Hyoscine Scopolamine

SCOPOLAMINE
Evaluaciones de DRUGDEX
DOSING/ADMINISTRATION
Adult Dosing
Normal Dosage
Important Note
Scopolamine
Beers Criteria: Use caution or avoid use as potentially inappropriate in older adults
[1].
Scopolamine Hydrobromide
[1].
Scopolamine
Transdermal route
Motion sickness
1) Usual dosage: Apply 1 transdermal system to the hairless area behind the
ear at least 4 hours before antiemetic effect is needed for use for up to 3
days. If longer therapy is required, remove the first transdermal system and
apply a new one behind the other ear (each patch delivers approximately 1
mg over 3 days) [2].
Postoperative nausea and vomiting; Prophylaxis
1) Usual dosage (for surgeries other than cesarean section): Apply 1
transdermal system to the hairless area behind the ear the evening before
scheduled surgery. Remove the transdermal system 24 hours following
surgery [2].
Intramuscular route
Amnesia, induction in obstetrics
1) Usual dose: 0.32 to 0.65 mg IM [12]
Delirium tremens
1) Usual dose: 0.6 mg IM 3 or 4 times per day [12]
Mania
Preoperative sedation
1) Usual dose: 0.32 to 0.65 mg IM [12][13] administered 45 to 60 minutes
prior to anesthesia. The dose should be reduced for elderly or debilitated
patients [12].
Sedation
Intravenous route
1) Usual dose: 0.32 to 0.65 mg IV [12].
Delirium tremens
1) Usual dose: 0.6 mg IV 3 or 4 times per day [12]
Mania
Sedation
Ophthalmic route
Diagnostic procedure on eye proper, mydriasis induction and cycloplegic
refraction
1) Usual dose: 1 or 2 drops (0.25% ophthalmic solution) instilled in the
eye(s) 1 hour before refraction [14].
Uveitis, iridocyclitis
eye(s) up to 4 times daily. To avoid ophthalmic systemic absorption apply
digital pressure to lacrimal sac for 2 to 3 minutes after instillation [14].
Oral route
Increased intestinal motility
1) Usual dose: 0.4 to 0.8 mg ORALLY [16]
Motion sickness; Prophylaxis
Postencephalitic parkinsonism
1) Usual dose: 0.4 to 0.8 mg ORALLY, dose may be cautiously increased in
parkinsonism [16]
Spasticity
spasticity [16]
Subcutaneous route
1) Usual dose: 0.32 to 0.65 mg subQ [12].
Delirium tremens
1) Usual dose: 0.6 mg subQ 3 or 4 times per day [12]
Mania
Sedation
Vomiting
1) Usual dose: 0.6 to 1 mg subQ [12]
Dosage in Geriatric Patients
A) Scopolamine Hydrobromide
1) Lower doses may be required in geriatric and debilitated patients [12]
Pediatric Dosing
Normal Dosage
Important Note
Scopolamine
[1].
[1].
Scopolamine
Transdermal route
a) General Dosage Information
1) Safety and effectiveness have not been established in pediatric patients [2].
Intramuscular route
1) (age 6 months to 3 years) 0.1 to 0.15 mg IM [12]
2) (age 3 to 6 years) 0.2 to 0.3 mg IM [12]
Intravenous route
1) (age 6 months to 3 years) 0.1 to 0.15 mg IV [12]
2) (age 3 to 6 years) 0.2 to 0.3 mg IV [12]
Subcutaneous route
1) (age 6 months to 3 years) 0.1 to 0.15 mg subQ [12]
2) (age 3 to 6 years) 0.2 to 0.3 mg subQ [12]
Vomiting
1) Usual dose: 6 mcg/kg/dose subQ [12]
FDA Uses
Motion sickness
FDA Labeled Indication

1) Overview
FDA Approval: Adult, yes; Pediatric, no
Efficacy: Adult, Effective
Recommendation: Adult, Class IIa
Strength of Evidence: Adult, Category B
See Drug Consult reference: RECOMMENDATION AND EVIDENCE RATINGS
2) Summary:
Indication
Transdermal scopolamine is indicated in adults for the prevention of nausea and vomiting
associated with motion sickness [2].
Evidence
Transdermal scopolamine was effective in preventing motion sickness in up to 75% of
patients [3], and was more effective than oral dimenhydrinate [4]. Pyridostigmine (30 mg
orally 3 times daily) prevented the peripheral antimuscarinic side effects of transdermal
scopolamine in healthy subjects [5].
FDA Labeled Indication

1) Overview
FDA Approval: Adult, yes; Pediatric, no
2) Summary:
Indication
Transdermal scopolamine is indicated in adults for the prevention of post-operative nausea
and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and
surgery [2].
Evidence
Transdermal scopolamine placed behind the ear at least 8 hours prior to laparoscopic surgery
significantly reduced postoperative nausea, retching, and vomiting compared with placebo
(37% vs 68%; N=138). Additionally, antiemetic therapy was required in only 13% of
scopolamine-treated patients compared with 32% of patients receiving placebo [6].
Combination treatment with transdermal scopolamine plus ondansetron was superior to

ondansetron alone for prevention of postoperative nausea and vomiting in a randomized
study in adult women (N=608) [7].
Non-FDA Uses
Scopolamine
Acquired nystagmus
a) Overview
FDA Approval: Adult, no; Pediatric, no
Efficacy: Adult, Ineffective
Recommendation: Adult, Class III
Strength of Evidence: Adult, Category C
b) Summary:
Ineffective in controlling nystagmus arising from demyelinating, ischemic, and other
lesions
c) Adult:
1) The transdermal administration of scopolamine (SPM) was ineffective in altering the
visual acuity of patients experiencing oscillopsia associated with acquired nystagmus. In
an open-labeled study, patients experiencing functional visual impairment due to
nystagmus related to a disparate collection of neurologic disorders (multiple sclerosis,
Chiari malformation, brainstem stroke, potential AVM, and a right medullary lesion;
n=7)) received transdermal treatment with scopolamine 1.5 milligrams via a skin patch
placed posterior to 1 ear. All patients were tested for visual function and for the
magnitude of nystagmus (fixation of small target; saccades; smooth pursuit mechanics;
and the vestibulo-ocular reflex), at baseline and after 4 hours of treatment. All patients
were intolerant or unresponsive to a trial of gabapentin in the past. Visual acuity did not
improve for any patient after 4 hours of scopolamine treatment, although 3 patients
reported modest improvements in oscillopsia. Eye speed measurements showed small
yet significant decreases in 3 patients (p less than 0.01); however, another 2 patients
experienced significant increases in eye speed (p less than 0.01). There were no
changes seen in the motion frequency in any case of pendular nystagmus. Four patients
complained of adverse effects - blurring of vision, an alteration of balance, a mild
dizziness, and a feeling similar to mild alcohol intoxication [11].
Excessive salivation; Prophylaxis
a) Overview
Efficacy: Adult, Evidence favors efficacy; Pediatric, Evidence is inconclusive
Recommendation: Adult, Class IIb; Pediatric, Class III
Strength of Evidence: Adult, Category B; Pediatric, Category C
b) Summary:
Transdermal scopolamine may be more useful than other dosage forms for treating
SIALORRHEA
c) Adult:
1) Transdermal scopolamine offers advantages compared to oral dosage forms for
treatment of drooling (Dreyfuss et al, 1991). Central nervous system side effects
including sedation, confusion, restlessness, and hallucinations have been reported
occasionally (Rogawski, 1984).
2) Of 109 patients with different etiologies for HYPERSALIVATION, the following
percentage of patients responded to treatment with transdermal scopolamine: (1)
malignancies of the upper aerodigestive tract preoperatively (70%) and postoperatively
(68%); (2) patients who had had parotidectomies (71%); (3) selected cases of patients
with tracheotomies (43%); (4) peritonsillar abscesses (55%); (5) patients with tonsillitis
or pharyngitis (70%); (6) patients with neurologic disorders (100%); and (7)
miscellaneous etiologies (71%). Blurred vision and urinary retention were reported in 7
and 3 patients, respectively; 4 patients discontinued treatment due to these adverse
effects. The duration of therapy was not specifically stated but appeared to be no more
than a week in most cases [8].
3) In healthy volunteers and mentally retarded patients with drooling, transdermal
scopolamine reduced salivation compared to placebo [9]. In this double-blind, placebo-
controlled, crossover trial, 6 healthy volunteers (age 26 to 49 years) had saliva collected
the day before, each of 3 days during transdermal scopolamine therapy, and for 2 days
after the scopolamine patch was removed. A marked reduction in salivation was noted 6
hours after application of transdermal scopolamine; this lasted until approximately 12
hours after removal of the patch. Of the 18 mentally retarded patients (age 20 to 62
years) with different etiologies for their drooling, staff members monitored drooling
using a 10-centimeter visual analog scale. Of the 15 mentally retarded patients who
finished the study, drooling was reduced compared to placebo although it did not reach
statistical significance until after the drug had been applied for 24 hours. Three patients
were withdrawn from the study due to a loss of the scopolamine patch. One patient
each reported loss of appetite and increased swallowing difficulties during drug therapy.
Changes in behavior were evident in 3 patients; however, 2 patients experienced
positive behavioral changes while 1 developed restlessness during placebo treatment.
d) Pediatric:
1) In a 4-year-old child with multiple birth defects caused by anoxia, transdermal
scopolamine effectively reduced drooling and the associated gagging during 2 years of
continuous treatment [10]. Excessive drooling resulted from impairment of normal
swallowing; this caused gagging, coughing, and irritability. A transdermal scopolamine
patch was applied every 72 hours. Drooling was reduced per the mother's assessment.
No evidence of side effects including drowsiness, mydriasis, urinary retention, or
constipation was noted. The mother noted improvement in his disposition after
beginning therapy.

a) Overview
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
b) Summary:
This drug has not been found by the US Food and Drug Administration (FDA) to be safe
and effective, and the drug product labeling has not been approved by the FDA.
Scopolamine is used for obstetric amnesia [16]
Delirium tremens
a) Overview
b) Summary:
Scopolamine may be used for the treatment delirium tremens [12]
Diagnostic procedure on eye proper, mydriasis induction and cycloplegic refraction

a) Overview
b) Summary:
For use before diagnostic procedures to produce mydriasis and cycloplegia [14]
c) Adult:
1) Ophthalmic SCOPOLAMINE is used before, during, and after intraocular surgery to
produce mydriasis and cycloplegia. The presence of mydriasis does not ensure sufficient
cycloplegia, for mydriasis generally occurs prior to cycloplegia, persists longer, and can
be achieved with lower concentrations of drug [15].
a) Overview
b) Summary:
Scopolamine is used for excessive motility and hypertonus of the GI tract in conditions
such as irritable colon syndrome, mild dysentery, diverticulitis, pylorospasm, and
cardiospasm [16]
Mania
a) Overview
b) Summary:
Scopolamine may be used for the treatment of mania [12]

a) Overview
b) Summary:
Scopolamine is used for the prevention of motion sickness [16]
a) Overview
b) Summary:
Scopolamine is used for the symptomatic treatment of postencephalitic parkinsonism

and paralysis agitans [16]
a) Overview
Efficacy: Adult, Evidence favors efficacy; Pediatric, Evidence favors efficacy
Recommendation: Adult, Class IIb; Pediatric, Class IIb
Strength of Evidence: Adult, Category B; Pediatric, Category B
b) Summary:
Scopolamine is used as a preanesthetic agent for it sedative-tranquilizing and

antisecretory activity [12]
Sedation
a) Overview
b) Summary:
Scopolamine hydrobromide is used as a sedative and tranquilizing depressant [12]
Spasticity
a) Overview
b) Summary:
Scopolamine is used for the symptomatic treatment of spastic states[16]
a) Overview
b) Summary:
Used for treating iridocyclitis, a type of anterior uveitis [14]
c) Adult:
1) Ophthalmic scopolamine has been used to treat anterior uveitis by relieving pains.
Cycloplegics are used adjunctively to treat anterior uveitis by relaxing the ciliary muscle,
and to prevent complications by reducing abnormal vascular permeability.[15].
Vomiting
a) Overview
Efficacy: Adult, Evidence favors efficacy; Pediatric, Evidence favors efficacy
Recommendation: Adult, Class IIb; Pediatric, Class IIb
Strength of Evidence: Adult, Category B; Pediatric, Category B
b) Summary:
Scopolamine hydrobromide is used as an antiemetic [12]
Dose Adjustments
Adult Dosage
Normal Dosage
Important Note
Scopolamine
[1].
[1].
Scopolamine
Transdermal route
Motion sickness
1) Usual dosage: Apply 1 transdermal system to the hairless area behind the
ear at least 4 hours before antiemetic effect is needed for use for up to 3
days. If longer therapy is required, remove the first transdermal system and
apply a new one behind the other ear (each patch delivers approximately 1
mg over 3 days) [2].
1) Usual dosage (for surgeries other than cesarean section): Apply 1
transdermal system to the hairless area behind the ear the evening before
scheduled surgery. Remove the transdermal system 24 hours following
surgery [2].
Intramuscular route
1) Usual dose: 0.32 to 0.65 mg IM [12]
Delirium tremens
Mania
1) Usual dose: 0.32 to 0.65 mg IM [12][13] administered 45 to 60 minutes
prior to anesthesia. The dose should be reduced for elderly or debilitated
patients [12].
Sedation
Intravenous route
Delirium tremens
Mania
Sedation
Ophthalmic route
Diagnostic procedure on eye proper, mydriasis induction and cycloplegic
refraction
eye(s) 1 hour before refraction [14].
eye(s) up to 4 times daily. To avoid ophthalmic systemic absorption apply
digital pressure to lacrimal sac for 2 to 3 minutes after instillation [14].
Oral route
parkinsonism [16]
Spasticity
spasticity [16]
Subcutaneous route
Delirium tremens
Mania
Sedation
Vomiting
1) Usual dose: 0.6 to 1 mg subQ [12]
Dosage in Geriatric Patients
1) Lower doses may be required in geriatric and debilitated patients [12]
Pediatric Dosage
Normal Dosage
Important Note
Scopolamine
[1].
[1].
Scopolamine
Transdermal route
a) General Dosage Information
1) Safety and effectiveness have not been established in pediatric patients [2].
Intramuscular route
1) (age 6 months to 3 years) 0.1 to 0.15 mg IM [12]
2) (age 3 to 6 years) 0.2 to 0.3 mg IM [12]
Intravenous route
1) (age 6 months to 3 years) 0.1 to 0.15 mg IV [12]
2) (age 3 to 6 years) 0.2 to 0.3 mg IV [12]
Subcutaneous route
1) (age 6 months to 3 years) 0.1 to 0.15 mg subQ [12]
2) (age 3 to 6 years) 0.2 to 0.3 mg subQ [12]
Vomiting
1) Usual dose: 6 mcg/kg/dose subQ [12]
Administration
A) Scopolamine
1) Preparation
a) Transdermal route
1) Preparation
a) Do not cut the transdermal system [2].
2) Administration
a) Only 1 transdermal system should be worn at a time. Apply the transdermal system to skin in
the postauricular area (hairless area behind 1 ear). After application, wash hands thoroughly with
soap and water and dry hands [2].
b) If the transdermal system becomes displaced, discard it and apply a new 1 on the hairless
area behind the other ear [2].
c) Upon removal, fold the used transdermal system in half with the sticky side together and
discard in household trash in a manner that prevents accidental contact or ingestion by children,
pets, or others [2].
B) Scopolamine Hydrobromide
1) Preparation
a) Ophthalmic route
1) Lacrimal sac should be compressed by digital pressure for 2 to 3 minutes after instillation [14]
C) Ophthalmic route
1) Solution
a) Stored between 8 and 27 degrees C (46 and 80 degrees F). Protect from light [59][19].
D) Transdermal route
1) Patch, Extended Release
a) Store pouch in an upright position at a controlled room temperature between 20 and 25
degrees C (68 and 77 degrees F). Do not bend or roll pouch [2].
Comparative Efficacy
Atropine
Anxiety
a) Scopolamine hydrobromide 0.4 mg IV alone or in combination with morphine sulfate
(5 to 10 mg IV) produced better anxiety relief, sedation, and patient acceptance than
atropine 0.4 mg IV alone or in combination with morphine. However, amnesia appeared
to be more pronounced with atropine therapy [66].
Efficacy
a) Scopolamine differs from atropine in antimuscarinic activity. In general, atropine has more
potent activity on the heart, intestine, and bronchial muscle, as well as a more prolonged
duration of action than scopolamine. Scopolamine has more potent activity on the iris, ciliary
body, and salivary, bronchial, and sweat glands [67]. Scopolamine exhibits significantly more
CNS depressant activity than atropine in therapeutic doses, causing drowsiness, euphoria,
amnesia, fatigue and dreamless sleep [67], as well as a reduction in REM sleep [68].
b) In ophthalmology, scopolamine is a potent mydriatic and cycloplegic, similar to atropine,
but has a shorter duration of action than the latter (cycloplegia persisting for approximately 3
days). Scopolamine may be utilized in patients exhibiting allergic reactions to atropine [69].
Cimetidine
Anxiety
a) Scopolamine hydrobromide 0.4 mg IV alone or in combination with morphine sulfate
(5 to 10 mg IV) produced better anxiety relief, sedation, and patient acceptance than
atropine 0.4 mg IV alone or in combination with morphine. However, amnesia appeared
to be more pronounced with atropine therapy [81].
Duodenal ulcer disease
a) Transdermal scopolamine (0.5 mg patch) produced NO significant effect on mean 24
hour acid secretion, gastric acid volume, or hydrogen ion concentration in a small study
involving seven men with chronic duodenal ulcer [85]. The combination of transdermal
scopolamine plus cimetidine (400 mg PO BID) was no more effective than cimetidine
alone in reducing total acid secretion over 24 hours, hydrogen ion concentration, or
gastric acid volume. It does not appear that transdermal scopolamine, in the doses
utilized, can cause sufficient reduction in gastric acid secretion for duodenal ulcer
patients.
Efficacy
a) Scopolamine differs from atropine in antimuscarinic activity. In general, atropine has more
potent activity on the heart, intestine, and bronchial muscle, as well as a more prolonged
duration of action than scopolamine. Scopolamine has more potent activity on the iris, ciliary
body, and salivary, bronchial, and sweat glands [82]. Scopolamine exhibits significantly more
CNS depressant activity than atropine in therapeutic doses, causing drowsiness, euphoria,
amnesia, fatigue and dreamless sleep [82], as well as a reduction in REM sleep [83].
b) In ophthalmology, scopolamine is a potent mydriatic and cycloplegic, similar to atropine,
but has a shorter duration of action than the latter (cycloplegia persisting for approximately 3
days). Scopolamine may be utilized in patients exhibiting allergic reactions to atropine [84].
Dexamethasone
Chemotherapy-induced nausea and vomiting

a) Addition of transdermal scopolamine to a regimen of metoclopramide and
dexamethasone was superior to metoclopramide and dexamethasone alone in reducing
chemotherapy-induced emesis (including cisplatin-induced emesis in a randomized study
involving 31 patients). Patients were randomzied to receive either a combination of
dexamethasone (20 mg IV 1 hour prior to chemotherapy) plus metoclopramide (2 mg/kg
IV 30 minutes prior to chemotherapy, repeated Q2H for 3 doses) or this same regimen
plus a scopolamine patch (Transderm Scop(R)) applied to the skin behind 1 ear between
10 minutes and 1 hour prior to the dexamethasone infusion. All patients were receiving
their first cycle of chemotherapy with a combination regimen including cisplatin in doses
of at least 60 mg/m(2). The mean number of episodes of emesis was significantly lower
in the scopolamine group (0.63) as compared to patients not receiving scopolamine
(2.27). There was also a trend towards inhibition of metoclopramide-induced
extrapyramidal reactions with scopolamine patches [79].
Dimenhydrinate
Motion sickness
a) In a study involving 140 subjects, transdermally administered scopolamine at a rate of
10 mcg/hour was more effective than oral dimenhyDRINATE (50 mg) at the prevention
of motion sickness at sea. Transdermal scopolamine afforded 62% protection against
motion sickness as compared to 49% protection with dimenhyDRINATE [64].
Adverse Effects
a) The incidence of side effects was compared in four double-blind clinical trials of subjects
with a history of motion sickness. Subjects used transdermal scopolamine (13.5 to 16 hours
before motion), oral dimenhyDRINATE of unknown dose (1.5 hours before and 2.5 hours after
motion began) or placebo and appropriate control placebos. Patients were classified as sick if
they requested supplemental medication (0.2 mg scopolamine HBr, IM) or if they vomited.
Subjects reported their side effects every 1 to 2 hours. Dry mouth was the only side effect
associated with the transdermal scopolamine and the subjects rated this as tolerable.
Transdermal scopolamine efficacy reached a level of p=0.0001 and oral dimenhyDRINATE a
level of p=0.05 for motion sickness protection, as compared to placebo [65].
Droperidol

a) In two parallel, randomized, double-blind sham and placebo-controlled studies
(n=150), premedication with transdermal scopolamine (TDS) was as effective as
droperidol or ondansetron in preventing nausea and vomiting in the early and late
postoperative periods. In the first study, patients undergoing major laparoscopic (n=80)
were randomly assigned to receive either a TDS patch (1.5 milligrams (mg) programmed
to deliver approximately 1 mg over 72 hours) or ondansetron 4 mg intravenously (IV)
administered near the end of the procedure. In the second study, patients undergoing
plastic surgery procedures (n=70) were randomly assigned to receive either a TDS patch
(1.5 mg programmed to deliver approximately 1 mg over 72 hours) or droperidol 1.25
mg IV administered near the end of the procedure. In both studies ,the patches were
applied behind one ear, approximately 60 minutes before entering the operating room
and dexamethasone (4 mg IV) was administered to all patients after induction of
anesthesia. Metoclopramide (10 mg IV) and promethazine (12.5 to 25 mg
intramuscularly (IM)) were also administered to patients undergoing major laparoscopic
surgery as rescue medications in the predischarge period and recovery room,
respectively. Ondansetron (4 mg IV) and promethazine (12.5 to 25 mg IM) were
administered to patients undergoing major plastic surgery as rescue medications in the
recovery room and on the postsurgical ward, respectively. Prochlorperazine (25 mg
suppository) was given to patients at the time of discharge to treat postdischarge emetic
symptoms. A blinded observer recorded the occurrence of postoperative nausea and
vomiting/retching, need for rescue antiemetics, and the complete response rates (eg;
absence of protracted nausea or repeated episodes of emesis requiring antiemetic rescue
medication). Additionally, complaints of visual disturbances, dry mouth, drowsiness, and
restlessness were observed at 24, 48, and 72 hours after surgery. In the first 72 hours
after surgery, no significant differences in any of the emetic outcomes or need for rescue
antiemetics among the TDS, droperidol, and ondansetron groups were observed. The
complete response rates did not significantly differ among the treatment groups (41% to
51%). Dry mouth was reported significantly more often in the TDS groups than in the
droperidol and ondansetron groups combined (21% vs 3%) [60].
Ephedrine
Motion sickness
a) Ephedrine 25 mg was compared to 0.3 mg of scopolamine, both administered
intramuscularly, in treating motion sickness induced by a rotating chair in 40 healthy
volunteers [86]. Ephedrine administration resulted in a significant improvement in post-
rotational performance when compared to placebo. Scopolamine administration resulted
in a decrease in performance after rotation.
Meclizine
Motion sickness
a) Transdermal scopolamine was reported more effective than meclizine in the
prevention of motion sickness in a controlled study [72].
b) SUMMARY: Oral or parenteral scopolamine is superior to meclizine and other
antihistamines in the treatment of motion sickness, although antihistamines may produce
fewer adverse effects [73][74][75].
c) Meclizine orally was less effective than transdermal scopolamine in preventing motion
sickness in one double-blind study [76]. The efficacy of oral meclizine 25 milligrams,
transdermal scopolamine 2.5 cm(2) circular patch (1.5 mg), and placebo were compared
in preventing motion sickness in a double-blind study involving 36 healthy subjects.
Meclizine was administered 2 hours prior to the beginning of the study; scopolamine
patches were applied at bedtime, at least 12 hours prior to motion exposure. Placebo
was supplied as matching tablets and patches. Subjects were exposed to motion on 3
occasions for 90 minutes each in a ship-motion simulator which provided evaluations of
mild motion seasickness. Scopolamine patches were superior to meclizine and placebo for
the entire experimental period. For the whole period, meclizine was not significantly
different than placebo; however, during the last half of the trial, the difference between
meclizine and placebo was significant. The efficacy of transdermal scopolamine and oral
meclizine in preventing motion sickness (% protection) was 60% and 20%, respectively.
Dryness of the mouth occurred more frequently in scopolamine-treated patients;
however, the incidence of drowsiness, blurred vision, dizziness, or capability to carry-out
daily activities was similar with all 3 regimens. This study employed low therapeutic
doses of meclizine; more studies are required evaluating a higher dose (50 milligrams).
In addition, these results suggest that meclizine may not be fully effective when given 2
hours prior to the onset of motion, as the drug appeared to be effective only during the
last half of the trial. More studies investigating administration of the drug at longer
intervals prior to motion (4 to 8 hours) are suggested.
Vertigo
a) One controlled study reported the comparable efficacy of oral meclizine 25 milligrams
4 times daily and transdermal scopolamine patches, delivering 0.17 mg daily, in the
treatment of induced vertigo [77]. Transdermal scopolamine was applied once and left in
place for 7 days; meclizine was given for 7 days. Prior to each treatment, and on days 1
and 7, subjects received two warm (44 degrees Centigrade) caloric irrigations of each
external auditory canal to induce vertigo. Following the 7-day treatment period, patients
were crossed over to the opposite regimen after a 1-week interval, and the caloric
irrigation protocol was repeated. Transdermal scopolamine was superior to meclizine in
placebo with regard to lessening of vertigo symptoms on day 1 of treatment; on day 7,
vertigo symptoms were significantly less with both scopolamine and meclizine as opposed
to placebo. On the first day of treatment, meclizine did not significantly reduce vertigo
symptoms as compared to placebo. Drowsiness was greater with meclizine as opposed to
scopolamine throughout 7 days of treatment. These data suggest that transdermal
scopolamine is superior to meclizine in the treatment of vertigo induced by warm caloric
irrigation in healthy subjects.
Memantine
Pendular nystagmus
a) Memantine was more effective than scopolamine for treatment of acquired pendular
nystagmus in patients with multiple sclerosis. Eleven patients experienced complete
cessation of the nystagmus after receiving an average oral dose of 40
milligrams(mg)/day for 7 days. Scopolamine was applied as a plaster on the right
mastoid and release of the active agent was 0.5 mg/72 hours; however, it was only
effective in 2 of 8 patients. Neuro-ophthalmologic examinations, electro-oculographic
recordings and video recordings of eye movements were performed before and during
treatment. Two reports of transient mydriasis occurred in the scopolamine group; 1 case
of dizziness, 2 cases of fatigue, and 2 cases of muscle weakness were reported in the
memantine group [78].
Methscopolamine
1) Efficacy
a) Methscopolamine has been used in the past to increase cardiac heart rate because of the
absence of central nervous system stimulation [61]. In one study, the effects of
methscopolamine bromide and atropine were compared. To increase heart rate at least 20%,
a total dose of 1.5 micrograms/kilogram of methscopolamine was required compared to a total
dose of 5.3 micrograms/kilogram of atropine [62].
Metoclopramide
Chemotherapy-induced nausea and vomiting

a) The addition of transdermal scopolamine to a regimen of metoclopramide plus
dexamethasone was superior to metoclopramide plus dexamethasone in reducing
chemotherapy-induced emesis (including cisplatin-induced emesis) in a randomized study
involving 31 patients. Patients were randomized to receive either a combination of
dexamethasone (20 mg intravenously 1 hour prior to chemotherapy) plus
metoclopramide (2 mg/kg intravenously 30 minutes prior to chemotherapy, repeated
every 2 hours for 3 doses) or this same regimen plus a scopolamine patch (Transderm
Scop(R)) applied to the skin behind 1 ear between 10 minutes and 1 hour prior to the
dexamethasone infusion. All patients were receiving their first cycle of chemotherapy
with a combination regimen including cisplatin in doses of at least 60 mg/m(2). The
mean number of episodes of emesis was significantly lower in the scopolamine group
(0.63) as compared to patients not receiving scopolamine (2.27). There was also a trend
towards inhibition of metoclopramide-induced extrapyramidal reactions with scopolamine
patches [87].
Ondansetron

a) In two parallel, randomized, double-blind sham and placebo-controlled studies
(n=150), premedication with transdermal scopolamine (TDS) was as effective as
droperidol or ondansetron in preventing nausea and vomiting in the early and late
postoperative periods. In the first study, patients undergoing major laparoscopic (n=80)
were randomly assigned to receive either a TDS patch (1.5 milligrams (mg) programmed
to deliver approximately 1 mg over 72 hours) or ondansetron 4 mg intravenously (IV)
administered near the end of the procedure. In the second study, patients undergoing
plastic surgery procedures (n=70) were randomly assigned to receive either a TDS patch
(1.5 mg programmed to deliver approximately 1 mg over 72 hours) or droperidol 1.25
mg IV administered near the end of the procedure. In both studies ,the patches were
applied behind one ear, approximately 60 minutes before entering the operating room
and dexamethasone (4 mg IV) was administered to all patients after induction of
anesthesia. Metoclopramide (10 mg IV) and promethazine (12.5 to 25 mg
intramuscularly (IM)) were also administered to patients undergoing major laparoscopic
surgery as rescue medications in the predischarge period and recovery room,
respectively. Ondansetron (4 mg IV) and promethazine (12.5 to 25 mg IM) were
administered to patients undergoing major plastic surgery as rescue medications in the
recovery room and on the postsurgical ward, respectively. Prochlorperazine (25 mg
suppository) was given to patients at the time of discharge to treat postdischarge emetic
symptoms. A blinded observer recorded the occurrence of postoperative nausea and
vomiting/retching, need for rescue antiemetics, and the complete response rates (eg;
absence of protracted nausea or repeated episodes of emesis requiring antiemetic rescue
medication). Additionally, complaints of visual disturbances, dry mouth, drowsiness, and
restlessness were observed at 24, 48, and 72 hours after surgery. In the first 72 hours
after surgery, no significant differences in any of the emetic outcomes or need for rescue
antiemetics among the TDS, droperidol, and ondansetron groups were observed. The
complete response rates did not significantly differ among the treatment groups (41% to
51%). Dry mouth was reported significantly more often in the TDS groups than in the
droperidol and ondansetron groups combined (21% vs 3%) [60].
Pirenzepine
Bowel imaging
a) Pirenzepine (0.1 milligram/kilogram (mg/kg) intravenous (IV) single dose) was more
effective (p equals 0.02) than scopolamine methyl bromide (20 mg IV single dose) in
colon distension during double-contrast radiological exams in a single-blind randomized
study of 60 patients. Pirenzepine, in contrast to scopolamine methyl bromide, did not
have any effect on heart rate and did not precipitate adverse reactions. Dry mouth, visual
accommodation defects, dizziness and faintness were reported with scopolamine methyl
bromide use [70].
Coronary arteriosclerosis
a) In a single-blind, placebo-controlled study, low-dose pirenzepine (25 mg oral dose
twice a day) significantly (p less than 0.0001) increased indexes of cardiac vagal activity
(time and frequency domain mesasures of electrocardiogram RR variability and
baroreceptor reflex sensitivity) in 20 postinfarction patients like transdermal scopolamine
(0.5 mg/day) but with lower side effects (5% versus 50%) [71]. Potential role of low-
dose (parasympathomimetic activity) pirenzepine for preventing malignant ventricular
arrhythmias after infarction will be considered.
Promethazine
1) Adverse Effects
a) Promethazine, scopolamine, and cinnarizine were demonstrated to significantly reduce
psychological performance at various times. Twelve normal subjects were administered single
doses of promethazine 25 mg, scopolamine 0.6 mg, and cinnarizine 30 mg in a double-blind,
placebo controlled trial. Logical performance tests and a feeling state questionnaire before
drug administration and at 2-hour intervals. promethazine 3 to 4 hours, scopolamine 1 to 4
hours, and cinnarizine 5 to 6 hours post dose. Performance for promethazine and cinnarizine
remained depressed for 8 to 9 hours after drug administration [63].
Trimethobenzamide
Motion sickness
a) Oral trimethobenzamide 750 mg was found to be one of the least effective agents in
an 8-patient, double-blind, cross-over study comparing it with meclizine, hyoscine,
hyoscine plus amphetamine, amphetamine, thiethylperazine, and prochlorperazine in the
treatment of motion sickness. Effectiveness was measured using a relative effectiveness
scale based on the number of head movements. Trimethobenazmide received a score of
minus 10 as compared to plus 18 for prochlorperazine and plus 24 for meclizine. The
amphetamine, hyoscine, and hyoscine plus amphetamine regimens scored the highest
with scores in excess of 90 or more [80].
Place In Therapy
A) Motion Sickness
1) Transderm scopolamine is indicated in adults for the prevention of nausea and vomiting
associated with motion sickness [2].
2) Transdermal scopolamine was effective in preventing motion sickness in up to 75% of patients
[3], and was more effective than oral dimenhydrinate [4].
B) Post-operative Nausea and Vomiting
1) Transderm scopolamine is indicated in adults for the prevention of post-operative nausea and
vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery [2].
2) Transdermal scopolamine placed behind the ear at least 8 hours prior to laparoscopic surgery
significantly reduced postoperative nausea, retching, and vomiting compared with placebo (37% vs
68%; N=138). Additionally, antiemetic therapy was required in only 13% of scopolamine-treated
patients compared with 32% of patients receiving placebo [6]. Combination treatment with
transdermal scopolamine plus ondansetron was superior to ondansetron alone for prevention of
postoperative nausea and vomiting in a randomized study in adult women (N=608) [7].
MEDICATION SAFETY
Contraindications
A) Scopolamine
1) Angle-closure glaucoma [2]
2) Hypersensitivity to scopolamine, other belladonna alkaloids, or any ingredient or component in
the formulation or the delivery system [2]
1) Chronic lung disease; repeated administration may increase the risk of adverse events [12]
2) Glaucoma, primary, or a tendency toward glaucoma (eg, narrow anterior chamber angle) [14]
3) Hepatic impairment [16]
4) Hypersensitivity to scopolamine hydrobromide [16], any component of the product [14], other
belladonna alkaloids, anticholinergic drugs, or barbiturates [12]
5) Narrow-angle (angle-closure) glaucoma [16]
6) Prostatic hypertrophy [16]
7) Pyloric obstruction [16]
8) Renal impairment [16]
Precautions
A) Scopolamine
1) Beers Criteria: Avoid use as an antispasmodic due to highly anticholinergic effects and uncertain
effectiveness. Avoid use in patients with or at risk for delirium, dementia, or cognitive impairment
due to increased risk for CNS adverse effects and strong anticholinergic properties that may worsen
conditions. Avoid use in men with lower urinary tract symptoms or benign prostatic hyperplasia due
to increased risk for urinary retention and decreased urinary flow [1].
2) Concomitant use: Avoid use of other agents associated with CNS adverse events and
anticholinergic agents [2]
3) Dermatologic: Skin burns at the patch site have been reported in patients wearing an aluminized
transdermal system during an MRI; remove patch prior to MRI [2]
4) Gastrointestinal: May decrease gastrointestinal motility; more frequent monitoring recommended
in patients with pyloric obstruction or suspected intestinal obstruction, and in those receiving other
anticholinergic agents [2]
5) Hepatic: Impairment is associated with an increased risk of CNS adverse events; consider more
frequent monitoring [2]
6) Neurologic: CNS adverse events have been reported including impairment of mental and
physical abilities, especially with concomitant use of alcohol, sedatives, hypnotics, opiates, and
anxiolytics or anticholinergic agents (eg, other belladonna alkaloids, sedating antihistamines,
meclizine, tricyclic antidepressants, and muscle relaxants) [2]
7) Neurologic: May cause cognitive adverse events, including drowsiness, disorientation, and
confusion; elderly and pediatric patients (unapproved use) may be more sensitive; discontinue use
with occurrence [2]
8) Neurologic: Seizures and seizure-like activity have been reported; evaluate benefit risk of
therapy in patients with a history of seizures, including those receiving antiepileptics or with risk
factors that can lower the seizure threshold.[2]
9) Ophthalmic: May cause temporary dilation of pupils resulting in blurred vision with ophthalmic
contact; proper handling required [2]
10) Ophthalmic: May increase intraocular pressure resulting in acute angle closure glaucoma;
monitoring recommended in patients with open-angle glaucoma; dosage adjustment of glaucoma
therapy may be necessary; remove patch immediately if symptoms of acute angle closure glaucoma
occur (eg, eye pain or discomfort, blurred vision, visual halos or colored images in association with
red eyes from conjunctival congestion and corneal edema) [2]
11) Psychiatric: May exacerbate psychosis; other psychiatric reactions have also been reported,
including acute toxic psychosis, agitation, speech disorder, hallucinations, paranoia, and delusions;
monitoring recommended, especially in patients receiving other drugs concomitantly that are
associated with similar psychiatric effects [2]
12) Renal: May cause urinary retention; more frequent monitoring recommended in patients with
urinary bladder neck obstruction and in those receiving other anticholinergic agents; discontinue if
difficulty urinating develops [2]
13) Renal: Impairment is associated with an increased risk of CNS adverse events; consider more
frequent monitoring [2]
14) Special populations: Elderly may be more sensitive to neurological (drowsiness, disorientation,
confusion) and psychiatric effects; consider more frequent monitoring [2]
15) Special populations: Eclamptic seizures have been reported in pregnant women with severe
preeclampsia soon after injection of IV and IM scopolamine; avoid use of scopolamine patch in
patients with severe preeclampsia [2]
16) Withdrawal: Symptoms may occur usually after several days of use (eg, including disturbances
of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental
confusion, muscle weakness, bradycardia and hypotension); onset is generally 24 hours or more
after the transdermal system has been removed; medical management may be needed [2]
1) Beers Criteria: Avoid use as an antispasmodic due to highly anticholinergic effects and uncertain
effectiveness. Avoid use in patients with or at risk for delirium, dementia, or cognitive impairment
due to increased risk for CNS adverse effects and strong anticholinergic properties that may worsen
conditions. Avoid use in men with lower urinary tract symptoms or benign prostatic hyperplasia due
to increased risk for urinary retention and decreased urinary flow [1].
2) Cardiovascular: Patients with preexisting hypertension may experience both exaggerated
orthostatic hypotension and tachycardia [12]
3) Cardiovascular: Increased risk of adverse events in patients with cardiac disease including
tachycardia, other tachyarrhythmias, coronary heart disease, congestive heart disease [16][12]
4) Endocrine and metabolic: Increased risk of adverse events in patients with preexisting
hyperthyroidism [12]
5) Immunologic: Higher incidence of hypersensitivity reactions in patients with a history of allergies
or bronchial asthma [12]
6) Neurologic: May exacerbate symptoms of preexisting autonomic neuropathy [12]
7) Neurologic: Increased risk of adverse events in patients with brain damage, Down syndrome
(mongolism), spasticity, or light irides [12]
8) Neurologic: Sudden withdrawal of large doses may cause vomiting, malaise, sweating, and
salivation in patients with parkinsonism [12]
9) Reproductive: Monitoring recommended in patients with prostatic hypertrophy [12]
10) Special populations: Infants and children may have increased risk of adverse events and
poisoning [12]
11) Special populations: Increased risk of elevated intraocular pressure, urinary difficulty and
retention, and constipation in elderly patients [16][12]
Adverse Effects
Cardiovascular Effects
Hypotension
1) Adult Clinical Trials
a) Premedicant for abdominal surgery with cyclopropane anesthesia (subQ route): 38%
with scopolamine plus morphine (n=201) [17]
Dermatologic Effects
Application site irritation

1) Postmarketing
a) Application site burning has been reported with postmarketing use of transdermal
scopolamine [2].
Rash
1) General Information
a) Of 68 patients who used transdermal scopolamine to prevent motion sickness, 4.4%
discontinued treatment due to contact dermatitis [29]. In addition, a 10-year-old boy
developed a retroauricular skin rash about 2 weeks after starting transdermal
scopolamine [30].
2) Postmarketing
a) Generalized rash has been reported with postmarketing use of transdermal
scopolamine [2].
Gastrointestinal Effects
Xerostomia
1) Incidence: 29% to approximately 66% [2]
a) Motion sickness (transdermal route): Approximately 66% with scopolamine [2]
b) Post-operative nausea and vomiting (transdermal route): 29% with scopolamine
(n=461) vs 16% with placebo (n=457) [2]
Neurologic Effects
Amnesia
1) Postmarketing
a) Has been reported with postmarketing use of transdermal scopolamine [2]
Confusion
1) Incidence: 4% [2]
a) Scopolamine may cause confusion [2].
b) Elderly and pediatric patients may be more sensitive to neurological and psychiatric
adverse effects [2].
3) Management
a) Discontinue use if signs or symptoms of cognitive impairment develop [2].
a) Post-operative nausea and vomiting (transdermal route): 4% with scopolamine
Disorientated
a) Scopolamine may cause disorientation [2].
2) Management
3) Postmarketing
Disturbance of attention
1) Postmarketing
Dizziness
1) Incidence: 12% to less than 16.7% [2]
a) Motion sickness (transdermal route): Less than 16.7% with scopolamine [2]
Headache
1) Postmarketing
Incoordination
1) Postmarketing
Meningism
1) Adult Case Reports
a) Deep coma and meningism were described in a 52-year-old woman following
premedication with scopolamine 0.4 mg IM, hydroxyzine 50 mg IM and meperidine 100
mg IM for a pancreatoduodenectomy. Following administration, the patient was deeply
comatose and marked nuchal rigidity was noted. Naloxone produced little change in
level of consciousness, and physostigmine 1 mg IV had no effect. A second dose of
physostigmine 1 mg IV administered 10 minutes later produced a dramatic effect, with
the patient awakening and becoming alert and oriented. Deep tendon reflexes and
Babinski responses returned to normal and no rigidity was observed. The authors
suggest that since the patient had abnormal liver function prior to the episode, as well
as low serum albumin levels, this may have combined synergistically with hydroxyzine
and meperidine to contribute to the profound CNS depression and coma. Since the
patient did not respond to naloxone, meperidine probably had no effect on muscle
rigidity, and the most likely cause of meningismus was scopolamine [18].
Restlessness
1) Postmarketing
Seizure
a) Seizures and seizure-like activity have been reported in patients receiving
scopolamine [2].
2) Prevention
a) Weigh potential risks versus benefits before prescribing in patients with a history of
seizures, including those receiving anti-epileptic medication or who have risk factors that
can lower the seizure threshold [2].
Somnolence
a) Scopolamine may cause drowsiness [2].
3) Management
Vertigo
1) Postmarketing
Ophthalmic Effects
Amblyopia
1) Postmarketing
Anisocoria
a) A 38-year-old woman developed agitation, confusion, and a dilated right pupil after
using a scopolamine patch for nausea and vomiting associated with epidural analgesia.
Symptoms occurred about 2 hours after the scopolamine patch was removed.
Pilocarpine 1% eye drops were instilled in both eyes; however, only the left eye
constricted. Since the symptoms were likely induced by scopolamine, physostigmine 0.5
mg was administered to a total dose of 1.5 mg, and all symptoms were rapidly reversed.
Within 12 hours, the patient was alert and both pupils were of normal size. Most cases
of scopolamine-induced dilated pupil occur in the eye on the same side as the patch.
The etiology may be related to inadvertent transfer of drug from the patch to eye by the
hand or absorption of drug into the internal carotid artery and the ophthalmic artery
[25].
b) Anisocoria was described in a 27-year-old woman secondary to application of a
scopolamine patch behind the left ear to prevent motion sickness. The patient presented
with a dilated, 6-mm left pupil that failed to constrict with light. The patient had applied
the scopolamine patch 7 days previously and had not removed it. Patch removal resulted
in normalization of the pupil response over the next 2 hours [26].
c) Anisocoria was described in a 25-year-old woman during scopolamine patch use. The
patient presented with an enlarged left pupil, drowsiness, and diarrhea of 1 day's
duration and the diagnosis of intracranial neoplasm or aneurysm was considered. A
scopolamine patch was located behind the left ear for prophylaxis against motion
sickness, and anisocoria subsided over the next 4 hours as well as other symptoms. The
patient inadvertently transferred scopolamine into her left eye by contact from her finger
after the patch application [27].
Blurred vision
1) Incidence: Less than 16.7% [2]
a) Temporary dilation of the pupils resulting in blurred vision may occur if scopolamine
comes into contact with eyes [2].
3) Prevention
a) Immediately wash hands thoroughly with soap and water after handling the
transdermal system [2].
Dry eyes
1) Postmarketing
Esotropia
1) Pediatric Case Reports
a) A 4-year-old boy, who was treated with one-fourth of a transdermal scopolamine
patch 1.5 mg every 3 days for drooling, developed esotropia (eg, cross-eye or
convergent strabismus) within 5 days of starting treatment. Following a complete
ophthalmic examination which identified esotropia, the transdermal scopolamine patch
was stopped at the recommendation of the ophthalmologist. At a follow-up ophthalmic
examination one month after stopping the transdermal scopolamine patch, abnormalities
related to accommodation were absent. Rechallenge was not performed. The authors
postulated that systemic anticholinergic effects of scopolamine were sufficient to induce
esotropia. Since use of transdermal scopolamine is common in children with
developmental disabilities and excessive drooling, clinicians should be aware of this
possible adverse effect [28].
Eye irritation
1) Postmarketing
a) Eyelid irritation has been reported with postmarketing use of transdermal
scopolamine [2].
Glaucoma
a) The mydriatic effect of scopolamine may cause an increase in intraocular pressure
resulting in acute angle closure glaucoma [2].
2) Prevention and Management
a) Monitor intraocular pressure in patients with open angle glaucoma and adjust
glaucoma therapy as necessary during treatment with scopolamine [2].
b) Advise patients to immediately remove the transdermal scopolamine system and
contact a healthcare provider if symptoms of acute angle closure glaucoma (eg, eye pain
or discomfort, blurred vision, visual halos or colored images in association with red eyes
from conjunctival congestion, and corneal edema) occur [2].
3) Postmarketing
a) Angle closure glaucoma has been reported with postmarketing use of transdermal
scopolamine [2]
Itching of eye
1) Postmarketing
Mydriasis
1) Incidence: 4% to less than 16.7% [2]
a) Temporary dilation of the pupils resulting in blurred vision may occur if scopolamine
comes into contact with eyes [2].
b) Systemic scopolamine products cause mydriasis, which results in blurred vision and
photophobia. At higher doses, cycloplegia has also been reported [19][20][21][22];[23].
3) Prevention
a) Immediately wash hands thoroughly with soap and water after handling the
transdermal system [2].
a) A 20-year-old woman on vacation in Mexico was noted to have a unilateral dilated
pupil. History revealed no familial aneurysms, no head trauma, no nuchal rigidity, and no
visual defect in that eye. It was noted that the patient removed a transdermal
scopolamine disc the evening before and had also removed her contact lenses. It was
concluded that the patient either touched her eye or contaminated her soft contact
lenses which were reinserted in the morning. It is stressed that patients handle the
transdermal scopolamine disc carefully, wash hands following application or removal,
and avoid contact with the eyes [24].
Visual impairment
Psychiatric Effects
Agitation
Hallucinations
1) Postmarketing
Paranoid disorder
1) Postmarketing
Psychotic disorder
a) Scopolamine has been reported to exacerbate psychosis [2]
b) Psychiatric symptoms including acute toxic psychosis, agitation, speech disorder,
hallucinations, paranoia, and delusions have been reported [2].
c) Elderly and pediatric patients may be more sensitive to neurological and psychiatric
a) Although transdermal scopolamine was thought to obviate most symptoms associated
with other forms of scopolamine, psychosis developed in a 71-year-old woman. The
patient became psychotic, agitated, and paranoid, complained of visual hallucinations,
and experienced tachycardia and mydriasis within 3 days of application of a Transderm-
Scop(R) disc. The patient was also receiving propranolol, isosorbide, digoxin,
furosemide, and meclizine. It is possible that the psychotic reaction was caused by
combination of scopolamine and meclizine. Haloperidol 2 mg IM did not improve
behavior. The transdermal disc was removed and the patient received physostigmine
salicylate 1 mg IM; within 3 hours, psychotic symptoms, tachycardia, and cycloplegia
resolved [31].
b) Toxic psychosis was reported in a 67-year-old woman who received eyedrops
containing atropine 0.02 g/mL, scopolamine 5 mg/mL, and phenylephrine 40 mg/mL.
The patient received 6 to 8 drops of this preparation in each eye for ophthalmologic
laser therapy. The onset of symptoms was sudden. In addition, the symptoms
reappeared after rechallenge. The psychotic symptoms were similar to those induced by
atropine [32].
3) Postmarketing
a) Acute psychosis including has been reported with postmarketing use of transdermal
scopolamine [2]
Renal Effects
Dysuria
1) Postmarketing
Urinary retention
a) Scopolamine may cause urinary retention due to its anticholinergic properties and
decreasing gastrointestinal motility [2].
2) Management
a) Discontinue use in patients who develop difficulty in urinary [2].
Reproductive Effects
Eclamptic seizure
a) Eclamptic seizures have been reported in pregnant women with severe preeclampsia
soon after injection of IV and IM scopolamine [2].
2) Prevention
a) Avoid use in patients with severe preeclampsia [2].
Respiratory Effects
Pharyngitis
Other
Withdrawal symptom
a) Discontinuation of transdermal scopolamine, usually after several days of use, may
result in withdrawal symptoms [2].
b) Symptoms may include disturbances of equilibrium, dizziness, nausea, vomiting,
abdominal cramps, sweating, headache, mental confusion, muscle weakness,
bradycardia, and hypotension [2].
c) Onset is usually 24 hours or more after the transdermal system has been removed
[2].
2) Management
a) Advise patients to seek medical attention if symptoms occur [2].
Black Box Warning
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Drug Interactions (single)
Drug-Drug Combinations
Alfentanil
1) Interaction Effect: increased risk of drowsiness, dizziness, and disorientation
2) Summary: Concomitant use of scopolamine with other drugs that cause CNS adverse
reactions of drowsiness, dizziness, or disorientation (eg sedatives, hypnotics, opiates,
anxiolytics) may potentiate the effects of scopolamine. Either drug should be chosen,
depending on the importance of the drug to the patient. If the coadministration cannot
be avoided, monitor patients for CNS adverse reactions[2].
3) Severity: major
4) Onset: unspecified
5) Substantiation: theoretical
6) Clinical Management: Concomitant use of scopolamine with other drugs that cause
CNS adverse reactions of drowsiness, dizziness, or disorientation (eg sedatives,
hypnotics, opiates, anxiolytics) may potentiate the effects of scopolamine. Either drug
should be chosen, depending on the importance of the drug to the patient. If the
coadministration cannot be avoided, monitor patients for CNS adverse reactions[2].
7) Probable Mechanism: additive CNS depression
Alprazolam
3) Severity: major
Amantadine
1) Interaction Effect: potentiation of anticholinergic effects
2) Summary: Concomitant use of amantadine with anticholinergic drugs may potentiate
the anticholinergic-like side effects of amantadine[38]. Coadministration has been
resulted in a potentiation of anticholinergic side effects, including confusion and
hallucinations in patients receiving close to maximum tolerable doses of an
anticholinergic (trihexyphenidyl, benztropine) [39]. If they must be used concurrently,
reduce the dose of the anticholinergic drug or amantadine if atropine-like side effects
occur [38].
3) Severity: moderate
6) Clinical Management: Concomitant use of amantadine with anticholinergic drugs may
potentiate the anticholinergic-like side effects of amantadine. If they must be used
concurrently, reduce the dose of the anticholinergic drug or amantadine if atropine-like
side effects occur[38].
7) Probable Mechanism: additive anticholinergic properties
8) Literature Reports
a) Concomitant amantadine and anticholinergic drug therapy has been reported to result
in a potentiation of anticholinergic side effects, including confusion and hallucinations in
patients receiving close to maximum tolerable doses of an anticholinergic
(trihexyphenidyl, benztropine) [39].
Amifampridine
1) Interaction Effect: increased risk of seizures
2) Summary: Concomitant use of amifampridine and this drug may increase the risk of
seizures. Consider this risk if these agents are to be used concomitantly[33].
3) Severity: major
6) Clinical Management: Concomitant use of amifampridine and this drug may increase
the risk of seizures. Consider this risk if these agents are to be used concomitantly[33].
7) Probable Mechanism: unknown
Amitriptyline
1) Interaction Effect: increased risk of CNS adverse reactions, intestinal obstruction, and
urinary retention
2) Summary: Concomitant use of scopolamine with other anticholinergic agents may
potentiate the effects of scopolamine and increase the risk of CNS adverse reactions,
intestinal obstruction, and urinary retention. Either drug should be chosen, depending on
the importance of the drug to the patient. If the coadministration cannot be avoided,
more frequent monitoring is recommended[2].
3) Severity: major
6) Clinical Management: Concomitant use of scopolamine with other anticholinergic
agents may potentiate the effects of scopolamine and increase the risk of CNS adverse
reactions, intestinal obstruction, and urinary retention. Either drug should be chosen,
be avoided, more frequent monitoring is recommended[2].
7) Probable Mechanism: additive anticholinergic affects
Amobarbital
3) Severity: major
Amoxapine
urinary retention
3) Severity: major
Anileridine
3) Severity: major
Atropine
urinary retention
3) Severity: major
Baclofen
3) Severity: major
Belladonna
urinary retention
3) Severity: major
Benzhydrocodone
3) Severity: major
Benztropine
urinary retention
3) Severity: major
Biperiden
urinary retention
3) Severity: major
Bromazepam
3) Severity: major
Brompheniramine
urinary retention
3) Severity: major
Buprenorphine
3) Severity: major
Bupropion
1) Interaction Effect: lower seizure threshold
2) Summary: Use extreme caution when prescribing bupropion with drugs that lower
seizure threshold (eg, antipsychotics, antidepressants, theophylline, systemic
corticosteroids). Begin treatment with a low initial dose and increase dose gradually[35].
3) Severity: major
6) Clinical Management: Use extreme caution when prescribing bupropion with drugs
that lower seizure threshold (eg, antipsychotics, antidepressants, theophylline, systemic
corticosteroids). Begin treatment with a low initial dose and increase dose gradually[35].
Buspirone
3) Severity: major
Butabarbital
3) Severity: major
Butorphanol
3) Severity: major
Carbinoxamine
urinary retention
2) Summary: Concomitant use of scopolamine with other anticholinergic CNS depressant
3) Severity: major
6) Clinical Management: Concomitant use of scopolamine with other anticholinergic CNS
depressant agents may potentiate the effects of scopolamine and increase the risk of
CNS adverse reactions, intestinal obstruction, and urinary retention. Either drug should
be chosen, depending on the importance of the drug to the patient. If the
coadministration cannot be avoided, more frequent monitoring is recommended[2].
7) Probable Mechanism: additive anticholinergic and CNS depressant effects
Carisoprodol
urinary retention
3) Severity: major
Chloral Hydrate
3) Severity: major
Chlordiazepoxide
3) Severity: major
Chlorpheniramine
urinary retention
3) Severity: major
Chlorpromazine
urinary retention
3) Severity: major
Chlorzoxazone
3) Severity: major
Cisapride
1) Interaction Effect: loss of cisapride efficacy
2) Summary: Concurrent use of an anticholinergic agent with cisapride is likely to
counteract gastrointestinal motility normally induced by cisapride[41][42].
3) Severity: minor
4) Onset: delayed
6) Clinical Management: The beneficial effects of cisapride are expected to be largely lost
if an anticholinergic medication such as scopolamine is given concomitantly.
7) Probable Mechanism: pharmacodynamic antagonism
a) The effects of cisapride on peristaltic contractions were completely blocked by the
anticholinergic atropine, irrespective of whether atropine was administered before or
after cisapride. Lower esophageal sphincter pressure response to cisapride varied
according to the sequence of drug administration. When cisapride followed atropine,
cisapride exerted no effect. When this sequence was reversed, no significant atropine-
induced inhibition of cisapride-stimulated lower esophageal sphincter pressure occurred
[40].
Clemastine
urinary retention
3) Severity: major
Clidinium
urinary retention
3) Severity: major
Clobazam
3) Severity: major
Clomipramine
urinary retention
3) Severity: major
Clonazepam
3) Severity: major
Clorazepate
3) Severity: major
Clozapine
urinary retention
3) Severity: major
Codeine
3) Severity: major
Cyclobenzaprine
urinary retention
3) Severity: major
Cyclopentolate
urinary retention
3) Severity: major
Cyproheptadine
urinary retention
3) Severity: major
Darifenacin
urinary retention
3) Severity: major
Desipramine
urinary retention
3) Severity: major
Dexmedetomidine
3) Severity: major
Diacetylmorphine
3) Severity: major
Diazepam
3) Severity: major
Dicyclomine
urinary retention
3) Severity: major
Difenoxin
3) Severity: major
Dihydrocodeine
3) Severity: major
Dimenhydrinate
urinary retention
3) Severity: major
Diphenhydramine
urinary retention
3) Severity: major
Diphenoxylate
3) Severity: major
Donepezil
1) Interaction Effect: reduced seizure threshold
2) Summary: Seizure threshold lowering effects have been associated with
donepezil[36]. Use extreme caution when prescribing donepezil with drugs that lower
corticosteroids). Begin treatment with a low initial dose and increase dose gradually.
3) Severity: major
6) Clinical Management: Seizure threshold lowering effects have been associated with
donepezil[36]. Use extreme caution when prescribing donepezil with drugs that lower
corticosteroids). Begin treatment with a low initial dose and increase dose gradually.
Doxepin
urinary retention
3) Severity: major
Doxylamine
3) Severity: major
Estazolam
3) Severity: major
Eszopiclone
3) Severity: major
Ethchlorvynol
3) Severity: major
Ethylmorphine
3) Severity: major
Fentanyl
3) Severity: major
Flavoxate
urinary retention
3) Severity: major
Flunitrazepam
3) Severity: major
Fluphenazine
urinary retention
3) Severity: major
Flurazepam
3) Severity: major
Fospropofol
3) Severity: major
Glycopyrrolate
urinary retention
3) Severity: major
Glycopyrronium Tosylate
urinary retention
3) Severity: major
Halazepam
3) Severity: major
Homatropine
urinary retention
3) Severity: major
Hydrocodone
3) Severity: major
Hydromorphone
3) Severity: major
Hydroxyzine
urinary retention
3) Severity: major
Hyoscyamine
urinary retention
3) Severity: major
Imipramine
urinary retention
3) Severity: major
Ipratropium
urinary retention
3) Severity: major
Ketazolam
3) Severity: major
Ketobemidone
3) Severity: major
Levorphanol
3) Severity: major
Lorazepam
3) Severity: major
Loxapine
urinary retention
3) Severity: major
Meclizine
urinary retention
3) Severity: major
Mepenzolate
urinary retention
3) Severity: major
Meperidine
3) Severity: major
Mephobarbital
3) Severity: major
Meprobamate
3) Severity: major
Meptazinol
3) Severity: major
Metaxalone
3) Severity: major
Methadone
3) Severity: major
Methocarbamol
3) Severity: major
Methohexital
3) Severity: major
Methotrimeprazine
3) Severity: major
Midazolam
3) Severity: major
Morphine
3) Severity: major
Morphine Sulfate Liposome
3) Severity: major
Nalbuphine
3) Severity: major
Nicomorphine
3) Severity: major
Nitrazepam
3) Severity: major
Nortriptyline
urinary retention
3) Severity: major
Olanzapine
urinary retention
3) Severity: major
Opium
3) Severity: major
Opium Alkaloids
3) Severity: major
Orphenadrine
urinary retention
3) Severity: major
Oxazepam
3) Severity: major
Oxitropium Bromide
urinary retention
3) Severity: major
Oxybutynin
urinary retention
3) Severity: major
Oxycodone
3) Severity: major
Oxymorphone
3) Severity: major
Papaveretum
3) Severity: major
Paregoric
3) Severity: major
Paroxetine
urinary retention
3) Severity: major
Pentazocine
3) Severity: major
Pentobarbital
3) Severity: major
Perampanel
3) Severity: major
Perphenazine
urinary retention
3) Severity: major
Phenobarbital
3) Severity: major
Pimozide
urinary retention
3) Severity: major
Pipenzolate Bromide
urinary retention
3) Severity: major
Pirenzepine
urinary retention
3) Severity: major
Piritramide
3) Severity: major
Potassium
1) Interaction Effect: risk of gastrointestinal lesions
2) Summary: Concomitant administration of solid oral dosage forms of potassium
chloride and drugs with anticholinergic properties, such as scopolamine, may cause the
arrest or delay of the potassium chloride dose through the gastrointestinal (GI) tract,
particularly at doses that sufficiently exert anticholinergic effects. This could lead to an
increased risk of GI lesions and, therefore, such use is contraindicated[43][44][45].
3) Severity: contraindicated
4) Onset: rapid
6) Clinical Management: The concomitant use of a solid oral dosage form of potassium
chloride is contraindicated in patients who may be receiving agents with anticholinergic
properties, such as scopolamine. Such agents, particularly at doses to sufficiently exert
anticholinergic effects, could potentially cause an arrest or delay of potassium chloride
tablet passage through the gastrointestinal tract, thereby increasing the risk of
gastrointestinal lesions[43][44][45].
7) Probable Mechanism: arrest or delay of potassium chloride solid dose form passage
through the gastrointestinal tract
Prazepam
3) Severity: major
Primidone
3) Severity: major
Prochlorperazine
urinary retention
3) Severity: major
Procyclidine
urinary retention
3) Severity: major
Promethazine
urinary retention
3) Severity: major
Propantheline
urinary retention
3) Severity: major
Propiverine
urinary retention
3) Severity: major
Propofol
3) Severity: major
Protriptyline
urinary retention
3) Severity: major
Quazepam
3) Severity: major
Ramelteon
3) Severity: major
Remifentanil
3) Severity: major
Revefenacin
1) Interaction Effect: increased risk of anticholinergic side effects
2) Summary: Treatment with both revefenacin and other anticholinergics may increase
the risk of additive anticholinergic effects, including worsening of narrow-angle glaucoma
and urinary retention. Avoid coadministration with other anticholinergic-containing
drugs[37].
3) Severity: major
6) Clinical Management: Treatment with both revefenacin and other anticholinergics may
increase the risk of additive anticholinergic effects, including worsening of narrow-angle
glaucoma and urinary retention. Avoid coadministration with other anticholinergic-
containing drugs[37].
7) Probable Mechanism: additive anticholinergic effects
Secobarbital
3) Severity: major
Secretin Human
1) Interaction Effect: false positive stimulation test results with secretin human
2) Summary: Concomitant use of anticholinergic drugs may cause a hyporesponse to
secretin stimulation resulting in a false positive test for pancreatic disease. Discontinue
anticholinergic drugs at least 5 half-lives before administering secretin human and
consider additional testing and clinical assessments for aid in diagnosis[34].
3) Severity: major
6) Clinical Management: Concomitant use of anticholinergic drugs may cause a
hyporesponse to secretin stimulation resulting in a false positive test for pancreatic
disease. Discontinue anticholinergic drugs at least 5 half-lives before administering
secretin human and consider additional testing and clinical assessments for aid in
diagnosis[34].
7) Probable Mechanism: hyporesponse to secretin stimulation
Sodium Oxybate
3) Severity: major
Solifenacin
urinary retention
3) Severity: major
Stramonium
urinary retention
3) Severity: major
Sufentanil
3) Severity: major
Tapentadol
3) Severity: major
Temazepam
3) Severity: major
Terodiline
urinary retention
3) Severity: major
Thiopental
3) Severity: major
Thioridazine
urinary retention
3) Severity: major
Thiothixene
urinary retention
3) Severity: major
Tilidine
3) Severity: major
Tiotropium
urinary retention
3) Severity: major
Tizanidine
urinary retention
3) Severity: major
Tolterodine
urinary retention
3) Severity: major
Topiramate
3) Severity: major
Tramadol
3) Severity: major
Triazolam
3) Severity: major
Trifluoperazine
urinary retention
3) Severity: major
Trihexyphenidyl
urinary retention
3) Severity: major
Trimipramine
urinary retention
3) Severity: major
Tropicamide
urinary retention
3) Severity: major
Trospium
urinary retention
3) Severity: major
Umeclidinium
urinary retention
3) Severity: major
Zaleplon
3) Severity: major
Zolpidem
3) Severity: major
Zopiclone
3) Severity: major
Drug-Lab Modifications
Gastric secretory study

1) Interaction Effect: interference with test results
2) Summary: Scopolamine will interfere with the gastric secretion test. Discontinue
scopolamine 10 days prior to testing[2].
3) Severity: moderate
4) Onset: rapid
6) Clinical Management: Scopolamine will interfere with the gastric secretion test.
Discontinue scopolamine 10 days prior to testing[2].
7) Probable Mechanism: unknown mechanism
IV Compatibility (single)
Pregnancy & Lactation
A) Teratogenicity/Effects in Pregnancy
1) Micromedex Pregnancy Rating: Fetal risk cannot be ruled out.
a) Available evidence is inconclusive or is inadequate for determining fetal risk when used in
pregnant women or women of childbearing potential. Weigh the potential benefits of drug
treatment against potential risks before prescribing this drug during pregnancy.
See Drug Consult reference: PREGNANCY RISK CATEGORIES
2) Crosses Placenta: Yes
3) Clinical Management
a) Avoid use of transdermal scopolamine in pregnant women with severe pre-eclampsia due to the
potential for the development of eclamptic seizures [2]. Administer transdermal scopolamine
during pregnancy only if the potential maternal benefit outweighs the potential fetal risk.
a) There are insufficient human data from observational studies and postmarketing reports with
the use of scopolamine in pregnant women to determine the risk for major birth defects,
miscarriage, or adverse fetal outcomes. Two pregnant women with severe pre-eclampsia were
administered IV and IM scopolamine, respectively, and developed eclamptic seizures shortly after
scopolamine administration. In animal reproduction studies, there were no adverse effects
observed when pregnant rats were administered IV scopolamine daily; however, embryotoxicity
was observed when pregnant rabbits were administered IV scopolamine daily at doses
corresponding to plasma levels about 100 times the levels achieved in humans using a transdermal
system. Parenteral administration of scopolamine to rats and rabbits did not affect uterine
contractions or increase the duration of labor when administered at doses higher than the dose
delivered from transdermal scopolamine [2].
b) Two studies examining the teratogenic potential of scopolamine did not find an increased risk of
fetal malformations with first trimester exposure to the drug (relative risk: 1.05; 95% confidence
interval: 0.7 to 1.59) [46].
c) In one study, 27 newborns were exposed to scopolamine during the first trimester between
1985 and 1992. Overall one (3.7%) major birth defect was noted. No other anomalies were
reported [47].
d) Scopolamine toxicity was reported in a neonate exposed during delivery by a mother who had
received multiple doses of scopolamine, in addition to meperidine, levallorphan, and inhalation
anesthetic. The infant's Apgar scores were 10 and 10, but on admission to the nursery, her
temperature was 100.4 degrees Fahrenheit, heart rate was 200 beats per minute, and she was
lethargic. Physostigmine 0.1 mg was give intramuscularly, and 15 minutes later the heart rate was
140; the fever resolved over the next several hours [48].
e) The Collaborative Perinatal Project found no association between the use of scopolamine and
congenital defects in 309 pregnancies exposed during the first trimester or 88 pregnancies exposed
anytime during pregnancy. However, the use of parasympatholytic drugs was associated with
minor malformations [49].
f) In two case reports, pregnant women experienced eclamptic seizures one and 1.5 hours after
administration of scopolamine (one intravenous, the other intramuscular) for preeclampsia with
symptoms of epigastralgia. The authors concluded that administration of anticholinergics, such as
scopolamine, to pregnant women with preeclampsia may enhance the actions of the sympathetic
nervous system and predispose the patient to eclamptic seizures [50].
g) In animal fertility studies, there was no evidence of fertility impairment or fetal harm when
female rats were administered subQ scopolamine daily; however, maternal body weights were
decreased at the highest dose administered, which corresponded to a plasma level about 500
times the level achieved in humans using a transdermal system. Fertility studies were not
conducted in male animals [2].
B) Breastfeeding
1) Micromedex Lactation Rating: Infant risk cannot be ruled out.
a) Available evidence and/or expert consensus is inconclusive or is inadequate for determining
infant risk when used during breastfeeding. Weigh the potential benefits of drug treatment against
potential risks before prescribing this drug during breastfeeding.
2) Clinical Management
a) Weigh the benefits of breastfeeding with the mother's clinical need for treatment with
transdermal scopolamine and the potential for adverse effects on the breastfed infant or from the
mother's underlying clinical diagnosis or condition [2].
a) Scopolamine is present in human milk; however, the effects on milk production and the impact
on the breastfed infant are unknown. There have been no consistent reports of adverse effects in
breastfed infants over decades of use [2].
Monitoring
A) Scopolamine
1) Therapeutic
a) Physical Findings
1) Prevention of nausea and vomiting is indicative of efficacy.
2) Toxic
a) Physical Findings
1) Evaluate the benefit/risk of treatment prior to initiation in patients with a history of seizures,
including those receiving antiepileptic medication or who have risk factors that can lower the
seizure threshold [2].
2) Monitor intraocular pressure in patients with open angle glaucoma [2].
3) Monitor for new or worsening psychiatric symptoms during treatment (eg, acute toxic
psychosis, agitation, speech disorder, hallucinations, paranoia, and delusions) and especially in
those receiving other drugs that are associated with similar psychiatric effects [2].
4) Consider more frequent monitoring in the elderly, who may be more sensitive to neurological
(drowsiness, disorientation, confusion) and psychiatric effects [2].
5) Consider more frequent monitoring in patients suspected of having intestinal obstruction,
pyloric obstruction, or urinary bladder neck obstruction and in patients receiving other
anticholinergic drugs as decreased gastrointestinal motility and urinary retention may occur [2].
6) Consider more frequent monitoring for CNS adverse events in patients with renal or hepatic
impairment due to an increased risk [2].
1) Therapeutic
a) Decrease in nausea and vomiting associated with motion sickness.
b) Decrease in salivation when used as a premedicant.
2) Toxic
a) Monitor for anticholinergic toxicity; monitor heart rate and blood pressure.
Do Not Confuse
MECHANISM OF ACTION
Mechanism of Action
A) Scopolamine
1) Mechanism of Action
a) Scopolamine (also known as hyoscine) is a belladonna alkaloid with anticholinergic properties
that competitively inhibits muscarinic receptors for acetylcholine and acts as a nonselective
muscarinic antagonist [51], producing both peripheral antimuscarinic properties and central
sedative, antiemetic, and amnestic effects [52]. The proposed mechanism of action of scopolamine
in the treatment of motion sickness is a disturbance in the balance between the cholinergic and
adrenergic systems in the CNS, secondary to vestibular stimuli. In response to vestibular stimuli,
impulses are transmitted to vestibular nuclei and reticular formation neurons, areas which contain
both cholinergic and adrenergic receptors. Activation of cholinergic receptors activates the vomiting
center. A functional vestibular system is required before motion sickness can occur; deaf subjects
with non-functional vestibular systems are immune to even severe exposures to motion. Drugs
which either inhibit the cholinergic system (scopolamine) or stimulate the adrenergic system have
been proven effective in preventing motion sickness [53][54].
1) Mechanism of Action
a) Scopolamine hydrobromide (also known as hyoscine hydrobromide) competitively inhibits
muscarinic receptors for acetylcholine and acts as a nonselective muscarinic antagonist, producing
both peripheral antimuscarinic properties and central sedative, antiemetic and amnestic effects. It
exerts its effect by blocking the action of acetylcholine (ACh) on autonomic effectors innervated by
postganglionic cholinergic nerves and smooth muscles that lack cholinergic innervation. It has
minimal activity on the actions of ACh in nicotinic receptor sites [58][52].
PHARMACOKINETICS
Pharmacokinetics
Onset and Duration
A) Onset
1) Scopolamine Hydrobromide
a) Initial Response
1) Cycloplegia/mydriasis, ophthalmic: less than 15 minutes [55]
a) The initial onset of cycloplegia and mydriasis occurred within 15 minutes of instillation of
scopolamine hydrobromide 0.025% ophthalmic drops (3 separate drops, administered at 5
minute intervals) when evaluated in 5 subjects [55].
b) Peak Response
1) Cycloplegia, ophthalmic: 50 minutes [55]
a) The mean peak response of scopolamine hydrobromide 0.025% ophthalmic drops (3
separate drops, administered at 5 minute intervals) on paralysis of accommodation was 50
minutes when evaluated in 5 subjects [55].
2) Mydriasis, ophthalmic: 30 minutes [55]
a) The mean peak response of scopolamine hydrobromide 0.025% ophthalmic drops (3
separate drops, administered at 5 minute intervals) on pupil diameter was 30 minutes when
evaluated in 5 subjects [55].
3) Salivary flow depression, intramuscular: 1.5 hours [56]
a) The peak response of hyoscine intramuscular 0.4 mg injection on depression of salivary
flow was seen within 1.5 hours, with well-defined effect seen in 45 minutes. The effect was
sustained for up to 3 hours [56].
B) Duration
1) Scopolamine Hydrobromide
a) Single Dose
1) Cycloplegia, ophthalmic: 4 to 6 days [55]
a) The duration of cycloplegia after instillation of scopolamine hydrobromide 0.025%
ophthalmic drops (3 separate drops, administered at 5 minute intervals) was 4 to 6 days
when evaluated in 5 subjects [55].
2) Mydriasis, ophthalmic: more than 6 days [55]
a) The duration of mydriasis after instillation of scopolamine hydrobromide 0.025%
ophthalmic drops (3 separate drops, administered at 5 minute intervals) exceeded 6 days
when evaluated in 5 subjects [55].
3) Salivary flow depression, intramuscular: 3 to 6 hours [56]
a) The duration of salivary flow depression after intramuscular administration of hyoscine
0.4 mg was 3 hours. However, after dose levels of 0.2 mg and 0.1 mg, salivation remained
depressed for up to 6 hours [56].
Drug Concentration Levels
A) Scopolamine
1) Therapeutic Drug Concentration
a) Motion sickness, Transdermal: 87 picograms/mL [2]
1) The average plasma concentrations achieved with auricular application of a scopolamine
transdermal patch (programmed to deliver 1 mg over 3 days) is 87 picograms/mL for free
scopolamine and 354 picograms/mL for total scopolamine (free + conjugates). Following
removal of the used transdermal system, there is some degree of continued systemic
absorption of scopolamine bound in the skin layers [2].
2) Time to Peak Concentration

a) Transdermal: Within 24 hours [2]
1) Following auricular application of a scopolamine transdermal patch (programmed to
deliver 1 mg over 3 days), plasma levels are detected in 4 hours and reach mean Cmax
within 24 hours [2].
1) Peak Concentration
a) Ophthalmic, single-dose, 1 drop (0.25%): 550 picograms/mL [57]
1) The mean Cmax was 550 +/- 60 picograms/mL after unilateral ophthalmic administration
of one drop (40 microliters) of scopolamine hydrobromide 0.25% in 8 subjects [57].
2) Time to Peak Concentration

a) Ophthalmic: 8 minutes [57]
1) Mean peak plasma concentrations of 550 +/- picograms/mL were achieved in a median
time of 8 minutes (range, 3 to 60 minutes) following unilateral ophthalmic administration of
one drop (40 microliters) of scopolamine hydrobromide 0.25% in 8 subjects [57].
ADME
Absorption
1) Bioavailability
a) Ophthalmic: rapid [57]
1) Scopolamine hydrobromide 0.25% ophthalmic solution is rapidly absorbed after
ocular administration. The most probable sites of absorption include ocular conjunctiva,
nasal mucosa, lacrimal passages, throat mucosa, and distal portion of the
gastrointestinal tract [57].
Distribution
A) Distribution Sites
1) Protein Binding
a) The distribution of scopolamine is not well characterized, but may be reversibly
bound to plasma proteins [51].
2) Tissues and Fluids
a) Placenta and Blood Brain Barrier
1) The distribution of scopolamine is not well characterized, but is known to cross the
placenta and blood brain barrier [51].
Metabolism
A) Metabolism Sites and Kinetics
1) Scopolamine is metabolized and conjugated. The enzymes responsible for
metabolizing scopolamine are unknown. [2].
Excretion
A) Kidney
1) Renal Excretion (%)
a) Less than 10%, less than 5% unchanged [51]
1) After 108 hours, less than 10% of a scopolamine transdermal dose is recovered in
the urine as parent drug and metabolites, with less than 5% unchanged [51].
Elimination Half-life
A) Parent Compound
1) 9.5 hours [51]
a) Following removal of a transdermal scopolamine patch, plasma levels decrease with
a t(1/2) of 9.5 hours [51].
PATIENT EDUCATION
Medication Counseling
Patient Handouts
A) Scopolamine (Absorbed through the skin)

Scopolamine
Prevents nausea and vomiting caused by motion sickness, anesthesia, narcotic pain medicines, and
surgery.
When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to scopolamine,
or if you have narrow-angle glaucoma.
How to Use This Medicine:

Patch
Your doctor will tell you how many patches to use, where to apply them, and how often to apply
them. Do not use more patches or apply them more often than your doctor tells you to.
This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not
have one.
To prevent motion sickness, apply the patch at least 4 hours before the activity. The patch should
be left in place for 24 hours after surgery.
Wash and dry your hands thoroughly before and after applying the patch.
Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open
carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been
cut by accident.
Take the liner off the sticky side before applying. Do not touch the metallic sticky surface on the
patch.
Apply the patch to a dry, hairless skin area behind the ear. Avoid areas that have cuts, pain, or
tenderness.
Limit contact with water while swimming and bathing because the patch may fall off. If the patch is
loose or falls off, throw it away and apply a new patch behind the other ear.
After you take off the patch, wash the skin area where the patch was placed.
Only one patch should be used at any time. Do not cut it.
Missed dose: If you forget to wear or change a patch, put one on as soon as you can. If it is almost
time to put on your next patch, wait until then to apply a new patch and skip the one you missed.
Do not apply extra patches to make up for a missed dose.
Store the patches at room temperature in a closed container, away from heat, moisture, and direct
light.
Fold the used patch in half with the sticky sides together. Throw any used patch away so that
children or pets cannot get to it. You will also need to throw away old patches after the expiration
date has passed.
Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter
medicines, vitamins, and herbal products.
Some medicines can affect how scopolamine works. Tell your doctor if you are using a muscle
relaxant, medicine to treat depression (including TCAs), or any other oral medicine.
Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy
medicine, narcotic pain medicine, and alcohol.
Do not drink alcohol while you are using this medicine.
Warnings While Using This Medicine:

Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, kidney disease,
glaucoma (open-angle), prostate problems, trouble urinating, bowel blockage, or a history of
seizures or mental illness.
This medicine may cause the following problems:
Increased pressure in the eye
Increased risk of seizures or worsening of mental problems
This medicine can temporarily increase the size of your pupil and cause blurry vision if it comes in
contact with your eyes. It may also cause problems with urination. If any of these reactions occur,
call your doctor right away.
This medicine may cause seizures in pregnant women with severe preeclampsia (pregnancy with
high blood pressure and high protein levels in the urine or organ problems).
This medicine may make you dizzy, drowsy, or confused. Do not drive or do anything else that
could be dangerous until you know how this medicine affects you. If you plan to participate in
underwater sports, you may feel lost or confused (disoriented). Talk with your doctor if you have
concerns.
Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect
certain medical test results. The patch contains aluminum, which can cause skin burns during an
MRI scan.
Your doctor will check your progress and the effects of this medicine at regular visits. Keep all
appointments.
Keep all medicine out of the reach of children. Never share your medicine with anyone.
Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:
Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth
or throat, chest tightness, trouble breathing
Blurred vision or other change in vision, severe eye pain
Confusion, seeing, hearing, or feeling things that are not there, problems with speech, agitation
Fast, slow, or uneven heartbeat
Lightheadedness, dizziness, drowsiness, fainting, nausea, vomiting, stomach cramps, sweating,
headache, muscle weakness, slow heartbeat
Seizures
Trouble urinating
If you notice these less serious side effects, talk with your doctor:
Dry mouth
Dry, itchy, or red eyes
Restlessness
If you notice other side effects that you think are caused by this medicine, tell your doctor.
B) Scopolamine (By injection)
Scopolamine
Helps you relax during surgery or other medical procedure.

You should not receive this medicine if you have had an allergic reaction to scopolamine,
belladonna, or to barbiturates. You should not receive this medicine if you have a certain type of
glaucoma.

Injectable
Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine
is given as a shot under your skin, into a muscle, or into a vein.
A nurse or other health provider will give you this medicine.

Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy
medicine, narcotic pain medicine, and alcohol.
Make sure your doctor knows if you are using antacid medicines, medicine for depression (such as
amitriptyline, doxepin, nortriptyline, Elavil®, Pamelor®, or Sinequan®), or phenothiazines (such as
Compazine®, Phenergan®, Serentil®, or Thorazine®). Tell your doctor about all other medicines
you are using.

Make sure your doctor knows if you are pregnant or breast feeding.
Make sure your doctor knows if you have lung disease such as emphysema, an overactive thyroid
gland, an enlarged prostate gland, asthma, allergies, heart disease, heart failure, high blood
pressure, heart rhythm problems, or Parkinson's disease.
This medicine may make you dizzy or drowsy, or cause blurred vision. Avoid driving, using
machines, or doing anything else that could be dangerous if you are not alert or cannot see well.
This medicine may make your eyes sensitive to light. Wear sunglasses if you go outside.
This medicine may make you sweat less and cause your body to get too hot. Be careful in hot
weather, especially if you are exercising or working.
Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect
certain medical test results.

Decrease in how much or how often you urinate.
Fast heartbeat.
Hallucinations (seeing things that aren't there).
Constipation.
Dry mouth or dry skin.
Increased thirst or difficulty in swallowing.
Pain, itching, swelling, burning, or lump under your skin at the site of injection.
Problems with walking.
Toothache.
Tremors or restlessness.
Warmth or redness in your face, neck, arms, or upper chest.
C) Scopolamine (Into the eye)
Scopolamine
Used during eye exams to relax the muscles of the eye and make your pupils larger, and treats
other eye conditions.

You should not use this medicine if you have had an allergic reaction to scopolamine or
benzalkonium chloride, or if you have glaucoma.

Liquid, Drop
Your doctor will tell you how much medicine to use. Do not use more than directed.
Wash your hands with soap and water before and after using this medicine.
Lie down or tilt your head back. With your index finger, pull down the lower lid of your eye to form
a pocket.
Hold the dropper close to your eye with the other hand. Drop the correct number of drops into the
pocket made between your lower lid and eyeball. Gently close your eyes. Place your index finger
over the inner corner of your eye for 2 to 3 minutes. Do not rinse or wipe the dropper or allow it to
touch anything, including your eye. Put the cap on the bottle right away. Keep the bottle upright
when you are not using it.
If you are giving this medicine to a child, be careful not to get any medicine in the child's mouth.
Be sure to wash your hands and your child's hands when you are done giving the medicine.
If a Dose is Missed:
Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and
take a regular dose. Do not take extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine:

Store this medicine at room temperature, away from heat and direct light.
Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used
medicine container and any leftover medicine after you have finished your treatment. You will also
need to throw away old medicine after the expiration date has passed.
Keep all medicine out of the reach of children. Never share your medicine with anyone.


Make sure your doctor knows if you are pregnant or breast feeding, or if you have high blood
pressure or heart disease.
This medicine may make you drowsy and your vision blurry. Avoid driving, using machines, or
doing anything else that could be dangerous if you are not alert or cannot see well.
This medicine might make your eyes sensitive to light. Wear sunglasses if you go outside.

Eye burning or watering that does not go away.
Eye redness, pain, or swelling.
Hallucinations (seeing things that are not really there).
Rash or itching around your eyes.
Blurred vision.
Drowsiness or dizziness.
Dry mouth.
TOXICOLOGY
Clinical Effects
Range of Toxicity

Treatment
ABOUT
How Supplied
Drug Properties
A) Information on specific products and dosage forms can be obtained by referring to the
Tradename List (Product Index)
B) Synonyms
Hyoscine
Hyoscine Hydrobromide
Scop Hydrobrom
Scopine Tropate
Scopolamine
Scopolamine Aminoxide Hydrobromide
Scopolamine HCl
Scopolamine Hydrochloride
Scopolamine Methonitrate
Scopolamine Methylnitrate
Scopolamine N-Oxide Hydrobromide
C) Physicochemical Properties
1) Molecular Weight
a) 303.35 [2]
2) pKa
a) 7.55 to 7.81 [2]
Storage & Stability
A) Scopolamine
1) Preparation
a) Transdermal route
1) Preparation
a) Do not cut the transdermal system [2].
2) Administration
a) Only 1 transdermal system should be worn at a time. Apply the transdermal system to skin in
the postauricular area (hairless area behind 1 ear). After application, wash hands thoroughly with
soap and water and dry hands [2].
b) If the transdermal system becomes displaced, discard it and apply a new 1 on the hairless
area behind the other ear [2].
c) Upon removal, fold the used transdermal system in half with the sticky side together and
discard in household trash in a manner that prevents accidental contact or ingestion by children,
pets, or others [2].
1) Preparation
a) Ophthalmic route
1) Lacrimal sac should be compressed by digital pressure for 2 to 3 minutes after instillation [14]
C) Ophthalmic route
1) Solution
a) Stored between 8 and 27 degrees C (46 and 80 degrees F). Protect from light [59][19].
D) Transdermal route
1) Patch, Extended Release
a) Store pouch in an upright position at a controlled room temperature between 20 and 25
degrees C (68 and 77 degrees F). Do not bend or roll pouch [2].
Trade Names
Regulatory Status
References
1. American Geriatrics Society Beers Criteria Update Expert Panel: American Geriatrics Society 2019
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PubMed Abstract: http://www.ncbi.nlm.nih.gov/...
PubMed Article: http://www.ncbi.nlm.nih.gov/...
2. Product Information: Transderm Scop(R) transdermal system patch, scopolamine transdermal

system patch. GlaxoSmithKline Consumer Healthcare (per FDA), Warren, NJ, 2019.
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Last Modified: July 08, 2019
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SCOPOLAMINE

Dosage in Geriatric Patients

FDA Labeled Indication

Postoperative nausea and vomiting; Prophylaxis

FDA Labeled Indication

Combination treatment with transdermal scopolamine plus ondansetron was superior to

Amnesia, induction in obstetrics

Scopolamine is used for obstetric amnesia [16]

Scopolamine may be used for the treatment delirium tremens [12]

Diagnostic procedure on eye proper, mydriasis induction and cycloplegic refraction

Scopolamine may be used for the treatment of mania [12]

Motion sickness; Prophylaxis

Scopolamine is used for the prevention of motion sickness [16]

Scopolamine is used for the symptomatic treatment of postencephalitic parkinsonism

Scopolamine is used as a preanesthetic agent for it sedative-tranquilizing and

Scopolamine hydrobromide is used as a sedative and tranquilizing depressant [12]

Scopolamine is used for the symptomatic treatment of spastic states[16]

Used for treating iridocyclitis, a type of anterior uveitis [14]

Scopolamine hydrobromide is used as an antiemetic [12]

Dosage in Geriatric Patients

Chemotherapy-induced nausea and vomiting

Postoperative nausea and vomiting; Prophylaxis

Chemotherapy-induced nausea and vomiting

Postoperative nausea and vomiting; Prophylaxis

Application site irritation

Black Box Warning

No hay resultados disponibles

Drug Interactions (single)

Gastric secretory study

No hay resultados disponibles

Pregnancy & Lactation

No hay resultados disponibles

Onset and Duration

Drug Concentration Levels

2) Time to Peak Concentration

2) Time to Peak Concentration

No hay resultados disponibles

A) Scopolamine (Absorbed through the skin)

When This Medicine Should Not Be Used:

How to Use This Medicine:

Drugs and Foods to Avoid:

Warnings While Using This Medicine:

Possible Side Effects While Using This Medicine:

Helps you relax during surgery or other medical procedure.

When This Medicine Should Not Be Used:

How to Use This Medicine:

Drugs and Foods to Avoid:

Warnings While Using This Medicine:

Possible Side Effects While Using This Medicine:

When This Medicine Should Not Be Used:

How to Use This Medicine:

How to Store and Dispose of This Medicine:

Drugs and Foods to Avoid:

Warnings While Using This Medicine:

Possible Side Effects While Using This Medicine:

No hay resultados disponibles

No hay resultados disponibles

No hay resultados disponibles

No hay resultados disponibles

Storage & Stability

No hay resultados disponibles

No hay resultados disponibles

2. Product Information: Transderm Scop(R) transdermal system patch, scopolamine transdermal

3. Attias J, Gordon C, Ribak J, et al: Efficacy of transdermal scopolamine against seasickness: a 3-