NDC 0065-0817 Atropine Sulfate
Solution Ophthalmic

Product Information

What is NDC 0065-0817?

The NDC code 0065-0817 is assigned by the FDA to the product Atropine Sulfate which is a human prescription drug product labeled by Alcon Laboratories, Inc.. The product's dosage form is solution and is administered via ophthalmic form. The product is distributed in 2 packages with assigned NDC codes 0065-0817-01 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper, 0065-0817-02 1 bottle, dropper in 1 carton / 2 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0065-0817
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Atropine Sulfate
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Atropine Sulfate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Ophthalmic - Administration to the external eye.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Alcon Laboratories, Inc.
Labeler Code0065
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA208151
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-01-2022
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Atropine Sulfate?


Product Packages

NDC Code 0065-0817-01

Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

NDC Code 0065-0817-02

Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER

Product Details

What are Atropine Sulfate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ATROPINE SULFATE 10 mg/mL - An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE. Hyoscyamine is the 3(S)-endo isomer of atropine.

Atropine Sulfate Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Atropine Sulfate Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Atropine Sulfate Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



1 Indications And Usage



Atropine Sulfate Ophthalmic Solution, 1% is indicated for:


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.


5.1 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 [seeWarningsandPrecautions(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.


7.1 Monoamine Oxidase Inhibitors



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


8.1 Pregnancy



Risk Summary
There are no adequate and self-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.


8.3 Lactation



There is no information to inform risk regarding the presence of atropine in human milk folowing 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, 1% is a sterile topical ophthalmic solution. Each mL of Atropine Sulfate Ophthalmic, 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 benzene acetic 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 Sulfate, 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.


12.1 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.


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 Section



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:

  • 5 mL filed in 8-mL bottles                  NDC 0065-0817-01 
  • 15 mL filed in 15-mL bottles              NDC 0065-0817-03
  • Storage: Store Atropine Sulfate Ophthalmic Solution,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
    Fort Worth, Texas 76134 USA
    © 2021 Alcon Inc.


Principal Display Panel



NDC 0065-0817-01

Alcon

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.

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

300051225-1121

PRINCIPAL DISPLAY PANEL

NDC 0065-0817-01


Alcon

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.

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

300052619-1121


* Please review the disclaimer below.