ISOPTO ATROPINE (ATROPINE SULFATE) SOLUTION [ALCON LABORATORIES, INC.]

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ISOPTO ATROPINE (ATROPINE SULFATE) SOLUTION [ALCON LABORATORIES, INC.]
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NDC 0065-0303-15, 0065-0303-55
Set ID 20491566-e6eb-8d4a-3083-77ea429f7bc4
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class Anticholinergic
Product Number
Application Number NDA208151
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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ISOPTO® ATROPINE safely and effectively. See full prescribing information for ISOPTO® ATROPINE

    ISOPTO® ATROPINE (atropine sulfate ophthalmic solution) 1%, for topical  ophthalmic use
    Initial U.S. Approval: 1960

    INDICATIONS AND USAGE

    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)

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

    DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution: 1% atropine sulfate (10mg/mL) (3)

    CONTRAINDICATIONS

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

    WARNINGS AND 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)

    ADVERSE REACTIONS

    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.

    DRUG INTERACTIONS

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

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 12/2016

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    1.1 Mydriasis

    1.2 Cycloplegia

    1.3 Penalization of the healthy eye in the treatment of amblyopia

    2 DOSAGE AND ADMINISTRATION

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    5 WARNINGS AND PRECAUTIONS

    5.1 Photophobia and Blurred Vision

    5.2 Elevation of Blood Pressure

    5.3 Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions

    6 ADVERSE REACTIONS

    6.1 Ocular Adverse Reactions

    6.2 Systemic Adverse Reactions

    7 DRUG INTERACTIONS

    7.1 Monoamine Oxidase Inhibitors

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.2 Lactation

    8.4 Pediatric Use

    8.5 Geriatric Use

    10 OVERDOSAGE

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    12.2 Pharmacodynamics

    12.3 Pharmacokinetics

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    14 CLINICAL STUDIES

    16 HOW SUPPLIED/STORAGE AND HANDLING

    17 PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE

    ISOPTO® Atropine 1% is indicated for:

    1.1 Mydriasis

    1.2 Cycloplegia

    1.3 Penalization of the healthy eye in the treatment of amblyopia

  • 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.

  • 3 DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution: 1% atropine sulfate (10mg/mL)

  • 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.

  • 5 WARNINGS AND PRECAUTIONS

    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.

  • 6 ADVERSE REACTIONS

    The following adverse reactions are described below and elsewhere in the labeling:

    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.

    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.

  • 7 DRUG INTERACTIONS

    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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary
    There are no adequate and well-controlled studies with ISOPTO® Atropine 1% administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see Clinical Pharmacology (12.3)]. ISOPTO® Atropine 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

    8.2 Lactation

    There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of ISOPTO® Atropine 1% to the mother. The effects on breastfed infants and the effects on milk production are also unknown.  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ISOPTO® Atropine 1% and any potential adverse effects on the breastfed child from ISOPTO® Atropine 1%.

    8.4 Pediatric Use

    Due to the potential for systemic absorption of atropine sulfate ophthalmic solution the use of ISOPTO® Atropine 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day.  Safety and efficacy in children above the age of 3 months has been established in adequate and well controlled trials.

    8.5 Geriatric Use

    No overall differences in safety or effectiveness have been observed between elderly and adult patients.

  • 10 OVERDOSAGE

    In the event of accidental ingestion or toxic overdosage with atropine sulfate ophthalmic solution supportive care may include a short acting barbiturate or diazepam as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended.

    Physostigmine, given by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required.

    Artificial respiration with oxygen may be necessary. Cooling measures may be needed to help to reduce fever, especially in pediatric populations.

    The fatal pediatric and adult doses of atropine are not known.

  • 11 DESCRIPTION

    ISOPTO® Atropine 1% is  a sterile topical ophthalmic solution. Each mL of ISOPTO® Atropine 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:

    Chemical Structure

    Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83.

    ISOPTO® Atropine 1% has a pH of 3.5 to 6.0.
    Active ingredient: atropine sulfate monohydrate 1.0%
    Preservative: benzalkonium chloride 0.01%

    Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Atropine acts as a competitive antagonist of the parasympathetic (and sympathetic) acetylcholine muscarinic receptors. Topical atropine on the eye induces mydriasis by inhibiting contraction of the circular pupillary sphincter muscle normally stimulated by acetylcholine. This inhibition allows the countering radial pupillary dilator muscle to contract which results in dilation of the pupil. Additionally, atropine induces cycloplegia by paralysis of the ciliary muscle which controls accommodation while viewing objects.

    12.2 Pharmacodynamics

    The onset of action after administration of ISOPTO Atropine 1% generally occurs in minutes with maximal effect seen in hours and the effect can last multiple days [see Clinical Studies (14)].

    12.3 Pharmacokinetics

    In a study of healthy subjects, after topical ocular administration of 30 µL of atropine sulfate ophthalmic solution, 1%, the mean (± SD) systemic bioavailability of l-hyoscyamine was reported  to be approximately 64 ± 29% (range 19% to 95%) as compared to intravenous administration of atropine sulfate.   The mean (± SD) time to maximum plasma concentration (Tmax) was approximately 28 ± 27 minutes (range 3 to 60 minutes),  and the mean (±SD) peak plasma concentration (Cmax) of l-hyoscyamine was 288 ± 73 pg/mL. The mean (±SD) plasma  half-life was reported  to be approximately 2.5 ± 0.8 hours.

    In a separate study of patients undergoing ocular surgery, after topical ocular administration of 40 µL of atropine sulfate ophthalmic solution, 1%,  the mean (± SD) plasma Cmax of l‑hyoscyamine was 860 ± 402 pg/mL.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Atropine sulfate was negative in the Salmonella/microsome mutagenicity test. Studies to evaluate carcinogenicity and impairment of fertility have not been conducted.

  • 14 CLINICAL STUDIES

    Topical administration of ISOPTO® Atropine 1% results in mydriasis and/or cycloplegia, with efficacy demonstrated in both adults and children. The maximum effect for mydriasis is achieved in about 30–40 minutes after administration, with recovery after approximately 7–10 days. The maximum effect for cycloplegia is achieved within 60–180 minutes after administration, with recovery after approximately 7–12 days.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    ISOPTO® Atropine 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows:

    • 5 mL filled in 8-mL bottles             NDC 0065-0303-55
    • 15 mL filled in 15-mL bottles         NDC 0065-0303-15

    Storage: Store ISOPTO® Atropine 1% at 2–25°C (36–77°F).

  • 17 PATIENT COUNSELING INFORMATION

    • Advise patients not to drive or engage in other hazardous activities while pupils are dilated.
    • Advise patient that they may experience blurry vision and sensitivity to light and should protect their eyes in bright illumination during dilation. These effects may last up to a couple weeks.
    • Advise patients that they may experience drowsiness.
    • Advise patients not to touch the dispenser tip to any surface, as this may contaminate the solution.

    ALCON®
    A Novartis company
    Fort Worth, Texas 76134 USA
    © 2016, 2018 Novartis

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 0065-0303-55

    Alcon®

    Isopto® Atropine
    (atropine sulfate ophthalmic solution) 1%

    5 mL Sterile
    USUAL ADULT DOSAGE: One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert.

    PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

    STORAGE: Store at 2°-25°C (36°-77°F). Read enclosed insert.

    Rx Only

    INGREDIENTS: Each mL     contains: Active: atropine sulfate monohydrate 1.0%.

    Preservative:     benzalkonium chloride 0.01%.

    Inactives:     hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

    © 2003, 2018 Novartis

    Alcon®
    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    Product of Germany

    9016388-0618

    SN:
    LOT:
    EXP.:
    GTIN: 00300650303552

    5 mL Carton

    NDC 0065-0303-55

    Alcon®

    Isopto® Atropine
    (atropine sulfate ophthalmic solution) 1%
    Sterile 5mL

    Rx Only

    INGREDIENTS: Each mL contains:
    Active: atropine sulfate monohydrate 1.0%.

    Preservative: benzalkonium chloride 0.01%.

    Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

    PRECAUTION:     Do not touch dropper tip to any surface, as this may contaminate the solution.

    USUAL ADULT DOSAGE:     One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert. FOR TOPICAL OPHTHALMIC USE.

    STORAGE:     Store at 2°-25°C (36°-77°F).

    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    ©2018 Novartis

    H15250-0318

    5 mL Label

    NDC 0065-0303-15

    Alcon®

    Isopto® Atropine
    (atropine sulfate ophthalmic solution) 1.0%

    15 mL Sterile

    Rx Only

    INGREDIENTS: Each mL     contains: Active: atropine sulfate monohydrate 1.0%.

    Preservative:     benzalkonium chloride 0.01%.

    Inactives:     hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

    USUAL ADULT DOSAGE: One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert.

    PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

    STORAGE: Store at 2°-25°C (36°-77°F).

    Read enclosed insert.

    Alcon®
    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    Product of Germany
    © 2000, 2018 Novartis

    9016389-0618

    LOT:      EXP.:

    15 mL Carton

    NDC 0065-0303-15

    Alcon®

    Isopto® Atropine
    (atropine sulfate ophthalmic solution) 1%
    Sterile 15 mL
    Rx Only

    INGREDIENTS: Each mL contains:
    Active: atropine sulfate monohydrate 1.0%.

    Preservative: benzalkonium chloride 0.01%.

    Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

    PRECAUTION:     Do not touch dropper tip to any surface, as this may contaminate the solution.

    USUAL ADULT DOSAGE:     One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert.

    FOR TOPICAL OPHTHALMIC USE.

    STORAGE:     Store at 2°-25°C (36°-77°F).

    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    © 2006, 2016, 2018 Novartis

    H15251-0318

    15 mL Label
  • INGREDIENTS AND APPEARANCE
    ISOPTO ATROPINE 
    atropine sulfate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0303
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Atropine Sulfate (UNII: 03J5ZE7KA5) (Atropine - UNII:7C0697DR9I) Atropine Sulfate10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Boric Acid (UNII: R57ZHV85D4)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0303-151 in 1 CARTON12/09/2016
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-0303-551 in 1 CARTON12/09/2016
    25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20815112/09/2016
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boehringer Ingelheim Pharma GmbH & Co. KG551147440API MANUFACTURE(0065-0303) , ANALYSIS(0065-0303)
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