Medicine guide

Atropine Sulfate

.1 mg/mL · Injection

Prescription only
Anticholinergic

Active substance: Atropine Sulfate
Made by: Accord Healthcare, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-10-06

The FDA lists this product in a current shortage

Pharmacies may have trouble getting it. Your pharmacist can suggest what to do. · Updated 2026-10-01 FDA drug shortages

What it is

Anticholinergic

Used for

Atropine Sulfate Injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic…

The label’s usual adult dose

Initial single dose of 0.5 mg to 1 mg ( 2.2 ) Antidote for organophosphorus or muscarinic mushroom poisoning:

Full directions ↓

Do not take it if

None. None. ( 4 )

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

53other products contain Atropine Sulfate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Atropine Sulfate Injection is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects.
( 1 )

From the official label · 2025-10-06 · DailyMed

How it works

From this product’s own US prescribing label.

Atropine is an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters.
Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated.

How it leaves the body

Much of the drug is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to 50% is excreted unchanged in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-06

Do not take it if

None. None. ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

For intravenous administration ( 2.1 ) Titrate according to heart rate, PR interval, blood pressure and symptoms ( 2.1 ) Adult dosage Antisialagogue or for antivagal effects:
Initial single dose of 0.5 mg to 1 mg ( 2.2 ) Antidote for organophosphorus or muscarinic mushroom poisoning:
Initial single dose of 2 mg to 3 mg, repeated every 20-30 minutes ( 2.2 ) Bradyasystolic cardiac arrest:
1 mg dose, repeated every 3-5 minutes if asystole persists ( 2.2 ) Patients with Coronary Artery Disease:
Limit the total dose to 0.03 mg/kg to 0.04 mg/kg ( 2.4 )
2.1 General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer unless solution is clear and seal is intact.
Each syringe is intended for single dose only.
Discard unused portion.
For intravenous administration.
Titrate based on heart rate, PR interval, blood pressure and symptoms.
INSTRUCTIONS FOR USE:
CAUTION:
Certain glass syringes may malfunction, break or clog when connected to some Needleless Luer Access Devices (NLADs).
This syringe has a larger internal syringe tip and an external collar (luer collar).
The external collar must remain attached to the syringe.
Data shows that, the syringe achieves acceptable connection with the following NLADs:
BD SmartSite ™ , BBraun Ultrasite ™ , BD Q-Syte ™ , BD MaxPlus ™ , and BBraun Safsite ™ .
Assure that the needle or NLAD is securely attached before beginning the injection.
Visually inspect the glass syringe-needle or glass syringe-NLAD connection before and during drug administration.
2.2 Adult Dosage Table 1:
Recommended Dosage Use Dose (adults) Repeat Antisialagogue or other antivagal 0.5 to 1 mg 1-2 hours Organophosphorus or muscarinic mushroom poisoning 2 to 3 mg 20-30 minutes Bradyasystolic cardiac arrest 1 mg 3-5 minutes; 3 mg maximum total dose
2.3 Pediatric Dosage Dosing in pediatric populations has not been well studied.
Usual initial dose is 0.01 to 0.03 mg/kg.
2.4 Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 mg/kg to 0.04 mg/kg [see Warnings and Precautions (5.1) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Tachycardia ( 5.1 ) Glaucoma ( 5.2 ) Pyloric obstruction ( 5.3 ) Worsening urinary retention ( 5.4 ) Viscid bronchial plugs ( 5.5 )
5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to
avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand.
5.2 Acute Glaucoma Atropine may precipitate acute glaucoma.
5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction.
5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy.
5.5 Viscid Plugs Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations).
Available data from published observational studies on atropine sulfate use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
Animal developmental and reproductive toxicity studies have not been conducted with atropine.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated.
Life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus.
Data Human Data Atropine crosses the placenta [see Clinical Pharmacology (12.3)].
No adequate and well-controlled studies are available regarding use of atropine in pregnant women.
In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformations.
In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected.
No specific pattern of major defects was identified.
In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations.
Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug-associated risk during pregnancy.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations).
Available data from published observational studies on atropine sulfate use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
Animal developmental and reproductive toxicity studies have not been conducted with atropine.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated.
Life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus.
Data Human Data Atropine crosses the placenta [see Clinical Pharmacology (12.3)].
No adequate and well-controlled studies are available regarding use of atropine in pregnant women.
In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformations.
In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected.
No specific pattern of major defects was identified.
In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations.
Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug-associated risk during pregnancy.
8.2 Lactation Risk Summary Trace amounts of atropine have been reported in human milk.
There are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production.
Clinical Considerations Minimizing Exposure The elimination half-life of atropine is more than doubled in children less than 2 years of age [see Clinical Pharmacology (12.3)].
To minimize potential infant exposure to Atropine Sulfate Injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant.
8.4 Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials.
8.5 Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Mexiletine: Decreases rate of mexiletine absorption.
( 7.1 )
7.1 Mexiletine Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia.
Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma.
Depression and circulatory collapse occur only with severe intoxication.
In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma.
The fatal adult dose of atropine is not known.
In pediatric populations, 10 mg or less may be fatal.
In the event of toxic overdosage, a short acting barbiturate or diazepam may be given 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 as an atropine antidote 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.
Ice bags and alcohol sponges help to reduce fever, especially in pediatric populations.
Atropine is not removed by dialysis.

Quoted from the official label, section “Overdosage”.

Use in children

Recommendations for use in pediatric patients are not based on clinical trials.

Quoted from the official label, section “Pediatric Use”.

Use in older people

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

The following adverse reactions have been identified during post-approval use of atropine sulfate.
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 of the side effects of atropine are directly related to its antimuscarinic action.
Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur.
Anhidrosis can produce heat intolerance.
Constipation and difficulty in micturition may occur in elderly patients.
Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.
Most adverse reactions are directly related to atropine's antimuscarinic action.
Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

FORMS AND STRENGTHS Injection:
0.05 mg/mL and 0.1 mg/mL in Glass Syringes. 0.05 mg/mL injection in Glass Syringe ( 3 ) 0.1 mg/mL injection in Glass Syringe ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

September 2025Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows:
Unit of Sale and Product Description Strength (Concentration) NDC One syringe per carton 5 mL Single-Dose Glass Syringe 0.25 mg/5 mL (0.05 mg/mL) 16729-483-31 One syringe per carton 10 mL Single-Dose Glass Syringe 1 mg/10 mL (0.1 mg/mL) 16729-484-03 One syringe per carton 5 mL Single-Dose Glass Syringe 0.5 mg/5 mL (0.1 mg/mL) 16729-484-31 Ten syringes per carton 5 mL Single-Dose Glass Syringe 0.25 mg/5 mL (0.05 mg/mL) 16729-483-03 Ten syringes per carton 10 mL Single-Dose Glass Syringe 1 mg/10 mL (0.1 mg/mL) 16729-484-45 Ten syringes per carton 5 mL Single-Dose Glass Syringe 0.5 mg/5 mL (0.1 mg/mL) 16729-484-90 The Glass syringe is presented in a tray with polypropylene plunger rod.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] Manufactured For:
Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA.
Manufactured By:
Intas Pharmaceuticals Limited, Ahmedabad-380 054, India. 10 5231 4 6036329 Issued September 2025

Quoted from the official label, section “How Supplied”.

What is in it

Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic.
It is administered parenterally by intravenous injection.
Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, and sodium chloride, 9 mg.
May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH 3.0 to 4.0.
Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na + ) and chloride (Cl - ) ions.
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection.
When smaller doses are required the unused portion should be discarded.
Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17 H 23 NO 3 ) 2 H 2 SO 4 H 2 O, colorless crystals or white crystalline powder very soluble in water.
It has the following structural formula:
Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. structural formula atropine sulfate

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (16)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 16 of 16

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (1)

CanadaNo exact match for this strength and form

Every strength and form (10)

Details

Made by	Accord Healthcare, Inc.
Active substance	Atropine Sulfate
Strength	.1 mg/mL
Form	Injection
Route	Intravenous
Packs	10 mL in 1 SYRINGE, GLASS · 5 mL in 1 SYRINGE, GLASS
NDC	16729-484

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

51 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Injection, Solution24 products
- .05 mg/mL2
  .05 mg/mL · 2 companies
  - Henry Schein, Inc.
  - Hospira, Inc.
- .1 mg/mL9
  .1 mg/mL · 9 companies
  +1 more
- .4 mg/mL9
  .4 mg/mL · 9 companies
  +1 more
- 1 mg/mL4
  1 mg/mL · 4 companies
Injection13 products
- .05 mg/mL
- .1 mg/mL7
  .1 mg/mL · 7 companies
  - A-S Medication Solutions
  - Accord Healthcare, Inc. · this page
  - HF Acquisition Co LLC, DBA HealthFirst
  - International Medication Systems, Limited
  - Medical Purchasing Solutions, LLC
  - ProPharma Distribution
  - REMEDYREPACK INC.
- .4 mg/mL4
  .4 mg/mL · 4 companies
- 1 mg/mL
Solution8 products
- .4 mg/mL3
  .4 mg/mL · 3 companies
- 1 mg/mL2
  1 mg/mL · 2 companies
  - Medical Purchasing Solutions, LLC
  - Somerset Therapeutics, LLC
- 10 mg/mL3
  10 mg/mL · 3 companies
Solution/ Drops5 products
- 10 mg/mL5
  10 mg/mL · 5 companies

Show all forms · 5 forms

Ointment1 products
- 10 mg/g

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Atropine10 mg/mLPrescription onlySolution/ Drops A-S Medication Solutions · Atropine Sulfate Atropine10 mg/mLPrescription onlySolution/ Drops Amneal Pharmaceuticals NY LLC · Atropine Sulfate Atropine10 mg/mLPrescription onlySolution/ Drops Apotex Corp. · Atropine Sulfate Atropine10 mg/mLPrescription onlySolution/ Drops Redpharm Drug · Atropine Sulfate Atropine10 mg/mLPrescription onlySolution/ Drops Gland Pharma Limited · Atropine Sulfate Atropine Sulfate10 mg/mLPrescription onlySolution Alcon Laboratories, Inc. · Atropine Sulfate

See every product with Atropine Sulfate