ATROPINE SULFATE- atropine sulfate monohydrate solution/ drops

Atropine Sulfate by

Drug Labeling and Warnings

Atropine Sulfate by is a Prescription medication manufactured, distributed, or labeled by Somerset Therapeutics, LLC, Somerset Therapeutics Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Atropine sulfate ophthalmic solution 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, USP (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:

    • 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.

    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 atropine sulfate ophthalmic solution 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)]. Atropine sulfate ophthalmic solution 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 atropine sulfate ophthalmic solution 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 atropine sulfate ophthalmic solution 1% and any potential adverse effects on the breastfed child from atropine sulfate ophthalmic solution 1%.

    8.4 Pediatric Use

    Due to the potential for systemic absorption of atropine sulfate ophthalmic solution the use of atropine sulfate ophthalmic solution 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

    Atropine sulfate ophthalmic solution, USP 1% is a sterile topical ophthalmic solution. Each mL of atropine sulfate ophthalmic solution, USP 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:

    Image

    Atropine sulfate monohydrate is colorless, almost white to white solid and has a molecular weight of 694.83.

    Atropine sulfate ophthalmic solution, USP 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), water for injection.

  • 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 atropine sulfate ophthalmic solution 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 atropine sulfate ophthalmic solution 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

    Atropine sulfate ophthalmic solution, USP 1% is supplied sterile in natural LDPE bottle with natural LDPE nozzle and red HDPE cap as follows:

    • 5 mL filled in 10 mL bottles         NDC 70069-716 -01

    Storage: Store atropine sulfate ophthalmic solution, USP 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.
  • SPL UNCLASSIFIED

    Manufactured for:

    Somerset Therapeutics, LLC

    Somerset, NJ 08873

    Customer Care # 1-800-417-9175

    Made in India

    Code No.: KR/DRUGS/KTK/28/289/97

    1200814

    ST-ATP/P/00

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Container Label

    NDC: 70069-716-01

    ATROPINE SULFATE OPHTHALMIC SOLUTION 1%

    Sterile

    FOR TOPICAL OPHTHALMIC USE

    Rx only

    5 mL

    Image

    Carton Label

    NDC: 70069-716-01

    ATROPINE SULFATE OPHTHALMIC SOLUTION 1%

    Sterile

    FOR TOPICAL OPHTHALMIC USE

    Rx only

    5 mL

    Image
  • INGREDIENTS AND APPEARANCE
    ATROPINE SULFATE 
    atropine sulfate monohydrate solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70069-716
    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)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70069-716-011 in 1 CARTON05/24/2024
    15 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21779105/24/2024
    Labeler - Somerset Therapeutics, LLC (079947873)
    Registrant - Somerset Therapeutics, LLC (079947873)
    Establishment
    NameAddressID/FEIBusiness Operations
    Somerset Therapeutics Limited677236695ANALYSIS(70069-716) , LABEL(70069-716) , PACK(70069-716) , MANUFACTURE(70069-716)
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