Label: PHYSOSTIGMINE SALICYLATE injection
- NDC Code(s): 51662-1439-1
- Packager: HF Acquisition Co LLC, DBA HealthFirst
- This is a repackaged label.
- Source NDC Code(s): 17478-510
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Updated February 22, 2020
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- SPL UNCLASSIFIED
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.
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 & USAGE
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.
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.
- USAGE IN PRENANCY
Nausea, vomiting and salivation; can be offset by reducing dosage. Bradycardia and convulsions, if intravenous administration is too rapid. See DOSAGE AND ADMINISTRATION.
- DOSAGE & ADMINISTRATION
- OVERDOSAGE OF DRUGS THAT CAUSE ANTICHOLINERGIC:
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.
PHYSOSTIGMINE SALICYLATE INJECTION is supplied in the following dosage forms.
PHYSOSTIGMINE SALICYLATE INJECTION (1mg/mL) 2mL AMPULE
HF Acquisition Co LLC, DBA HealthFirst
Mukilteo, WA 98275
Also supplied in the following manufacture supplied dosage forms
2 mL Ampules packed 10 per box, 1 mg per mL.
STORAGE: Store at 20° to 25°C (68° to 77°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.
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
- PRINCIPAL DISPLAY PANEL - AMPULE LABEL
- PRINCIPAL DISPLAY PANEL - SERIALIZED AMPULE LABELING
INGREDIENTS AND APPEARANCE
physostigmine salicylate injection
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1439(NDC:17478-510) Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYSOSTIGMINE SALICYLATE (UNII: 2046ZRO9VU) (PHYSOSTIGMINE - UNII:9U1VM840SP) PHYSOSTIGMINE SALICYLATE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM METABISULFITE (UNII: 4VON5FNS3C) BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51662-1439-1 2 mL in 1 AMPULE; Type 0: Not a Combination Product 12/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/22/2019 Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305) Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305) Establishment Name Address ID/FEI Business Operations HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel(51662-1439)