ATROPINE SULFATE ointment

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)

Disponível em:

AvPAK

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract. 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.

Resumo do produto:

Atropine Sulfate Ophthalmic Ointment, 1% is supplied in an ophthalmic tip applicator tube in the following size: 3.5 g tubes - NDC 50268-118-35

Status de autorização:

unapproved drug other

Características técnicas

ATROPINE SULFATE- ATROPINE SULFATE OINTMENT
AVPAK
_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:
17
23
3
2
2
4
2
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 (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 systemic absorptio