Scopolamine
Generic Name: scopolamine
Brand Names:
Scopolamine
11 DESCRIPTION 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 to 7.81.
Overview
11 DESCRIPTION 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 to 7.81.
Uses
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
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.
Side Effects
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) ] 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.
Interactions
7 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 scopolamine transdermal system 10 days prior to testing.
Warnings
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. 4 CONTRAINDICATIONS Scopolamine transdermal system 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) ] .
Pregnancy
8.1 Pregnancy Risk Summary Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. Avoid use of scopolamine transdermal system in patients with severe preeclampsia [see Warnings and Precautions (5.3) and Data ] . Available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes.
Storage
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. 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.
Frequently Asked Questions
What is Scopolamine used for?▼
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 )
What are the side effects of Scopolamine?▼
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) ] 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.
Can I take Scopolamine during pregnancy?▼
8.1 Pregnancy Risk Summary Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. Avoid use of scopolamine transdermal system in patients with severe preeclampsia [see Warnings and Precautions (5.3) and Data ] . Available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes.
What are the important warnings for Scopolamine?▼
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. 4 CONTRAINDICATIONS Scopolamine transdermal system 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) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.