ATROPINE SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)

Available from:

Bausch & Lomb Americas Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. NDC  82260-001-01  10 single-dose vials. 2 foil pouches each containing one strip of 5 single-dose vials. 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.

Authorization status:

New Drug Application

Summary of Product characteristics

ATROPINE SULFATE- ATROPINE SULFATE SOLUTION
BAUSCH & LOMB AMERICAS INC.
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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:
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•
•
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
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•
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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*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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 2 weeks
(5.1).
Risk of blood pressur