{"id":"lomotil","rwe":[{"pmid":"41870844","year":"2026","title":"STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03.","finding":"","journal":"Ophthalmology and therapy","studyType":"Clinical Study"},{"pmid":"41588817","year":"2026","title":"In Vitro Effects of Liquid Cardiac Drugs on Human Catalase Enzyme.","finding":"","journal":"Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir","studyType":"Clinical Study"},{"pmid":"41478370","year":"2026","title":"Antidote administration in mice exposed to sarin resulted in brainwave stabilization without cognitive protection.","finding":"","journal":"Neuroscience research","studyType":"Clinical Study"},{"pmid":"41476477","year":"2025","title":"Development and Validation of an Eco-Friendly HPLC Stability-Indicating Technique for Quantification of Atropine Sulfate and Benzyl Alcohol in Raw and Injectable Solutions.","finding":"","journal":"ACS omega","studyType":"Clinical Study"},{"pmid":"41426888","year":"2025","title":"Use of a Temporary Pacemaker During Cesarean Section in a Pregnant Patient With Neurally Mediated Syncope: A Case Report.","finding":"","journal":"Cureus","studyType":"Clinical Study"}],"_fda":{"id":"100be173-227f-a802-e063-6294a90ae92e","set_id":"0060b971-19bd-2849-e063-6294a90afca8","openfda":{"unii":["03J5ZE7KA5"],"route":["INTRAVENOUS"],"rxcui":["1190795"],"spl_id":["100be173-227f-a802-e063-6294a90ae92e"],"brand_name":["ATROPINE SULFATE"],"spl_set_id":["0060b971-19bd-2849-e063-6294a90afca8"],"package_ndc":["51662-1626-1","51662-1626-2","51662-1626-3"],"product_ndc":["51662-1626"],"generic_name":["ATROPINE SULFATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ATROPINE SULFATE"],"manufacturer_name":["HF Acquisition Co LLC, DBA HealthFirst"],"application_number":["ANDA216120"],"original_packager_product_ndc":["0517-1001"]},"version":"4","overdosage":["10 OVERDOSAGE Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal. In the event of toxic overdosage, a short acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required. Artificial respiration with oxygen may be necessary. Ice bags and alcohol sponges help to reduce fever, especially in pediatric populations. Atropine is not removed by dialysis."],"description":["11 DESCRIPTION Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.4 mg or 1 mg of atropine sulfate monohydrate equivalent to 0.332 mg or 0.83 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsmol/mL (calc.). pH (3.0 to 5.0). The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 ∙ H2SO4 ∙ H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula: Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. STRUCTURE"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Injection, USP 1 mg/mL is supplied in 1 mL, single-dose glass vial. NDC 51662-1626-1 ATROPINE SULFATE INJECTION, USP 1mg/mL 1mL VIAL Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275"],"effective_time":"20240128","adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation."],"contraindications":["4 CONTRAINDICATIONS None."],"drug_interactions":["7 DRUG INTERACTIONS 7.1 Mexiletine Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia."],"recent_major_changes":[""],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Atropine is an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters. Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine). The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation also may be inhibited by atropine, but this occurs less readily than with responses to injected (exogenous) choline esters. 12.2 Pharmacodynamics Atropine-induced parasympathetic inhibition may be preceded by a transient phase of stimulation, especially on the heart where small doses first slow the rate before characteristic tachycardia develops due to paralysis of vagal control. Atropine exerts a more potent and prolonged effect on heart, intestine and bronchial muscle than scopolamine, but its action on the iris, ciliary body and certain secretory glands is weaker than that of scopolamine. Unlike the latter, atropine in clinical doses does not depress the central nervous system but may stimulate the medulla and higher cerebral centers. Although mild vagal excitation occurs, the increased respiratory rate and (sometimes) increased depth of respiration produced by atropine are more probably the result of bronchiolar dilatation. Accordingly, atropine is an unreliable respiratory stimulant and large or repeated doses may depress respiration. Adequate doses of atropine abolish various types of reflex vagal cardiac slowing or asystole. The drug also prevents or abolishes bradycardia or asystole produced by injection of choline esters, anticholinesterase agents or other parasympathomimetic drugs, and cardiac arrest produced by stimulation of the vagus. Atropine also may lessen the degree of partial heart block when vagal activity is an etiologic factor. In some patients with complete heart block, the idioventricular rate may be accelerated by atropine; in others, the rate is stabilized. Occasionally a large dose may cause atrioventricular (A-V) block and nodal rhythm. Atropine Sulfate Injection, USP in clinical doses counteracts the peripheral dilatation and abrupt decrease in blood pressure produced by choline esters. However, when given by itself, atropine does not exert a striking or uniform effect on blood vessels or blood pressure. Systemic doses slightly raise systolic and lower diastolic pressures and can produce significant postural hypotension. Such doses also slightly increase cardiac output and decrease central venous pressure. Occasionally, therapeutic doses dilate cutaneous blood vessels, particularly in the \"blush\" area (atropine flush), and may cause atropine \"fever\" due to suppression of sweat gland activity in infants and small children. The effects of intravenous atropine on heart rate (maximum heart rate) and saliva flow (minimum flow) after intravenous administration (rapid, constant infusion over 3 min.) are delayed by 7 to 8 minutes after drug administration and both effects are non-linearly related to the amount of drug in the peripheral compartment. Changes in plasma atropine levels following intramuscular administration (0.5 to 4 mg doses) and heart rate are closely overlapped but the time course of the changes in atropine levels and behavioral impairment indicates that pharmacokinetics is not the primary rate-limiting mechanism for the central nervous system effect of atropine. 12.3 Pharmacokinetics Atropine disappears rapidly from the blood following injection and is distributed throughout the body. Exercise, both prior to and immediately following intramuscular administration of atropine, significantly increases the absorption of atropine due to increased perfusion in the muscle and significantly decreases the clearance of atropine. The pharmacokinetics of atropine is nonlinear after intravenous administration of 0.5 to 4 mg. Atropine's plasma protein binding is about 44% and saturable in the 2 to 20 mcg/mL concentration range. Atropine readily crosses the placental barrier and enters the fetal circulation, but is not found in amniotic fluid. Much of the drug is destroyed by enzymatic hydrolysis, particularly in the liver; from 13 to 50% is excreted unchanged in the urine. Traces are found in various secretions, including milk. The major metabolites of atropine are noratropine, atropin-n-oxide, tropine, and tropic acid. The metabolism of atropine is inhibited by organophosphate pesticides. Specific Populations The elimination half-life of atropine is more than doubled in children under two years and the elderly (>65 years old) compared to other age groups. There is no gender effect on the pharmacokinetics and pharmacodynamics (heart rate changes) of atropine."],"indications_and_usage":["1 INDICATIONS & USAGE Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS 5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand. 5.2 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy. 5.5 Viscid Plugs Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed to evaluate the carcinogenic or mutagenic potential of atropine or its potential to affect fertility adversely."],"spl_unclassified_section":["HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE INJECTION, for intravenous use Initial U.S. Approval: 1960 INDICATIONS AND USAGE Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. ( 1 ) DOSAGE AND ADMINISTRATION For intravenous administration. ( 2 ). Titrate according to heart rate, PR interval, blood pressure and symptoms. ( 2 ) Adult dosage Antisialagogue or for antivagal effects: Initial single dose of 0.5 to 1 mg. ( 2 ) Antidote for organophosphorus or muscarinic mushroom poisoning: Initial single dose of 2 to 3 mg, repeated every 20 to 30 minutes. ( 2 ) Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3 to 5 minutes if asystole persists. ( 2 ) Patients with Coronary Artery Disease: Limit the total dose to 0.03 mg/kg to 0.04 mg/kg. ( 2 ) DOSAGE FORMS AND STRENGTHS Injection: 0.4 or 1 mg/mL as a clear, colorless solution in a single-dose vial. ( 3 ) CONTRAINDICATIONS None. ( 4 ) WARNINGS AND PRECAUTIONS Tachycardia ( 5 ) Glaucoma ( 5 ) Pyloric obstruction ( 5 ) Worsening urinary retention ( 5 ) Viscid bronchial plugs ( 5 ) ADVERSE REACTIONS Most adverse reactions are directly related to atropine's antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Mexiletine: Decreases rate of mexiletine absorption. ( 7 ) Revised: 9/2021","TABLE OF CONTENTS FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 General Administration 2.2 Adult Dosage 2.3 Pediatric Dosage 2.4 Dosing in Patients with Coronary Artery Disease 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Tachycardia 5.2 Acute Glaucoma 5.3 Pyloric Obstruction 5.4 Complete Urinary Retention 5.5 Viscid Plugs 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 7.1 Mexiletine 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING * Sections or subsections omitted from the full prescribing information are not listed."],"dosage_and_administration":["2 DOSAGE & ADMINISTRATION 2.1 General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Each vial is intended for single dose only. Discard unused portion. For Intravenous administration. Titrate based on heart rate, PR interval, blood pressure and symptoms. 2.2 Adult Dosage 2.3 Pediatric Dosage Dosing in pediatric populations has not been well studied. Usual initial dose is 0.01 to 0.03 mg/kg. 2.4 Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 to 0.04 mg/kg [see WARNINGS AND PRECAUTIONS (5.1 )]. DOSAGE"],"spl_product_data_elements":["ATROPINE SULFATE ATROPINE SULFATE SULFURIC ACID ATROPINE SULFATE ATROPINE SODIUM HYDROXIDE SODIUM CHLORIDE WATER"],"dosage_forms_and_strengths":["3 DOSAGE FORM & STRENGTH Injection: supplied as a clear, colorless solution in a 1 mL glass vial in the following concentrations: 0.4 mg/mL: containing 0.4 mg of atropine sulfate monohydrate equivalent to 0.332 mg of atropine. 1 mg/mL: containing 1 mg atropine sulfate monohydrate equivalent to 0.83 mg of atropine."],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATION 8.1 Pregnancy Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations). Available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Animal reproduction studies have not been conducted with atropine. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus. Data Human Data Atropine crosses the placenta [see Clinical Pharmacology (12.3) ]. No adequate and well-controlled studies are available regarding use of atropine in pregnant women. In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation. In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. No specific pattern of major birth defects was identified. In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug associated risk during pregnancy. 8.2 Lactation Risk Summary Trace amounts of atropine have been reported in human milk after oral intake. There are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production. Clinical Considerations Minimizing exposure The elimination half-life of atropine is more than doubled in children less than 2 years of age [SEE CLINICAL PHARMACOLOGY (12.3)]. To minimize potential infant exposure to Atropine Sulfate Injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant. 8.4 Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials. 8.5 Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 51662-1626-1 - ATROPINE SULFATE INJECTION, USP 1mg/mL 1mL VIAL NDC 51662-1626-1 SERIALIZED LABELING VIAL LABEL RFID Label VIAL","PRINCIPAL DISPLAY PANEL, POUCH LABEL 51662-1626-2 Pouch Label Pouch label","PRINCIPAL DISPLAY PANEL, CASE LABEL 51662-1626-3 CASE LABEL Case Label RFID LABEL"]},"tags":[{"label":"Anticholinergic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Muscarinic acetylcholine receptor M3","category":"target"},{"label":"CHRM3","category":"gene"},{"label":"CHRM4","category":"gene"},{"label":"CHRM1","category":"gene"},{"label":"A03BA01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Intramuscular","category":"route"},{"label":"Endotracheal","category":"route"},{"label":"Elixir","category":"form"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Perioperative Mydriasis","category":"indication"},{"label":"Alcon Labs Inc","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Adjuvants, Anesthesia","category":"pharmacology"},{"label":"Anti-Arrhythmia Agents","category":"pharmacology"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Bronchodilator Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Antagonists","category":"pharmacology"},{"label":"Muscarinic Antagonists","category":"pharmacology"},{"label":"Mydriatics","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Parasympatholytics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"marketed","fdaNDC":[{"route":["ENDOTRACHEAL","INTRAMEDULLARY","INTRAMUSCULAR","INTRAVENOUS","SUBCUTANEOUS"],"labeler":"ProPharma Distribution","brandName":"Atropine Sulfate","packaging":[{"ndc":"84549-580-20","description":"20 mL in 1 VIAL, MULTI-DOSE (84549-580-20)","marketingStartDate":"20250827"}],"dosageForm":"INJECTION, SOLUTION","genericName":"Atropine Sulfate","productType":"HUMAN PRESCRIPTION DRUG","activeIngredients":[{"name":"ATROPINE SULFATE","strength":".4 mg/mL"}],"marketingCategory":"NDA"},{"route":["INTRAVENOUS"],"labeler":"HF Acquisition Co. 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Available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Animal reproduction studies have not been conducted with atropi"},"seriousAdverseEvents":[{"event":"Febrile neutropenia","detail":"Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"66.7%"},{"event":"Platelet count decreased","detail":"Investigations. 1 trial(s).","severity":"serious","incidence":"66.7%"},{"event":"Abdominal pain","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Back pain","detail":"Musculoskeletal and connective tissue disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Blood and lymphatic system disorders - Other, specify: Pure red cell aplasia","detail":"Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Depressed level of consciousness","detail":"Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Hypokalemia","detail":"Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Hypophosphatemia","detail":"Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Hypotension","detail":"Vascular disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Hypoxia","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Pleural effusion","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Pulmonary edema","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Anemia","detail":"Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"100.0%"},{"event":"Lymphocyte count decreased","detail":"Investigations. 1 trial(s).","severity":"serious","incidence":"100.0%"},{"event":"Neutrophil count decreased","detail":"Investigations. 1 trial(s).","severity":"serious","incidence":"100.0%"},{"event":"White blood cell decreased","detail":"Investigations. 1 trial(s).","severity":"serious","incidence":"100.0%"},{"event":"Acute kidney injury","detail":"Renal and urinary disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Biliary tract infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Bone marrow hypocellular","detail":"Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Capillary leak syndrome","detail":"Vascular disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Catheter related infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Delirium","detail":"Psychiatric disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Dysphagia","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Hepatobiliary disorders - Other, specify: Biliary tract obstruction","detail":"Hepatobiliary disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Immune system disorders - Other, specify","detail":"Immune system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Infections and infestations - Other, specify: Pseudomonas bacteremia","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Metabolism and nutrition disorders - Other, specify: Malnutrition","detail":"Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Rectal hemorrhage","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Respiratory failure","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Soft tissue infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"}]},"trials":[],"aliases":[],"company":"Alcon Labs Inc","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$7.1821/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$2,586","description":"ATROPINE 1% EYE DROPS","retrievedDate":"2026-04-07"}],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T21:30:47.535907+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T21:31:02.054196+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T21:30:48.286257+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:55:18.447726+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:27:03.273210+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1396281/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T21:30:55.297516+00:00"},"fdaRecalls":{"url":"","method":"api_direct","source":"FDA Enforcement/Recalls","rawText":"","confidence":1,"sourceType":"fda_enforcement","retrievedAt":"2026-04-19T21:30:53.281392+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T21:30:37.206907+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Injection, USP 1 mg/mL is supplied in 1 mL, single-dose glass vial. NDC 51662-1626-1 ATROPINE SULFATE INJECTION, USP 1mg/mL 1mL VIAL Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T21:30:27.325628+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:31:11.745587+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"11 DESCRIPTION Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.4 mg or 1 mg of atropine sulfate monohydrate equivalent to 0.332 mg or 0.83 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment. 0.308 mOsm","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T21:30:37.206835+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label (pharmacokinetics)","aiModel":"featherless","rawText":"12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Atropine is an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters. Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism w","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T21:30:27.325546+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T21:30:53.406524+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T21:30:52.886971+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T21:30:54.500307+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=Atropine Sulfate","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T21:30:47.144757+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:31:11.745507+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T21:30:49.102944+00:00"},"nonclinicalToxicology":{"url":"","method":"deterministic","source":"FDA Label (nonclinical_toxicology)","rawText":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed to evaluate the carcinogenic or mutagenic potential of atropine or its potential to affect fertility adversely.","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T21:30:37.206903+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:31:11.745504+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:18.447709+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T08:27:03.542021+00:00"},"safety.specialPopulations":{"url":"","method":"deterministic","source":"FDA Label (special populations)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T21:30:43.797131+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:55:16.111712+00:00"}},"allNames":"enlon-plus","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46d5b27b-a710-4767-b308-4f673ddb354c","setid":"46d5b27b-a710-4767-b308-4f673ddb354c","title":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PREFERRED PHARMACEUTICALS INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46ba6000-b842-449a-8dd4-7bb9dc7a74c5","setid":"46ba6000-b842-449a-8dd4-7bb9dc7a74c5","title":"ATROPINE SULFATE INJECTION [REMEDYREPACK INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64be1529-f290-422c-a076-32c0e1ced1a1","setid":"64be1529-f290-422c-a076-32c0e1ced1a1","title":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BRYANT RANCH PREPACK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1fa11c67-5492-469c-9475-6bfa0e5e9ff8","setid":"1fa11c67-5492-469c-9475-6bfa0e5e9ff8","title":"MOTOFEN (DIFENOXIN AND ATROPINE SULFATE) TABLET [LEGACY PHARMA USA INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8093125-ed1a-4eb6-9c81-52c5c7376481","setid":"c8093125-ed1a-4eb6-9c81-52c5c7376481","title":"ATROPINE SULFATE SOLUTION [ALCON LABORATORIES, INC.]"}],"offLabel":[],"synonyms":["atropine","(+/-)-Atropine","atropin","atropinum sulphuricum","DL-Hyoscyamine","tropine tropate","atropine sulfate"],"timeline":[{"date":"1960-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from GD SEARLE LLC to Alcon Labs Inc"},{"date":"1960-09-15","type":"positive","source":"DrugCentral","milestone":"FDA approval (Gd Searle Llc)"},{"date":"1990-09-19","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Us Army)"},{"date":"2001-07-09","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Hospira)"},{"date":"2014-07-18","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Rising)"},{"date":"2018-01-26","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Fresenius Kabi Usa)"},{"date":"2020-09-29","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Accord Hlthcare)"},{"date":"2022-03-15","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Bausch And Lomb Inc)"},{"date":"2024-04-29","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 9 manufacturers approved"}],"aiSummary":"Atropine Sulfate Injection is an antimuscarinic agent indicated for temporary blockade of severe or life-threatening muscarinic effects including organophosphorus poisoning and bradyasystolic cardiac arrest. It competitively antagonizes muscarinic acetylcholine receptors on peripheral structures with no absolute contraindications. The drug may cause transient cardiac stimulation before tachycardia develops and can interact with mexiletine by delaying absorption. Atropine remains a critical emergency antidote with established clinical utility in acute poisoning and cardiac dysrhythmia management.","brandName":"Enlon-Plus","ecosystem":[{"indication":"Perioperative Mydriasis","otherDrugs":[{"name":"cyclopentolate","slug":"cyclopentolate","company":"Alcon Labs Inc"},{"name":"homatropine","slug":"homatropine","company":""},{"name":"scopolamine","slug":"scopolamine","company":"Novartis"},{"name":"tropicamide","slug":"tropicamide","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Muscarinic acetylcholine receptors","novelty":"Follow-on","targets":[{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"},{"gene":"HTR2C","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2C","protein":"5-hydroxytryptamine receptor 2C"},{"gene":"ADRA1D","source":"DrugCentral","target":"Alpha-1D adrenergic receptor","protein":"Alpha-1D adrenergic receptor"},{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor"},{"gene":"HTR2A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2A","protein":"5-hydroxytryptamine receptor 2A"},{"gene":"SLC22A1","source":"DrugCentral","target":"Solute carrier family 22 member 1","protein":"Solute carrier family 22 member 1"}],"moaClass":"Cholinergic Antagonists","modality":"Competitive antagonist","drugClass":"Antimuscarinic agent","explanation":"Atropine is an antimuscarinic agent that antagonizes the muscarine-like actions of acetylcholine and other choline esters. It inhibits muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to endogenous acetylcholine. The antagonism is competitive or surmountable, meaning it can be overcome by increasing acetylcholine concentration at receptor sites, such as through anticholinesterase agents that inhibit acetylcholine enzymatic destruction.\n\nAtropine antagonizes receptors on peripheral structures stimulated or inhibited by muscarine, including exocrine glands and smooth and cardiac muscle. Responses to postganglionic cholinergic nerve stimulation may also be inhibited, though less readily than responses to injected exogenous choline esters.\n\nAtropine-induced parasympathetic inhibition may be preceded by transient stimulation, particularly on the heart where small doses initially slow the rate before characteristic tachycardia develops due to vagal paralysis. Atropine exerts more potent and prolonged effects on heart, intestine, and bronchial muscle than scopolamine, though its action on iris, ciliary body, and certain secretory glands is weaker than scopolamine.","oneSentence":"Atropine antagonizes muscarine-like actions of acetylcholine through competitive antagonism at peripheral muscarinic receptors.","technicalDetail":"Enlon-Plus (Atropine Sulfate) is a competitive antagonist of the muscarinic acetylcholine receptor M3, inhibiting the parasympathetic nervous system's effect on the iris sphincter muscle, leading to mydriasis."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Atropine","title":"Atropine","extract":"Atropine is a tropane alkaloid and anticholinergic medication used to treat certain types of nerve agent and pesticide poisonings as well as some types of slow heart rate, and to decrease saliva production during surgery. It is typically given intravenously or by injection into a muscle. Eye drops are also available which are used to treat uveitis and early amblyopia. The intravenous solution usually begins working within a minute and lasts half an hour to an hour. Large doses may be required to treat some poisonings.","wiki_history":"==History==\nthumb|Atropa belladonna\n\nThe name atropine was coined in the 19th century, when pure extracts from the belladonna plant Atropa belladonna were first made. The medicinal use of preparations from plants in the nightshade family is much older however. Mandragora (mandrake) was described by Theophrastus in the fourth century BC for the treatment of wounds, gout, and sleeplessness, and as a love potion. By the first century AD Dioscorides recognized wine of mandrake as an anaesthetic for treatment of pain or sleeplessness, to be given before surgery or cautery. claims that the practice was also current in Paris.\n\nThe pharmacological study of belladonna extracts was begun by the German chemist Friedlieb Ferdinand Runge (1795–1867). In 1831, the German pharmacist Heinrich F. G. Mein (1799-1864) succeeded in preparing a pure crystalline form of the active substance, which was named atropine. The substance was first synthesized by German chemist Richard Willstätter in 1901.","wiki_society_and_culture":"==Society and culture==\nThe species name \"belladonna\" ('beautiful woman' in Italian) comes from the original use of deadly nightshade to dilate the pupils of the eyes for cosmetic effect. Both atropine and the genus name for deadly nightshade derive from Atropos, one of the three Fates who, according to Greek mythology, chose how a person was to die. Ryjunea was authorized for medical use in the European Union in June 2025.\n\nIn March 2025, the CHMP recommended the refusal of a pediatric use marketing authorization for Atropine sulfate FGK, a medicine intended for the treatment of myopia (short-sightedness) in children aged 6 to 10 years of age. In June 2025, FGK Representative Service requested a re-examination by the CHMP."},"chemblData":{"prodrug":-1,"chemblId":"CHEMBL1396281","maxPhase":null,"chirality":-1,"parenteral":false,"availability":-1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"launchDate":"1960","_launchSource":"DrugCentral (FDA 1960-09-15, GD SEARLE LLC)"},"fdaRecalls":[{"date":"20171020","reason":"SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent","status":"Terminated","distribution":"Nationwide in the USA","classification":"Class I"},{"date":"20230703","reason":"Presence of Particulate Matter: Particulate matter identified as fiber.","status":"Terminated","distribution":"Nationwide within the United States","classification":"Class II"},{"date":"20231221","reason":"Presence of Particulate Matter; identified as glass","status":"Ongoing","distribution":"Nationwide in the USA and Puerto Rico.","classification":"Class I"},{"date":"20151013","reason":"Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.","status":"Terminated","distribution":"Nationwide","classification":"Class III"},{"date":"20220413","reason":"cGMP deviations: Temperature abuse","status":"Terminated","distribution":"USA nationwide.","classification":"Class II"},{"date":"20241216","reason":"Failed Impurities/Degradation Specifications","status":"Terminated","distribution":"Nationwide within the United States","classification":"Class III"}],"overdosage":"10 OVERDOSAGE Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal. In the event of toxic overdosage, a short acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations","references":[{"id":1,"url":"https://drugcentral.org/drugcard/260","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Atropine%20Sulfate","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Atropine Sulfate","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Atropine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T01:43:13.055638","_validation":{"fieldsValidated":5,"lastValidatedAt":"2026-04-20T08:27:04.679471+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"amfetamine","drugSlug":"amfetamine","fdaApproval":"1955-09-09","relationship":"same-target"},{"drugName":"amiodarone","drugSlug":"amiodarone","fdaApproval":"1985-12-24","patentExpiry":"Mar 13, 2029","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amisulpride","drugSlug":"amisulpride","fdaApproval":"2020-02-26","patentExpiry":"Mar 10, 2031","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amitraz","drugSlug":"amitraz","fdaApproval":"","relationship":"same-target"},{"drugName":"amitriptyline","drugSlug":"amitriptyline","fdaApproval":"1961-04-07","genericCount":33,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"amlodipine","drugSlug":"amlodipine","fdaApproval":"1992-07-31","patentExpiry":"Feb 24, 2041","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amoxapine","drugSlug":"amoxapine","fdaApproval":"1980-09-22","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"apomorphine","drugSlug":"apomorphine","fdaApproval":"2004-04-20","patentExpiry":"Jun 11, 2030","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"apraclonidine","drugSlug":"apraclonidine","fdaApproval":"1987-12-31","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"aripiprazole","drugSlug":"aripiprazole","fdaApproval":"2002-11-15","patentExpiry":"Sep 24, 2033","patentStatus":"Patent protected","relationship":"same-target"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"},{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"atropine sulfate","howSupplied":"16 HOW SUPPLIED/STORAGE AND HANDLING Atropine Sulfate Injection, USP 1 mg/mL is supplied in 1 mL, single-dose glass vial. NDC 51662-1626-1 ATROPINE SULFATE INJECTION, USP 1mg/mL 1mL VIAL Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275","indications":{"approved":[{"name":"Perioperative Mydriasis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No patient eligibility criteria specified"}],"offLabel":[],"pipeline":[]},"currentOwner":"Alcon Labs Inc","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"amfetamine","brandName":"amfetamine","genericName":"amfetamine","approvalYear":"1955","relationship":"same-target"},{"drugId":"amiodarone","brandName":"amiodarone","genericName":"amiodarone","approvalYear":"1985","relationship":"same-target"},{"drugId":"amisulpride","brandName":"amisulpride","genericName":"amisulpride","approvalYear":"2020","relationship":"same-target"},{"drugId":"amitraz","brandName":"amitraz","genericName":"amitraz","approvalYear":"","relationship":"same-target"},{"drugId":"amitriptyline","brandName":"amitriptyline","genericName":"amitriptyline","approvalYear":"1961","relationship":"same-target"},{"drugId":"amlodipine","brandName":"amlodipine","genericName":"amlodipine","approvalYear":"1992","relationship":"same-target"},{"drugId":"amoxapine","brandName":"amoxapine","genericName":"amoxapine","approvalYear":"1980","relationship":"same-target"},{"drugId":"apomorphine","brandName":"apomorphine","genericName":"apomorphine","approvalYear":"2004","relationship":"same-target"},{"drugId":"apraclonidine","brandName":"apraclonidine","genericName":"apraclonidine","approvalYear":"1987","relationship":"same-target"},{"drugId":"aripiprazole","brandName":"aripiprazole","genericName":"aripiprazole","approvalYear":"2002","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT02858310","phase":"PHASE1, PHASE2","title":"E7 TCR T Cells for Human Papillomavirus-Associated Cancers","status":"","acronym":null,"sponsor":"National Cancer Institute (NCI)","isPivotal":false,"primaryCI":"","primaryHR":"","enrollment":224,"indication":"Papillomavirus Infections, Cervical Intraepithelial Neoplasia","endpointCount":3,"primaryPValue":"","completionDate":"","primaryEndpoint":"Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR)"},{"nctId":"NCT05470881","phase":"PHASE1","title":"Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201","status":"","acronym":"PRO-201","sponsor":"Laboratorios Sophia S.A de C.V.","isPivotal":false,"primaryCI":"","primaryHR":"","enrollment":29,"indication":"Myopia","endpointCount":5,"primaryPValue":"","completionDate":"","primaryEndpoint":"Number of Unexpected Adverse Events"}],"genericFilers":[],"latestUpdates":[{"url":"https://biospectrumjobs.com/insights-analysis/financial-analysis/financial-insights-from-20-pharma-giants","date":"2026-04-07","type":"news","title":"Big Pharma's Earnings Tracker 2025: Revenue, Growth Drivers","source":"biospectrumjobs.com"},{"url":"https://www.drugdiscoverytrends.com/pharma-50-2026-the-top-spot-in-pharma-rarely-lasts-lilly-is-betting-it-can-change-that/","date":"2026-04-07","type":"news","title":"Pharma 50 2026: The top spot in pharma rarely lasts. Lilly is betting ...","source":"www.drugdiscoverytrends.com"},{"url":"https://doc.irasia.com/listco/hk/cspc/annual/2025/res.pdf","date":"2026-04-07","type":"news","title":"[PDF] CSPC PHARMACEUTICAL GROUP LIMITED 石藥集團有限公司","source":"doc.irasia.com"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019677Orig1s011lbl.pdf","date":"2026-04-07","type":"news","title":"[PDF] NDA 019677/S-011 Page 4 - accessdata.fda.gov","source":"www.accessdata.fda.gov"},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf","date":"2026-04-07","type":"news","title":"[PDF] ENLON-PLUS (edrophonium chloride, USP and atropine sulfate ...","source":"www.accessdata.fda.gov"}],"manufacturing":[],"administration":{"route":"Oral, Intramuscular, Endotracheal","formulation":"Elixir, Injection","formulations":[{"form":"ELIXIR","route":"ORAL","productName":"Donnatal"},{"form":"ELIXIR","route":"ORAL","productName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"form":"ELIXIR","route":"ORAL","productName":"Phenohytro"},{"form":"ELIXIR","route":"ORAL","productName":"QUADRAPAX"},{"form":"ELIXIR","route":"ORAL","productName":"RE-PB HYOS ELIXIR"},{"form":"ELIXIR","route":"ORAL","productName":"Donnatal"},{"form":"ELIXIR","route":"ORAL","productName":"PHENOBARBITAL WITH BELLADONNA ALKALOIDS"},{"form":"ELIXIR","route":"ORAL","productName":"Phenobarbital with Belladonna Alkaloids - Grape"},{"form":"ELIXIR","route":"ORAL","productName":"Phenobarbital with Belladonna Alkaloids - Mint"},{"form":"INJECTION","route":"ENDOTRACHEAL","productName":"ATROPINE SULFATE"},{"form":"INJECTION","route":"ENDOTRACHEAL","productName":"Atropine Sulfate"},{"form":"INJECTION","route":"INTRAMUSCULAR","productName":"ATROPEN Auto-Injector"},{"form":"INJECTION","route":"INTRAMUSCULAR","productName":"N/A"},{"form":"INJECTION","route":"INTRAMUSCULAR","productName":"ATROPINE SULFATE"},{"form":"INJECTION","route":"INTRAMUSCULAR","productName":"Atropine Sulfate"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147687","MMSL":"27333","NDDF":"001715","UNII":"7C0697DR9I","VUID":"4019591","CHEBI":"CHEBI:16684","VANDF":"4017410","RXNORM":"1223","UMLSCUI":"C0004259","chemblId":"CHEMBL1396281","ChEMBL_ID":"CHEMBL2146146","KEGG_DRUG":"D00113","DRUGBANK_ID":"DB00572","PDB_CHEM_ID":" OIN","PUBCHEM_CID":"174174","SNOMEDCT_US":"372832002","IUPHAR_LIGAND_ID":"320","SECONDARY_CAS_RN":"5908-99-6","MESH_DESCRIPTOR_UI":"D001285"},"drugDescription":{"pH":"3.0 to 5.0","structure":"colorless crystals or white crystalline powder very soluble in water","appearance":"colorless crystals or white crystalline powder","composition":"Each milliliter (mL) contains 0.4 mg or 1 mg of atropine sulfate monohydrate equivalent to 0.332 mg or 0.83 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment.","molecularWeight":"","molecularFormula":"(C17H23NO3)2 ∙ H2SO4 ∙ H2O"},"formularyStatus":[],"_enricherVersion":"v2","chemblMechanisms":[],"developmentCodes":[],"ownershipHistory":[{"period":"1960-","companyName":"Gd Searle Llc","relationship":"Original Developer"},{"period":"present","companyName":"Alcon Labs Inc","relationship":"Current Owner"}],"pharmacokinetics":{"tmax":"7 to 8 minutes (after IV administration)","halfLife":"","linearPK":"no (effects are non-linearly related to the amount of drug in the peripheral compartment)","clearance":"","excretion":"","metabolism":"","proteinBinding":"","bioavailability":"","specialPopulations":{"age":"In infants and small children, atropine may cause 'atropine fever' due to suppression of sweat gland activity.","renal":"","weight":"","hepatic":""},"volumeOfDistribution":""},"publicationCount":1314,"therapeuticAreas":["Other"],"atcClassification":{"source":"DrugCentral","atcCode":"A03BA01","allCodes":["A03BA01","A03CB03","S01FA01"]},"biosimilarFilings":[],"faersTotalReports":25793,"originalDeveloper":"Gd Searle Llc","commercialAnalysis":{"text":"Enlon-Plus, a marketed product by Alcon Labs Inc., is a mydriatic agent used for perioperative mydriasis. According to recent data, the global biopharma and healthcare sector closed 2025 with a mix of resilience, portfolio transitions, and innovation-led growth [Biospectrum Jobs, 06 Apr 2026]. While Enlon-Plus's revenue is not explicitly mentioned, the overall market is expected to be driven by clinical sequencing demand and execution on strategic pillars [Biospectrum Jobs, 06 Apr 2026].\n\nThe competitive landscape for Enlon-Plus is dominated by other mydriatic agents, with Alcon Labs Inc. facing competition from established players in the market. CSPC Pharmaceutical Group Limited, a major player in the pharmaceutical industry, reported a 10.4% decline in total revenue in 2025, with finished drugs segment experiencing a 13.3% decline [doc.irasia.com, 2026]. This decline may indicate a challenging market environment for Enlon-Plus.\n\nKey upcoming catalysts for Enlon-Plus include patent cliffs, label expansions, and pipeline competitors. However, specific information on these catalysts is not available in the provided sources. The market outlook for Enlon-Plus is uncertain, and further research is needed to determine its potential growth prospects.\n\nIn conclusion, Enlon-Plus operates in a competitive market with a declining revenue trend in the pharmaceutical industry. While Alcon Labs Inc. faces challenges in the market, the company's performance is expected to be driven by clinical sequencing demand and execution on strategic pillars [Biospectrum Jobs, 06 Apr 2026]. 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A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","unitOfMeasure":"Participants","reportingStatus":"POSTED"}],"primaryEndpoints":[{"type":"PRIMARY","title":"Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR)","results":[{"value":"5","spread":"","groupId":"OG000","groupTitle":"Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"At 12 weeks, every 3 months x 3, and every 6 months for approximately 5 years","description":"Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Compete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.","unitOfMeasure":"Participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Phase I: Number of Dose Limiting Toxicities (DLT)","results":[{"value":"0","spread":"","groupId":"OG000","groupTitle":"Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells","lowerLimit":"","upperLimit":""},{"value":"0","spread":"","groupId":"OG001","groupTitle":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells","lowerLimit":"","upperLimit":""},{"value":"1","spread":"","groupId":"OG002","groupTitle":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"NUMBER","timeFrame":"From the day of cell infusion (Day 0) to Day +30","description":"Adverse events were assessed by the Common Terminology Criteria for Adverse Events v4.0. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event. A DLT is defined as all Grade 3 and greater toxicities occurring within 30 days of the cell infusion with the exception of: Cytokine Release Syndrome (CRS) that resolves ≤ grade 2 within 14 days of the last dose of aldesleukin. Autoimmune toxicity that resolves to ≤ grade 2 within 14 days for starting symptom treatment (e.g. steroids). Cardiac, gastrointestinal, dermatological, hepatic, pulmonary, renal, hematologic, neurologic toxicity, or toxicity in Appendix C of the protocol attributable to aldesleukin that resolves to ≤ grade 2 within 14 days of the last dose of aldesleukin. Transient grade 3 hypoxia associated with cell infusion that corrects to ≤ grade 2 with supplemental oxygen and/or that resolves to ≤ grade 2 within 24 hours or before starting aldesleukin.","unitOfMeasure":"toxicities","reportingStatus":"POSTED"}],"secondaryEndpoints":[{"type":"SECONDARY","title":"Progression-free Survival","results":[{"value":"5.5","spread":"","groupId":"OG000","groupTitle":"Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells","lowerLimit":"3","upperLimit":"8"},{"value":"4","spread":"","groupId":"OG001","groupTitle":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells","lowerLimit":"1","upperLimit":"9"},{"value":"3.5","spread":"","groupId":"OG002","groupTitle":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells","lowerLimit":"1","upperLimit":"8"},{"value":"2","spread":"","groupId":"OG003","groupTitle":"Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells","lowerLimit":"1","upperLimit":"12"}],"analyses":[],"paramType":"MEDIAN","timeFrame":"From the time of cell infusion (Day 0) until documented progressive disease; a maximum of 12 months","description":"Progression-free survival is the time from start of treatment to disease progression or death from any cause. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.","unitOfMeasure":"Months","reportingStatus":"POSTED"}]},{"nctId":"NCT05470881","phase":"PHASE1","title":"Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201","acronym":"PRO-201","sponsor":"Laboratorios Sophia S.A de C.V.","isPivotal":false,"conditions":["Myopia"],"enrollment":29,"otherEndpoints":[{"type":"OTHER_PRE_SPECIFIED","title":"Changes in Intraocular Pressure (IOP)","results":[{"value":"14.02","spread":"2.32","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)","description":"The change in IOP after exposure to investigation product, compared to basal value.","unitOfMeasure":"mmHg","reportingStatus":"POSTED"},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Cases With Corneal and Conjunctival Staining With Fluorescein","results":[{"value":"1","spread":"","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"NUMBER","timeFrame":"Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)","description":"It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \\>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.","unitOfMeasure":"Eyes (right)","reportingStatus":"POSTED"},{"type":"OTHER_PRE_SPECIFIED","title":"Measurement of Vital Signs (Systolic Blood Pressure)","results":[{"value":"119.41","spread":"7.48","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)","description":"The change in blood pressure after exposure to investigation product, compared to basal value.","unitOfMeasure":"mmHg","reportingStatus":"POSTED"},{"type":"OTHER_PRE_SPECIFIED","title":"Measurement of Vital Signs (Heart Rate)","results":[{"value":"74.93","spread":"8.11","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)","description":"The change in heart rate after exposure to investigation product, compared to basal value.","unitOfMeasure":"pulse per minutes","reportingStatus":"POSTED"},{"type":"OTHER_PRE_SPECIFIED","title":"Value of the Ocular Comfort Index (OCI) Questionnaire.","results":[{"value":"25.05","spread":"10.39","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"Days: 1 (Basal Visit), 16 ± 1 (Final Visit)","description":"It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome.\n\nSimilar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.","unitOfMeasure":"scores on a scale","reportingStatus":"POSTED"},{"type":"OTHER_PRE_SPECIFIED","title":"Number of Cases With Corneal and Conjunctival Staining With Lissamine Green","results":[{"value":"0","spread":"","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"NUMBER","timeFrame":"Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)","description":"It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \\>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.","unitOfMeasure":"Eyes (right)","reportingStatus":"POSTED"}],"primaryEndpoints":[{"type":"PRIMARY","title":"Number of Unexpected Adverse Events","results":[{"value":"41","spread":"","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"NUMBER","timeFrame":"Through Day 21 ± 1 (Safety Call)","description":"The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.","unitOfMeasure":"adverse events","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Number of Patients With Photophobia","results":[{"value":"27","spread":"","groupId":"OG000","groupTitle":"PRO-201","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)","description":"The number of cases of 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