Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Atropine Sulfate Ophthalmic Ointment, 1% is supplied in an ophthalmic tip applicator tube in the following size: 3.5 g tubes - NDC 24208-825-55 Image 1; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-825-55 Atropine Sulfate Ophthalmic Ointment, 1% (Sterile) FOR OPHTALMIC USE ONLY Rx only Net. Wt. 1/8 oz. (3.5g) BAUSCH + LOMB carton
- HOW SUPPLIED Atropine Sulfate Ophthalmic Ointment, 1% is supplied in an ophthalmic tip applicator tube in the following size: 3.5 g tubes - NDC 24208-825-55 Image 1
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-825-55 Atropine Sulfate Ophthalmic Ointment, 1% (Sterile) FOR OPHTALMIC USE ONLY Rx only Net. Wt. 1/8 oz. (3.5g) BAUSCH + LOMB carton
Overview
Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula: (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •H 2 O Mol. Wt. 694.83 Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo -(±)-, sulfate (2:1) (salt), monohydrate. Each gram contains: ACTIVE: Atropine Sulfate, 1% (10 mg); INACTIVES: Lanolin oil, mineral oil, purified water, and white petrolatum. chem_structure.jpg
Indications & Usage
For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.
Dosage & Administration
Apply a small amount of ointment to the conjunctival sac once or twice a day, or as directed by a physician. FOR OPHTHALMIC USE ONLY
Warnings & Precautions
WARNINGS In pediatric patients, use with extreme caution. Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. If this occurs, discontinue medication and use appropriate therapy as outlined in OVERDOSAGE .
Contraindications
This product should not be used in patients with primary glaucoma or a predisposition to narrow anterior chamber angle glaucoma. This product should not be used in pediatric patients who have previously had a severe systemic reaction to atropine. This product should not be used in those persons showing hypersensitivity to any component of this preparation.
Adverse Reactions
Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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