Atropine Sulfate

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

In individuals from three (3) months of age or greater, 1 drop topically to the cul-de-sac of the conjunctiva in one or both eyes as indicated, 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.

Discard the single-dose vial immediately after use in one or both eyes.

Atropine Sulfate Ophthalmic Solution, USP 1%: each mL contains 10 mg of atropine sulfate.

Atropine Sulfate Ophthalmic Solution, USP 1% 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.

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.

In the event of accidental ingestion or toxic overdosage with Atropine Sulfate Ophthalmic Solution, USP 1%, 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.

Atropine Sulfate Ophthalmic Solution, USP 1% is an aseptically prepared, sterile solution for topical ophthalmic use. The product does not contain an antimicrobial preservative. The active ingredient is represented by the chemical structure:

Chemical Name:           Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate.

Molecular Formula:     (C ₁₇H ₂₃NO ₃) ₂• H ₂SO ₄• H ₂O

Molecular Weight:        694.84 g/mol

Each mL of Atropine Sulfate Ophthalmic Solution, USP 1% contains: Active:atropine sulfate 10 mg equivalent to 8.3 mg of atropine.

Inactives:boric acid, hydroxypropyl methylcellulose, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.

Topical administration of Atropine Sulfate Ophthalmic Solution, USP 1% results in mydriasis and/or cycloplegia with efficacy demonstrated in both adults and children. The maximum effect for mydriasis is achieved in about 30–40 minutes after administration, with recovery after approximately 7–10 days. The maximum effect for cycloplegia is achieved within 60–180 minutes after administration, with recovery after approximately 7–12 days.

Atropine Sulfate Ophthalmic Solution, USP 1% is supplied as an aseptically prepared, sterile solution for topical ophthalmic use supplied as a 0.4 mL fill in a translucent, low-density polyethylene, single-dose vial. One (1) strip of 5 single-dose vials is packaged into a foil pouch.

NDC  82260-001-01  10 single-dose vials. 2 foil pouches each containing one strip of 5 single-dose vials.

Storage and Handling:

Store at 20°C to 25°C (68°F to 77°F).

Store single-dose vials in the foil pouches. Opened vials cannot be resealed and should be discarded immediately after use.

• Advise patients that drops will sting upon instillation that they may experience blurry vision and sensitivity to light and should protect their eyes in bright illumination during dilation. These effects may last up to a couple weeks.
• Advise patients to keep the single-dose vials in the foil pouches until ready to use. The solution from one single-dose vial is to be used immediately after opening to dose one or both eye(s) of a single patient. The single-dose vial, including any remaining contents, should be discarded immediately after administration [see Dosage and Administration (2)] .
• Advise patients not to touch the tip of the single-dose vial to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA

© 2022 Bausch & Lomb Incorporated or its affiliates

9775600

NDC82260-001-01 

Atropine Sulfate
Ophthalmic
Solution, USP
1%

Sterile

FOR TOPICAL OPHTHALMIC USE
NOT FOR INJECTION

EYE IMAGE

Rx only

10 x 0.4 mL
Single-Dose Vials

BAUSCH + LOMB

9769201