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‫הודעה‬
___January 11, 2010 ____________________ ‫תאריך‬
SCOPOLAMINE HYDROBROMIDE _‫שם תכשיר באנגלית‬
_solution for injection
_________046 75 23657 22_________‫מספר רישום‬
Teva Pharmaceutical Industries Ltd., PO Box 3190, Petach-Tikva‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Known hypersensitivity to the drug.
Scopolamine should not be administered to patients
with symptoms of prostatism, or with narrow-angle
glaucoma or a predisposition to glaucoma (since its
effects on the eye can precipitate this condition) ,
tachycardia, pyloric obstruction, paralytic ileus, in
patients with prostatic hypertrophy or urinary bladder
neck obstruction (since it may lead to urinary
retention in these patients), obstructive uropathy or
myasthenia gravis.
Antimuscarinics are contraindicated in the presence
of tachycardia secondary to cardiac insufficiency or
thyrotoxicosis, since scopolamine may exacerbate the
tachycardia. Antimuscarinics are also contraindicated
in patients with acute hemorrhage whose
cardiovascular status is unstable.
Scopolamine should not be used in patients with
Down’s syndrome, myasthenia gravis, renal or
hepatic impairment.
Patients with porphyria.
Known hypersensitivity to the drug.
Scopolamine should not be administered
to patients with symptoms of prostatism, or
with narrow-angle , tachycardia, paralytic
ileus, obstructive uropathy or myasthenia
gravis.
Antimuscarinics are contraindicated in the
presence of tachycardia secondary to
cardiac insufficiency or thyrotoxicosis,.
Antimuscarinics are also contraindicated in
patients with acute hemorrhage whose
cardiovascular status is unstable.
Use in Pregnancy
Scopolamine crosses the placenta; safety of use in
pregnancy has not been established.
Administration before the onset of labor may cause
CNS depression and hemorrhage in neonates, and
may contribute to neonatal haemorrhage due to
reduction in Vitamin K-dependent clotting factors in
the neonate.
Use in Breastfeeding
Safety of use in breastfeeding has not been
established. Small quantities of scopolamine may be
excreted into breast milk However, as an
anticholinergic, scopolamine may inhibit lactation.
Therefore scopolamine is not recommended for use
during lactation.
Use with caution in patients with prostatic
hypertrophy, pyloric or intestinal obstruction,
coronary insufficiency, or cardiac failure.
Potentially alarming idiosyncratic reactions may
‫פרק בעלון‬
Contraindications
Use in Pregnancy
Scopolamine crosses the placenta; safety
of use in pregnancy has not been
established.
Administration before the onset of labor
may cause CNS depression and hemorrhage
in neonates,
Warnings
Use in Breastfeeding
Safety of use in breastfeeding has not
been established.
However, as an
anticholinergic, scopolamine may inhibit
lactation.
Use with caution in patients with prostatic
hypertrophy,
pyloric
or
intestinal
obstruction, coronary insufficiency, or
cardiac failure.
Precautions
develop following the use of therapeutic doses of
scopolamine.
Scopolamine should also be administered with
caution in elderly patients, or in patients with
impaired metabolic, hepatic or renal function, since
adverse CNS effects are more likely to occur in these
groups.
Scopolamine should be administered with caution in
patients with fever, since reduction in sweating may
inhibit heat loss and lead to hyperpyrexia.
Scopolamine should be administered with caution in
patients undergoing cardiac surgery, and in patients
with cardiac disease, since the transient increase in
heart rate which may be caused by scopolamine may
be undesirable in these circumstances.
There have been reports of an increase in frequency
of seizures in epileptic patients.
Heat prostration can occur at high ambient
temperatures due to decreased sweating.
Elevation of intraocular pressure may be produced
by the administration of anticholinergic agents such as
scopolamine in patients with undiagnosed and
therefore untreated narrow angle glaucoma.
Therefore,
patients
should
seek
urgent
ophthalmological advice in case they should develop
a painful, red eye with loss of vision after the
injection of Buscopan
Scopolamine may impair mental alertness, physical
coordination or visual acuity.
Patients should be warned against activities such as
driving a car or operating machinery whilst affected
by scopolamine. Patients should also avoid alcohol.
Cardiovascular system
Bradycardia (at low doses), initial tachycardia
followed by bradycardia (at higher doses),
hypotension, arrythmia.
Central Nervous system
Sedation, drowsiness, irritability, disorientation,
hallucinations, impairment of memory and
concentration, dizziness, confusion, tremor, acute
toxic psychosis, restlessness, delerium, excitement.
Symptoms of CNS depression predominate at
therapeutic doses. Symptoms of CNS stimulation
predominate at higher doses, and at therapeutic doses
in the presence of pain.
Gastrointestinal system
Dry mouth, constipation, nausea, vomiting.
Genito-urinary system
Difficulty in urinating
Ocular
Blurred vision, mydriasis, closed angle glaucoma.
Average or large doses may cause dryness
of the mouth, nose, throat or skin,
drowsiness, accelerated pulse rate, flushing,
bradycardia, mydriasis, blurred vision,
urinary retention, constipation, and raised
intraocular pressure, decreased sweating,
temporary loss of memory, redness or other
signs of irritation at injection site.
Adverse events
Skin and appendages
Rashes, erythema, redness or irritation at injection
site
Average or large doses may cause dryness of the
mouth, nose, throat or skin, drowsiness, accelerated
pulse rate, flushing, bradycardia, mydriasis, blurred
vision, urinary retention, constipation, and raised
intraocular pressure, decreased sweating, temporary
loss of memory, redness or other signs of irritation at
injection site.
Antihistamines:
Concurrent use of scopolamine and antihistamines
possessing anticholinergic effects may result in an
intensification of the anticholinergic effect.
Concurrent use of scopolamine and antihistamines
possessing CNS depression effects may result in a
potentiation of the CNS depression and increased
sedation.
Belladonna alkaloids
Concurrent use of scoplamine and belladonna
alkaloids may result in an intensification of the
anticholinergic effect.
Monoamine Oxidase (MAO) Inhibitors
Concurrent use of scopolamine and MAO inhibitors
possessing anticholinergic effects may result in an
intensification of the anticholinergic effect.
Concurrent use of hyoscine hydrobromide and MAO
inhibitors possessing CNS depression effects may
result in a potentiation of the CNS depression and
increased sedation.
Oral medications
Since scopolamine decreases gastrointestinal tone
and gastric secretions, it may affect the absorption of
oral medications.
Phenothiazines
Concurrent use of scopolamine and phenothiazines
possessing anticholinergic effects may result in an
intensification of the anticholinergic effect.
Concurrent use of scopolamine and phenothiazines
possessing CNS depression effects may result in a
potentiation of the CNS depression and increased
sedation.
Procainamide
Concurrent use of procainamide and scopolamine
may result in additive antivagal effects on AV node
conduction.
Tricyclic antidepressants
Concurrent use of scopolamine and tricyclic
antidepressants possessing anticholinergic effects may
result in an intensification of the anticholinergic
effect.
Drug Interactions
Concurrent use of hyoscine hydrobromide and
tricyclic antidepressants possessing CNS depression
effects may result in a potentiation of the CNS
depression and increased sedation.
-Adrenergic Agents
The tachycardic effects of beta-adrenergic agents
may be enhanced by scopolamine.
Dopamine Antagonists
Concomitant treatment with dopamine antagonists
such as metoclopramide may result in diminution of
the effects of both drugs on the gastrointestinal tract.
Interference with Laboratory Tests
Gastric acid secretion test
Administration
of
cholinergics
including
scopolamine is not recommended in the 24 hours
prior to the test since anticholinergics may antagonize
the effects of the drugs used in the evaluation of
gastric acid secretory function.
Neuroradiological tests
Mydriasis and cycloplegia may affect the results of
neuroradiological tests for intracranial neoplasm,
subdural haematoma or aneurysm.
Overdosage
Manifestations
Symptoms associated with overdosage of
scopolamine include CNS stimulation (restlessness,
confusion, excitement, delirium, incoordination,
disorientation, memory disturbances, hallucinations,
paranoid and psychotic reactions), tachycardia,
hyperpyrexia, blurred vision, mydriasis, rapid
respiration or respiratory difficulties.
Severe overdosage may cause coma, respiratory
depression, cardiac arrythmia, and may result in
death.
Treatment
Treatment of overdose involves the following
measures:

symptomatic and supportive therapy

diazepam
or
other
short
acting
benzodiazepine or barbiturate may be given
to control CNS stimulation

if hyperthermia occurs, dissipation of heat
should be undertaken (i.e. by cold baths).
Physostigmine by slow intravenous injection in a
dose of 1 to 4mg has been used to reverse the
anticholinergic effects, but this drug is rapidly
metabolized. Neostigmine by slow intravenous
injection in a dose of 0.5 to 2 mg antagonises only the
peripheral effects. Diazepam may be given to control
excitement
Overdosage