WARNINGS
Glaucoma therapy in patients with chronic open-angle (wide-angle) glaucoma should be monitored and may need to be adjusted during Transderm Scóp use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure.
Transderm Scóp should not be used in children and should be used with caution in the elderly. See PRECAUTIONS.
Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.
Rarely, idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, rambling speech, hallucinations, paranoid behaviors, and delusions.
PRECAUTIONS
General
Scopolamine should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or antimuscarinic drug to patients suspected of having intestinal obstruction.
Transderm Scóp should be used with caution in the elderly or in individuals with impaired liver or kidney functions because of the increased likelihood of CNS effects.
Caution should be exercised in patients with a history of seizures or psychosis, since scopolamine can potentially aggravate both disorders.
Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal systems during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scop® contains aluminum, it is recommended to remove the system before undergoing an MRI.
Information for Patients
Since scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.
Patients should be advised to remove the patch immediately and promptly contact a physician in the unlikely event that they experience symptoms of acute narrow-angle glaucoma (pain and reddening of the eyes, accompanied by dilated pupils). Patients should also be instructed to remove the patch if they develop any difficulties in urinating.
Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine. A patient brochure is available.
Drug Interactions
The absorption of oral medications may be decreased during the concurrent use of scopolamine because of decreased gastric motility and delayed gastric emptying.
Scopolamine should be used with care in patients taking other drugs that are capable of causing CNS effects such as sedatives, tranquilizers, or alcohol. Special attention should be paid to potential interactions with drugs having anticholinergic properties; e.g., other belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
Laboratory Test Interactions
Scopolamine will interfere with the gastric secretion test.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been completed to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated. Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system).
Pregnancy Category C
Teratogenic studies were performed in pregnant rats and rabbits with scopolamine hydrobromide administered by daily intravenous injection. No adverse effects were recorded in rats. Scopolamine hydrobromide has been shown to have a marginal embryotoxic effect in rabbits when administered by daily intravenous injection at doses producing plasma levels approximately 100 times the level achieved in humans using a transdermal system. During a clinical study among women undergoing cesarean section treated with Transderm Scóp in conjunction with epidural anesthesia and opiate analgesia, no evidence of CNS depression was found in the newborns. There are no other adequate and well-controlled studies in pregnant women. Other than in the adjunctive use for delivery by cesarean section, Transderm Scóp should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Because scopolamine is excreted in human milk, caution should be exercised when Transderm Scóp is administered to a nursing woman.
Labor and Delivery
Scopolamine administered parenterally at higher doses than the dose delivered by Transderm Scóp does not increase the duration of labor, nor does it affect uterine contractions. Scopolamine does cross the placenta.
Pediatric Use
The safety and effectiveness of Transderm Scóp in children has not been established. Children are particularly susceptible to the side effects of belladonna alkaloids. Transderm Scóp should not be used in children because it is not known whether this system will release an amount of scopolamine that could produce serious adverse effects in children.
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