Drug Facts
Composition & Profile
Identifiers & Packaging
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.; PRINCIPAL DISPLAY PANEL - AMPULE LABEL AMPULE LABEL; PRINCIPAL DISPLAY PANEL - NDC 51662-1439-1 SERIALIZED AMPULE LABELING SERIALIZED AMPULE LABELING; PRINCIPAL DISPLAY PANEL, NDC 51662-1439-2 POUCH LABELING NDC 51662-1439-2 POUCH LABELING AMPULE LABELING POUCH LABELING AMPULE; PRINCIPAL DISPLAY PANEL, NDC 51662-1439-3 CASE LABELING 51662-1539-3 CASE LABELING SERIALIZED RFID LABELING Case Labeling Serialized Label
- 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.
- PRINCIPAL DISPLAY PANEL - AMPULE LABEL AMPULE LABEL
- PRINCIPAL DISPLAY PANEL - NDC 51662-1439-1 SERIALIZED AMPULE LABELING SERIALIZED AMPULE LABELING
- PRINCIPAL DISPLAY PANEL, NDC 51662-1439-2 POUCH LABELING NDC 51662-1439-2 POUCH LABELING AMPULE LABELING POUCH LABELING AMPULE
- PRINCIPAL DISPLAY PANEL, NDC 51662-1439-3 CASE LABELING 51662-1539-3 CASE LABELING SERIALIZED RFID LABELING Case Labeling Serialized Label
Overview
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
Indications & Usage
INDICATIONS & USAGE To reverse the effect upon the central nervous system, caused by clinical or toxic dosages of drugs capable of producing the anticholinergic syndrome.
Dosage & Administration
DOSAGE & 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.
Warnings & Precautions
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.
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
Nausea, vomiting and salivation; can be offset by reducing dosage. Bradycardia and convulsions, if intravenous administration is too rapid. See DOSAGE AND ADMINISTRATION.
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