Scopolamine

Drug overview for SCOPOLAMINE (scopolamine):

Generic name: SCOPOLAMINE (skoe-POL-a-meen)
Drug class: Antiemetic
Therapeutic class: Gastrointestinal Therapy Agents

Scopolamine is a naturally occurring tertiary amine antimuscarinic.

Scopolamine is used principally for the prevention of nausea and vomiting induced by motion or recovery from anesthesia and surgery. The drug is also used as an adjunct to anesthesia. Scopolamine's usefulness in chronic forms of therapy (e.g., in the adjunctive treatment of peptic ulcer disease) is generally limited by its adverse effects, especially CNS effects.

DRUG IMAGES

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The following indications for SCOPOLAMINE (scopolamine) have been approved by the FDA:

Indications:
Motion sickness
Prevention of motion sickness
Prevention of post-operative nausea and vomiting

Professional Synonyms:
Postop nausea and vomiting prophylaxis
Postoperative nausea and vomiting prophylaxis
Prevention of riders' vertigo
Riders' vertigo

The following dosing information is available for SCOPOLAMINE (scopolamine):

Dosing
Administration
SCOPOLAMINE
SCOPOLAMINE

The usual adult IM, IV, or subcutaneous dose of scopolamine hydrobromide is 0.3-0.65 mg; if necessary, these doses may be repeated 3 or 4 times daily.

The usual pediatric IM, IV, or subcutaneous dose of scopolamine hydrobromide is 0.006 mg/kg (6 mcg/kg) or 0.2 mg/m2.

Alternatively, adult parenteral doses of scopolamine hydrobromide of 0.2-1 mg have been suggested for antiemetic effect, 0.2-0.6

mg for inhibition of salivation, 0.32-0.65 mg for amnestic effect, or 0.6

mg for sedation or tranquilization.

For the prevention of motion sickness, the usual adult dose of scopolamine transdermal system is one system programmed to deliver approximately 1 mg of scopolamine over 72 hours. The system is applied at least 4 hours prior to anticipated exposure to motion and may be used for up to 72 hours if necessary; the transdermal system may be removed during the 72-hour period when an antiemetic effect is no longer required. When continued therapy is necessary beyond 72 hours, the initial system should be removed and another system placed behind the ear at a different site.

For prevention of postoperative nausea and vomiting, the transdermal scopolamine system should be applied the evening before scheduled surgery. If the transdermal scopolamine system is used prophylactically in patients undergoing cesarean section, the system should be applied one hour prior to surgery to minimize exposure of the infant to the drug. The transdermal system should remain in place for 24 hours following surgery, then removed and discarded.

The usual oral dose range of scopolamine hydrobromide soluble tablets is 0.4-0.8 mg.

For the prevention of motion sickness, 0.25-0.8 mg of the drug may be administered 1 hour before exposure to motion; subsequent doses of 0.25-0.8

mg may be given 3 times daily as needed and as tolerated.

Scopolamine hydrobromide is administered orally or by IM, direct IV, or subcutaneous injection. Scopolamine is administered percutaneously by topical application of a transdermal system (Transderm Scop(R)). For direct IV administration, scopolamine hydrobromide injection should be diluted with sterile water for injection prior to administration.

When given as a preoperative medication, scopolamine hydrobromide injection is given 30-60 minutes prior to the anticipated time of induction of anesthesia or at the time other preanesthetic medications (e.g., opiates, sedatives) are administered. When scopolamine hydrobromide is administered orally or IM for the prevention of motion sickness, the drug should generally be administered 1 hour (range: 0.5-1.5 hours) before anticipated exposure to motion. When scopolamine is administered percutaneously as the transdermal system for the prevention of motion sickness, the system should be applied topically at least 4 hours (e.g., 4-24 hours) before anticipated exposure to motion.

For prevention of postoperative nausea and vomiting, transdermal scopolamine should be applied the evening before scheduled surgery. If transdermal scopolamine is used prophylactically in patients undergoing cesarean section, the drug should be applied one hour prior to surgery to minimize exposure of the fetus to the drug. Patients should be carefully instructed in the use of transdermal scopolamine.

To obtain optimum results, patients also should be given a copy of the patient instructions provided by the manufacturer. The scopolamine transdermal system should not be cut, and only one transdermal system should be worn at any time. Prior to administration of the transdermal system, the area behind the ear should be wiped with a clean, dry tissue to ensure that the area is dry.

To expose the adhesive surface of the system, the clear plastic protective strip should be peeled and discarded prior to administration; finger contact with the exposed adhesive layer should be avoided to prevent contamination of the fingers with scopolamine. The transdermal system is applied topically to a dry, hairless area of skin behind the ear (postauricular) by firmly pressing the system with the adhesive side touching the skin. Patients should be warned to thoroughly wash their hands after handling (e.g., initial application, removal) the scopolamine transdermal system, since contamination of fingers and subsequent contact with the eyes may result in cycloplegia (i.e., mydriasis and blurred vision).

Individuals who assist the patient in the application or removal of the transdermal system also should thoroughly wash their hands with soap and water afterwards. If the system becomes dislodged during the intended period of use (up to 72 hours), it should be removed and replaced with another system at a different postauricular site. The system is generally not affected by limited exposure to water (e.g., during bathing or swimming). Following removal of the transdermal system, the application site should be thoroughly washed with soap and water to remove any traces of scopolamine that might remain on the skin.

Dosing information for SCOPOLAMINE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
SCOPOLAMINE 1 MG/3 DAY PATCH	Maintenance	Adults apply 1 patch by transdermal route to the hairless area behind 1 ear at least 4 hr before effect is required; reapply every 3 days as needed

Generic dosing information for SCOPOLAMINE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
SCOPOLAMINE 1 MG/3 DAY PATCH	Maintenance	Adults apply 1 patch by transdermal route to the hairless area behind 1 ear at least 4 hr before effect is required; reapply every 3 days as needed

The following drug interaction information is available for SCOPOLAMINE (scopolamine):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 6 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
Solid Oral Potassium Tablets/Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concentrated potassium may damage the lining of the GI tract. Anticholinergics delay gastric emptying, resulting in the potassium product remaining in the gastrointestinal tract for a longer period of time.(1-16) CLINICAL EFFECTS: Use of solid oral dosage forms of potassium in patients treated with anticholinergics may result in gastrointestinal erosions, ulcers, stenosis and bleeding.(1-16) PREDISPOSING FACTORS: Diseases or conditions which may increase risk for GI damage include: preexisting dysphagia, strictures, cardiomegaly, diabetic gastroparesis, elderly status, or insufficient oral intake to allow dilution of potassium.(1-10,21) Other drugs which may add to risk for GI damage include: nonsteroidal anti-inflammatory drugs (NSAIDs), bisphosphonates, or tetracyclines.(21) PATIENT MANAGEMENT: Regulatory agency and manufacturer recommendations regarding this interaction: - In the US, all solid oral dosage forms (including tablets and extended release capsules) of potassium are contraindicated in patients receiving anticholinergics at sufficient dosages to result in systemic effects.(2-8) Patients receiving such anticholinergic therapy should use a liquid form of potassium chloride.(2) - In Canada, solid oral potassium is contraindicated in any patient with a cause for arrest or delay in tablet/capsule passage through the gastrointestinal tract and the manufacturers recommend caution with concurrent anticholinergic medications.(1,9-10) Evaluate each patient for predisposing factors which may increase risk for GI damage. In patients with multiple risk factors for harm, consider use of liquid potassium supplements, if tolerated. For patients receiving concomitant therapy, assure any potassium dose form is taken after meals with a large glass of water or other fluid. To decrease potassium concentration in the GI tract, limit each dose to 20 meq; if more than 20 meq daily is required, give in divided doses.(2) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. Patients should be instructed to immediately report any difficulty swallowing, abdominal pain, distention, severe vomiting, or gastrointestinal bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. DISCUSSION: In clinical trials, there was a higher incidence of gastric and duodenal lesions in patients receiving a high dose of a wax-matrix controlled-release formulation with a concurrent anticholinergic agent. Some lesions were asymptomatic and not accompanied by bleeding, as shown by a lack of positive Hemoccult tests.(1-17) Several studies suggest that the incidence of gastric and duodenal lesions may be less with the microencapsulated formulation of potassium chloride.(14-17)	KLOR-CON 10, KLOR-CON 8, KLOR-CON M10, KLOR-CON M15, KLOR-CON M20, POTASSIUM CHLORIDE, POTASSIUM CITRATE ER, UROCIT-K
Solid Oral Potassium Capsules/Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concentrated potassium may damage the lining of the GI tract. Anticholinergics delay gastric emptying, resulting in the potassium product remaining in the gastrointestinal tract for a longer period of time.(1-16)) CLINICAL EFFECTS: Use of solid oral dosage forms of potassium in patients treated with anticholinergics may result in gastrointestinal erosions, ulcers, stenosis and bleeding.(1-16) PREDISPOSING FACTORS: Diseases or conditions which may increase risk for GI damage include: preexisting dysphagia, strictures, cardiomegaly, diabetic gastroparesis, elderly status, or insufficient oral intake to allow dilution of potassium.(1-10,21) Other drugs which may add to risk for GI damage include: nonsteroidal anti-inflammatory drugs (NSAIDs), bisphosphonates, or tetracyclines.(21) PATIENT MANAGEMENT: Regulatory agency and manufacturer recommendations regarding this interaction: - In the US, all solid oral dosage forms (including tablets and extended release capsules) of potassium are contraindicated in patients receiving anticholinergics at sufficient dosages to result in systemic effects.(2-8) Patients receiving such anticholinergic therapy should use a liquid form of potassium chloride.(2) - In Canada, solid oral potassium is contraindicated in any patient with a cause for arrest or delay in tablet/capsule passage through the gastrointestinal tract and the manufacturers recommend caution with concurrent anticholinergic medications.(1,9-10) Evaluate each patient for predisposing factors which may increase risk for GI damage. In patients with multiple risk factors for harm, consider use of liquid potassium supplements, if tolerated. For patients receiving concomitant therapy, assure any potassium dose form is taken after meals with a large glass of water or other fluid. To decrease potassium concentration in the GI tract, limit each dose to 20 meq; if more than 20 meq daily is required, give in divided doses.(2) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. Patients should be instructed to immediately report any difficulty swallowing, abdominal pain, distention, severe vomiting, or gastrointestinal bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. DISCUSSION: In clinical trials, there was a higher incidence of gastric and duodenal lesions in patients receiving a high dose of a wax-matrix controlled-release formulation with a concurrent anticholinergic agent. The lesions were asymptomatic and not accompanied by bleeding, as shown by a lack of positive Hemoccult tests.(1-17) Several studies suggest that the incidence of gastric and duodenal lesions may be less with the microencapsulated formulation of potassium chloride.(14-17)	POTASSIUM CHLORIDE
Secretin/Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Anticholinergic drugs may result in an incorrect secretin stimulation test result.(1) CLINICAL EFFECTS: Concurrent use of anticholinergic drugs may impact the accuracy of the secretin stimulation test.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of human secretin states concurrent use of anticholinergic drugs at the time of stimulation testing may cause the patient to be hyporesponsive to the testing and suggest false positive results for pancreatic disease. The manufacturer recommends discontinuing anticholinergic drugs at least 5 half-lives prior to stimulation testing. Consider additional testing and clinical assessment for diagnosis.(1) DISCUSSION: Concurrent use of anticholinergic drugs may impact the accuracy of the secretin stimulation test.(1)	CHIRHOSTIM
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, PHENTERMINE-TOPIRAMATE ER, QSYMIA, TOPAMAX, TOPIRAMATE, TOPIRAMATE ER, TOPIRAMATE ER SPRINKLE, TROKENDI XR

The following contraindication information is available for SCOPOLAMINE (scopolamine):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 3 contraindications. Absolute contraindication.

Contraindication List
Angle-closure glaucoma
Magnetic resonance imaging
Severe pre-eclampsia

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Open angle glaucoma
Systemic mastocytosis

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
Benign prostatic hyperplasia
Bladder outflow obstruction
Intestinal obstruction
Kidney disease with reduction in glomerular filtration rate (GFr)
Lower seizure threshold
Psychotic disorder
Pyloroduodenal obstruction
Seizure disorder
Severe hepatic disease

The following adverse reaction information is available for SCOPOLAMINE (scopolamine):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 12 severe adverse reactions.

More Frequent	Less Frequent
None.	Gastrointestinal hypomotility Visual changes

Rare/Very Rare
Drug-induced psychosis Hallucinations Hyperthermia Ocular hypertension Paranoid disorder Secondary angle-closure glaucoma Seizure disorder Skin burn caused by transdermal patch worn during MRI Skin rash Urinary retention

There are 33 less severe adverse reactions.

More Frequent	Less Frequent
Anticholinergic toxicity Blurred vision Constipation Decreased sweating Dizziness Drowsy Memory impairment Mydriasis Xerostomia	Acute cognitive impairment Agitation Pharyngitis Pruritus of skin

Rare/Very Rare
Accidental fall Acute pain at drug application site Ataxia Delirium Disturbance of attention Dry eye Dysarthria Dysuria Erythema False sense of well-being Flatulence General weakness Headache disorder Insomnia Nausea Nervousness Ocular itching Skin irritation Toxic amblyopia Vertigo

The following precautions are available for SCOPOLAMINE (scopolamine):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Reproduction studies in rats and rabbits using IV scopolamine hydrobromide at dosages producing plasma concentrations of the drug 100 times greater than those achievable after application of the transdermal system in humans have shown a marginal embryotoxic effect in rabbits; no teratogenic effects were observed in rats. Scopolamine does not increase the duration of labor or affect uterine contractions during labor following parenteral administration; however, the drug crosses the placenta. Although one manufacturer states that adverse fetal effects have not been reported to date when scopolamine was used during labor and delivery, fetal toxicity, including tachycardia, fever, and lethargy, which responded to treatment with physostigmine, were reported in one infant following maternal administration of a total dosage of 1.8

mg of scopolamine during labor and delivery. Decreased heart rate variability and decreased heart rate deceleration also have been reported in infants of mothers who received scopolamine during labor and delivery. However, in one clinical study in women undergoing cesarean sections, adverse effects, including CNS depression, were not observed in neonates when transdermal scopolamine was used concomitantly with epidural anesthesia and opiate analgesics. There are no adequate and controlled studies to date using scopolamine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Scopolamine is distributed into milk. Although some manufacturers recommend that scopolamine be used with caution in nursing women, no observable change in infants associated with such exposure has been reported to date, and the American Academy of Pediatrics (AAP) considers scopolamine to be usually compatible with breast-feeding.

No enhanced Geriatric Use information available for this drug.