ATROPINE SULFATE ointment

Summary of Product characteristics

                                ATROPINE SULFATE- ATROPINE SULFATE OINTMENT
BAUSCH & LOMB INCORPORATED
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ATROPINE SULFATE
OPHTHALMIC OINTMENT, 1% (STERILE)
RX ONLY
DESCRIPTION:
Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical
anticholinergic for ophthalmic use. The
active ingredient is represented by the chemical structural formula:
(C
H NO ) •H SO •H 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.
CHEMICAL PHARMACOLOGY
The anticholinergic effect of this product blocks the responses of the
sphincter muscle of the iris and
the accommodative muscle of the ciliary body to cholinergic
stimulation, producing pupillary dilation
17
23
3 2
2
4
2
(mydriasis) and paralysis of accommodation (cycloplegia).
INDICATIONS AND USAGE
For mydriasis and/or cycloplegia. For cycloplegic refraction, for
pupillary dilation desired in
inflammatory conditions of the iris and uveal tract.
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.
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.
PRECAUTIONS
To avoid excessive
                                
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