ISOPTO ATROPINE Ophthalmic solution Ref.[10851] Active ingredients: Atropine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product 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:

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.

Dosage Forms and Strengths

Ophthalmic solution: 1% atropine sulfate (10mg/mL).
How Supplied

ISOPTO Atropine 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER dispensers with low-density polyethylene tips and red polypropylene caps as follows:

  • 5 mL filled in 8-mL bottles NDC 0065-0303-55
  • 15 mL filled in 15-mL bottles NDC 0065-0303-15

ALCON, A Novartis company, Fort Worth, Texas 76134 USA

Drugs

Drug Countries
ISOPTO ATROPINE Canada, Estonia, United States
 
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