Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Ophthalmic Solution, 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows: 2 mL filled in 4-mL bottles NDC 0065-0817-02 5 mL filled in 8-mL bottles NDC 0065-0817-01 Storage: Store Atropine Sulfate Ophthalmic Solution, 1% at 2°C to 25°C (36°F to 77°F). After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle.; PRINCIPAL DISPLAY PANEL NDC 0065-0817-02 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 2 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of India 300055337-0722; PRINCIPAL DISPLAY PANEL NDC 0065-0817-02 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 2 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Germany 300053026-0722; PRINCIPAL DISPLAY PANEL Atropine Sulfate Ophthalmic Solution, 1% NDC 0065-0817-02 Rx Only STORAGE: Store at 2°C to 25°C (36°F to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA 2 mL Sterile INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing information. FOR TOPICAL OPHTHALMIC USE; PRINCIPAL DISPLAY PANEL NDC 0065-0817-01 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 5 mL Sterile Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Germany 300057551-0722; PRINCIPAL DISPLAY PANEL NDC 0065-0817-01 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 5 mL Sterile Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of India 300057552-0722; PRINCIPAL DISPLAY PANEL Atropine Sulfate Ophthalmic Solution, 1% NDC 0065-0817-01 Sterile 5 mL Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing information. FOR TOPICAL OPHTHALMIC USE STORAGE: Store at 2°C to 25°C (36°F to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA 300058444-0722
- 16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Ophthalmic Solution, 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows: 2 mL filled in 4-mL bottles NDC 0065-0817-02 5 mL filled in 8-mL bottles NDC 0065-0817-01 Storage: Store Atropine Sulfate Ophthalmic Solution, 1% at 2°C to 25°C (36°F to 77°F). After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle.
- PRINCIPAL DISPLAY PANEL NDC 0065-0817-02 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 2 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of India 300055337-0722
- PRINCIPAL DISPLAY PANEL NDC 0065-0817-02 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 2 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Germany 300053026-0722
- PRINCIPAL DISPLAY PANEL Atropine Sulfate Ophthalmic Solution, 1% NDC 0065-0817-02 Rx Only STORAGE: Store at 2°C to 25°C (36°F to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA 2 mL Sterile INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing information. FOR TOPICAL OPHTHALMIC USE
- PRINCIPAL DISPLAY PANEL NDC 0065-0817-01 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 5 mL Sterile Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of Germany 300057551-0722
- PRINCIPAL DISPLAY PANEL NDC 0065-0817-01 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 5 mL Sterile Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F). Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Alcon ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Product of India 300057552-0722
- PRINCIPAL DISPLAY PANEL Atropine Sulfate Ophthalmic Solution, 1% NDC 0065-0817-01 Sterile 5 mL Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing information. FOR TOPICAL OPHTHALMIC USE STORAGE: Store at 2°C to 25°C (36°F to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA 300058444-0722
Overview
Atropine Sulfate Ophthalmic Solution, 1% is a sterile topical ophthalmic solution. Each mL of Atropine Sulfate Ophthalmic Solution, 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(+)-, sulfate(2:1) (salt), monohydrate. Its molecular formula is (C17H23NO3)2 • H2SO4 • H2O and it is represented by the chemical structure: Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83. Atropine Sulfate Ophthalmic Solution, 1% has a pH of 3.5 to 6.0. Active ingredient: atropine sulfate monohydrate 1% Preservative: benzalkonium chloride 0.01% Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
Indications & 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
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 ( 2.1 ) In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. ( 2.2 )
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 ) Increased adverse drug reaction susceptibility with certain central nervous system conditions ( 5.3 ) 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%. 5.3 Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions Individuals with Down syndrome, spastic paralysis, or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary, and gastrointestinal toxicity from systemic absorption of atropine.
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 )
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 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.
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.
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