atropine sulfate
Atropine Sulfate is an anticholinergic used to treat Bradycardia, Heart Arrest, Poisoning, Sinoatrial Block.
Anticholinergic · by Somerset
Generic of Isopto Atropine
⚠ 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
- Injectable, Solution
- Strength
- Atropine Sulfate 1%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- bradycardia, heart arrest, poisoning
- Manufacturer
- Somerset
- What the pharmacy pays
- ~$6.87 per ml — not your price
- FDA application
- ANDA217791
What is Atropine Sulfate?
From the FDA label:Atropine sulfate ophthalmic solution, USP 1% is a sterile topical ophthalmic solution. Each mL of atropine sulfate ophthalmic solution, USP 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 (C 17 H 23 NO 3 ) 2 • H 2 SO 4 • H 2 O and it is represented by the chemical structure: Atropine sulfate monohydrate is colorless, almost white to white solid and has a molecular weight of 694.83. Atropine sulfate ophthalmic solution, USP 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), water for injection. Image
How to use
Atropine Sulfate is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application ANDA217791 — follow the label that came with the product you were actually prescribed.
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) 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.
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 Somerset Therapeutics, LLC at 1-800-417-9175 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 commonly.…
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 Atropine Sulfate
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) See 17 for PATIENT COUNSELING INFORMATION. 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 Atropine Sulfate ranks — best-rated anticholinergic for:
Dosage forms
Injectable and 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 Atropine Sulfate treat?
- Atropine Sulfate (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 Atropine Sulfate work?
- Atropine Sulfate 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 Atropine Sulfate 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 Atropine Sulfate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Atropine Sulfate. To pay less, Atropine Sulfate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Atropine Sulfate?
- Atropine Sulfate is marketed by Somerset. You can see Somerset's full profile, rating, and other products on pharmaranks.
- Is Atropine Sulfate a brand-name or generic drug?
- Atropine Sulfate is a generic medication; its active ingredient is Atropine Sulfate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Atropine Sulfate available over the counter?
- No. Atropine Sulfate 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 Atropine Sulfate come in?
- Atropine Sulfate is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- What class of drug is Atropine Sulfate?
- Atropine Sulfate is classified as anticholinergic, cholinergic muscarinic antagonist, per the FDA's Established Pharmacologic Class.
- Is Atropine Sulfate FDA-registered?
- Atropine Sulfate is on record with the U.S. FDA under application number ANDA217791. You can verify this on its official FDA label.
- Is Atropine Sulfate safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Atropine Sulfate. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Atropine Sulfate?
- Atropine Sulfate'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 C… 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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