory processes by releasing inflammatory mediators from eosinophils, inhibiting the migration of mediators released from cellular cells and reducing capillary permeability.
Neomycin is a broad-spectrum antibiotic from the group of aminoglycosides. It has a bactericidal effect by disrupting protein synthesis in the microbial cell. It is active against gram-positive and gram-negative microorganisms, including Staphylococcus aureus, Streptococcus pneuoniae, Escherichia coli, Proteus spp., Shigella spp..
Less active against Pseudomonas aeruginosa and streptococci.
It is not active against pathogenic fungi, viruses, anaerobic flora. Resistance of microorganisms to neomycin develops slowly and to a lesser extent.
Polymyxin B – an antibiotic of polypeptide structure. The mechanism of action is due to the destruction of phossolipids present in the cell membrane of the microbe. Active against gram-negative microorganisms, including Escherichia coli, Shigella spp., Enterobacter spp., Klebsiella spp., Haemophilus influenzae, Salmonella spp., Bordetella pertussis. Highly active against Pseudomonas aeruginosa. Inactive against Proteus spp., Neisseria spp., obligate anaerobes and gram-positive bacteria.
Vibrio cholerae (except elto), as well as Coccidioides immitis, are sensitive to polymyxin B, although the fungi are mostly resistant to these antibiotics.
Indications for use
acute and chronic bacterial eye diseases:
- blepharitis;
- conjunctivitis;
- keratitis;
- iridocyclitis;
Prevention of postoperative inflammatory processes of the anterior segment of the eye.
acute and chronic otitis externa and otitis media; Infectious complications caused by surgical interventions on the hearing organ.
Contraindications
Neladex is contraindicated for:
- keratitis caused by Herpes simplex (dendritic keratitis);
- viral diseases of the cornea and conjunctiva (including chicken pox)
- mycobacterial eye infections;
- fungal eye diseases;
- Hypersensitivity to the components of the drug;
The drug is not prescribed after uncomplicated removal of a foreign body from the cornea.
Side effects
Neladex eye/ear drops can cause allergic reactions related to both dexamethasone and antibacterial components, as well as their combination.
Allergic reactions: itching, swelling of eyelids, redness of conjunctivitis (due to the action of antibiotics).
Method of use and dosage
Eye/ear drops for mild infections instill 1-2 drops into the conjunctival sac 4-6 times a day. In case of complex forms, eye drops can be used every hour. In case of weakening of the symptoms, we may reduce the frequency of administration.
For external ear infections, 4 drops 3-4 times a day;
4-10 drops 3-4 times a day for inflammation of the middle ear, infectious complications caused by surgical interventions on the ear and infectious otitis.
Overdose
There are no data on the drug Neladex overdose.
Interaction with other medicinal products
The interaction of the drug Neladex with other medicinal products has not been established.
Features of administration
The drug is intended for local use only.
When using preparations containing glucocorticosteroids for more than 10 days, regular tonometry of intraocular pressure is necessary;
It is not recommended to wear contact lenses during the treatment period.
The patient should avoid touching the dropper head to any surface to avoid microbial contamination of the contents of the vial.
The vial containing Neladex eye/ear drops should be opened before use.
Use during pregnancy and lactation:
the drug can be used in pregnant women under the prescription of the attending physician if the expected therapeutic effect exceeds the risk of developing side effects.
During lactation, the issue of stopping breastfeeding should be decided.
Release form
Neladex eye/ear drops are supplied in a 5 ml plastic dropper bottle with a screw cap.
1 dropper vial with a leaflet is placed in a cardboard box.
Storage conditions
Neladex eye/ear drops are stored at a temperature of 15-25ºC, out of the reach of children.
After opening the vial, the drug is used within one month.
Shelf life
2 years from the date of manufacture.
The drug is not used after the expiration date.
Conditions of release: Out of prescription.