ISOPTO ATROPINE- atropine sulfate solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Alcon Laboratories, Inc.

INN (Tên quốc tế):

Atropine Sulfate

Thành phần:

Atropine Sulfate 10 mg in 1 mL

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

ISOPTO® Atropine 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 ISOPTO® Atropine 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)] . ISOPTO® Atropine 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 ISOPTO® Atropine 1% to the mother. The effects on breastfed infants and the effects on milk production are also unknown.  The developmental a

Tóm tắt sản phẩm:

ISOPTO® Atropine 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 ISOPTO® Atropine 1% at 2–25°C (36–77°F).

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

ISOPTO ATROPINE- ATROPINE SULFATE SOLUTION
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ISOPTO® ATROPINE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ISOPTO®
ATROPINE
ISOPTO® ATROPINE (ATROPINE SULFATE OPHTHALMIC SOLUTION) 1%, FOR
TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
ISOPTO® Atropine 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 INFORMATION.
REVISED: 10/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.