Dexatrol

Dexatrol

dexamethasone + neomycin + polymyxin b

Manufacturer:

EIPICO

Distributor:

Averroes Pharma
Full Prescribing Info
Contents
Dexamethasone, neomycin sulphate, polymyxin B-sulphate.
Description
Each ml contains Dexamethasone 1.0 mg Neomycin sulphate equivalent to Neomycin 3.5 mg and Polymycin B-sulphate 6000 IU.
Action
Pharmacology: Pharmacodynamics: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing.
Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The anti-infective component in the combination is included to provide action against specific organism susceptible to it.
Neomycin sulfate is considered active against the following microorganisms: Staphylococcus aureus, Corynebacterium diphtheriae, Streptococcus viridans, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Aerobacter aerogenes, and Haemophilus influenza.
Polymyxin B Sulfate is considered active against the following microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Koch-Weeks bacillus.
Pharmacokinetics: When a decision to administer both a corticoid and an antimicrobial is made the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when types of drugs are in the same formulation and, particularly, that the correct volume of the drug is delivered and retained.
The relative potency of corticosteroids depends on the molecule structure, concentration and release from the vehicle.
Indications/Uses
Dexatrol Eye Drops indicated for local treatment for steroid-responsive inflammatory ocular conditions for which a corticosteroids is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Dosage/Direction for Use
For topical ophthalmic use only.
One or two drops in the conjunctival sac(s).
In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides.
In mild disease, drops may be used up to four to six times daily.
Overdosage
Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of up to 10 ml is unlikely to lead to any serious adverse effects.
Contraindications
Dexatrol Eye Drops must not be used in patients with: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and may other viral diseases of the cornea and conjunctiva.
Mycobacterial infection of the eye.
Fungal diseases of ocular structures.
Hypersensitivity to a component of the medication.
Warnings
Not for injection.
Do not touch dropper tip to any surface, as this may contaminate the contents. Prolonged use may result in galucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
Prolonged use may suppress the host response and thus increase the hazard of formation. In those diseases causing thinning of the cornea or sclera, perforation 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. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing.
This preparation contains sodium metabisulphite that may cause serious allergic type reactions in certain susceptible patients.
Do not use if known to be hypersensitive to bisulphites.
Use In Pregnancy & Lactation
There are no adequate or well- controlled studies in pregnant woman.
DEXATROL Eye Drops should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observe 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.
Because many drugs are excreted in human milk, caution should be exercised when DEXATROL Eye Drops is administered to a nursing woman.
Adverse Reactions
Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroids component, or the combination.
Reactions occurring most ofter from the presence of the anti-infective ingredient are allergic sensitizations.
The reactions due to the corticosteroid component 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 antimicrobials.
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroids.
The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.
Secondary bacterial ocular infection following suppression of host responses also occurs.
Drug Interactions
No relevant information on topical use.
Storage
Store at controlled room temperature below 30°C. Protect from light. Store at room temperature below 25° after opening.
Shelf-Life: 24 months from the date of manufacture if kept as recommended. This product can be use for 28 days after first opening if kept as recommended.
ATC Classification
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Presentation/Packing
Eye drops 5 mL (white suspension in flexible plastic dropper bottle) x 1's.
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