Scopolamine

7 DRUG INTERACTIONS • Drugs Causing Central Nervous System (CNS) Adverse Reactions : Monitor patients for CNS adverse reactions (drowsiness, dizziness or disorientations). ( 7.1 ) • Anticholinergic Drugs : Consider more frequent monitoring during treatment in patients receiving other anticholinergic drugs. ( 7.2 ) • Oral Drugs Absorbed in the Stomach : Monitor for increased or decreased therapeutic effect of the oral drug. ( 7.3 ) • Interaction with Gastric Secretion Test : Discontinue use of TRANSDERM SCŌP 10 days prior to testing. ( 7.4 )

7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions The concurrent use of TRANSDERM SCŌP with other drugs that cause CNS adverse reactions of drowsiness, dizziness or disorientation (e.g., sedatives, hypnotics, opiates, anxiolytics and alcohol) or have anticholinergic properties (e.g., other belladonna alkaloids, sedating antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants) may potentiate the effects of TRANSDERM SCŌP [see Warnings and Precautions ( 5.2 )] . Either TRANSDERM SCŌP or the interacting drug should be chosen, depending on the importance of the drug to the patient.

If the interacting drug cannot be avoided, monitor patients for CNS adverse reactions.

7.2 Anticholinergic Drugs Concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of CNS adverse reactions [see Drug Interactions ( 7.1 )], intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with TRANSDERM SCŌP in patients receiving anticholinergic drugs [see Warnings and Precautions ( 5.2 , 5.4 )] .

7.3 Oral Drugs Absorbed in the Stomach TRANSDERM SCŌP, as an anticholinergic, may delay gastric and upper gastrointestinal motility and, therefore, the rate of absorption of other orally administered drugs. Monitor patients for modified therapeutic effect of concomitant orally administered drugs with a narrow therapeutic index.

7.4 Interaction with Gastric Secretion Test Scopolamine will interfere with the gastric secretion test. Discontinue TRANSDERM SCŌP 10 days prior to testing.

8.1 Pregnancy Risk Summary Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. Avoid use of TRANSDERM SCOP in patients with severe preeclampsia [see Warnings and Precautions ( 5.3 ) and Data] . Available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. In animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats.

Embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data In published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see Warnings and Precautions ( 5.3 )] . Animal Data In animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. An embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system.

Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by TRANSDERM SCŌP did not affect uterine contractions or increase the duration of labor.