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The following indications for IPRATROPIUM BROMIDE (ipratropium bromide) have been approved by the FDA:
Indications:
Chronic non-allergic rhinitis
Perennial allergic rhinitis
Rhinorrhea
Professional Synonyms:
Atopic rhinitis
Chronic nonallergic rhinitis
Non-seasonal allergic rhinitis
Indications:
Chronic non-allergic rhinitis
Perennial allergic rhinitis
Rhinorrhea
Professional Synonyms:
Atopic rhinitis
Chronic nonallergic rhinitis
Non-seasonal allergic rhinitis
The following dosing information is available for IPRATROPIUM BROMIDE (ipratropium bromide):
Intranasal spray pump delivers 0.07 mL of solution per actuation.
Ipratropium bromide 0.03% nasal spray delivers 21 mcg of ipratropium bromide per spray and about 345 sprays per bottle.
Ipratropium bromide 0.06% nasal spray delivers 42 mcg of ipratropium bromide per spray and about 165 sprays per bottle.
Ipratropium bromide 0.03% nasal spray delivers 21 mcg of ipratropium bromide per spray and about 345 sprays per bottle.
Ipratropium bromide 0.06% nasal spray delivers 42 mcg of ipratropium bromide per spray and about 165 sprays per bottle.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| IPRATROPIUM 0.03% SPRAY | Maintenance | Adults spray 2 sprays (42 mcg) in each nostril by intranasal route 2-3 times daily |
| IPRATROPIUM 0.06% SPRAY | Maintenance | Adults spray 2 sprays (84 mcg) in each nostril by intranasal route 3 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| IPRATROPIUM 0.03% SPRAY | Maintenance | Adults spray 2 sprays (42 mcg) in each nostril by intranasal route 2-3 timesdaily |
| IPRATROPIUM 0.06% SPRAY | Maintenance | Adults spray 2 sprays (84 mcg) in each nostril by intranasal route 3 times per day |
The following drug interaction information is available for IPRATROPIUM BROMIDE (ipratropium bromide):
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 |
|---|---|
| Methacholine/Beta-Agonists; Anticholinergics; Theophylline SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway.(1) CLINICAL EFFECTS: The result of the methacholine challenge test may not be accurate.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The following drugs should be held before a methacholine challenge for the the duration indicated:(1) - short-acting beta-agonists: 6 hours - long-acting beta-agonists: 36 hours - short-acting anti-cholinergics: 12 hours - long-acting anti-cholinergics: at least 168 hours (7 days) - oral theophylline: 12-48 hours DISCUSSION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway and cause inaccurate test results. |
METHACHOLINE CHLORIDE, PROVOCHOLINE |
| 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, PHENTERMINE-TOPIRAMATE ER, QSYMIA, TOPAMAX, TOPIRAMATE, TOPIRAMATE ER, TOPIRAMATE ER SPRINKLE, TROKENDI XR |
The following contraindication information is available for IPRATROPIUM BROMIDE (ipratropium bromide):
Drug contraindication overview.
*Known hypersensitivity to ipratropium or any ingredient in the formulation, or to atropine or its derivatives.
*Known hypersensitivity to ipratropium or any ingredient in the formulation, or to atropine or its derivatives.
There are 0 contraindications.
There are 0 severe contraindications.
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Angle-closure glaucoma |
| Benign prostatic hyperplasia |
| Bladder outflow obstruction |
| Urinary retention |
The following adverse reaction information is available for IPRATROPIUM BROMIDE (ipratropium bromide):
Adverse reaction overview.
Nasal dryness, epistaxis.
Nasal dryness, epistaxis.
There are 12 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Angioedema Blurred vision Bronchospastic pulmonary disease Cardiac arrhythmia Dysphagia Dysuria Ocular pain Skin rash Stomatitis Tachycardia Urticaria Visual changes |
There are 13 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Crusted nasal mucosa Dry nose Headache disorder Nasal passage irritation Xerostomia |
None. |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Constipation Diarrhea Dry throat Epistaxis Nasal congestion Nausea Nervousness |
The following precautions are available for IPRATROPIUM BROMIDE (ipratropium bromide):
Safety established based on studies in children. Efficacy based on extrapolation from studies in adults with perennial rhinitis and adults and adolescents with common cold or seasonal allergic rhinitis and on the likelihood that the disease course, pathophysiology, and the drug's effect in children are similar to those in adults. Safety and efficacy of 0.03%
nasal spray not established in children <6 years of age. Safety and efficacy of 0.06% nasal spray not established in children <5 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
nasal spray not established in children <6 years of age. Safety and efficacy of 0.06% nasal spray not established in children <5 years of age.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category B.
Not known whether ipratropium is distributed into milk following intranasal administration. Caution advised.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for IPRATROPIUM BROMIDE (ipratropium bromide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for IPRATROPIUM BROMIDE (ipratropium bromide)'s list of indications:
| Chronic non-allergic rhinitis | |
| J31.0 | Chronic rhinitis |
| Perennial allergic rhinitis | |
| J31.0 | Chronic rhinitis |
| Rhinorrhea | |
| R09.82 | Postnasal drip |
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