isopto atropine
Isopto Atropine (Atropine Sulfate) is an anticholinergic used to treat Bradycardia, Heart Arrest, Poisoning, Sinoatrial Block.
Atropine Sulfate · by Alcon
Available as a generic: Atropine Sulfate
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Atropine Sulfate
- Drug class
- Anticholinergic
- Form
- Solution
- Strength
- Atropine Sulfate 1%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- bradycardia, heart arrest, poisoning
- Manufacturer
- Alcon
- What the pharmacy pays
- ~$6.87 per ml — not your price
- FDA application
- NDA208151
What is Isopto Atropine?
From the FDA label: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.
How to use
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. 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 )
Side effects
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. 6.1 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…
Warnings
Important safety information
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 ) 5.1 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.
Who should not take Isopto Atropine
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 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.
Drug class
How this class works, per Muscarinic Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Isopto Atropine ranks — best-rated anticholinergic for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Isopto Atropine treat?
- Isopto Atropine (Atropine Sulfate) may be used to treat bradycardia, heart arrest, poisoning, sinoatrial block, stomach ulcer, uveitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Isopto Atropine work?
- Isopto Atropine is a anticholinergic. Anticholinergic drugs block acetylcholine, the chemical messenger of the body's "rest and digest" nervous system, by occupying its muscarinic receptors. This eases muscle spasms, dries up secretions, relaxes the bladder and airways, and speeds the heart, depending on the tissue.
- How much does Isopto Atropine cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $6.87 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Atrovent Hfa — about $0.62 on the same basis.
- Is there a coupon or discount for Isopto Atropine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Isopto Atropine. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Isopto Atropine?
- Isopto Atropine is marketed by Alcon. You can see Alcon's full profile, rating, and other products on pharmaranks.
- Is Isopto Atropine a brand-name or generic drug?
- Isopto Atropine is a brand-name product with the active ingredient Atropine Sulfate. Lower-cost generic equivalents containing Atropine Sulfate are available — ask your pharmacist.
- Is Isopto Atropine available over the counter?
- No. Isopto Atropine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Isopto Atropine come in?
- Isopto Atropine is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Isopto Atropine?
- Isopto Atropine is classified as anticholinergic, cholinergic muscarinic antagonist, per the FDA's Established Pharmacologic Class.
- Is Isopto Atropine FDA-registered?
- Isopto Atropine is on record with the U.S. FDA under application number NDA208151. You can verify this on its official FDA label.
- Is Isopto Atropine safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Isopto Atropine. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Isopto Atropine?
- Isopto Atropine's side effects are taken directly from its FDA label. From the label: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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