ATROPINE SULFATE solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Atropine Sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I)

Disponível em:

Alcon Laboratories, Inc.

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Atropine Sulfate Ophthalmic Solution, 1% is indicated for: Atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. Risk Summary There are no adequate and well-controlled studies with Atropine Sulfate Ophthalmic Solution, 1% administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see  Clinical  Pharmacology  (12.3)] . Atropine Sulfate Ophthalmic Solution, 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of Atropine Sulfate Ophthalmic Solution, 1% to the mother. The effects on breas

Resumo do produto:

Atropine Sulfate Ophthalmic Solution, 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows: Storage: Store Atropine Sulfate Ophthalmic Solution, 1% at 2°C to 25°C (36°F to 77°F).  After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle.

Status de autorização:

New Drug Application

Características técnicas

ATROPINE SULFATE- ATROPINE SULFATE SOLUTION
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ATROPINE SULFATE - ATROPINE SULFATE SOLUTION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATROPINE SULFATE
OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ATROPINE SULFATE OPHTHALMIC SOLUTION.
ATROPINE SULFATE OPHTHALMIC SOLUTION, 1%, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL 1960
INDICATIONS AND USAGE
Atropine Sulfate Ophthalmic Solution, 1% is a muscarinic antagonist
indicated for:
Mydriasis (1.1)
Cycloplegia (1.2)
Penalization of the healthy eye in the treatment of amblyopia (1.3)
DOSAGE AND ADMINISTRATION
In individuals from three (3) months of age or greater 1 drop
topically to the cul-de-sac of the
conjunctiva, forty minutes prior to the intended maximal dilation time
(2.1)
In individuals 3 years of age or greater, doses may be repeated up to
twice daily as needed. (2.2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution: 1% atropine sulfate (10mg/mL) (3)
CONTRAINDICATIONS
Hypersensitivity or allergic reaction to any ingredient in the
formulation (4)
WARNINGS AND PRECAUTIONS
Photophobia and blurred vision due to pupil unresponsiveness and
cycloplegia may last up to 2 weeks.
(5.1)
Risk of blood pressure increase from systemic absorption (5.2)
Increased adverse drug reaction susceptibility with certain central
nervous system conditions (5.3)
ADVERSE REACTIONS
The most common adverse reactions that have been reported are eye pain
and stinging on
administration, blurred vision, photophobia, superficial keratitis,
decreased lacrimation, drowsiness,
increased heart rate and blood pressure. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALCON LABORATORIES,
INC., AT 1-800-757-
9195 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
The use of atropine and monoamine oxidase inhibitors (MAOI) is
generally not recommended because of
the potential to precipitate hypertensive crisis. (7)
SEE 17 FOR PATIENT COUNSELING INFORMATIO