Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)
Bausch & Lomb Incorporated
OPHTHALMIC
PRESCRIPTION DRUG
Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for: Atropine Sulfate Ophthalmic Solution, USP 1% 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 of Atropine Sulfate Ophthalmic Solution, USP 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, USP 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Risk Summary There is no information to inform risk regarding the presence of atropine in human milk following ocular administrations of Atropine Sulfate Ophthalmic Solution, USP 1% to th
Atropine Sulfate Ophthalmic Solution, USP 1% is supplied as an aseptically prepared, sterile solution for topical ophthalmic use supplied as a 0.4 mL fill in a translucent, low-density polyethylene, single-dose vial. One (1) strip of 5 single-dose vials is packaged into a foil pouch. Storage and Handling: Store at 20°C to 25°C (68°F to 77°F). Store single-dose vials in the foil pouches. Opened vials cannot be resealed and should be discarded immediately after use.
New Drug Application
ATROPINE SULFATE- ATROPINE SULFATE SOLUTION BAUSCH & LOMB INCORPORATED ---------- 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 OPHTHALMIC USE INITIAL U.S. APPROVAL: 1960 INDICATIONS AND USAGE Atropine is an anti-muscarinic agent indicated for: • • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Ophthalmic solution: 1% atropine sulfate (10 mg/mL) (3). CONTRAINDICATIONS Hypersensitivity or allergic reaction to any ingredient in the formulation (4). WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS 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 BAUSCH & LOMB INCORPORATED AT 1-800- 553-5340 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: 3/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Photophobia and Blurred Vision Mydriasis (1.1) Cycloplegia (1.2) Penalization of the healthy eye in the treatment of amblyopia (1.3) 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). Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to Lire le document complet