- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Single Dose Ophthalmic Solutions
- Composition : Each unit (0.5ml) contains: Atropine sulphate 5 mg
- Active Substance : Atropine sulphate
As a topical mydriatic and cycloplegic.
Hypersensitivity to any component of the preparation.
Due to the risk of precipitating an acute attack, do not use in cases of confirmed narrow-angle glaucoma or where latent narrow angle glaucoma is suspected. If in doubt it is recommended that an alternative preparation is used.
Eye pain and stinging occurs upon instillation of atropine sulfate ophthalmic solution. Other commonly occurring adverse reactions include blurred vision, photophobia, superficial keratitis and decreased lacrimation. Allergic reactions such as papillary conjunctivitis, contact dermatitis, and eyelid edema may also occur less commonly.
Side effects rarely occur but include anticholinergic effects such as dry mouth and skin, flushing, increased body temperature, urinary symptoms, gastrointestinal symptoms and tachycardia.
These effects are more likely to occur in infants and children.
Interaction with other medicinal products:
The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.
Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.
Elevation in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution, 1%.
Individuals with Down syndrome, spastic paralysis, or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary, and gastrointestinal toxicity from systemic absorption of atropine.
The protracted mydriasis which is difficult to reverse, may be a disadvantage.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Pregnancy and lactation
The safety for use in pregnancy and lactation has not been established, therefore, use only when directed by a physician.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.
POSOLOGY AND METHOD OF ADMINISTRATION:
USUAL ADULT DOSAGE: One drop topically in the eye(s) up to twice daily.
Systemic reactions to topical atropine are unlikely at normal doses. Symptoms which can occur following an overdose, however, include anticholinergic effects, cardiovascular changes (tachycardia, atrial arrhythmias, and atrio-ventricular dissociation) and central nervous system effects (confusion, ataxia, restlessness, hallucination, convulsions). Treatment is supportive.
Store below 25°C. Do not freeze. Protect from light
0.5 mL single dose ampoules, polyethylene, packed in cartons to contain 10 ampoules
0.5 mL single dose ampoules, polyethylene, packed in cartons to contain 30 ampoules