May 25, 2017
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Isopto Atropine

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Isopto Atropine Sterile Topical Ophthalmic Solution

ISOPTO® ATROPINE
(atropine sulfate) Sterile Topical Ophthalmic Solution 1%

DRUG DESCRIPTION

ISOPTO® Atropine 1% is a sterile topical ophthalmic solution. Each mL of ISOPTO® Atropine 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(±)-, sulfate(2:1) (salt), monohydrate. Its molecular formula is (C17H23NO3)2 • H2SO4 • H2O and it is represented by the chemical structure:

ISOPTO® ATROPINE (atropine sulfate) Structural Formula Illustration

Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83.

ISOPTO® Atropine 1% has a pH of 3.5 to 6.0.
Active ingredient: atropine sulfate monohydrate 1.0%
Preservative: benzalkonium chloride 0.01%

Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

Last reviewed on RxList: 12/15/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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