Atropine
Atropine Sulfate · Solution/ Drops · Ophthalmic
Uses
Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for: 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia Atropine is an anti-cholinergic indicated in adults and pediatric patients aged three (3) months and older for:
• Cycloplegia (1.1)
• Mydriasis (1.2)
• Penalization of the healthy eye in the treatment of amblyopia (1.3)
Dosage and administration
Apply 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time. In adults and pediatric patients aged 3 years and older, doses may be repeated up to twice daily as needed.
• Apply 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time. ( 2 .)
• In adults and pediatric patients aged 3 years and older, doses may be repeated up to twice daily as needed. ( 2 .)
Dosage forms and strengths
Ophthalmic Solution: 1% atropine sulfate. Ophthalmic solution: 1% atropine sulfate ( 3 )
Contraindications
Hypersensitivity or allergic reaction to any ingredient in formulation. ( 4.1 ) 4.1 Hypersensitivity Atropine Sulfate Ophthalmic Solution 1% is contraindicated in patients who have demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation.
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 ) 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 Elevations in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of Atropine Sulfate Ophthalmic Solution, 1%. 5.3 Risk of Contamination Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution.
Side effects
The following serious 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 )] The following adverse reactions were identified in clinical studies or postmarketing reports 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. Most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, decreased lacrimation, increased heart rate and blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Ocular Adverse Reactions Eye pain and stinging occurs upon instillation. Other commonly occurring adverse reactions include, blurred vision, photophobia, superficial keratitis and decreased lacrimation. Allergic reactions such as papillary conjunctivitis, contact dermatitis, and lid 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; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck.
Drug interactions
The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis. ( 7 ) 7.1 Monoamine Oxidase Inhibitors (MAOI) 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
Should only be used in pregnant women if clearly needed. ( 8.1 ) 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of atropine sulfate administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see Clinical Pharmacology ( 12.3 )] . Atropine Sulfate Ophthalmic Solution 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. 8.2 Lactation Risk Summary There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of atropine sulfate 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 and any potential adverse effects on the breastfed child from atropine sulfate. 8.4 Pediatric Use The safety and effectiveness of Atropine Sulfate Ophthalmic Solution 1% have been established in pediatric patients aged 3 months and older. Use of Atropine Sulfate Ophthalmic Solution 1% is supported by evidence from adequate and well-controlled trials with additional safety data from published literature. Due to the potential for systemic absorption, the use of Atropine Sulfate Ophthalmic Solution 1% in pediatric patients aged 3 months to 3 years should be limited to no more than one drop per eye per day. Use in pediatric patients younger than 3 months of age is not recommended. 8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of atropine sulfate 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
8.4 Pediatric Use The safety and effectiveness of Atropine Sulfate Ophthalmic Solution 1% have been established in pediatric patients aged 3 months and older. Use of Atropine Sulfate Ophthalmic Solution 1% is supported by evidence from adequate and well-controlled trials with additional safety data from published literature. Due to the potential for systemic absorption, the use of Atropine Sulfate Ophthalmic Solution 1% in pediatric patients aged 3 months to 3 years should be limited to no more than one drop per eye per day. Use in pediatric patients younger than 3 months of age is not recommended.
Geriatric use
8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
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 adult dose of atropine is not known. In pediatric patients, 10 mg or less may be fatal.
Description
Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure: Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2
• H2SO4
• H2O Molecular Weight: 694.83 g/mol Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active : atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives : benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP. atropine-sulfate-oph-spl-str
Mechanism of action
12.1 Mechanism of Action Atropine is a reversible antagonist of muscarine-like actions of acetyl-choline and is therefore classified as an antimuscarinic agent. Atropine is relatively selective for muscarinic receptors. Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically. Atropine does not distinguish among the M1, M2, and M3 subgroups of muscarinic receptors. The pupillary constrictor muscle depends on muscarinic cholinoceptor activation. This activation is blocked by topical atropine resulting in unopposed sympathetic dilator activity and mydriasis. Atropine also weakens the contraction of the ciliary muscle, or cycloplegia. Cycloplegia results in loss of the ability to accommodate such that the eye cannot focus for near vision.
How supplied
Atropine Sulfate Ophthalmic Solution USP, 1% is supplied in a plastic dropper bottle with a red cap in the following sizes: NDC 68083-669-01 2 mL fill in 5 mL bottle NDC 68083-670-01 5 mL fill in 5 mL bottle NDC 68083-671-01 15 mL fill in 15 mL bottle Storage: Store at 20°C to 25°C (68°F to 77°F). Keep tightly closed. After opening, Atropine Sulfate Ophthalmic Solution can be used until the expiration date on the bottle.
Patient information
Risk of Contamination Advise patients to not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution. Keep the bottle tightly closed. Instillation Site Pain Advise patients that drops will sting upon instillation. Sensitivity to Light and Blurred Vision Advise patients that they will experience sensitivity to light and blurred vision which may last for a couple of weeks. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad - 500043, India Revised: 12/2025
Label text from the FDA structured product label by Gland Pharma Limited (revised Aug 3, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Atropine Sulfate in 10 products
Atropine NDC products (10)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7000 | Atropine Sulfate 10 mg/mL Solution/ Drops | A-S Medication Solutions | ANDA |
| 50090-7313 | Atropine Sulfate 10 mg/mL Solution/ Drops | A-S Medication Solutions | ANDA |
| 60219-1748 | Atropine Sulfate 10 mg/mL Solution/ Drops | Amneal Pharmaceuticals NY LLC | ANDA |
| 60219-1749 | Atropine Sulfate 10 mg/mL Solution/ Drops | Amneal Pharmaceuticals NY LLC | ANDA |
| 60219-1750 | Atropine Sulfate 10 mg/mL Solution/ Drops | Amneal Pharmaceuticals NY LLC | ANDA |
| 60505-6226 | Atropine Sulfate 10 mg/mL Solution/ Drops | Apotex Corp. | ANDA |
| 68083-669 | Atropine Sulfate 10 mg/mL Solution/ Drops | Gland Pharma Limited | ANDA |
| 68083-670 | Atropine Sulfate 10 mg/mL Solution/ Drops | Gland Pharma Limited | ANDA |
| 68083-671 | Atropine Sulfate 10 mg/mL Solution/ Drops | Gland Pharma Limited | ANDA |
| 67296-2200 | Atropine Sulfate 10 mg/mL Solution/ Drops | Redpharm Drug | ANDA |
Frequently asked questions
What is Atropine used for?
Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for: 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia Atropine is an anti-cholinergic indicated in adults and pediatric patients aged three (3) months and older for: • Cycloplegia (1.1) • Mydriasis (1.2) • Penalization of the healthy…
What are the side effects of Atropine?
The following serious 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 )] The following adverse reactions were identified in clinical studies or postmarketing reports following use of atropine sulfate ophthalmic solution. Because these… See the full label for the complete list.
Who makes Atropine?
Atropine is listed by 5 labelers in the FDA NDC directory, including A-S Medication Solutions, Amneal Pharmaceuticals NY LLC, Apotex Corp., Gland Pharma Limited.