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ATROPINE SULFATE .1 mg/mL Injection — NDC 71872-7298-01 package photo

ATROPINE SULFATE .1 mg/mL Injection

by Medical Purchasing Solutions, LLC · 1 SYRINGE, GLASS in 1 BAG (71872-7298-1) / 10 mL in 1 SYRINGE, GLASS
NDC 71872-7298-01
🏷️ FDA NDC (as labeled) 71872-7298-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Atropine Sulfate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0795-2026
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0235-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71872-7298-1
Product NDC 71872-7298
11-digit billing NDC 71872729801
RxCUI 1190546
UNII 03J5ZE7KA5
UPC 0316729484039
Application # ANDA212868
SPL Set ID fa1c953b-723b-1abe-e053-6394a90a967f
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-30
Route INTRAVENOUS
Dosage form INJECTION
Substance ATROPINE SULFATE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 71872-7298-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71872-7298-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMedical Purchasing Solutions, LLC
Application holderACCORD HEALTHCARE INC
FDA applicationANDA212868 (ANDA)
Labeler code71872
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio250 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Atropine works by blocking a nerve signal that, when overactive, can cause a dangerously slow heart rate, flooding secretions, or — in poisoning — life-threatening over-stimulation...
  • Why am I being given atropine — what does it actually do?
  • It's very common to notice a dry mouth, blurred vision, light sensitivity, a faster heartbeat, flushing, or difficulty urinating — those are expected effects of how atropine works...
  • What side effects should I expect, and which ones mean I need to call for help?
📖 Read our full Atropine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 9 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.
  • UNII O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
  • 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.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atropine Sulfate .1 mg/mL 00409-1630-10 Hospira, 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 16729-0484-03 Accord 10 ml — AP FDA listed —
Atropine Sulfate .1 mg/mL 50090-5924-00 A-S 1 ml — AP FDA listed —
Atropine Sulfate .1 mg/mL 51662-1207-01 HF 1 syringe — — FDA listed —
Atropine Sulfate .1 mg/mL 51662-1289-01 HF 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 51662-1527-01 HF 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 64253-0400-91 Medefil, 10 syringes — AP FDA listed —
atropine sulfate .1 mg/mL 70121-1706-01 Amneal 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 70518-3120-00 REMEDYREPACK 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 71872-7002-01 Medical 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 71872-7252-01 Medical 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mLthis 71872-7298-01 Medical 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 76329-3340-01 International 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 84549-0340-01 ProPharma 10 ml — AP FDA listed —
Atropine Sulfate .1 mg/mL 84549-0400-91 ProPharma 10 ml — AP FDA listed —
Atropine Sulfate .1 mg/mL 00404-9784-05 Henry 1 syringe — AP FDA listed —
atropine sulfate .1 mg/mL 70121-1705-07 Amneal 1 syringe — AP FDA listed —
Atropine Sulfate .1 mg/mL 51662-1208-01 HF 1 syringe — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Atropine Sulfate — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Atropine Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.44M
Claims incl. refills
57.2K
Beneficiaries
42.2K
Spend / beneficiary
$57.89
Spend / claim
$42.70
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Atropine Sulfate — the ingredient across all brands.

Top reported reactions

Diarrhoea3,500
Nausea2,326
Fatigue2,111
Death1,470
Vomiting1,432
Pain1,348
Dyspnoea1,214

Age at onset

Neonate56
Infant89
Child77
Adolescent49
Adult1,559
Elderly1,378

Reporter sex

26,510 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization10,628
Death3,747
Life-threatening1,841
Disabling545
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,233 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71872-7298-01 You're viewing this 1 SYRINGE, GLASS in 1 BAG (71872-7298-1) / 10 mL in 1 SYRINGE, GLASS 2022-08-08 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71872-7298-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71872-7298-01, written without dashes as 71872729801. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71872-7298-01, the first segment (71872) is the labeler code FDA assigned to Medical Purchasing Solutions, LLC; the middle segment (7298) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Medical Purchasing Solutions, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medical Purchasing Solutions, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 59 words ▾

1 INDICATIONS AND USAGE 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 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION 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 )

2.1General 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.

2.2Adult 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

2.3Pediatric Dosage Dosing in pediatric populations has not been well studied. Usual initial dose is 0.01 to 0.03 mg/kg.

2.4Dosing 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) ].

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE 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 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 131 words ▾

5 WARNINGS AND PRECAUTIONS Tachycardia ( 5.1 ) Glaucoma ( 5.2 ) Pyloric obstruction ( 5.3 ) Worsening urinary retention ( 5.4 ) Viscid bronchial plugs ( 5.5 )

5.1Tachycardia 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.

5.2Acute Glaucoma Atropine may precipitate acute glaucoma.

5.3Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction.

5.4Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy.

5.5Viscid Plugs Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.

🤒 Adverse Reactions 150 words ▾

6 ADVERSE REACTIONS 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 .

🔄 Drug Interactions 48 words ▾

7 DRUG INTERACTIONS Mexiletine: Decreases rate of mexiletine absorption. ( 7.1 )

7.1Mexiletine 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.

👥 Use in Specific Populations 134 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity.

8.3Nursing Mothers Trace amounts of atropine was found in breast milk. The clinical impact of this is not known.

8.4Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials.

8.5Geriatric 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.

🤰 Pregnancy 33 words ▾

8.1Pregnancy Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials.

🧓 Geriatric Use 61 words ▾

8.5Geriatric 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.

🆘 Overdosage 210 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine).

The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation also may be inhibited by atropine but this occurs less readily than with responses to injected (exogenous) choline esters.

12.2Pharmacodynamics Atropine-induced parasympathetic inhibition may be preceded by a transient phase of stimulation, especially on the heart where small doses first slow the rate before characteristic tachycardia develops due to paralysis of vagal control. Atropine exerts a more potent and prolonged effect on heart, intestine and bronchial muscle than scopolamine, but its action on the iris, ciliary body and certain secretory glands is weaker than that of scopolamine. Unlike the latter, atropine in clinical doses does not depress the central nervous system but may stimulate the medulla and higher cerebral centers.

Although mild vagal excitation occurs, the increased respiratory rate and (sometimes) increased depth of respiration produced by atropine are more probably the result of bronchiolar dilatation. Accordingly, atropine is an unreliable respiratory stimulant and large or repeated doses may depress respiration. Adequate doses of atropine abolish various types of reflex vagal cardiac slowing or asystole.

The drug also prevents or abolishes bradycardia or asystole produced by injection of choline esters, anticholinesterase agents or other parasympathomimetic drugs, and cardiac arrest produced by stimulation of the vagus. Atropine also may lessen the degree of partial heart block when vagal activity is an etiologic factor. In some patients with complete heart block, the idioventricular rate may be accelerated by atropine; in others, the rate is stabilized.

Occasionally a large dose may cause atrioventricular (A-V) block and nodal rhythm. Atropine Sulfate Injection in clinical doses counteracts the peripheral dilatation and abrupt decrease in blood pressure produced by choline esters. However, when given by itself, atropine does not exert a striking or uniform effect on blood vessels or blood pressure.

Systemic doses slightly raise systolic and lower diastolic pressures and can produce significant postural hypotension. Such doses also slightly increase cardiac output and decrease central venous pressure. Occasionally, therapeutic doses dilate cutaneous blood vessels, particularly in the "blush" area (atropine flush) and may cause atropine "fever" due to suppression of sweat gland activity in infants and small children.

The effects of intravenous atropine on heart rate (maximum heart rate) and saliva flow (minimum flow) after intravenous administration (rapid, constant infusion over 3 min.) are delayed by 7 to 8 minutes after drug administration and both effects are non-linearly related to the amount of drug in the peripheral compartment. Changes in plasma atropine levels following intramuscular administration (0.5 to 4 mg doses) and heart rate are closely overlapped but the time course of the changes in atropine levels and behavioral impairment indicates that pharmacokinetics is not the primary rate-limiting mechanism for the central nervous system effect of atropine.

12.3 Pharmacoki…

🧬 Mechanism of Action 143 words ▾

12.1Mechanism of Action 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. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine).

The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation also may be inhibited by atropine but this occurs less readily than with responses to injected (exogenous) choline esters.

📦 How Supplied / Storage and Handling 178 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atropine 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., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad-380 054, India. 10 5231 2 6017607 Issued May 2022

📋 Description ~1 min read ▾

11 DESCRIPTION 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.