Atropine Sulfate Ophthalmic Ointment

Name: Atropine Sulfate Ophthalmic Ointment

Description

 Atropine Sulfate Ophthalmic Ointment USP, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula:

(C17H23NO3)2•H2SO4•H2O                                                                     
Mol. wt. 694.84

Chemical name:

Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-(3.2.1)oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate.

Each Gram Contains:

Atropine Sulfate Ophthalmic Ointment USP, 1%, contains in each gram of ointment: ACTIVE: Atropine Sulfate USP, 1% (10mg); INACTIVES: White Petrolatum, Mineral Oil, Lanolin Oil and Purified Water.

Contraindications

This product should not be used in patients with primary glaucoma or a predisposition to narrow anterior chamber angle glaucoma.

This product should not be used in pediatric patients who have previously had a severe systemic reaction to atropine. This product should not be used in those persons showing hypersensitivity to any component of this preparation.

Warnings

In pediatric patients, use with extreme caution. Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. If this occurs, discontinue medication, and use appropriate therapy as outlined in “OVERDOSAGE” section.

Adverse reactions

Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young.

Overdosage

Systemic atropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in pediatric patients),blurred vision, a rapid and irregular pulse, fever, abdominal distension in infants, mental aberration (hallucinosis) and loss of neuromuscular coordination.


Atropine poisoning, although distressing, is rarely fatal, even with large doses of atropine, and is self-limited if the cause is recognized and the atropine medication is discontinued. In severe intoxication, physostigmine salicylate may be administered parenterally to provide more prompt relief of the intoxication. Give physostigmine salicylate as 1-5 mL IV of dilution containing 1 mg in 5 mL of saline. The smaller dose is for pediatric patients, and injection should take not less than two minutes. EKG control is advisable. Dosage can be repeated every five minutes up to a total dose of 2 mg in pediatric patients and 6 mg in adults every 30 minutes. Physostigmine is contraindicated in hypotensive reactions. Atropine (1 mg) should be available for immediate injection if physostigmine causes bradycardia, convulsions or bronchoconstriction. In pediatric patients, the body surface must be kept moist.


Use extreme caution when employing short-acting barbiturates to control excitement.

Package/label principal display panel

NDC 24208-825-55

BAUSCH + LOMB

Atropine

Sulfate

Ophthalmic

Ointment USP,

1% (Sterile)

Rx only

[icon-eye] [icon-1%] [icon-ointment] [icon-3.5gm]

Net wt. 1/8 oz

(3.5g)

ATROPINE SULFATE 
atropine sulfate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24208-825
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
MINERAL OIL  
LANOLIN OIL  
WATER  
Packaging
# Item Code Package Description
1 NDC:24208-825-55 1 TUBE in 1 CARTON
1 3.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-825)
Revised: 01/2017   Bausch & Lomb Incorporated
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