Physostigmine Salicylate
Injection · Intravenous
Uses
To reverse the effect upon the central nervous system, caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome.
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. 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.
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.
Side effects
Nausea, vomiting and salivation; can be offset by reducing dosage. Bradycardia and convulsions, if intravenous administration is too rapid. See DOSAGE AND ADMINISTRATION.
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
Can cause a cholinergic crisis. Appropriate antidote is atropine sulfate. 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.
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. STRUCTURE
How supplied
HOW SUPPLIED PHYSOSTIGMINE SALICYLATE INJECTION is supplied in the following dosage forms. NDC 51662-1439-1 PHYSOSTIGMINE SALICYLATE INJECTION (1mg/mL) 2mL AMPULE NDC 51662-1439-2 PHYSOSTIGMINE SALICYLATE INJECTION (1mg/mL) 2mL AMPULE, 1 AMPULE/POUCH NDC 51662-1439-3 PHYSOSTIGMINE SALICYLATE INJECTION (1mg/mL) 2mL AMPULE, 1 AMPULE/POUCH, 10 POUCHES/CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 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.
Label text from the FDA structured product label by HF Acquisition Co LLC, DBA HealthFirst (revised Jan 9, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Physostigmine Salicylate in 1 product
Physostigmine Salicylate NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 51662-1439 | Physostigmine Salicylate 1 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Physostigmine Salicylate used for?
To reverse the effect upon the central nervous system, caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome.
What are the side effects of Physostigmine Salicylate?
Nausea, vomiting and salivation; can be offset by reducing dosage. Bradycardia and convulsions, if intravenous administration is too rapid. See DOSAGE AND ADMINISTRATION. See the full label for the complete list.
Who makes Physostigmine Salicylate?
Physostigmine Salicylate is listed by 1 labeler in the FDA NDC directory, including HF Acquisition Co LLC, DBA HealthFirst.