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Therapeutic Category
- OPHTHALMOLOGICAL DRUGS
- ANTI-INFLAMMATORY AGENTS
- ANTI-INFECTIVE AGENTS
- Pharmaceutical Form : Eye Drops
- Composition : Dexamethasone (Sod.) Phos.1 mg+ Neomycin ( as Sulfate ) 3.5 mg / 1ml
- Active Substance : (Dexamethasone (Sod.) Phos +Neomycin ( as Sulfate
PROPERTIES :
DEXAMED -N are ophthalmic solution for antimicrobial drug neomycin sulfate and corticosteroid dexamethasone sodium phosphate neomycin sulfate is active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae
INDICATIONS AND USAGE :
* For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection a risk of bacterial ocular infection exists
* Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
*The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
* The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species , Neisseria species .
*The product does not provide adequate coverage against: Pseudomonas aeruginosa, Serratia marcescens , Streptococci, including Streptococcus pneumoniae
CONTRAINDICATIONS
*in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), and also in mycobacterial infection of the eye
*fungal diseases of ocular structures
*in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, including sulfites, and to other corticosteroids (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)
PRECAUTIONS
*Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation, If this product is used for 10 days or longer, intraocular pressure should be routinely monitored
*Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections
*In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
*In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
*Corticosteroids should be used with caution in the presence of ocular hypertension and/or glaucoma
*The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs
*Neomycin sulfate may occasionally cause cutaneous sensitization. If any reaction indicating such sensitivity is observed, discontinue use.
*The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate
*If redness, irritation, swelling or pain persists or becomes aggravated, the patient should be advised to consult a physician
*One of the preservatives in Ophthalmic Solution DEXAMED-N, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling Ophthalmic Solution DEXAMED-N before they insert their lenses
*There are no adequate and well-controlled studies in pregnant women. Ophthalmic Solution DEXAMED-N should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
*It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk . Systemically-administered corticosteroids appear in human milk and could suppress growth, discontinue the drug, taking into account the importance of the drug to the mother. *Safety and effectiveness in pediatric patients have not been established
ADVERSE REACTIONS:
*Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
*Secondary Infection:The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobial. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid
DOSAGE AND ADMINISTRATION
The duration of treatment will vary with the type of lesion and may extend from a few days to several weeks, according to therapeutic response. Instill one or two drops of Ophthalmic Solution DEXAMED-N into the conjunctival sac every two hours as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms
PACKING : 5-10 ml Ophthalmic Solution .