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Isopto Atropine atropine sulfate 10 mg/mL Solution — NDC 00065-0303-55 package photo

Isopto Atropine atropine sulfate 10 mg/mL Solution

by Alcon Laboratories, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (0065-0303-55) / 5 mL in 1 BOTTLE, DROPPER
NDC 00065-0303-55
🏷️ FDA NDC (as labeled) 0065-0303-55 billing pads the labeler segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Atropine Sulfate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0795-2026
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0235-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1035-2022
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0065-0303-55
Product NDC 0065-0303
11-digit billing NDC 00065030355
NCPDP billing unit ML — per mL (volume)
RxCUI 1190655, 1190664
UNII 03J5ZE7KA5
Application # NDA208151
SPL Set ID 20491566-e6eb-8d4a-3083-77ea429f7bc4
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2018-08-01
Route OPHTHALMIC
Dosage form SOLUTION
Substance ATROPINE SULFATE
GPI-14 86350010102010
GPI class Isopto Atropine
GCN Seq No 007866
GCN 32952
HICL code 002004
Ingredient (HICL) Atropine Sulfate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6J
Therapeutic class — specific (HIC3) Mydriatics
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name ISOPTO ATROPINE 1% EYE DROP
FDB brand name Isopto Atropine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT2 · RLD · RS
Why two NDCs? The FDA registers this code as 0065-0303-55 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00065-0303-55. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES INC
FDA applicationNDA208151 (NDA)
Labeler code00065
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio55 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ISOPTO ATROPINE 1% EYE DROP Ingredient Atropine Sulfate
📗 Our plain-language guide HelloPharmacist
  • Atropine works by blocking a nerve signal that, when overactive, can cause a dangerously slow heart rate, flooding secretions, or — in poisoning — life-threatening over-stimulation...
  • Why am I being given atropine — what does it actually do?
  • It's very common to notice a dry mouth, blurred vision, light sensitivity, a faster heartbeat, flushing, or difficulty urinating — those are expected effects of how atropine works...
  • What side effects should I expect, and which ones mean I need to call for help?
📖 Read our full Atropine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $9.701 $48.51 / 5 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Apr 2021 Feb 2022 Apr 2022 Aug 2022 $9.718 $9.221
▲ Up 5% over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atropine 10 mg/mL 60219-1750-08 Amneal 1 bottle $3.916 AT1 Availability likely save 60%
Atropine sulfate 10 mg/mL 70069-0583-01 Somerset 1 bottle $3.916 AT1 Availability likely save 60%
Atropine Sulfate 10 mg/mL 70756-0653-35 Lifestar 1 bottle $3.916 AT1 Availability likely save 60%
Atropine 10 mg/mL 60219-1749-03 Amneal 1 bottle $5.540 AT1 Availability likely save 43%
Atropine sulfate 10 mg/mL 70069-0582-01 Somerset 1 bottle $5.540 AT1 Availability likely save 43%
Atropine Sulfate 10 mg/mL 70756-0652-25 Lifestar 1 bottle $5.540 AT1 Availability likely save 43%
Isopto Atropine 10 mg/mLthis 00065-0303-55 Alcon 1 bottle $9.701 AT2 Discontinued —
atropine sulfate 10 mg/mL 00065-0817-01 Alcon 1 bottle $11.605 AT2 Availability likely +20%
Atropine Sulfate 10 mg/mL 70069-0716-01 Somerset 1 bottle $11.605 AT2 Availability likely +20%
Atropine sulfate 10 mg/mL 42799-0826-01 Edenbridge 1 bottle $12.878 AT1 Availability likely +33%
Atropine 10 mg/mL 60219-1748-02 Amneal 1 bottle $12.878 AT1 Availability likely +33%
Atropine 10 mg/mL 60505-6226-00 Apotex 1 bottle $12.878 AT1 Availability likely +33%
Atropine sulfate 10 mg/mL 70069-0581-01 Somerset 1 bottle $12.878 AT1 Availability likely +33%
Atropine Sulfate 10 mg/mL 70756-0651-25 Lifestar 1 bottle $12.878 AT1 Availability likely +33%
Atropine Sulfate 10 mg/mL 72603-0264-01 NorthStar 1 bottle $12.878 AT1 Availability likely +33%
Atropine Sulfate 10 mg/mL 24208-0965-01 Bausch 10 vials — — FDA listed —
Atropine 10 mg/mL 50090-7000-00 A-S 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 50090-7313-00 A-S 1 bottle — AT1 FDA listed —
Atropine Sulfate 10 mg/mL 67296-2124-05 Redpharm 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 67296-2200-05 Redpharm 1 bottle — AT1 FDA listed —
Atropine Sulfate 10 mg/mL 82260-0001-01 Bausch 10 vials — — FDA listed —
Atropine 10 mg/mL 68083-0671-01 Gland 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 68083-0669-01 Gland 1 bottle — AT1 FDA listed —
Atropine 10 mg/mL 68083-0670-01 Gland 1 bottle — AT1 FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Atropine Sulfate (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Atropine Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.44M
Claims incl. refills
57.2K
Beneficiaries
42.2K
Spend / beneficiary
$57.89
Spend / claim
$42.70
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Isopto Atropine (this brand).

Top reported reactions

Macular Degeneration196
Nausea188
Pyrexia157
Diarrhoea141
Pain132
Malaise129
Headache124

Age at onset

Neonate3
Infant4
Child13
Adolescent8
Adult222
Elderly198

Reporter sex

0 reports

Serious outcomes

Hospitalization945
Disabling73
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 237 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00065-0303-55 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (0065-0303-55) / 5 mL in 1 BOTTLE, DROPPER 2018-08-01 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0065-0303-55, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00065-0303-55, written without dashes as 00065030355. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00065-0303-55, the first segment (00065) is the labeler code FDA assigned to Alcon Laboratories, Inc.; the middle segment (0303) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (55) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Alcon Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 56 words ▾

1 INDICATIONS AND USAGE ISOPTO ® Atropine 1% is indicated for: 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 )

1.1 Mydriasis

1.2 Cycloplegia

1.3 Penalization of the healthy eye in the treatment of amblyopia

⏱️ Dosage and Administration 104 words ▾

2 DOSAGE AND ADMINISTRATION

2.1In 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.

2.2In 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 )

💊 Dosage Forms and Strengths 20 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: 1% atropine sulfate (10mg/mL) Ophthalmic solution: 1% atropine sulfate (10mg/mL) ( 3 )

⛔ Contraindications 45 words ▾

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

⚠️ Warnings and Cautions 134 words ▾

5 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 )

5.1Photophobia and Blurred Vision Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.

5.2Elevation 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%.

5.3Increased 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.

🤒 Adverse Reactions ~1 min read ▾

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.

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.

6.1Ocular 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.

6.2Systemic 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 52 words ▾

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

7.1Monoamine Oxidase Inhibitors The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.

🔄 Drug / Laboratory Test Interactions 25 words ▾

7.1Monoamine Oxidase Inhibitors The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation 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%.

8.4Pediatric 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.

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients.

🤰 Pregnancy 75 words ▾

8.1Pregnancy 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.

🧒 Pediatric Use 75 words ▾

8.4Pediatric 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.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients.

🆘 Overdosage 144 words ▾

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.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics 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) ].

12.3Pharmacokinetics 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.

🧬 Mechanism of Action 72 words ▾

12.1Mechanism 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.

📦 How Supplied / Storage and Handling 43 words ▾

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

📋 Description 123 words ▾

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.

💬 Information for Patients 88 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00065-0092-65 · Alcon, 00065-0343-02 · Alcon →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.