WARNINGS
Addiction does not occur, although vomiting, malaise, sweating and salivation have been reported in patients with parkinsonism upon sudden withdrawal of large doses of scopolamine. Scopolamine is one of the most important drugs of the belladonna group from the standpoint of poisoning; infants and young children are especially susceptible to the belladonna alkaloids. Scopolamine is usually stated more toxic than atropine. Idiosyncrasy is more common with scopolamine than with atropine and ordinary therapeutic doses sometimes cause alarming reactions.
PRECAUTIONS
General
If there is mydriasis and photophobia, dark glasses should be worn. Appropriate dosage precautions must be taken with infants, children, persons with mongolism, brain damage, spasticity, or light irides. Elevated intraocular pressure, urinary difficulty and retention and constipation are more probable in elderly persons. Men with prostatic hypertrophy should especially be monitored for urinary function. Because of the tachycardic effects of the drugs, care must be exercised when tachycardia, other tachyarrhythmias, coronary heart disease, congestive heart disease or hyperthyroidism preexist. Persons with hypertension may experience both exaggerated orthostatic hypotension and tachycardia. Similarly, autonomic neuropathy requires caution. Persons with a history of allergies or bronchial asthma will show a higher than normal incidence of hypersensitivity reactions.
Laboratory Tests
Barbiturates may increase Bromosulfonphthalein (BSP) levels; administration is not recommended during the 24 hours preceding the test.
Drug Interactions
Other drugs, such as phenothiazines, tricyclic antidepressants, certain antihistamines, meperidine, etc., which have weak antimuscarinic activity, may considerably intensify the effects of antimuscarinic drugs. Aluminum- and magnesium trisilicate-containing antacids have been shown to decrease the absorption of some antimuscarinic drugs and may possibly do so with all of them.
Pregnancy Category C
Scopolamine hydrobromide can pass the placental barrier; the threat to the fetus
in utero
is unknown, but use during pregnancy may cause respiratory depression in the neonate and may contribute to neonatal hemorrhage due to reduction in Vitamin K-dependent clotting factors in the neonate.
Scopolamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Problems in humans have not been documented; however, risk-benefit must be considered since barbiturates and belladonna alkaloids are excreted in breast milk.
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