Composition
Atropine Sulphate IP 1% w/v
Chlorbutol (as preservative) IP 0.5% w/v
Aqueous Base q.s.
Dosage Form
Ophthalmic Solution (Eye Drops)
Category
Mydriatic & Cycloplegic
Description
Atropine sulfate ophthalmic solution, 1% is an anticholinergic prepared as a sterile topical ophthalmic solution. This anti cholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).
Indications
For mydriasis and/or cycloplegia. For cycloplegic refraction, for papillary dilation desired in inflammatory conditions of the iris and uveal tract.
Dosage
Uveitis- one or two drops topically to the eye(s) up to four times daily.
Mydriasis-One or two drops topically to the eye(s) 2-3 times.
Contraindications
Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g., narrow anterior chamber angle, and in those persons showing hypersensitivity to any component of this preparation.
Precautions
Pregnanacy Category C
Animal reproduction studies have not been performed with atropine. It is also not known whether atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Atropine should be given to pregnant women only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when atropine is administered to a nursing woman.
Adverse Effects
The most frequently reported adverse reactions have been burning, stinging, ocular irritation, and conjunctival hyperemia. Blood dyscrasias, allergic or inflammatory reactions due to individual hypersensitivity, angioneurotic edema, urticaria, vesicular and macula papular dermatitis have also been reported
Storage
Store in a cool dark place, protect from light.
Presentation
Atrosun is available in 5ml plastic bottle.