Country: United States
Language: English
Source: NLM (National Library of Medicine)
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)
Amneal Pharmaceuticals NY LLC
OPHTHALMIC
PRESCRIPTION DRUG
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. 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, 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, 1% is administered to a nursing woman. Due to the potential for systemic absorption of atropine sulfate ophthalmic solution, the use of atropine sulfate ophthalmic solution, 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
Atropine Sulfate Ophthalmic Solution USP, 1% is supplied sterile in white opaque low density polyethylene plastic bottles and natural low density polyethylene tips with red high density polyethylene caps in the following sizes: 2 mL in 5 mL Container: NDC 60219-1748-2 5 mL in 5 mL Container: NDC 60219-1749-3 15 mL in 15 mL Container: NDC 60219-1750-8 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed.
Abbreviated New Drug Application
ATROPINE- ATROPINE SULFATE SOLUTION/ DROPS AMNEAL PHARMACEUTICALS NY LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 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. (2.1) In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. (2.2) DOSAGE FORMS AND STRENGTHS 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 AMNEAL PHARMACEUTICALS AT 1-877-835- 5472 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: 7/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia Read the complete document