Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING TRANSDERM SCŌP (scopolamine transdermal system) 1 mg/3 days is available as the following: Cartons of 4, 10, and 24 transdermal systems, packaged into individual foil pouches. • Carton of 4 transdermal systems. NDC 10019-008-04 • Carton of 10 transdermal systems. NDC 10019-008-10 • Carton of 24 transdermal systems. NDC 10019-008-24 Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Store pouch(es) in an upright position. Do not bend or roll pouch(es). Wash hands thoroughly with soap and water immediately after handling the transdermal system. Avoid touching the system during the treatment. 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 Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.7 )] .; PRINCIPAL DISPLAY PANEL Container Label Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration: 1 . Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time. Do not cut the transdermal system. 3 . Remove and discard clear plastic backing from transdermal system. 4 . Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5 . Wash and dry hands thoroughly after application. See accompanying prescribing information for details. Keep this and all medication out of reach of children. FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Marketed by Baxter Healthcare Corporation, Deerfield , IL 60015 USA Baxter Logo Rev 11-24 BARCODE (01)00310019008011 1002653 07-07-00-2612 CUT ALONG LINE TO OPEN Rx only NDC 10019-008-01 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Contents: 1 Transdermal System Caution: WASH HANDS IMMEDIATELY AFTER APPLICATION. CONTACT WITH EYES MAY CAUSE IRRITATION. May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing an MRI (Magnetic Resonance Imaging) procedure. Store upright at controlled room temperature between 20°C and 25°C (68°F and 77°F) TRANSDERM SCŌP Image 07-07-00-3156 Carton Label TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM,1 mg/3 days 4 Transdermal Systems Multipack Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration : 1. Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time.Do not cut the transdermal system. 3. Remove and discard clear plastic backing from transdermal system. 4. Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5. Wash your hands with soap and water after application. See accompanying prescribing information for details. Caution : May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing MRI (Magnetic Resonance Imaging) procedure. Keep this and all medication out of reach of children. Store upright at controlled room temperature between 20°C-25°C (68°F-77°F). Baxter Logo Marketed by Baxter Healthcare Corporation Deerfield, IL 60015 USA Trademarks are owned by or licensed to Baxter International Inc. or its subsidiaries. AVUS0104 FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Rev 11-24 1002654 GTIN 20310019008046 SN XXXXXXXXXXXX LOT XXXXX EXP YYYY-MM-DD NDC 10019-008-04 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Formulated delivery of approximately 1 mg over three days 4 Transdermal Systems Multipack RX ONLY TRANSDERM SCŌP Image Barcode (01) 20310019008046 Transderm Scōp (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 4 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 4 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) 07-03-00-1416 Carton Label TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM,1 mg/3 days 24 Transdermal Systems Multipack TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 24 Transdermal Systems Multipack Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration : 1. Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time.Do not cut the transdermal system. 3. Remove and discard clear plastic backing from transdermal system. 4. Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5. Wash your hands with soap and water after application. See accompanying prescribing information for details. Caution : May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing MRI (Magnetic Resonance Imaging) procedure. Keep this and all medication out of reach of children. Store upright at controlled room temperature between 20°C-25°C (68°F-77°F). Baxter Logo Marketed by Baxter Healthcare Corporation Deerfield, IL 60015 USA Trademarks are owned by or licensed to Baxter International Inc. or its subsidiaries. AVUS0124 FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Rev 11-24 1002656 Transderm Scōp (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 24 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) GTIN 20310019008244 SN XXXXXXXXXXXX LOT XXXXX EXP YYYY-MM-DD NDC 10019-008-24 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Formulated delivery of approximately 1 mg over three days 24 Transdermal Systems Multipack RX ONLY TRANSDERM SCŌP Image Barcode (01) 20310019008244 07-03-00-1534 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 24 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) 07-03-00-1416 Carton Label TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration: 1. Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time.Do not cut the transdermal system. 3. Remove and discard clear plastic backing from transdermal system. 4. Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5. Wash your hands with soap and water after application. See accompanying prescribing information for details. Caution : May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing MRI (Magnetic Resonance Imaging) procedure. Keep this and all medication out of reach of children. Store upright at controlled room temperature between 20°C-25°C (68°F-77°F). Baxter Logo Marketed by Baxter Healthcare Corporation Deerfield, IL 60015 USA Trademarks are owned by or licensed to Baxter International Inc. or its subsidiaries. AVUS0110 FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Rev 11-24 1002655 Transderm Scōp (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) GTIN 20310019008107 SN XXXXXXXXXXXX LOT XXXXX EXP YYYY-MM-DD NDC 10019-008-10 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Formulated delivery of approximately 1 mg over three days 10 Transdermal Systems Multipack RX ONLY TRANSDERM SCŌP Image Barcode (01) 20310019008107 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) 07-03-00-1416 Transderm Scop Representative Container Label 10019-008-01 1 of 2 Transderm Scop Representative Container Label 10019-008-01 2 of 2 Transderm Scop Carton Label 10019-008-04 Transderm Scop Carton Label 10019-008-24 Transderm Scop Carton Label 10019-008-10
- 16 HOW SUPPLIED/STORAGE AND HANDLING TRANSDERM SCŌP (scopolamine transdermal system) 1 mg/3 days is available as the following: Cartons of 4, 10, and 24 transdermal systems, packaged into individual foil pouches. • Carton of 4 transdermal systems. NDC 10019-008-04 • Carton of 10 transdermal systems. NDC 10019-008-10 • Carton of 24 transdermal systems. NDC 10019-008-24 Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Store pouch(es) in an upright position. Do not bend or roll pouch(es). Wash hands thoroughly with soap and water immediately after handling the transdermal system. Avoid touching the system during the treatment. 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 Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.7 )] .
- PRINCIPAL DISPLAY PANEL Container Label Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration: 1 . Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time. Do not cut the transdermal system. 3 . Remove and discard clear plastic backing from transdermal system. 4 . Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5 . Wash and dry hands thoroughly after application. See accompanying prescribing information for details. Keep this and all medication out of reach of children. FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Marketed by Baxter Healthcare Corporation, Deerfield , IL 60015 USA Baxter Logo Rev 11-24 BARCODE (01)00310019008011 1002653 07-07-00-2612 CUT ALONG LINE TO OPEN Rx only NDC 10019-008-01 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Contents: 1 Transdermal System Caution: WASH HANDS IMMEDIATELY AFTER APPLICATION. CONTACT WITH EYES MAY CAUSE IRRITATION. May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing an MRI (Magnetic Resonance Imaging) procedure. Store upright at controlled room temperature between 20°C and 25°C (68°F and 77°F) TRANSDERM SCŌP Image 07-07-00-3156 Carton Label TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM,1 mg/3 days 4 Transdermal Systems Multipack Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration : 1. Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time.Do not cut the transdermal system. 3. Remove and discard clear plastic backing from transdermal system. 4. Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5. Wash your hands with soap and water after application. See accompanying prescribing information for details. Caution : May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing MRI (Magnetic Resonance Imaging) procedure. Keep this and all medication out of reach of children. Store upright at controlled room temperature between 20°C-25°C (68°F-77°F). Baxter Logo Marketed by Baxter Healthcare Corporation Deerfield, IL 60015 USA Trademarks are owned by or licensed to Baxter International Inc. or its subsidiaries. AVUS0104 FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Rev 11-24 1002654 GTIN 20310019008046 SN XXXXXXXXXXXX LOT XXXXX EXP YYYY-MM-DD NDC 10019-008-04 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Formulated delivery of approximately 1 mg over three days 4 Transdermal Systems Multipack RX ONLY TRANSDERM SCŌP Image Barcode (01) 20310019008046 Transderm Scōp (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 4 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 4 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) 07-03-00-1416 Carton Label TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM,1 mg/3 days 24 Transdermal Systems Multipack TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 24 Transdermal Systems Multipack Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration : 1. Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time.Do not cut the transdermal system. 3. Remove and discard clear plastic backing from transdermal system. 4. Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5. Wash your hands with soap and water after application. See accompanying prescribing information for details. Caution : May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing MRI (Magnetic Resonance Imaging) procedure. Keep this and all medication out of reach of children. Store upright at controlled room temperature between 20°C-25°C (68°F-77°F). Baxter Logo Marketed by Baxter Healthcare Corporation Deerfield, IL 60015 USA Trademarks are owned by or licensed to Baxter International Inc. or its subsidiaries. AVUS0124 FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Rev 11-24 1002656 Transderm Scōp (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 24 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) GTIN 20310019008244 SN XXXXXXXXXXXX LOT XXXXX EXP YYYY-MM-DD NDC 10019-008-24 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Formulated delivery of approximately 1 mg over three days 24 Transdermal Systems Multipack RX ONLY TRANSDERM SCŌP Image Barcode (01) 20310019008244 07-03-00-1534 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 24 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) 07-03-00-1416 Carton Label TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack Each transdermal system contains 1.3 mg scopolamine formulated to deliver in vivo approximately 1 mg over 3 days. The inactive components are crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, ethylene vinyl acetate copolymer and aluminized polyester film. Dosage and Administration: 1. Before applying transdermal system, wash and dry hands thoroughly. 2. Use only one transdermal system at a time.Do not cut the transdermal system. 3. Remove and discard clear plastic backing from transdermal system. 4. Apply to the hairless area behind one ear as indicated in accompanying prescribing information. 5. Wash your hands with soap and water after application. See accompanying prescribing information for details. Caution : May cause drowsiness, blurred vision. To avoid possible burns, remove Transderm Scōp before undergoing MRI (Magnetic Resonance Imaging) procedure. Keep this and all medication out of reach of children. Store upright at controlled room temperature between 20°C-25°C (68°F-77°F). Baxter Logo Marketed by Baxter Healthcare Corporation Deerfield, IL 60015 USA Trademarks are owned by or licensed to Baxter International Inc. or its subsidiaries. AVUS0110 FOIL-SEALED FOR YOUR PROTECTION. DO NOT USE IF SEAL IS BROKEN. Rev 11-24 1002655 Transderm Scōp (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) GTIN 20310019008107 SN XXXXXXXXXXXX LOT XXXXX EXP YYYY-MM-DD NDC 10019-008-10 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days Formulated delivery of approximately 1 mg over three days 10 Transdermal Systems Multipack RX ONLY TRANSDERM SCŌP Image Barcode (01) 20310019008107 TRANSDERM SCŌP (scopolamine) TRANSDERMAL SYSTEM, 1 mg/3 days 10 Transdermal Systems Multipack For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) 07-03-00-1416 Transderm Scop Representative Container Label 10019-008-01 1 of 2 Transderm Scop Representative Container Label 10019-008-01 2 of 2 Transderm Scop Carton Label 10019-008-04 Transderm Scop Carton Label 10019-008-24 Transderm Scop Carton Label 10019-008-10
Overview
TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C 17 H 21 NO 4 and its structural formula is: Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌP transdermal system is a circular, 0.2 mm thick, 2.5 cm 2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system: Scopolamine structural formula Cross section of transdermal system
Indications & Usage
TRANSDERM SCŌP 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. TRANSDERM SCŌP 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 & Administration
Application and Removal ( 2.1 ): • Each TRANSDERM SCŌP 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 TRANSDERM SCŌP 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 TRANSDERM SCŌP 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 TRANSDERM SCŌP transdermal system behind the other ear. PONV For surgeries other than cesarean section : Apply one TRANSDERM SCŌP transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery.
Warnings & 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 TRANSDERM SCŌP prior to MRI scan. ( 5.8 ) 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 )] . In cases of psychiatric reactions occurring TRANSDERM SCŌP should be removed at once. If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention. 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. If, despite this, the symptoms persist in a severe form, instruct patients to seek medical attention. 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 patients with impeded flow of urine (e.g., in diseases of the prostate 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 Hyperthermia Serious adverse reactions of hyperthermia have been reported postmarketing in adult and pediatric patients receiving transdermal scopolamine, including fatal cases. Anticholinergic agents, including scopolamine, can increase core body temperature and reduce sweating, which may cause further increases in body temperature. Hyperthermia may be exacerbated by exposure to external heat sources or high environmental temperature. Pediatric and geriatric patients may be more susceptible to these anticholinergic effects on thermoregulation. Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, to remove the transdermal system and contact their healthcare provider. Symptoms may persist following removal of the used transdermal system as there may be continued systemic absorption of scopolamine through the skin. TRANSDERM SCŌP is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 , 8.5 )]. 5.6 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. 5.7 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, do not touch the system while wearing it, and wash hands and the application site with soap and water after transdermal system removal [see Dosage and Administration ( 2.1 )] . 5.8 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.
Contraindications
TRANSDERM SCŌP is contraindicated in patients with: • angle closure glaucoma [see Warnings and Precautions ( 5.1 )] . • hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. Reactions have included rash generalized and erythema [see Adverse Reactions ( 6.2 ), Description ( 11 )] . • Angle closure glaucoma. ( 4 , 6.2 ) • Hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component of the formulation or delivery system. ( 4 , 7 )
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 )] • Hyperthermia [see Warnings and Precautions ( 5.5 )] • Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions ( 5.6 )] • Blurred Vision [see Warnings and Precautions ( 5.7 )] • MRI Skin Burns [see Warnings and Precautions ( 5.8 )] 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 Baxter Healthcare Corporation at 1-866-888-2472 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 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: disorientation, hallucinations, and paranoia Nervous system disorders : amnesia, coordination abnormalities, disturbance in attention, headache, restlessness, speech disorder General disorders and administration site conditions : application site reactions (including blistering, burning, pruritus, and rash) and hyperthermia Eye disorders : amblyopia, angle closure glaucoma, dry eyes, eyelid irritation, eye pruritus Skin and subcutaneous tissue disorders : erythema, rash generalized, skin irritation Renal and urinary disorders : dysuria Ear and labyrinth disorders : vertigo
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.
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