NDC 0409-1630 Atropine Sulfate
Injection, Solution Intravenous

Product Information

What is NDC 0409-1630?

The NDC code 0409-1630 is assigned by the FDA to the product Atropine Sulfate which is a human prescription drug product labeled by Hospira, Inc.. The product's dosage form is injection, solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0409-1630-10 10 carton in 1 package / 1 syringe, plastic in 1 carton / 10 ml in 1 syringe, plastic (0409-1630-15). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0409-1630
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Atropine Sulfate
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Atropine Sulfate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormInjection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Hospira, Inc.
Labeler Code0409
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA021146
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-19-2006
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Atropine Sulfate?


Product Packages

NDC Code 0409-1630-10

Package Description: 10 CARTON in 1 PACKAGE / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC (0409-1630-15)

Product Details

What are Atropine Sulfate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ATROPINE SULFATE .1 mg/mL - An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE. Hyoscyamine is the 3(S)-endo isomer of atropine.

Atropine Sulfate Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Atropine Sulfate Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Atropine Sulfate Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



1 Indications And Usage



Atropine Sulfate Injection, USP, 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.


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.

Intravenous administration is usually preferred, but subcutaneous, intramuscular, and endotracheal administration are possible. For administration via an endotracheal tube, dilute 1-2 mg in no more than 10 mL of sterile water or normal saline.

Titrate based on heart rate, PR interval, blood pressure and symptoms.


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)].


3 Dosage Forms And Strengths



Injection: 0.05 mg/mL and 0.1 mg/mL in Ansyr™ Plastic Syringes containing a clear, colorless solution in a polypropylene syringe.

Each Ansyr™ 5 mL Plastic Syringe contains 0.25 mg of atropine sulfate (0.05 mg/mL concentration).

Each Ansyr™ 5 mL Plastic Syringe contains 0.5 mg of atropine sulfate (0.1 mg/mL concentration).

Each Ansyr™ 10 mL Plastic Syringe contains 1 mg of atropine sulfate (0.1 mg/mL concentration).


4 Contraindications



None.


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.


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.


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.


8.1 Pregnancy



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.


8.3 Nursing Mothers



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


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.


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.


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 subcutaneous, intramuscular or 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 6.5).

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, (C17H23NO3)2 ∙ H2SO4 ∙ H2O, 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.

The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.


12.1 Mechanism 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.


12.2 Pharmacodynamics



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, USP 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 Pharmacokinetics



Atropine disappears rapidly from the blood following injection and is distributed throughout the body. Exercise, both prior to and immediately following intramuscular administration of atropine, significantly increases the absorption of atropine due to increased perfusion in the muscle and significantly decreases the clearance of atropine. The pharmacokinetics of atropine is nonlinear after intravenous administration of 0.5 to 4 mg. Atropine's plasma protein binding is about 44% and saturable in the 2-20 μg/mL concentration range. Atropine readily crosses the placental barrier and enters the fetal circulation, but is not found in amniotic fluid. Much of the drug is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to 50% is excreted unchanged in the urine. Traces are found in various secretions, including milk. The major metabolites of atropine are noratropine, atropin-n-oxide, tropine, and tropic acid. The metabolism of atropine is inhibited by organophosphate pesticides.

Specific Populations

The elimination half-life of atropine is more than doubled in children under two years and the elderly (>65 years old) compared to other age groups. There is no gender effect on the pharmacokinetics and pharmacodynamics (heart rate changes) of atropine.


13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility



Studies have not been performed to evaluate the carcinogenic or mutagenic potential of atropine or its potential to affect fertility adversely.


16 How Supplied/Storage And Handling



Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows:

Syringes

Concentration

(mg/mL)

Fill Volume

Total Atropine Content

NDC#

Ansyr™ Plastic Syringe

0.1 mg/mL

5 mL

0.5 mg

0409-9629-05

Ansyr™ Plastic Syringe

0.1 mg/mL

10 mL

1 mg

0409-1630-10

Ansyr™ Plastic Syringe

0.05 mg/mL

5 mL

0.25 mg

0409-9630-05

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.]

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                         

LAB-1041-2.0


Principal Display Panel - 10 Ml Syringe Label



Atropine Sulfate 1 mg/10 mL (0.1 mg/mL)

10 mL Single-Dose Syringe

NDC 0409-1630-10
Rx only

Atropine Sulfate Injection, USP
1 mg/10 mL (0.1 mg/mL)

Hospira

For Intravenous, Intramuscular, Subcutaneous or Endotracheal use.

Hospira, Inc., Lake Forest, IL 60045 USA

RL-5389


Principal Display Panel - 10 Ml Syringe Carton



NDC 0409-1630-10
Rx only

10 mL

Atropine
Sulfate

Injection, USP

1 mg/10 mL
(0.1 mg/mL)

For Intravenous,
Intramuscular,
Subcutaneous or
Endotracheal Use

Ansyr

Single-Dose Syringe

Hospira

◀ PRESS AND PULL TO OPEN ▶


Principal Display Panel - 0.1 Mg/Ml Syringe Label



ATROPINE SULFATE 0.1 mg/mL

5 mL Single-dose
NDC 0409-9629-05

ATROPINE SULFATE Inj., USP
0.5 mg (0.1 mg/mL) Rx only

Hospira

For I.V., I.M. or S.C. use. See insert
for dosage. Sterile, nonpyrogenic.

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0164 (5/04)


Principal Display Panel - 0.1 Mg/Ml Syringe Carton



NDC 0409-9629-05

5 mL

Atropine
Sulfate

Injection, USP

0.5 mg (0.1 mg/mL)

Ansyr

Unit of Use Syringe

LifeShield

with male luer lock adapter

Rx only

Hospira

◀ PUSH AND PULL TO OPEN ▶


Principal Display Panel - 0.05 Mg/Ml Syringe Label



Atropine Sulfate 0.25 mg/5 mL (0.05 mg/mL)

5 mL Single-Dose Syringe
Rx only
NDC 0409-9630-05

PEDIATRIC 0.25 mg/5 mL (0.05 mg/mL)
Atropine Sulfate Injection, USP

Hospira

For Intravenous, Intramuscular, Subcutaneous or Endotracheal Use.

Hospira, Inc., Lake Forest, IL 60045 USA

RL-5391


Principal Display Panel - 0.05 Mg/Ml Syringe Carton



NDC 0409-9630-05
Rx only

5 mL

Pediatric
Atropine
Sulfate

Injection, USP

0.25 mg/5 mL
(0.05 mg/mL)

For Intravenous,
Intramuscular,
Subcutaneous or
Endotracheal Use

Ansyr

Single-Dose Syringe

Hospira

◀ PRESS AND PULL TO OPEN ▶


* Please review the disclaimer below.