Physostigmine Salicylate

Akorn
Human Prescription Drug
NDC 17478-510

Physostigmine Salicylate is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Physostigmine Salicylate is 17478-510. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Physostigmine Salicylate drug includes Physostigmine Salicylate - 1 mg/mL . The currest status of Physostigmine Salicylate drug is Active.

Drug Information:

Drug NDC:	17478-510
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Physostigmine Salicylate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Physostigmine Salicylate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Akorn
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Injection
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	PHYSOSTIGMINE SALICYLATE - 1 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	10 Aug, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Akorn
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	990982
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0317478510024
UPC stands for Universal Product Code.
UNII:	2046ZRO9VU
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
17478-510-02	10 AMPULE in 1 CARTON (17478-510-02) / 2 mL in 1 AMPULE	10 Aug, 2010	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Physostigmine salicylate physostigmine salicylate physostigmine salicylate physostigmine sodium metabisulfite benzyl alcohol water

Indications and Usage:

Indications and usage: to reverse the effect upon the central nervous system, caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome.

Warnings:

Warnings: contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. the overall prevalence of sulfite sensitivity in the general population is unknown and probably low. sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. if excessive symptoms of salivation, emesis, urination and defecation occur, the use of physostigmine salicylate injection should be terminated. if excessive sweating or nausea occur, the dosage should be reduced. intravenous administration should be at a slow, controlled rate, no more than 1 mg per minute (see dosage ). rapid administration can cause bradycardia, hypersalivation leading to a respiratory difficulties and possible convulsions. an overdosage of physostigmine salicylate injection can cause a cholinergic crisis.

Dosage and Administration:

Dosage and administration: past anesthesia care: 0.5 to 1.0 mg intramuscularly or intravenously. intravenous administration should be at a slow controlled rate of no more than 1 mg per minute. dosage may be repeated at intervals of 10 to 30 minutes if desired patient response is not obtained.

Contraindications:

Contraindications: physostigmine salicylate injection should not be used in the presence of asthma, gangrene, diabetes, cardiovascular disease, mechanical obstruction of the intestine or urogenital tract or any vagotonic state, and in patients receiving choline esters and depolarizing neuromuscular blocking agents (decamethonium, succinylcholine). for post-anesthesia, the concomitant use of atropine with physostigmine salicylate is not recommended, since the atropine antagonizes the action of physostigmine.

Adverse Reactions:

Adverse reactions: nausea, vomiting and salivation; can be offset by reducing dosage. bradycardia and convulsions, if intravenous administration is too rapid. see dosage and administration .

Use in Pregnancy:

Usage in pregnancy: safe use in pregnancy and lactation has not been established; therefore, use in pregnant women, nursing mothers or women who may become pregnant requires that possible benefits be weighed against possible hazards to mother and child.

Overdosage:

Overdosage: can cause a cholinergic crisis. appropriate antidote is atropine sulfate.

Description:

Description: physostigmine salicylate injection is a derivative of the calabar bean, and its active moiety, physostigmine, is also known as eserine. its chemical structure is: it is soluble in water and a 0.5% aqueous solution has a ph of 5.8. physostigmine salicylate injection is available in 2 ml ampules, each ml containing 1 mg of physostigmine salicylate in a vehicle composed of sodium metabisulfite 0.1%, benzyl alcohol 2.0% as a preservative in water for injection. chemical structure

Clinical Pharmacology:

Clinical pharmacology: physostigmine salicylate injection is a reversible anticholinesterase which effectively increases the concentration of acetylcholine at the sites of cholinergic transmission. the action of acetylcholine is normally very transient because of its hydrolysis by the enzyme, acetylcholinesterase. physostigmine salicylate injection inhibits the destructive action of acetylcholinesterase and thereby prolongs and exaggerates the effect of the acetylcholine. physostigmine salicylate injection contains a tertiary amine and easily penetrates the blood brain barrier, while an anticholinesterase, such as neostigmine, which has a quaternary ammonium ion is not capable of crossing the barrier. physostigmine salicylate injection can reverse both central and peripheral anticholinergia. the anticholinergic syndrome has both central and peripheral signs and symptoms. central toxic effects include anxiety, delirium, disorientation, hallucinations, hyperactivity and seizures. severe Read more...

poisoning may produce coma, medullary paralysis and death. peripheral toxicity is characterized by tachycardia, hyperpyrexia, mydriasis, vasodilation, urinary retention, diminution of gastrointestinal motility, decrease of secretion in salivary and sweat glands, and loss of secretions in the pharynx, bronchi, and nasal passages. dramatic reversal of the effects of anticholinergic symptoms can be expected in minutes after the intravenous administration of physostigmine salicylate injection, if the diagnosis is correct and the patient has not suffered anoxia or other insult. the duration of action of physostigmine salicylate injection is relatively short, approximately 45 to 60 minutes. numerous drugs and some plants produce the anticholinergic syndrome either directly or as a side effect; this undesirable or potentially dangerous phenomenon may be brought about by either therapeutic doses or overdoses of the drugs. such drugs include among others, atropine, other derivatives of the belladonna alkaloids, tricyclic antidepressants, phenothiazines, and antihistamines.

How Supplied:

How supplied: ndc 17478-510-02 2 ml ampules packed 10 per box, 1 mg per ml. storage: store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. some drugs which produce the anticholinergic syndrome amitriptyline, amoxapine, anisotropine, atropine, benztropine, biperiden, carbinoxamine, clidinium, cyclobenzaprine, desipramine, doxepin, homatropine, hyoscine, hyoscyamine, hyoscyamus, imipramine, lorazepam, maprotiline, mepenzolate, nortriptyline, propantheline, protriptyline, scopolamine, trimipramine. some plants that produce the anticholinergic syndrome black henbane, deadly night shade, devil's apple, jimson weed, loco seeds or weeds, matrimony vine, night blooming jessamine, stinkweed. akorn distributed by: akorn operating company llc gurnee, il 60031 ps00n rev. 10/22

Package Label Principal Display Panel:

Principal display panel text for carton label: ndc 17478-510-02 physostigmine salicylate injection (1 mg/ml) for intramuscular or intravenous use 10 ampules (2 ml each) rx only akorn logo principal display panel text for carton label

Principal display panel text for container label: ndc 17478-510-02 physostigmine salicylate injection (1 mg/ml) for i.m or i.v. use 2 ml single dose ampule rx only principal display panel text for container label

Comments/ Reviews:

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