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

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

1. Indications and Usage

ISOPTO Atropine 1% is indicated for:

  • Mydriasis
  • Cycloplegia
  • Penalization of the healthy eye in the treatment of amblyopia

2. 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.

In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed.

10. Overdosage

In the event of accidental ingestion or toxic overdosage with atropine sulfate ophthalmic solution supportive care may include a short acting barbiturate or diazepam as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended.

Physostigmine, given by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required.

Artificial respiration with oxygen may be necessary. Cooling measures may be needed to help to reduce fever, especially in pediatric populations.

The fatal pediatric and adult doses of atropine are not known.

16.2. Storage and Handling

Store ISOPTO Atropine 1% at 2–25°C (36–77°F).

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