Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Atropine sulfate ophthalmic solution, USP 1% is supplied in a white bottle, plugged with nozzle and capped with red screw cap in the following sizes: NDC 70069-581-01 2 mL fill in a 5 mL capacity bottle NDC 70069-582-01 5 mL fill in a 5 mL capacity bottle NDC 70069-583-01 15 mL fill in a 15 mL capacity bottle Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep tightly closed.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container label – 2 mL Carton label – 2 mL Container label – 5 mL Carton label – 5 mL Container label – 15 mL Carton label – 15 mL Image Image Image Image Image Image
- 16 HOW SUPPLIED/STORAGE AND HANDLING Atropine sulfate ophthalmic solution, USP 1% is supplied in a white bottle, plugged with nozzle and capped with red screw cap in the following sizes: NDC 70069-581-01 2 mL fill in a 5 mL capacity bottle NDC 70069-582-01 5 mL fill in a 5 mL capacity bottle NDC 70069-583-01 15 mL fill in a 15 mL capacity bottle Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep tightly closed.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container label – 2 mL Carton label – 2 mL Container label – 5 mL Carton label – 5 mL Container label – 15 mL Carton label – 15 mL Image Image Image Image Image Image
Overview
Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. 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 17 H 23 NO 3 ) 2 • H 2 SO 4 • H 2 O Molecular Weight: 694.83 g/mol Each mL Contains: Active: Atropine sulfate, 10 mg (1%) equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate heptahydrate, edetate disodium dihydrate, hypromellose (2910), monobasic sodium phosphate monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP. Image
Indications & Usage
Atropine sulfate ophthalmic solution, 1% is indicated for: Atropine is an anti-muscarinic agent indicated for: Cycloplegia (1.1) Mydriasis (1.2) Penalization of the healthy eye in the treatment of amblyopia (1.3) 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the healthy eye in the treatment of amblyopia
Dosage & Administration
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. 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) In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. (2)
Warnings & Precautions
Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks. (5.1) Risk of blood pressure increase from systemic absorption (5.2) 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 Elevation in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution, 1%.
Contraindications
Hypersensitivity or allergic reaction to any ingredient in formulation (4.1) 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.
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. Most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, decreased lacrimation, increased heart rate and blood pressure (6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or the 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 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.
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 (MAOI) The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.