ATROPINE- atropine sulfate solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MWI

INN (International Name):

Atropine Sulfate

Composition:

Atropine Sulfate 10 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Atropine Sulfate Ophthalmic Solution, USP 1% is supplied in a plastic dropper bottle with a red cap in the following size: Storage: Store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Authorization status:

New Drug Application

Summary of Product characteristics

ATROPINE- ATROPINE SULFATE SOLUTION/ DROPS
MWI
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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 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: 4/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
1.1 Cycloplegia
1.2 Mydriasis
1.3 Penalization of the healthy e