SONEXA-C
Sterile
Eye Drops
Composition:
Chloramphenicol
BP 5 mg
Dexamethasone
Sodium Phosphate
BP 1 mg
Actions:
Chloramphenicol
is a bacteriostatic antibiotic with a broad spectrum of action
against both Gram-positive and Gram-negative bacteria as well
as some other organisms.
Dexamethasone
is glucocorticoid. It has an anti-inflammatory and anti-allergic
action. It is used topically in the treatment of inflammatory
conditions of the anterior segment of the eye.
Indications:
For steroid-responsive
inflammatory ocular condition for which a corticosteriod is
indicated and where bacterial infection or a risk of bacterial
ocular infection exists. For 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 conjunctivitis is accepted to obtain a diminution
in oedema and inflammation. For chronic anterior uveitis and
corneal injury from chemical, radiation or thermal burns,
or penetration of foreign bodies.
Dosage & administration:
1 or 2 drops
is instilled into the affected eyes every 3 or 4 hours, or
more frequently if deemed advisable by the prescribing physician.
Administration should be continued day and night for the first
48 hours, after which the interval between applications may
be increased. Treatment should be continued for at least 48
hours after the eye appears normal.
Contraindications:
It is contraindicated
in fungal, viral, tuberculous and other infections of the
eye and in glaucoma. It is also contraindicated in patients
hypersensitive to any component of this product. The use of
anti-infective and steroid is always contraindicated after
uncomplicated removal of a corneal foreign body.
Adverse Reactions:
Blood dyscrasias
have been reported in association with the local use of chloramphenicol.
Allergic sensitization may occur with the local use of chloramphenicol.
Elevation of intraocular pressure with possible development
of glaucoma, and infrequent optic nerve damage, posterior
subcapsular cataract formation, and delayed wound healing
may occur with the use of steroids. Secondary infection has
occurred after use of combinations containing steroids and
antimicrobials. Fungal infections of the cornea are particularly
prone to develop with the long term applications of steroids.
Secondary bacterial ocular infection following suppression
of host responses also occur.
Precautions:
Prolonged use of steroids containing product may result in
posterior subcapsular cataract formation and glaucoma with
optic nerve damage. Intraocular pressure monitoring needed.
It delays wound healing. The prolonged use of antibiotics
may occasionally result in over growth of non-susceptible
organisms, including fungi. If new infections appear during
treatment, the drug should be discontinued and appropriate
measures should be taken. In all serious infections topical
use of chloramphenicol should be supplemented by appropriate
systemic medication. Chloramphenicol should be reserved for
use only in infections for which it is specifically indicated.
Bone marrow hypoplasia, including aplastic anaemia has been
reported following topical use of chloramphenicol. The product
should not be used during pregnancy and lactation.
Storage condition
Store below 300C
and protect from light.
Pharmaceutical Precautions:
Keep all medicines
out of reach of the children.
Should be dispensed
only on the prescription of a registered physician.
Additional Information:
Close the bottle
immediately after use. Do not use more than one month after
first opening. If
the pack is unopened, Sonexa-C
Eye Drops can be used until the expiry date indicated with
“EXP” on the pack.
Packing:
Sonexa-C Sterile Eye Drops are
supplied in plastic dropper 5 ml bottle.
