ATROPINE SULFATE

Main information

  • Trade name:
  • ATROPINE SULFATE- atropine sulfate ointment
  • Composition:
  • ATROPINE SULFATE 10 mg in 1 g
  • Administration route:
  • OPHTHALMIC
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ATROPINE SULFATE- atropine sulfate ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract. 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.
  • Product summary:
  • Atropine Sulfate Ophthalmic Ointment, 1% is supplied in an ophthalmic tip applicator tube in the following size: 3.5 g tubes – NDC 24208-825-55

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • unapproved drug other
  • Authorization number:
  • 24208-825-55
  • Last update:
  • 26-05-2019

Summary of Product characteristics: dosage, interactions, side effects

ATROPINE SULFATE- atropine sulfate ointment

Bausch & Lomb Incorporated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Atropine Sulfate

Ophthalmic Ointment, 1% (Sterile)

Rx only

DESCRIPTION:

Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical anticholinergic for ophthalmic use. The

active ingredient is represented by the chemical structural formula:

H NO ) H SO H O

Mol. Wt. 694.83

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:

ACTIVE: Atropine Sulfate, 1% (10 mg); INACTIVES: Lanolin oil, mineral oil, purified water, and

white petrolatum.

CHEMICAL PHARMACOLOGY

The anticholinergic effect of this product blocks the responses of the sphincter muscle of the iris and

the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation

(mydriasis) and paralysis of accommodation (cycloplegia).

INDICATIONS AND USAGE

For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in

inflammatory conditions of the iris and uveal tract.

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.

PRECAUTIONS

To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for

two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the

depth of the angle of the anterior chamber should be made. Administration of atropine in infants requires

great caution.

Patient Warning:

Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated.

Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation.

Parents should be warned not to get this preparation in their children’s mouth and to wash their own

hands and the child’s hands following administration.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No studies have been conducted in animals or in humans to evaluate the potential of these effects.

Animal reproduction studies have not been performed with atropine. It is also not known whether

atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction

capacity. Atropine should be given to pregnant women only if clearly needed.

Pediatric Use:

See CONTRAINDICATIONS and WARNINGS.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant

Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

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 2 minutes. EKG control

is advisable. Dosage can be repeated every 5 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.

DOSAGE AND ADMINISTRATION

Apply a small amount of ointment to the conjunctival sac once or twice a day, or as directed by a

physician.

FOR OPHTHALMIC USE ONLY

HOW SUPPLIED

Atropine Sulfate Ophthalmic Ointment, 1% is supplied in an ophthalmic tip applicator tube in the

following size:

3.5 g tubes – NDC 24208-825-55

STORAGE:

Store between 15°-25°C (59°-77°F).

KEEP OUT OF REACH OF CHILDREN

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

Rev. 06/2017

9115202 (Folded)

9115302 (Flat)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-825-55

Atropine

Sulfate

Ophthalmic

Ointment, 1%

(Sterile)

FOR OPHTALMIC USE ONLY

Rx only

Net. Wt. 1/8 oz. (3.5g)

BAUSCH + LOMB

Bausch & Lomb Incorporated

ATROPINE SULFATE

atropine sulfate ointment

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:2420 8 -8 25

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ATRO PINE SULFATE (UNII: 0 3J5ZE7KA5) (ATROPINE - UNII:7C0 6 9 7DR9 I)

ATROPINE SULFATE

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

LANO LIN O IL (UNII: OVV5IIJ58 F)

MINERAL O IL (UNII: T5L8 T28 FGP)

WATER (UNII: 0 59 QF0 KO0 R)

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2420 8 -8 25-55

1 in 1 CARTON

0 9 /30 /19 9 0

1

3.5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Unappro ved drug o ther

0 9 /30 /19 9 0

Labeler -

Bausch & Lomb Incorporated (196603781)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bausch & Lo mb Inco rpo rated

0 79 58 76 25

MANUFACTURE(2420 8 -8 25) , LABEL(2420 8 -8 25) , PACK(2420 8 -8 25)

Revised: 6/2017