Atropine Sulfate
Generic: ATROPINE SULFATE MONOHYDRATE
Basic Information
Manufacturer
Somerset Therapeutics, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
bfdb85b2-86d0-4f32-a8fa-272af48a191c
Indications & Usage
1 INDICATIONS AND USAGE Atropine sulfate ophthalmic solution 1% is indicated for: Atropine sulfate ophthalmic solution 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
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 Somerset Therapeutics, LLC at 1-800-417-9175 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 adverse reactions include blurred vision, photophobia, superficial keratitis and decreased lacrimation.
Allergic reactions such as papillary conjunctivitis, contact dermatitis, and eyelid 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; drowsiness; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck.
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 Somerset Therapeutics, LLC at 1-800-417-9175 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 adverse reactions include blurred vision, photophobia, superficial keratitis and decreased lacrimation.
Allergic reactions such as papillary conjunctivitis, contact dermatitis, and eyelid 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; drowsiness; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck.