Scopolamine

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Scopolamine Transdermal System is indicated in adults for the prevention of: nausea and vomiting associated with motion sickness. post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: nausea and vomiting associated with motion sickness. ( 1 ) post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Application and Removal ( 2.1 ): Each scopolamine transdermal system delivers 1 mg of scopolamine over 3 days. Only wear one transdermal system at a time. Do not cut the transdermal system. Wash hands thoroughly with soap and water after application. Avoid touching or applying pressure to the transdermal system once applied. Upon removal, fold used transdermal system in half with sticky side together, discard to prevent accidental contact or ingestion, and wash the hands and application site with soap and water. Recommended Dosage: Motion Sickness : Apply one transdermal system to the hairless area behind one ear at least 4 hours before antiemetic effect is required for use up to 3 days. If therapy for more than 3 days is required, remove the first transdermal system and apply a new transdermal system behind the other ear. ( 2.2 ) PONV : For surgeries other than cesarean section, apply one transdermal system behind the ear the evening before surgery and remove 24 hours following surgery. ( 2.2 ) 2.1 Important Application and Removal Instructions Each scopolamine transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days. Only wear one transdermal system at any time. Do not cut the transdermal system. Apply the transdermal system to the skin in the postauricular area (hairless area behind one ear). After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands [see Warnings and Precautions (5.7) ] . If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear. Once the transdermal system has been affixed, avoid touching or applying pressure to the transdermal system while it is being worn, since pressure exerted on it may cause scopolamine to ooze out at the edge. Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets, or others. Wash the hands and application site with soap and water after transdermal system removal [see Warnings and Precautions (5.7) ]. 2.2 Recommended Adult Dosage Motion Sickness Apply one scopolamine transdermal system to the hairless area behind one ear at least 4 hours before the antiemetic effect is required – for use up to 3 days. If therapy is required for longer than 3 days, remove the first transdermal system and apply a new scopolamine transdermal system behind the other ear. PONV For surgeries other than cesarean section : Apply one scopolamine transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery. 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, patients with impeded urine flow, or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. ( 5.4 , 7.2 ) Hyperthermia : Serious adverse reactions have been reported postmarketing in adult and pediatric patients, including fatal cases. If symptoms occur, remove the transdermal system, and contact a healthcare provider. ( 5.5 ) Drug Withdrawal/Post-Removal Symptoms: Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.6 ) Blurred Vision : Avoid contact with the eyes. ( 2.1 , 5.7 ) Magnetic Resonance Imaging (MRI) Skin Burns : Remove scopolamine transdermal system prior to MRI scan. ( 5.8 ) 5.1 Acute Angle Closure Glaucoma T