{"id":"physostigmine","rwe":[],"_fda":{"id":"f1deeef3-92c7-a88e-e053-2a95a90a74a3","set_id":"9a448a78-356c-50f7-e053-2995a90adefa","openfda":{"unii":["2046ZRO9VU"],"route":["INTRAVENOUS"],"rxcui":["990982"],"spl_id":["f1deeef3-92c7-a88e-e053-2a95a90a74a3"],"brand_name":["PHYSOSTIGMINE SALICYLATE"],"spl_set_id":["9a448a78-356c-50f7-e053-2995a90adefa"],"package_ndc":["51662-1439-1","51662-1439-2","51662-1439-3"],"product_ndc":["51662-1439"],"generic_name":["PHYSOSTIGMINE SALICYLATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["PHYSOSTIGMINE SALICYLATE"],"manufacturer_name":["HF Acquisition Co LLC, DBA HealthFirst"],"original_packager_product_ndc":["17478-510"]},"version":"3","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."],"pregnancy":["USAGE IN PRENANCY 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.","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":["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"],"precautions":["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."],"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."],"effective_time":"20230109","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."],"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."],"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 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":["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."],"spl_unclassified_section":["SPL UNCLASSIFIED Rx only"],"dosage_and_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."],"spl_product_data_elements":["PHYSOSTIGMINE SALICYLATE PHYSOSTIGMINE SALICYLATE PHYSOSTIGMINE SALICYLATE PHYSOSTIGMINE SODIUM METABISULFITE BISULFITE ION BENZYL ALCOHOL WATER"],"package_label_principal_display_panel":["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"]},"tags":[{"label":"physostigmine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Acetylcholinesterase","category":"target"},{"label":"ACHE","category":"gene"},{"label":"CYP2D6","category":"gene"},{"label":"BCHE","category":"gene"},{"label":"S01EB05","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Anticholinergic Toxicity","category":"indication"},{"label":"Open-angle glaucoma","category":"indication"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinesterase Inhibitors","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Miotics","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"ANTICHOLINERGIC SYNDROME","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"NEUROMUSCULAR BLOCK PROLONGED","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"BLOOD CREATINE PHOSPHOKINASE INCREASED","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"BLOOD POTASSIUM INCREASED","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"BRADYCARDIA","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"CARDIAC ARREST","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"HYPERTHERMIA MALIGNANT","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"MYOGLOBIN BLOOD INCREASED","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"POOR QUALITY DRUG ADMINISTERED","source":"FDA FAERS","actionTaken":"1 reports"}],"commonSideEffects":[{"effect":"Bradycardia","drugRate":"reported","severity":"unknown"},{"effect":"Convulsions","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Salivation","drugRate":"reported","severity":"unknown"}],"contraindications":["Anterior uveitis","Asthma","Bradycardia","Diabetes mellitus","Disorder of cardiovascular system","Epilepsy","Gangrene","Gastrointestinal obstruction","Iritis","Keratitis","Neuromuscular block, function","Parkinsonism","Pupillary Block Glaucoma","Retinal detachment","Urinary tract obstruction"],"specialPopulations":{"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.","Paediatric use":"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 to 10 minute intervals until therapeutic effect is obtained or maximum of mg dosage is attained.IN ALL CASES OF POISONING, THE USUAL SUPPORTIVE MEASURES SHOULD BE UNDERTAKEN."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PHYSOSTIGMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:59:05.572961+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:59:29.671572+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:59:17.491297+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PHYSOSTIGMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:59:18.134099+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:59:03.356837+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:59:03.356964+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:59:19.601930+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4566020/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:59:18.603859+00:00"}},"allNames":"cogmine","offLabel":[],"synonyms":["physostigmine","cogmine","eserine","esromiotin","(-)-Physostigmine","physostigmine salicylate","eserine hemisulfate salt","eserine hemisulfate"],"timeline":[{"date":"1875-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"aiSummary":"Physostigmine (Cogmine) is a marketed drug primarily indicated for anticholinergic toxicity, with a key composition patent expiring in 2028. Its mechanism of temporarily blocking the breakdown of acetylcholine provides a distinct therapeutic advantage in managing conditions characterized by reduced cholinergic activity. The primary risk to Physostigmine's market position is the presence of multiple off-patent competitors, including pilocarpine, carbachol, and neostigmine, which are widely available as generics.","approvals":[{"date":"1875-01-01","orphan":false,"company":"","regulator":"YEAR INTRODUCED"}],"brandName":"Cogmine","ecosystem":[{"indication":"Anticholinergic Toxicity","otherDrugs":[],"globalPrevalence":null},{"indication":"Open-angle glaucoma","otherDrugs":[{"name":"acetazolamide","slug":"acetazolamide","company":"Teva Branded Pharm"},{"name":"apraclonidine","slug":"apraclonidine","company":"Alcon"},{"name":"betaxolol","slug":"betaxolol","company":"Alcon"},{"name":"bimatoprost","slug":"bimatoprost","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Acetylcholinesterase","targets":[{"gene":"ACHE","source":"DrugCentral","target":"Acetylcholinesterase","protein":"Acetylcholinesterase"},{"gene":"CYP2D6","source":"DrugCentral","target":"Cytochrome P450 2D6","protein":"Cytochrome P450 2D6"},{"gene":"BCHE","source":"DrugCentral","target":"Cholinesterase","protein":"Cholinesterase"}],"modality":"Small Molecule","drugClass":"physostigmine","explanation":"","oneSentence":"","technicalDetail":"Physostigmine is a reversible, competitive inhibitor of acetylcholinesterase, the enzyme responsible for hydrolyzing acetylcholine into choline and acetic acid. By inhibiting this enzyme, physostigmine increases the concentration and duration of action of acetylcholine in the synaptic cleft, leading to its therapeutic 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syndrome"},{"name":"Open-angle glaucoma","source":"DrugCentral","snomedId":84494001,"regulator":"FDA"}],"offLabel":[{"name":"Angle-closure glaucoma","source":"DrugCentral","drugName":"PHYSOSTIGMINE"},{"name":"Hereditary Ataxias","source":"DrugCentral","drugName":"PHYSOSTIGMINE","evidenceCount":5,"evidenceLevel":"emerging"},{"name":"Secondary glaucoma","source":"DrugCentral","drugName":"PHYSOSTIGMINE"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"pilocarpine","brandName":"pilocarpine","genericName":"pilocarpine","approvalYear":"1974","relationship":"same-class"},{"drugId":"carbachol","brandName":"carbachol","genericName":"carbachol","approvalYear":"1972","relationship":"same-class"},{"drugId":"echothiophate","brandName":"echothiophate","genericName":"echothiophate","approvalYear":"1960","relationship":"same-class"},{"drugId":"demecarium","brandName":"demecarium","genericName":"demecarium","approvalYear":"1959","relationship":"same-class"},{"drugId":"neostigmine","brandName":"neostigmine","genericName":"neostigmine","approvalYear":"2013","relationship":"same-class"},{"drugId":"fluostigmine","brandName":"fluostigmine","genericName":"fluostigmine","approvalYear":"1957","relationship":"same-class"},{"drugId":"acetylcholine","brandName":"acetylcholine","genericName":"acetylcholine","approvalYear":"1973","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06399679","phase":"PHASE2","title":"Rivastigmine 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Acetylcholine on Memory and Attention","status":"COMPLETED","sponsor":"National Institute of Mental Health (NIMH)","startDate":"2000-01","conditions":["Alzheimer's Disease","Healthy"],"enrollment":70,"completionDate":"2001-04"},{"nctId":"NCT00001917","phase":"","title":"Brain Imaging in Elderly People and Individuals With Alzheimer's Disease","status":"COMPLETED","sponsor":"National Institute of Mental Health (NIMH)","startDate":"1999-04","conditions":["Alzheimer's Disease","Healthy"],"enrollment":150,"completionDate":"2005-04"},{"nctId":"NCT00608621","phase":"","title":"Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients","status":"COMPLETED","sponsor":"Klinikum 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