atropine sulfate 10 mg/mL Solution — NDC 0065-0817-01 (Billing 00065-0817-01)
This is a package of atropine sulfate 10 mg/mL Solution from Alcon Laboratories, Inc., marketed since Nov 2022 and currently FDA-listed; retail pharmacies pay about $10.35 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0065-0817-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0065 labeler · 0817 product · 01 package
- Package marketed since
- Nov 1, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0300650817011, 0300650817028
- Medicaid fills, this package
- 760 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Atropine Sulfate (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007866
- GCN: 32952
- GPI-14 (Medi-Span): 86350010102010
- HICL (First Databank): 002004
- AHFS class code: 12:08.08.00
- RxCUI (RxNorm): 1190655
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 swelling and inflammation of the eye.
Read the full MedlinePlus article ↗- Atropine sulfate 1% eye drops widen the pupil and relax the eye's focusing muscle, which helps with eye exams and procedures. They are also used to blur the healthy eye as part of...
- You place 1 drop in the lower pocket of the eye, about 40 minutes before the maximum dilation is needed. People 3 and older may repeat it up to twice a day if needed. Children unde...
- Stinging when the drops go in is common. Blurred vision, light sensitivity and dry eyes can also happen. Some people feel drowsy, get a dry mouth or flushed face, or have a faster...
- Call if you notice swelling or itching around the eyelids, a rash, or a faster heartbeat. Also call for restlessness, confusion or irritability, or if your blurry vision lasts beyo...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Atropine Sulfate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $10.345 | $51.73 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $8.62 | $43.10 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $7.91 | $39.53 / 5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00065-0817-01 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER | $10.35 / mL | $51.73 | 2022-11-01 | — | Active |
| 00065-0817-02 0065-0817-02 | 1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER | $19.99 / mL | $39.97 | 2022-11-01 | — | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($10.35 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 97% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of atropine sulfate 10 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Atropine 10 mg/mL 60219-1750-08 | Amneal | 1 bottle | $4.162 | AT1 | Availability likely | save 60% |
| Atropine sulfate 10 mg/mL 70069-0583-01 | Somerset | 1 bottle | $4.162 | AT1 | Availability likely | save 60% |
| Atropine Sulfate 10 mg/mL 70756-0653-35 | Lifestar | 1 bottle | $4.162 | AT1 | Availability likely | save 60% |
| Atropine 10 mg/mL 60219-1749-03 | Amneal | 1 bottle | $5.134 | AT1 | Availability likely | save 50% |
| Atropine sulfate 10 mg/mL 70069-0582-01 | Somerset | 1 bottle | $5.134 | AT1 | Availability likely | save 50% |
| Atropine Sulfate 10 mg/mL 70756-0652-25 | Lifestar | 1 bottle | $5.134 | AT1 | Availability likely | save 50% |
| Isopto Atropine 10 mg/mL 00065-0303-55 | Alcon | 1 bottle | $9.701 | AT2 | Discontinued | save 6% |
| atropine sulfate 10 mg/mLthis 00065-0817-01 | Alcon | 1 bottle | $10.345 | AT2 | Availability likely | — |
| Atropine Sulfate 10 mg/mL 70069-0716-01 | Somerset | 1 bottle | $10.345 | AT2 | Availability likely | — |
| Atropine sulfate 10 mg/mL 42799-0826-01 | Edenbridge | 1 bottle | $11.515 | AT1 | Availability likely | +11% |
| Atropine 10 mg/mL 60219-1748-02 | Amneal | 1 bottle | $11.515 | AT1 | Availability likely | +11% |
| Atropine 10 mg/mL 60505-6226-00 | Apotex | 1 bottle | $11.515 | AT1 | Availability likely | +11% |
| Atropine sulfate 10 mg/mL 70069-0581-01 | Somerset | 1 bottle | $11.515 | AT1 | Availability likely | +11% |
| Atropine Sulfate 10 mg/mL 70756-0651-25 | Lifestar | 1 bottle | $11.515 | AT1 | Availability likely | +11% |
| Atropine Sulfate 10 mg/mL 72603-0264-01 | NorthStar | 1 bottle | $11.515 | AT1 | Availability likely | +11% |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Atropine Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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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.
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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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Alcon Laboratories, Inc. labeler code 00065
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- PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 7 mg/mL Solution NDC 0065-0816-01
- Systane Ultra Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1431-01
- Systane ULTRA polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1432-04
- Systane Balance propylene glycol .06 mg/mL Emulsion NDC 0065-1433-02
- SYSTANE HYDRATION PF PRESERVATIVE FREE Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1437-04
- Systane Day and Night Value Pack Polyethylene Glycol 400, Propylene Glycol 0.3% Kit NDC 0065-1502-10
- Systane Ultra Preservative Free Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1507-82
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Atropine Sulfate Ophthalmic Solution, 1% is indicated for: Atropine Sulfate Ophthalmic Solution, 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 ▾
2 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. In 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 ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: 1% atropine sulfate (10mg/mL) Ophthalmic solution: 1% atropine sulfate (10mg/mL) ( 3 )
⛔ Contraindications ▾
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 ▾
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 ▾
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 ▾
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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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%.
8.4Pediatric 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.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients.
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric 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.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients.
🆘 Overdosage ▾
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 ▾
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 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 )].
12.3Pharmacokinetics 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 ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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: 2 mL filled in 4-mL bottles NDC 0065-0817-02 5 mL filled in 8-mL bottles NDC 0065-0817-01 Storage: Store Atropine Sulfate Ophthalmic Solution, 1% at 2°C to 25°C (36°F to 77°F). After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle.
📋 Description ▾
11 DESCRIPTION Atropine Sulfate Ophthalmic Solution, 1% is a sterile topical ophthalmic solution. Each mL of Atropine Sulfate Ophthalmic Solution, 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. Atropine Sulfate Ophthalmic Solution, 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), purified water.
💬 Information for Patients ▾
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 © 2022 Alcon Inc.
🍼 Nursing Mothers ▾
8.2Lactation 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%.
🧬 Pharmacokinetics ▾
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.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics 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 )].
🔬 Clinical Studies ▾
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.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, 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.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0065-0817-02 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 2 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F).
Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Alcon ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA Product of India 300055337-0722
PRINCIPAL DISPLAY PANEL NDC 0065-0817-02 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 2 mL Sterile Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F).
Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Alcon ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA Product of Germany 300053026-0722
PRINCIPAL DISPLAY PANEL Atropine Sulfate Ophthalmic Solution, 1% NDC 0065-0817-02 Rx Only STORAGE: Store at 2°C to 25°C (36°F to 77°F). ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA 2 mL Sterile INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%.
Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Administration: See Prescribing information.
FOR TOPICAL OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL NDC 0065-0817-01 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 5 mL Sterile Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F).
Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%.
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 300057551-0722
PRINCIPAL DISPLAY PANEL NDC 0065-0817-01 For Topical Ophthalmic Use Alcon Atropine Sulfate Ophthalmic Solution, 1% 5 mL Sterile Dosage and Administration: See Prescribing Information. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. STORAGE: Store at 2°C to 25°C (36°F to 77°F).
Read enclosed insert. After opening, Atropine Sulfate Ophthalmic Solution 1% can be used until the expiration date on the bottle. Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%.
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 300057552-0722
PRINCIPAL DISPLAY PANEL Atropine Sulfate Ophthalmic Solution, 1% NDC 0065-0817-01 Sterile 5 mL Rx Only INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water. Dosage and Admini… [Excerpted — this section continues on DailyMed.]