| ARISTOBET – N
Eye,
Ear & Nasal Drops
Presentation:
Aristobet-N Sterile Eye Drops
contain Betamethasone sodium phosphate 0.1% w/v and neomycin
sulphate 0.5% w/v in a clear and colourless aqueous solution.
Uses:
Betamethasone has
topical corticosteroid activity. The presence of Neomycin should
prevent the development of bacterial infection.
Eye: Non-infected inflammatory
conditions (eg. uveitis, marginal keratitis, allergic conjunctivitis,
blepharitis and episcleritis) where development of bacterial
infection is likely.
Ear: Otitis externa and
other inflammatory conditions where bacterial infection is present
or suspected.
Nose: Inflammatory conditions
where infection is present or suspected.
Dosage & Administration:
Eye: 1 or 2 drops instilled
into the eye every one or two hours until control is achieved,
when the frequency may be reduced.
Ear: 2 or 3 drops instilled
into the ear, every two or three hours until control is achieved,
when the frequency can be reduced.
Nose: 2 or 3 drops instilled
into each nostril two or three times daily.
Contra-indications:
Viral, fungal, tuberculous or purulent conditions.
Use in the eye is contra-indicated if glaucoma is present or
where herpetic keratitis (e.g. dendritic ulcer) is considered
a possibility. Inadvertent use of topical steroids in the latter
condition can lead to extension of the ulcer and marked visual
deterioration.
Hypersensitivity to the preparation:
Preparations containing
neomycin should not be used for treating otitis externa when
the ear drum is perforated, because of the risk of ototoxicity.
Precautions:
Steroids should
not be administered to “red eyes” until a definitive diagnosis
has been made. Ophthalmological treatment with steroid preparations
should not be repeated or prolonged without regular review to
exclude raised intra-ocular pressure or unsuspected infections.
The unnecessary topical use of neomycin containing products
should be avoided in order to minimize the occurrence of neomycin-resistant
organisms (and organism cross-resistant to other aminoglycosides).
Topical administration of corticosteroids to pregnant animals
can cause abnormalities of foetal development. The relevance
of this finding to human beings has not been established; however,
topical steroids should not be used extensively in pregnancy,
i.e. in large amounts or for prolonged periods.
Side-effects:
Acute
sensitization to neomycin is a rare event but can occur after
topical application to the eye. Eye drops containing corticosteroids
cause a serious rise in intra-ocular pressure in a small percentage
of the population, including most of those with a family history
of glaucoma. A milder rise may be experienced by a larger proportion
of subjects if treatment is continued for longer than a few
weeks. Thinning of the cornea leading to perforation has occurred
with use of topical corticosteroids. Cataract is reported to
have occurred after unduly prolonged treatment of eye conditions
with topical corticosteroids.
Overdosage:
Excessive and prolonged intra-nasal usage above the recommended
dose may induce systemic steroid side-effects.
Pharmaceutical precautions:
-
Store
below 30º C, protect from light.
-
It
is desirable that the contents should not be used more than
four weeks after
first opening of the bottle. Slight colouration does not
affect the efficacy of the product.
-
To be dispensed only by or on the prescription
of a registered physician.
Self-Life:
If the pack is
unopened, Aristobet-N
Eye drops can be used until the expiry date indicated with “EXP”
on the pack.
Package quantities:
Plastic dropper bottles containing 5 ml.
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