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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Use with caution in patients with open angle glaucoma ( 5.1 ) • Stop use if patient experiences symptoms of angle closure glaucoma ( 5.1 , 6.2 ) • Can cause temporary dilation and blurred vision if scopolamine contacts the eyes ( 5.2 , 6 , 16 ) • Use caution in patients with a history of seizures or psychosis ( 5.4 ) • Use with caution in patients with pyloric obstruction, urinary bladder neck obstruction, or patients suspected of having intestinal obstruction ( 5.3 ) • Stop use if patient has difficulty urinating ( 5.3 , 6 ) • Idiosyncratic reactions, such as confusion, agitation, speech disorder, hallucinations, paranoia and delusions, may occur with therapeutic doses of scopolamine ( 5.5 , 6.2 ) • A safe and effective dose has not been established in the pediatric population ( 5.6 , 8.4 ) • Use with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion and dizziness ( 5.6 , 8.5 ) • Should be used with caution in patients with impaired renal or hepatic function because of the increased likelihood of CNS effects ( 5.6 , 8.5 , 8.6 ) • May cause drowsiness or disorienting effects, therefore patients should be cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery ( 5.7 ) • Skin burns have been reported in patients undergoing MRI testing ( 5.8 ) 5.1 Open Angle Glaucoma Patients currently being treated for Open Angle Glaucoma Glaucoma therapy in patients with open angle glaucoma should be monitored and may need to be adjusted during Transderm Scōp use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure. Patients should be advised to remove the patch immediately and promptly contact a physician in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils). 5.2 Temporary Dilation of the Pupil 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. [ see Adverse Reactions (6) ] In addition, it is important that used patches be disposed of properly to avoid contact with children or pets. [ see How Supplied/ Storage and Handling (16) ] 5.3 Preexisting Gastrointestinal or Urinary Bladder Obstructions Transderm Scōp should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or anticholinergic drug, including Transderm Scōp, to patients suspected of having intestinal obstruction. Patients should be instructed to remove the patch if they develop any difficulties in urinating. [see Adverse Reactions (6)] 5.4 History of Seizures or Psychosis Transderm Scōp should be used with caution in patients with a history of seizures or psychosis since scopolamine can potentially aggravate both disorders. 5.5 Idiosyncratic Reactions 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, speech disorder, hallucinations, paranoia, and delusions. [ see Adverse Reactions (6) ] 5.6 Specific Populations Pediatric A safe and effective dose has not been established in the pediatric population [ see Use in Specific Populations(8.4) ] . Children are particularly susceptible to the side effects of belladonna alkaloids; including mydriasis, hallucinations, amyblyopia, and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported when one half or one quarter of a patch has been applied. Elderly Transderm Scōp should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome. Clinical trials of Transderm Scop did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. [ see Use in Specific Populations (8.5) ] Renal and Hepatic Impaired Transderm Scōp should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. Transderm Scop has not been studied in these populations. [ see Use in Specific Populations (8.6) ] 5.7 Safety Hazards Drowsiness 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. Disorienting Effects Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine. [ see Patient Counseling Information (17) ] 5.8 MRI Skin Burns Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp contains aluminum, it is recommended to remove the system before undergoing an MRI.
6 ADVERSE REACTIONS Most common adverse reactions during motion sickness clinical trials are dry mouth, drowsiness and blurred vision. ( 6.1 ) Most common adverse reactions during PONV trials (≥ than 3%) are dry mouth, dizziness, somnolence, urinary retention, agitation, visual impairment, confusion, mydriasis and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Consumer Health, Inc. at 1-800-452-0051 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Motion Sickness In motion sickness clinical studies of Transderm Scōp, the most frequent adverse reaction was dry mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed. Post-Operative Nausea and Vomiting In a total of five clinical studies in which Transderm Scōp was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥3% of patients treated with Transderm Scop and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1). Table 6.1 PONV: Adverse Drug Reactions in ≥3% of Patients Transderm Scōp (N=461) Placebo (N=457) n % n % Adverse Drug Reactions 303 65.7 259 56.7 Dry mouth 133 28.9 72 15.8 Dizziness 57 12.4 33 7.2 Somnolence 36 7.8 16 3.5 Urinary Retention 33 7.2 30 6.6 Agitation 28 6.1 20 4.4 Visual Impairment 23 5.0 12 2.6 Confusion 18 3.9 14 3.1 Mydriasis 16 3.5 2 0.4 Pharyngitis 15 3.3 10 2.2 6.2 Postmarketing Experience The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scop. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship. In worldwide marketing with Transderm Scōp, the following adverse drug reactions were reported by body system. Psychiatric disorders: acute psychosis including : hallucinations disorientation, and paranoia. Nervous system disorders: headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness. General disorders and administration site conditions: application site burning. Eye disorders : dry eyes, eye pruritis, angle closure glaucoma, amblyopia, eyelid irritation. Skin and subcutaneous tissue disorders: rash generalized, skin irritation, erythema. Renal and urinary disorders: dysuria. Ear and Labyrinth Disorders : vertigo. 6.3 Drug Withdrawal/Post-Removal Symptoms Symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache mental confusion, muscle weakness, bradycardia and hypotension may occur following abrupt discontinuation of anticholinergic drugs such as Transderm Scōp. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scōp system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. These symptoms can be severe and may require medical intervention. Some symptoms may be related to adaptation from a motion environment to a motion-free environment. These symptoms can be severe and may require medical intervention.