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OCULERGE EYE DROPS
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
OCULERGE EYE DROPS
COMPOSITION:
Each 1 ml contains: )
Antazoline
HCl 0,5 mg
Tetrahydrozoline
HCl 0,4 mg
Preservatives:
Benzalkonium chloride 0,01% m/v
PHARMACOLOGICAL CLASSIFICATION:
A - 15.4 : Ophthalmic preparations, other
PHARMACOLOGICAL ACTION:
Antazoline a synthetic antihistamine is combined with tetrahydrozoline, a vasoconstrictor. Tetrahydrozoline causes
conjunctival decongestion.
INDICATIONS:
Hay-fever conjunctivitis
Allergic conjunctivitis
CONTRA-INDICATIONS:
Patients who experience hypersensitivity to any of the ingredients. Patients receiving monoamine oxidase inhibitors, or
within 14 days of its termination.
Closed-angle glaucoma.
Safety in pregnancy and lactation has not been established.
Not recommended for children under 6 years of age.
WARNINGS:
For external use only.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium
with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be
excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period
in patients with extensive ocular surface disease.
DOSAGE AND DIRECTIONS FOR USE:
1 drop, 3 or 4 times daily, or more, into the lower eyelid.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Transient irritation may occur.
Systemic reactions may occur.
Hypersensitivity reactions, nausea and headache have been reported. Drowsiness may be experienced by some patients.
OCULERGE EYE DROPS should be used with caution in the presence of hypertension, cardiac irregularities,
hyperglycaemia (diabetes mellitus) or hyperthyroid
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