APRODEX
Sterile Eye
& Ear Drops
Description:
Aprodex is a combination of Ciprofloxacin,
a synthetic fluoroquinolone antimicrobial and Dexamethasone,
a potent corticosteroid. The combination effectively resolves
inflammation and infection in severe eye or ear conditions.
Composition:
Each ml contains
Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin
3 mg and Dexamethasone Sodium Phosphate USP equivalent to
Dexamethasone Phosphate 1mg.
Indications:
Eye: Aprodex is indicated
for the treatment of steroid responsive inflammatory ocular
conditions where bacterial infections or risk of bacterial
infections co-exist. The use of a combination drug with an
anti-infective component is indicated where the risk of infection
is high or where is an expectation that potentially dangerous
numbers of bacteria will be present in the eye. The combination
can also be used for post-operative inflammation and any other
ocular inflammation associated with infection.
Ear: Aprodex is also indicated
in the treatment of ear infections accompanied by inflammation
such as otitis exterma, acute and chronic otitis media etc.
The combination may also be used post-operatively in the ear.
Dosage and Administration:
One or two drops
to be instilled into conjunctival sac(s) every four to six
hours. During the initial 24 to 48 hours, the dosage may be
increased to one to two drops every two hours.
Frequency should
be decreased gradually or warranted in clinical signs. Care
should be taken not to discontinue therapy prematurely.
Contraindications:
Known hypersensitivity to
any ingredient of the product. Herpes simplex and other viral
conditions, mycosis, glaucoma, newborn babies, fungal diseases
of ocular or auricular structures.
Side effects:
The most frequently
reported drug-related adverse reactions seen with Ciprofloxacin
are transient ocular burning or discomfort. Other reported
reactions include stinging, redness, itching, conjunctivitis/keratitis,
periocular/facial edema, foreign body sensation, photophobia,
blurred vision, tearing, dryness, and eye pain. Rare reports
of dizziness have been received.
The reactions
due to the steroid component are elevation of intraocular
pressure (IOP) with possible development of glaucoma, and
infrequent optic nerve damage, posterior sub capsular cataract
formation, and delayed wound healing.
Precautions and warning:
·
Prolonged use may result in overgrowth of nonsusceptible organisms
including fungi; in ocular hypertension and/or glaucoma, with
damage to the optic nerve, defects in visual acuity and fields
of vision and posterior sub capsular cataract formation.
·
Patients wearing contact lenses must not use the drops during
the time the lenses are worn.
Paediatric:
Safety &
effectiveness for the use of this eye drops in children below
the age of one year have not been established.
Pregnancy:
Aprodex should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Nursing Mother:
It is not known whether topical administration
of corticosteroids would result in sufficient systemic absorption
to produce detectable quantities in human milk. It is also
not known whether Ciprofloxacin is excreted in human milk
following topical ophthalmic administration. Because many
drugs are excreted in human milk, caution should be exercised
when the combination is administered to a nursing woman.
Moreover, because
of the potential of serious adverse reactions from Ciprofloxacin
in nursing infants, a decision should be made whether to discontinue
nursing or to discontinue the drug taking into account the
importance of the drug to the mother.
Storage condition
·
Store at room temperature (150-250C).
·
Protect from light.
·
Keep out of the reach of children.
Package
quantity:
Plastic dropper bottle containing 5ml eye
drops.
