Isopto Atropine 10 mg/mL

atropine sulfate · SOLUTION · Alcon Laboratories, Inc.

1 Recall on RecordCurrently in Shortage

Plain English

Isopto Atropine is a solution containing atropine sulfate at 10 mg/mL, taken ophthalmic. Manufactured by Alcon Laboratories, Inc..

Key Facts

Brand Name: Isopto Atropine
Generic Name: atropine sulfate
NDC Code (Product): 0065-0303
Manufacturer: Alcon Laboratories, Inc.
Strength: 10 mg/mL
Dosage Form: SOLUTION
Route: OPHTHALMIC
Marketing Status
Application #: NDA208151
Marketing Start: 08/01/2018

Recall History

1 Recall on Record

Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ISOPTO ® Atropine 1% is indicated for: ISOPTO® Atropine 1% is a muscarinic antagonist indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 ) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the healthy eye in the treatment of amblyopia

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 2.1 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. 2.2 In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. 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 ( 2.1 ) In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. ( 2.2 )

Contraindications

4 CONTRAINDICATIONS 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. Hypersensitivity or allergic reaction to any ingredient in the formulation ( 4 )

Drug Interactions

7 DRUG INTERACTIONS The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis. ( 7 ) 7.1 Monoamine Oxidase Inhibitors The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.

Adverse Reactions

6 ADVERSE REACTIONS The following 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) ] Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions [see Warnings and Precautions (5.3) ] 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. The most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, superficial keratitis, decreased lacrimation, drowsiness, increased heart rate and blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Ocular Adverse Reactions Eye pain and stinging occurs upon instillation of atropine sulfate ophthalmic solution. Other commonly occurring …

Frequently Asked Questions

What is Isopto Atropine used for?

Isopto Atropine contains atropine sulfate. It is a solution taken ophthalmic. Consult your doctor for specific uses.

Is Isopto Atropine a controlled substance?

Isopto Atropine is not classified as a controlled substance by the DEA.

What is the generic name for Isopto Atropine?

The generic name for Isopto Atropine is atropine sulfate. There are 12 other brand versions of atropine sulfate.

What is the NDC code for Isopto Atropine 10 mg/mL?

The NDC (National Drug Code) for Isopto Atropine 10 mg/mL is 0065-0303, listed by Alcon Laboratories, Inc..

Product NDC

0065-0303

Other Atropine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)