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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Acute Angle Closure Glaucoma : Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop. ( 5.1 ) • Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities. Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects. ( 5.2 , 7.1 ) • Eclamptic Seizures in Pregnant Women : Avoid use in patients with severe preeclampsia. ( 5.3 ) • Gastrointestinal and Urinary Disorders : Consider more frequent monitoring during treatment in patients suspected of having intestinal obstruction; patients with pyloric obstruction, urinary bladder neck obstruction or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. ( 5.4 , 7.2 ) • Drug Withdrawal/Post-Removal Symptoms : Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.5 ) • Blurred Vision : Avoid contact with the eyes. ( 2.1 , 5.6 ) • Magnetic Resonance Imaging (MRI) Skin Burns : Remove Transderm Scōp prior to MRI scan. ( 5.7 ) 5.1 Acute Angle Closure Glaucoma The mydriatic effect of scopolamine may cause an increase in intraocular pressure resulting in acute angle closure glaucoma. Monitor intraocular pressure in patients with open angle glaucoma and adjust glaucoma therapy during Transderm Scōp use, as needed. Advise patients to immediately remove the transdermal system and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). 5.2 Neuropsychiatric Adverse Reactions Psychiatric Adverse Reactions Scopolamine has been reported to exacerbate psychosis. Other psychiatric reactions have also been reported, including acute toxic psychosis, agitation, speech disorder, hallucinations, paranoia, and delusions [see Adverse Reactions ( 6.2 )] . Monitor patients for new or worsening psychiatric symptoms during treatment with Transderm Scōp. Also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects [see Drug Interactions ( 7.1 )] . Seizures Seizures and seizure-like activity have been reported in patients receiving scopolamine. Weigh this potential risk against the benefits before prescribing Transderm Scōp to patients with a history of seizures, including those receiving anti-epileptic medication or who have risk factors that can lower the seizure threshold. Cognitive Adverse Reactions Scopolamine can cause drowsiness, disorientation, and confusion. Discontinue Transderm Scōp if signs or symptoms of cognitive impairment develop. Elderly and pediatric patients may be more sensitive to the neurological and psychiatric effects of Transderm Scōp. Consider more frequent monitoring during treatment with Transderm Scōp in elderly patients [see Use in Specific Populations ( 8.5 )] . Transderm Scōp is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . Hazardous Activities Transderm Scōp may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery or participating in underwater sports. Concomitant use of other drugs that cause central nervous system (CNS) adverse reactions (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics) or have anticholinergic properties (e.g., other belladonna alkaloids, sedating antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants) may increase this effect [see Drug Interactions ( 7.1 )] . Inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that Transderm Scōp does not affect them adversely. 5.3 Eclamptic Seizures in Pregnant Women Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous and intramuscular scopolamine [see Use in Specific Populations ( 8.1 )] . Avoid use of Transderm Scōp in patients with severe preeclampsia. 5.4 Gastrointestinal and Urinary Disorders Scopolamine, due to its anticholinergic properties, can decrease gastrointestinal motility and cause urinary retention. Consider more frequent monitoring during treatment with Transderm Scōp in patients suspected of having intestinal obstruction, patients with pyloric obstruction or urinary bladder neck obstruction and patients receiving other anticholinergic drugs [see Drug Interactions ( 7.2 )] . Discontinue Transderm Scōp in patients who develop difficulty in urination. 5.5 Drug Withdrawal/Post-Removal Symptoms Discontinuation of Transderm Scōp, usually after several days of use, may result in withdrawal symptoms, such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. The onset of these symptoms is generally 24 hours or more after the transdermal system has been removed. Instruct patients to seek medical attention if they experience severe symptoms. 5.6 Blurred Vision Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes. Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system [see Dosage and Administration ( 2.1 )] . 5.7 Magnetic Resonance Imaging (MRI) Skin Burns Transderm Scōp contains an aluminized membrane. Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during an MRI scan. Remove Transderm Scōp before undergoing an MRI.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.1 )] • Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Eclamptic Seizures in Pregnant Women [see Warnings and Precautions ( 5.3 )] • Gastrointestinal and Urinary Disorders [see Warnings and Precautions ( 5.4 )] • Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions ( 5.5 )] • Blurred Vision [see Warnings and Precautions ( 5.6 )] • MRI Skin Burns [see Warnings and Precautions ( 5.7 )] Most common adverse reactions are: • Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils. ( 6.1 ) • PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline Consumer Healthcare at 1-800-398-5876 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/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 practice. Motion Sickness The most common adverse reaction (approximately two thirds) was dry mouth. Less common adverse reactions, included drowsiness (less than one sixth), blurred vision and dilation of the pupils. PONV Common adverse reactions, occurring in at least 3% of patients in PONV clinical trials are shown in Table 1 . Table 1 Common Adverse Reactions* in Surgical Patients for the Prevention of PONV *occurring in at least 3% of patients and at a rate higher than placebo Transderm Scōp % (N = 461) Placebo % (N = 457) Dry mouth 29 16 Dizziness 12 7 Somnolence 8 4 Agitation 6 4 Visual Impairment 5 3 Confusion 4 3 Mydriasis 4 0 Pharyngitis 3 2 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of scopolamine transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 pruritus, 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
adverse reactions table
<table ID="_Ref35881432" width="100%"><caption>Table 1 Common Adverse Reactions* in Surgical Patients for the Prevention of PONV</caption><col width="27%"/><col width="36%"/><col width="36%"/><tfoot><tr><td align="left" colspan="3" valign="top">*occurring in at least 3% of patients and at a rate higher than placebo</td></tr></tfoot><tbody><tr><td styleCode="Toprule " valign="top"/><td align="center" styleCode="Toprule " valign="top"><paragraph>Transderm Scōp</paragraph><paragraph>% (N = 461)</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>Placebo</paragraph><paragraph>% (N = 457)</paragraph></td></tr><tr><td valign="top"><paragraph>Dry mouth</paragraph></td><td align="center" valign="top"><paragraph>29</paragraph></td><td align="center" valign="top"><paragraph>16</paragraph></td></tr><tr><td valign="top"><paragraph>Dizziness</paragraph></td><td align="center" valign="top"><paragraph>12</paragraph></td><td align="center" valign="top"><paragraph>7</paragraph></td></tr><tr><td valign="top"><paragraph>Somnolence</paragraph></td><td align="center" valign="top"><paragraph>8</paragraph></td><td align="center" valign="top"><paragraph>4</paragraph></td></tr><tr><td valign="top"><paragraph>Agitation</paragraph></td><td align="center" valign="top"><paragraph>6</paragraph></td><td align="center" valign="top"><paragraph>4</paragraph></td></tr><tr><td valign="top"><paragraph>Visual Impairment</paragraph></td><td align="center" valign="top"><paragraph>5</paragraph></td><td align="center" valign="top"><paragraph>3</paragraph></td></tr><tr><td valign="top"><paragraph>Confusion</paragraph></td><td align="center" valign="top"><paragraph>4</paragraph></td><td align="center" valign="top"><paragraph>3</paragraph></td></tr><tr><td valign="top"><paragraph>Mydriasis</paragraph></td><td align="center" valign="top"><paragraph>4</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Pharyngitis</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>3</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>2</paragraph></td></tr></tbody></table>