PHYSOSTIGMINE SALICYLATE- physostigmine salicylate injection

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHYSOSTIGMINE SALICYLATE (UNII: 2046ZRO9VU) (PHYSOSTIGMINE - UNII:9U1VM840SP)
Available from:
A-S Medication Solutions
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
To reverse the effect upon the central nervous system, caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome. 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. 2.0 mg intramuscularly or INTRAVENOUSLY AT SLOW CONTROLLED RATE (SEE ABOVE). Dosage may be repeated if life threatening signs, such as arrhythmia, convulsions or coma occurs.
Product summary:
Product: 50090-4406 NDC: 50090-4406-0 2 mL in a AMPULE / 1 in a BAG
Authorization status:
unapproved drug other
Authorization number:
50090-4406-0

PHYSOSTIGMINE SALICYLATE- physostigmine salicylate injection

A-S Medication Solutions

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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Physostigmine Salicylate Injection

Rx only

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.

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 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.

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.

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.

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.

PRECAUTIONS:

Because of the possibility of hypersensitivity in an occasional patient, atropine sulfate injection should

always be at hand since it is an antagonist and antidote for physostigmine.

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.

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.

OVERDOSAGE:

Can cause a cholinergic crisis. Appropriate antidote is atropine sulfate.

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.

OVERDOSAGE OF DRUGS THAT CAUSE ANTICHOLINERGIC:

2.0 mg intramuscularly or INTRAVENOUSLY AT SLOW CONTROLLED RATE (SEE ABOVE).

Dosage may be repeated if life threatening signs, such as arrhythmia, convulsions or coma occurs.

PEDIATRIC DOSAGE:

Recommended dosage is 0.02 mg/kg; intramuscularly or by slow intravenous injection, no more than 0.5

mg per minute. If the toxic effects persist, and there is no sign of cholinergic effects, the dosage may

be repeated at 5 to 10 minute intervals until a therapeutic effect is obtained or a maximum of 2 mg

dosage is attained.

IN ALL CASES OF POISONING, THE USUAL SUPPORTIVE MEASURES SHOULD BE

UNDERTAKEN.

HOW SUPPLIED:

Product: 50090-4406

NDC: 50090-4406-0 2 mL in a AMPULE / 1 in a BAG

Storage

Manufactured by: Akorn, Inc. Lake Forest, IL 60045 Store at 20° to 25°C (68° to 77°F) [see USP

Controlled Room Temperature].

Physostigmine Salicylate

PHYSOSTIGMINE SALICYLATE

physostigmine salicylate injection

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 0 9 0 -440 6 (NDC:17478 -510 )

A-S Medication Solutions

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHYSO STIGMINE SALICYLATE (UNII: 20 46 ZRO9 VU) (PHYSOSTIGMINE -

UNII:9 U1VM8 40 SP)

PHYSOSTIGMINE

SALICYLATE

1 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

so dium meta bisulfite (UNII: 4VON5FNS3C)

benzyl a lco ho l (UNII: LKG8 49 4WBH)

wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -440 6 -0

1 in 1 BAG

0 7/0 1/20 19

1

2 mL in 1 AMPULE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 8 /10 /20 10

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -440 6 ) , REPACK(50 0 9 0 -440 6 )

Revised: 7/2019

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