国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Atropine Sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I)
Akorn
OPHTHALMIC
PRESCRIPTION DRUG
Atropine Sulfate Ophthalmic Solution, USP 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. Pregnancy Category C: There are no adequate and well-controlled studies of atropine sulfate in pregnant women. Animal development and reproduction studies have not been conducted with atropine sulfate. Since it is not known whether topically administered atropine sulfate can cause fetal harm, atropine sulfate ophthalmic solution, USP 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Traces of atropine have been found in human milk following administration of atropine solution for injection. Because some systemic absorption occurs from topical administration, caution should be exercised when Atropine Sulfate Ophthalmic Solution, USP 1% is administered to a nursing woman. Due to the potential fo
Atropine Sulfate Ophthalmic Solution, USP 1% is supplied in a plastic dropper bottle with a red cap in the following sizes: Storage: Store at 20° to 25°C (68° to 77°F). Keep tightly closed.
New Drug Application Authorized Generic
ATROPINE- ATROPINE SULFATE SOLUTION/ DROPS AKORN ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% FOR TOPICAL APPLICATION TO THE EYE. INITIAL U.S. APPROVAL: 1960 INDICATIONS AND USAGE Atropine is an anti-muscarinic agent indicated for: Cycloplegia (1.1) Mydriasis (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) In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. (2) DOSAGE FORMS AND STRENGTHS 1% ophthalmic solution (3) CONTRAINDICATIONS Hypersensitivity or allergic reaction to any ingredient in formulation. (4.1) 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) ADVERSE REACTIONS Most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, decreased lacrimation, increased heart rate and blood pressure. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT, AKORN OPERATING COMPANY LLC AT 1- 800-932-5676 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) USE IN SPECIFIC POPULATIONS Should only be used in pregnant women if clearly needed. (8) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 5/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1. INDICATIONS AND USAGE 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the healthy 阅读完整的文件