Atropine Sulfate USP 0.04% (0.4mg/1mL) 10x1mL

NDC: 82260-0001-01

Atropine Sulfate Ophthalmic Solution USP 1%, 10x4mL — Bausch + Lomb

Active ingredient	Atropine sulfate 1% (10 mg/mL)
Dosage form	Ophthalmic solution, single-dose vial
Route	Topical ophthalmic
Size	0.4 mL single-dose vial, 10 vials per box
Manufacturer	Bausch + Lomb
NDC	82260-0001-01

Indications and Usage

Indicated for mydriasis, cycloplegia, and penalization of the healthy eye in the treatment of amblyopia.

Dosage and Administration

In individuals from three months of age or greater, instill one drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time. In individuals three years of age or greater, doses may be repeated up to twice daily as needed. Discard the single-dose vial immediately after use.

Warnings and Precautions

• Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks
• Risk of blood pressure elevation from systemic absorption
• To avoid eye injury or contamination, avoid touching the single-dose vial to the eye or any other surface

Contraindications

Contraindicated in anyone with previous hypersensitivity or known allergic reaction to any ingredient of the formulation.

Adverse Reactions

Most common adverse reactions include eye pain and stinging on administration, blurred vision, photophobia, superficial keratitis, decreased lacrimation, drowsiness, increased heart rate, and increased blood pressure.

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.

How Supplied

Supplied as a 0.4 mL fill in a translucent, low-density polyethylene, single-dose vial. One strip of 5 single-dose vials is packaged into a foil pouch; supplied as 10 single-dose vials (2 foil pouches).

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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