NDC 0065-0303 Isopto Atropine

Atropine Sulfate

NDC Product Code 0065-0303

NDC 0065-0303-15

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC 0065-0303-55

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

NDC Product Information

Isopto Atropine with NDC 0065-0303 is a a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Isopto Atropine is atropine sulfate. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug 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.

Isopto Atropine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ATROPINE SULFATE 10 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • BORIC ACID (UNII: R57ZHV85D4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)

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.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA208151 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 12-09-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Atropine Ophthalmic

Atropine Ophthalmic is pronounced as (a' troe peen)

Why is atropine ophthalmic medication prescribed?
Ophthalmic atropine is used before eye examinations to dilate (open) the pupil, the black part of the eye through which you see. It is also used to relieve pain caused by...
[Read More]

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Isopto Atropine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

ISOPTO® Atropine 1% is indicated for:

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 [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.

7.1 Monoamine Oxidase Inhibitors

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

8.1 Pregnancy

Risk SummaryThere 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: 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.

12.1 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.

13.1 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 0065-0303-5515 mL filled in 15-mL bottles         NDC 0065-0303-15Storage: 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®ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA© 2016 Novartis

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