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Drug overview for DUODOTE (pralidoxime chloride/atropine sulfate):
Generic name: PRALIDOXIME CHLORIDE/ATROPINE SULFATE
Drug class: Organophosphate Poisoning Antidote
Therapeutic class: Antidotes and other Reversal Agents
Atropine (dl-hyoscyamine) is a naturally occurring tertiary amine antimuscarinic.
No enhanced Uses information available for this drug.
Generic name: PRALIDOXIME CHLORIDE/ATROPINE SULFATE
Drug class: Organophosphate Poisoning Antidote
Therapeutic class: Antidotes and other Reversal Agents
Atropine (dl-hyoscyamine) is a naturally occurring tertiary amine antimuscarinic.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for DUODOTE (pralidoxime chloride/atropine sulfate) have been approved by the FDA:
Indications:
Organophos insecticide poisoning
Organophosphorous overdose
Poisoning due to nerve agent
Professional Synonyms:
Organophosphate poisoning
Poisoning by war nerve agent
Indications:
Organophos insecticide poisoning
Organophosphorous overdose
Poisoning due to nerve agent
Professional Synonyms:
Organophosphate poisoning
Poisoning by war nerve agent
The following dosing information is available for DUODOTE (pralidoxime chloride/atropine sulfate):
Dosage of atropine sulfate should be individualized based on indication, patient characteristics, and response (e.g., heart rate, blood pressure); pediatric patients tend to be more susceptible than adults to the toxic effects of atropine overdosage.
Atropine sulfate is administered by IM, subcutaneous, or direct IV administration. IV administration is preferred for the treatment of severe or life-threatening muscarinic effects. Atropine also has been administered by intraosseous (IO) injection+ in the setting of advanced cardiovascular life support (ACLS), generally when IV access is not readily available; onset of action and systemic concentrations are comparable to those achieved with venous administration.
Atropine may be administered via an endotracheal tube when vascular access (IV or IO) is not possible; however, IV or IO administration is preferred because of more predictable drug delivery and pharmacologic effect. (See Pharmacokinetics: Absorption.) Atropine sulfate has been administered orally; however, an oral dosage form no longer is commercially available in the US. Atropine sulfate has been administered by oral inhalation using a nebulizer solution; however, a solution for oral inhalation no longer is commercially available in the US.
Atropine may be administered via an endotracheal tube when vascular access (IV or IO) is not possible; however, IV or IO administration is preferred because of more predictable drug delivery and pharmacologic effect. (See Pharmacokinetics: Absorption.) Atropine sulfate has been administered orally; however, an oral dosage form no longer is commercially available in the US. Atropine sulfate has been administered by oral inhalation using a nebulizer solution; however, a solution for oral inhalation no longer is commercially available in the US.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for DUODOTE (pralidoxime chloride/atropine sulfate):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Clozapine/Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clozapine has potent anticholinergic properties and inhibits serotonin receptors, including 5-HT3.(1-4) Both of these properties may cause inhibition of gastrointestinal (GI) smooth muscle contraction, resulting in decreased peristalsis.(3,4) These effects may be compounded by concurrent use of anticholinergic agents.(1-6) CLINICAL EFFECTS: Concurrent use of clozapine with other anticholinergic agents may increase the risk of constipation (common) and serious bowel complications (uncommon), including complete bowel obstruction, fecal impaction, paralytic ileus and intestinal ischemia or infarction.(1-6) PREDISPOSING FACTORS: The risk for serious bowel complications is higher with increasing age, higher frequency of constipation, and in patients on higher doses of clozapine or multiple anticholinergic agents.(1,5) PATIENT MANAGEMENT: Avoid the use of other anticholinergic agents with clozapine.(1-6) If concurrent use is necessary, evaluate the patient's bowel function regularly. Monitor for symptoms of constipation and GI hypomotility, including having bowel movements less than three times weekly or less than usual, difficulty having a bowel movement or passing gas, nausea, vomiting, and abdominal pain or distention.(2) Consider a prophylactic laxative in those with a history of constipation or bowel obstruction.(2) Review patient medication list for other anticholinergic agents. When possible, decrease the dosage or number of prescribed anticholinergic agents, particularly in the elderly. Counsel the patient about the importance of maintaining adequate hydration. Encourage regular exercise and eating a high-fiber diet.(2) DISCUSSION: In a prospective cohort study of 26,720 schizophrenic patients in the Danish Central Psychiatric Research Registry, the odds ratio (OR) for ileus was 1.99 with clozapine and 1.48 with anticholinergics. The OR for fatal ileus was 6.73 with clozapine and 5.88 with anticholinergics. Use of anticholinergics with 1st generation antipsychotics (FGA) increased the risk of ileus compare to FGA alone, but this analysis was not done with clozapine.(5) A retrospective cohort study of 24,970 schizophrenic patients from the Taiwanese National Health Insurance Research Database found that the hazard ratio (HR) for clozapine-induced constipation increased from 1.64 when clozapine is used alone, to 2.15 when used concomitantly with anticholinergics. However, there was no significant difference in the HR for ileus when clozapine is used with and without anticholinergics (1.95 and 2.02, respectively).(6) In the French Pharmacovigilance Database, 7 of 38 cases of antipsychotic-associated ischemic colitis or intestinal necrosis involved clozapine, and 5 of these cases involved use of concomitant anticholinergic agents. Three patients died, one of whom was on concomitant anticholinergics.(3) In a case series, 4 of 9 cases of fatal clozapine-associated GI dysfunction involved concurrent anticholinergic agents.(4) |
CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ |
| Eluxadoline/Anticholinergics; Opioids SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Eluxadoline is a mixed mu-opioid and kappa-opioid agonist and delta-opioid antagonist and may alter or slow down gastrointestinal transit.(1) CLINICAL EFFECTS: Constipation related adverse events that sometimes required hospitalization have been reported, including the development of intestinal obstruction, intestinal perforation, and fecal impaction.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid use with other drugs that may cause constipation. If concurrent use is necessary, evaluate the patient's bowel function regularly. Monitor for symptoms of constipation and GI hypomotility, including having bowel movements less than three times weekly or less than usual, difficulty having a bowel movement or passing gas, nausea, vomiting, and abdominal pain or distention.(1) Instruct patients to stop eluxadoline and immediately contact their healthcare provider if they experience severe constipation. Loperamide may be used occasionally for acute management of severe diarrhea, but must be discontinued if constipation develops.(1) DISCUSSION: In phase 3 clinical trials, constipation was the most commonly reported adverse reaction (8%). Approximately 50% of constipation events occurred within the first 2 weeks of treatment while the majority occurred within the first 3 months of therapy. Rates of severe constipation were less than 1% in patients receiving eluxadoline doses of 75 mg and 100 mg.(1) |
VIBERZI |
| Glucagon (Diagnostic)/Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Glucagon and anticholinergic agents may have additive effects on inhibition of gastrointestinal motility.(1) CLINICAL EFFECTS: Concurrent use of glucagon with anticholinergic agents may increase the risk of gastrointestinal hypomotility, including constipation and bowel complications.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Concurrent use of glucagon as a diagnotic aid is not recommended with the use of anticholinergic agents.(1) If concurrent use is necessary, evaluate the patient's bowel function. Monitor for symptoms of constipation and gastrointestinal hypomotility. DISCUSSION: Both glucagon and anticholinergic agents may have additive effects on inhibition of gastrointestinal motility and increase the risk of gastrointestinal adverse effects.(1) |
GLUCAGON HCL |
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Select Antipsychotics;Select Phenothiazines/Anticholinergics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Multiple mechanisms may be involved: 1. additive peripheral and CNS blockade of muscarinic receptors. 2. anticholinergic-induced inhibition of gastrointestinal absorption of phenothiazines. 3. antagonism of the dopamine blocking effects of selected antipsychotics and phenothiazines. CLINICAL EFFECTS: The dopamine blocking effects of selected antipsychotic agents or phenothiazines may be decreased while anticholinergic adverse effects may be increased. PREDISPOSING FACTORS: The risk for severe anticholinergic toxicities, e.g. delirium, hyperthermia, paralytic ileus is increased in the elderly and in patients on multiple anticholinergic agents. PATIENT MANAGEMENT: Anticholinergic agents may be required to treat or prevent antipsychotic induced extrapyramidal symptoms. When other indications lead to co-prescribing of the combination, assess patient response to the combination. Review patient medication list for other anticholinergic agents. When needed, decrease the dosage or number of prescribed anticholinergic agents, particularly in the elderly. DISCUSSION: Although numerous studies have been published regarding a possible interaction between phenothiazines and anticholinergics, the earlier reports were not double-blind or placebo controlled and patients may have received other drugs concomitantly. These earlier investigations reported increased side effects as well as increased, decreased and no effect on the therapeutic outcome. Double-blind studies have also reported conflicting results. Anticholinergic therapy varied from having no effect on phenothiazine concentration or patient outcome, to increasing phenothiazine levels. The discrepancies reported may be due to interpatient variability including age of the patient, type and duration of illness and treatment setting. |
ADASUVE, CHLORPROMAZINE HCL, LOXAPINE, PERPHENAZINE, PERPHENAZINE-AMITRIPTYLINE, PHENERGAN, PROMETHAZINE HCL, PROMETHAZINE HCL-0.9% NACL, PROMETHAZINE VC, PROMETHAZINE-CODEINE, PROMETHAZINE-DM, PROMETHAZINE-PHENYLEPHRINE HCL, PROMETHEGAN, THIORIDAZINE HCL, THIORIDAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HCL |
| Zonisamide/Anticholinergics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Zonisamide can cause decreased sweating and elevated body temperature. Agents with anticholinergic activity can predispose patients to heat-related disorders.(1-2) CLINICAL EFFECTS: Concurrent use of zonisamide with agents with anticholinergic activity may increase the incidence of oligohidrosis and hyperthermia, especially in pediatric or adolescent patients.(1-2) Overheating and dehydration can lead to brain damage and death. PREDISPOSING FACTORS: Pediatric and adolescent patients and patients with dehydration may be more likely to experience heat-related disorders.(1) PATIENT MANAGEMENT: The UK and US manufacturers of zonisamide state that caution should be used in adults when zonisamide is prescribed with other medicinal products that predispose to heat-related disorders, such as agents with anticholinergic activity.(1-2) Pediatric and adolescent patients must not take anticholinergic agents (e.g. clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin) concurrently with zonisamide.(1) Monitor for signs and symptoms of heat stroke: skin feels very hot with little or no sweating, confusion, muscle cramps, rapid heartbeat, or rapid breathing. Monitor for signs and symptoms of dehydration: dry mouth, urinating less than usual, dark-colored urine, dry skin, feeling tired, dizziness, or irritability. If signs or symptoms of dehydration, oligohidrosis, or elevated body temperature occur, discontinuation of zonisamide should be considered. DISCUSSION: Case reports of decreased sweating and elevated temperature have been reported, especially in pediatric patients. Some cases resulted in heat stroke that required hospital treatment and resulted in death.(1) |
ZONEGRAN, ZONISADE, ZONISAMIDE |
| Topiramate/Anticholinergics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Topiramate can cause decreased sweating and elevated body temperature. Agents with anticholinergic activity can predispose patients to heat-related disorders.(1-2) CLINICAL EFFECTS: Concurrent use of topiramate with agents with anticholinergic activity may increase the incidence of oligohidrosis and hyperthermia, especially in pediatric or adolescent patients.(1-2) Overheating and dehydration can lead to brain damage and death. PREDISPOSING FACTORS: Pediatric and adolescent patients and patients with dehydration may be more likely to experience heat-related disorders.(1) PATIENT MANAGEMENT: The manufacturer of topiramate states that caution should be used when topiramate is prescribed with other medicinal products that predispose to heat-related disorders, such as agents with anticholinergic activity (e.g. clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin) concurrently with zonisamide.(1) Monitor for signs and symptoms of heat stroke: skin feels very hot with little or no sweating, confusion, muscle cramps, rapid heartbeat, or rapid breathing. Monitor for signs and symptoms of dehydration: dry mouth, urinating less than usual, dark-colored urine, dry skin, feeling tired, dizziness, or irritability. If signs or symptoms of dehydration, oligohidrosis, or elevated body temperature occur, discontinuation of zonisamide should be considered. DISCUSSION: Case reports of decreased sweating and elevated temperature have been reported, especially in pediatric patients. Some cases resulted in heat stroke that required hospital treatment.(1) A 64-year old woman developed non-exertional hyperthemia while taking multiple psychiatric medications with topiramate.(2) |
EPRONTIA, QSYMIA, QUDEXY XR, TOPAMAX, TOPIRAMATE, TOPIRAMATE ER, TROKENDI XR |
The following contraindication information is available for DUODOTE (pralidoxime chloride/atropine sulfate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 9 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| 30 day risk period post-myocardial infarction |
| Angle-closure glaucoma |
| Atrial flutter |
| Benign prostatic hyperplasia |
| Bladder outflow obstruction |
| Chronic obstructive pulmonary disease |
| Hypertension |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Pyloroduodenal obstruction |
The following adverse reaction information is available for DUODOTE (pralidoxime chloride/atropine sulfate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 38 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Blurred vision Diplopia Dizziness Hypertension Hyperventilation Injection site sequelae Laryngismus Muscle rigidity Muscle weakness Reduced visual acuity Tachycardia Urinary retention |
Increased alanine transaminase Increased aspartate transaminase Kidney disease with reduction in glomerular filtration rate (GFr) |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Anaphylaxis Atrial fibrillation Atrial flutter Dehydration Fever Glaucoma Hallucinations Hypersensitivity drug reaction Laryngismus Manic disorder Ocular hypertension Orthostatic hypotension Paralytic ileus Pulmonary edema Pyloroduodenal obstruction Respiration changes Secondary angle-closure glaucoma Seizure disorder Urticaria Ventricular arrhythmias Ventricular fibrillation Ventricular premature beats |
There are 55 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anticholinergic toxicity Blurred vision Constipation Decreased sweating Drowsy Dry eye Headache disorder Increased creatine kinase level Injection site sequelae Nausea Palpitations Photophobia Urinary hesitancy Xerostomia |
Abdominal distension Abnormal hepatic function tests Accommodation disorder Acute cognitive impairment Dizziness Drowsy Dry skin Erectile dysfunction Excitement Libido changes Manic disorder Mydriasis Skin rash Vomiting Xerostomia |
| Rare/Very Rare |
|---|
|
Accidental fall Agitation Ataxia Concentration difficulty Dysphagia Dysuria Feeling of alcohol intoxication Flushing General weakness Headache disorder Hypertonia Insomnia Loss of taste Maculopapular rash Memory impairment Nausea Nervousness Paranoid disorder Petechiae Skin rash Symptoms of anxiety Syncope Tremor Vertigo Vomiting |
The following precautions are available for DUODOTE (pralidoxime chloride/atropine sulfate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Safe use of pralidoxime during pregnancy has not been established.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for DUODOTE (pralidoxime chloride/atropine sulfate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DUODOTE (pralidoxime chloride/atropine sulfate)'s list of indications:
| Organophos insecticide poisoning | |
| T60.0 | Toxic effect of organophosphate and carbamate insecticides |
| T60.0x | Toxic effect of organophosphate and carbamate insecticides |
| T60.0x1 | Toxic effect of organophosphate and carbamate insecticides, accidental (unintentional) |
| T60.0x1A | Toxic effect of organophosphate and carbamate insecticides, accidental (unintentional), initial encounter |
| T60.0x2 | Toxic effect of organophosphate and carbamate insecticides, intentional self-harm |
| T60.0x2A | Toxic effect of organophosphate and carbamate insecticides, intentional self-harm, initial encounter |
| T60.0x3 | Toxic effect of organophosphate and carbamate insecticides, assault |
| T60.0x3A | Toxic effect of organophosphate and carbamate insecticides, assault, initial encounter |
| T60.0x4 | Toxic effect of organophosphate and carbamate insecticides, undetermined |
| T60.0x4A | Toxic effect of organophosphate and carbamate insecticides, undetermined, initial encounter |
| Organophosphorous overdose | |
| T44.0x1A | Poisoning by anticholinesterase agents, accidental (unintentional), initial encounter |
| T44.0x2A | Poisoning by anticholinesterase agents, intentional self-harm, initial encounter |
| T44.0x3A | Poisoning by anticholinesterase agents, assault, initial encounter |
| T44.0x4A | Poisoning by anticholinesterase agents, undetermined, initial encounter |
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