Atropine Sulfate Ophthalmic Solution, USP

 

 

 

AK-Fluor

Important Safety Information

1. INDICATIONS AND USAGE

Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:

1.1 Cycloplegia
1.2 Mydriasis
1.3 Penalization of the healthy eye in the treatment of amblyopia.

4. CONTRAINDICATIONS
4.1 Hypersensitivity to any Component of this Medication

Atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur.

5. WARNINGS AND PRECAUTIONS
5.1 Photophobia and Blurred Vision

Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.

5.2 Elevation of Blood Pressure

Elevations in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution, USP 1%.

6. ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in the labeling:

  • Photophobia and Blurred Vision [See Warnings and Precautions (5.1)]
  • Elevation in Blood Pressure [See Warnings and Precautions (5.2)]

The following adverse reactions have been identified following use of atropine sulfate ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

6.1 Ocular Adverse Reactions

Eye pain and stinging occurs upon instillation of atropine sulfate ophthalmic solution. Other commonly occurring adverse reactions include, blurred vision, photophobia, superficial keratitis and decreased lacrimation. Allergic reactions such as papillary conjunctivitis, contact dermatitis, and lid edema may also occur less commonly.

6.2 Systemic Adverse Reactions

Systemic effects of atropine are related to its anti-muscarinic activity. Systemic adverse events reported include dryness of skin, mouth, and throat from decreased secretions from mucus membranes; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck.

7. DRUG INTERACTIONS
7.1 Monoamine oxidase inhibitors (MAOI)

The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.

 8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy

Pregnancy Category C:

There are no adequate and well-controlled studies of atropine sulfate in pregnant women. Animal development and reproduction studies have not been conducted with atropine sulfate. Since it is not known whether topically administered atropine sulfate can cause fetal harm, atropine sulfate ophthalmic solution, USP 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

Traces of atropine have been found in human milk following administration of atropine solution for injection. Because some systemic absorption occurs from topical administration, caution should be exercised when Atropine Sulfate Ophthalmic Solution, USP 1% is administered to a nursing woman.

8.4 Pediatric Use

Due to the potential for systemic absorption of atropine sulfate ophthalmic solution, the use of atropine sulfate ophthalmic solution, USP 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day.

8.5 Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

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 adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal.

17. PATIENT COUNSELING INFORMATION

Advise patients not to touch the dropper tip to any surface as this may contaminate the solution.

Advise patients that drops will sting upon instillation and advise patients that they will experience sensitivity to light and blurred vision which may last for a couple of weeks.