NDC 71872-7001 Atropine Sulfate

Atropine Sulfate

NDC Product Code 71872-7001

NDC 71872-7001-1

Package Description: 1 VIAL, SINGLE-DOSE in 1 BAG > 1 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Atropine Sulfate with NDC 71872-7001 is a a human prescription drug product labeled by Medical Purchasing Solutions, Llc. The generic name of Atropine Sulfate is atropine sulfate. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subcutaneous form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1666781.

Dosage Form: Injection, 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.

Product Type: Human Prescription Drug 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.

Atropine Sulfate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SULFURIC ACID (UNII: O40UQP6WCF)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Medical Purchasing Solutions, Llc
Labeler Code: 71872
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 11-01-1992 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

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Atropine Sulfate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Atropine Sulfate Injection, USP is a sterile, isotonic solution of Atropine Sulfate in Water for Injection q.s. Sodium Chloride added for isotonicity. pH adjusted with Sulfuric Acid. Preservative free.Atropine is a white crystalline alkaloid which may be extracted from belladonna root and hyoscyamine or may be produced synthetically. It is used in the form of atropine sulfate because this compound has much greater solubility in water. The structural formula of Atropine is as follows:

Clinical Pharmacology

Atropine has two actions. The most important therapeutic action is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves. Atropine also has central-nervous system activity, which may be stimulating or depressing depending upon the dose.

Indications And Usage

  • In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action.In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon.To relieve hypertonicity of the uterine muscle.To relax the spasm of biliary and uretered colic and bronchial spasm.To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders.To control the crying and laughing episodes in patients with brain lesions.In cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal EEG patterns, stupor and neurological signs.In the management of peptic ulcer.In anesthesia to control excessive salivation and bronchial secretions.To control rhinorrhea of acute rhinitis or hay fever.As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of Aminata and in cases of anticholinesterase insecticide poisoning.In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare “nerve gases”, large doses of atropine relieve the muscarine-like symptoms and some of the central-nervous-system manifestations. Adults suspected of contact with organic phosphorus insecticides of the parathion type should be given atropine sulfate, 0.8 mg, intramuscularly. If an atropine effect is not apparent within thirty minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements, and excessive sweating, salivation, and bronchial secretion), atropine sulfate, 2 mg, should be given intramuscularly at hourly intervals until signs of atropinization are observed. Up to two or three times this dose (4 to 6 mg) may be required in severe cases. Removing contaminated clothing, washing the skin, and commencing artificial respiration and supportive therapy are also indicated.

Contraindications

Conditions in which inhibition of postganglionic cholinergic nerves are undesirable, such as glaucoma and tachycardia. Also contraindicated in asthma, because the parenteral dose which might relieve asthma would have an excessive drying effect upon mucous plugs in the bronchi. Prostatic hypertrophy, while not a contraindication, requires special attention to signs of urinary retention.

Warnings

This drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children.

Doses of 0.5 to 1 mg of atropine are mildly stimulating to the central nervous system. Larger doses may produce mental disturbances; still larger doses are depressing. Death from atropine poisoning, though rare, is usually due to paralysis of the medullary centers.

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in mice in doses of 50 mg/kg of body weight and have revealed no evidence of impaired fertility or harm to the fetus due to Atropine Sulfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Adverse Reactions

  • Toxic effects from overdosage of atropine are not uncommon, especially in children. Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects.
  • 0.5 mg
  • Slight dryness of nose and mouth; bradycardia.
  • 1 mg
  • Greater dryness of nose and mouth, with thirst; slowing then acceleration of heart; slight mydriasis.
  • 2 mg
  • Very dry mouth; tachycardia with palpitation, mydriasis, slight blurring of near vision; flushed, dry skin.
  • 5 mg
  • Increase in above symptoms plus disturbance of speech; difficulty in swallowing; headache, hot, dry skin; restlessness, with asthenia.
  • 10 mg and over
  • Above symptoms to extreme degree, plus ataxia, excitement, disorientation, hallucinations, delirium, and coma.
  • 65 mg
  • May be fatal.A scarlatiniform rash may occur. Atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual.In the treatment of atropine poisoning, respiratory assistance and symptomatic support are indicated.Pilocarpine is sometimes given but is of limited value.

Overdosage

  • If marked excitement is present, a short acting barbiturate, chloral hydrate of paraldehyde may be used for sedation. Large doses should be avoided if possible and must be carefully controlled so that they will not add to the depressive stages of atropine poisoning.Artificial respiration with oxygen is necessary when respiration is depressed.Depression may be controlled by use of caffeine, sodium benzoate or picrotoxin together with the inhalation of oxygen.As a physiologic antidote, neostigmine methylsulfate may be given by intramuscular injection in doses of 500 mcg to 1 mg and repeated every 2 to 9 hours.Remaining therapy is purely symptomatic. Icebags and alcohol sponges help to reduce fever, especially in children. Careful nursing is essential. The room should be darkened, because of the patient’s marked photophobia.

Dosage And Administration

The usual adult dose of atropine is 0.4 to 0.6 mg. Suggested doses for children are as follows: 7 - 16 pounds - 0.1 mg 17 - 24 pounds - 0.15 mg 24 - 40 pounds - 0.2 mg 40 - 65 pounds - 0.3 mg 65 - 90 pounds - 0.4 mg Over 90 pounds - 0.4 to 0.6 mgAs indicated previously, however, these doses may be considerably exceeded in certain cases.Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

How Supplied

Product No. 


Concentration 


Vial/Ampule Size NDC 0517-0805-25 0.4 mg/0.5 mL 0.5 mL Ampule packed


in boxes of 25


 NDC 0517-0101-25 1.0 mg/1 mL 1 mL Ampule packed


in boxes of 25


 NDC 0517-0401-25 0.4 mg/1 mL 1 mL Single Dose Vial


packed in boxes of 25


 NDC 0517-1010-25 1.0 mg/1 mL 1 mL Single Dose Vial


packed in boxes of 25


Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).AMERICANREGENT, INC.SHIRLEY, NY 11967IN1010


Rev. 1/09

Outer Package Label

ATROPINE SULFATE
INJECTION, USP

Rx Only
0.4 mg/mLNDC 71872-7001-11 - 1 mL VialSINGLE DOSE VIALFOR INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS USEPRESERVATIVE FREEEach mL contains: Atropine Sulfate 0.4 mg, Sodium Chloride 9 mg, Water for Injection q.s. pH adjusted with Sulfuric Acid.WARNING: DISCARD UNUSED PORTION.
Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.

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