NELADEX eye/ear drops

Neladex (Eye/Ear Drops)
(Dexamethasone/Polymyxin B/Neomycin)

 

COMPOSITION
Each ml contains dexamethasone 1.0 mg, neomycin 3.5 mg, polymyxin В sulphate 6000 IU.

THERAPEUTIC INDICATIONS
- Blepharitis;
- Conjunctivitis;
- Keratitis;
- Iridocyclitis.
- Prophylaxis of postoperative inflammation of anterior eye part.
- Acute and chronic otitis externa and otitis media. Postoperative infectious complications following ear surgery.

CONTRAINDICATIONS
- Keratitis caused by Herpes simplex (dendritic keratitis);
- Viral cornea and conjunctiva (including varicella);
- Micobacterial eye infections;
- Fungal eye diseases;
- Hypersensitivity to any drug ingredients.
The drug is not prescribed in case of not complicated removal of foreign body from cornea.

ADVERSE EFFECTS
The adverse reactions caused by both dexamethasone, and antibacterial components, as well as their combination can appear at the application of the preparation. Allergic reactions: itching, eyelid swelling, reddening of conjunctiva (as a rule it is conditioned by antibacterial component). Adverse reactions due to dexamethasone:
- effects on organs of vision: intraocular pressure elevation with possible subsequent development of glaucoma; formation of back subcapsular cataract; wound healing slowing-down (perforation of fibrous tunic is possible in topical glucocorticoids application in diseases causing cornea and sclera thinning). Therefore administration of Neladex is not recommended in diseases associated with cornea epithelium defects. Secondary infection (including fungal) may appear following administration of glucocorticoids in combination with antibiotics. Secondary bacterial infection may occur as the result of inhibition of patient's human protective reaction. Glucocorticoids may mask or enhance underlying infectious process in acute purulent eye diseases. Occurrence of nonhealing ulcers on cornea following long-term steroid treatment may indicate on development of fungal invasion.

DOSAGE AND ADMINISTRATION
Eye/ear drops are instilled in 1-2 drops in conjunctival sac 4-6 times per day at mild forms of infections. At sever forms of infection the drops can be used every hour; eye drops can be used every hour; as the disease symptoms become weaken, the quantity of application can be reduced.
At exterior ear canal infections: 4 drops 3-4 times per day.
At infectious complications, connected with surgical operations on ear organs, and otitis media in 4-10 drops 3-4 times per day.

PREGNANCY AND LACTATION
The drug should be prescribed during pregnancy only if treatment efficacy justifies potential risk for fetus. It should be determined whether to cease the breast-feeding during lactation.

MANUFACTURED FORM
5 ml in plastic vial with a dropper and screwing protective cap, equipped with protective ring. 1 vial with insert in carton box.