DEEXA-N (Neomycin sulphate and Dexamethasone sodium phosphate)
Neomycin sulphate and Dexamethasone sodium phosphate ophthalmic solution has a dual effect; suppression of inflammation symptoms by the corticosteroidal component dexamethasone and anti-infective effect due to the presence of neomycin.
Dexamethasone is a synthetic glucorticoid with potent anti-inflammatory activity. Neomycin is an aminoglycoside antibiotic that primary exerts its effect on bacterial cells by inhibiting polypeptide assembly and synthesis on the ribosomes.
Dexamethasone, like other corticosteroids, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. Intraocular penetration of dexamethasone occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.
Neomycin is poorly absorbed from the gastrointestinal tract and after topical administration an insufficient amount is absorbed to produce systemic affects. Absorption has been reported to occur from wounds and inflamed skin. After absorption neomycin is rapidly excreted by the kidneys in active form.
Neomycin sulphate & dexamethasone sodium phosphate ophthalmic solution is indicated for the short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, the excluding the presence of fungal and vial disease.
- Hypersensitivity to the active substance or to any of the excipients.
- Herpes simplex keratitis
- Viral infection of the cornea or conjunctiva
- Fungal disease of ocular structures and mycobacterial ocular infection
Special precautions and warning
For ocular use only. Not for ingestion or injection
As with all antibacterial preparation prolonged use may lead to over-growth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
Sensitivity to topical applied aminoglycosides may occur in some patients. Cross-sensitivity to other aminoglycosides may also occur. If signs of serious reactions or hypersensitivity occur, discontinue the use of this product.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin.
Prolonged use of ophthalmic corticosteroids may result in ocular hypertension and/ or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects and posterior sub capsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently.
Pregnancy: there are no or limited amount of data from the use of Neomycin sulphate & Dexamethasone sodium phosphate ophthalmic solution in pregnant women. Neomycin sulphate & dexamethasone sodium phosphate ophthalmic solution should be used only if the potential benefit justifies the potential risk to the fetus.
Lactation: it is unknown whether topical ophthalmic dexamethasone or neomycin are excreted in human milk. Because systemic corticosteroids and aminoglycosides may be distributed into milk, it should not be used during breast-feeding unless the potential benefit overweight the risk to the fetus.
Dosage and directions for use:
Apply one or two drops to each affected eye up to six times daily or more frequently if required.
Neomycin and dexamethasone ophthalmic solution is usually given in to affected ear three or four times each day. Your doctor will tell you how often to give the drops to your child.
Three times a day: give the one drop once in the morning, once in the early afternoon and once in the evening. Ideally these times are atleast 6 hours apart, for example 8 am, 2 pm and 8 pm
Four times a day: this should be first thing in the morning, at about midday, late in the afternoon and at bedtime. Ideally, these times should be atleast 4 hours apart, for example 8 am, midday, 4 pm and 8 pm.
Adverse reactions have occurred with corticosteroids/ anti-infective drugs which can be attributed to the corticosteroid component, the anti-infective component or the combination. Exact incidence figures are not available since no denominator of treated patients is available.
Reactions occurring most often from the presence of anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage; posterior sub capsular cataract formation and delayed wound healing.
Corticosteroid-containing preparations have also been reported to cause perforation of the globe, keratitis, and conjunctivitis, corneal