Scopolamine Trandermal System 1 mg/1
scolopamine transdermal system · PATCH, EXTENDED RELEASE · Bryant Ranch Prepack
Scopolamine Transdermal System is a prescription patch that delivers medication through your skin to prevent nausea and vomiting, particularly from motion sickness or after surgery. It belongs to a class of drugs called anticholinergics that work by blocking certain nerve signals in the body.
Key Facts
- Brand Name
- Scopolamine Trandermal System
- Generic Name
- scolopamine transdermal system
- NDC Code (Product)
63629-8452- Manufacturer
- Bryant Ranch Prepack
- Strength
- 1 mg/1
- Dosage Form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- ANDA078830
- Drug Class
- Anticholinergic [EPC]
- Marketing Start
- 06/13/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Scopolamine transdermal system is indicated in adults for 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 & 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 after application. • Upon removal, fold used transdermal system in half with sticky side together, and discard to prevent accidental contact or ingestion. 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 …
Contraindications
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 )] . • Angle closure glaucoma ( 4 , 6.2 ) • Hypersensitivity to scopolamine or to other belladonna alkaloids or to any ingredient or component of the formulation or delivery system. ( 4 , 7 )
Drug 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. ( 7.4 ) 7.1 Drugs Causing Central Nervous System (CNS) Adverse Reactions The concurrent use of scopolamine transdermal system 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 scopolamine transdermal system [see Warnings and Precautions ( 5.2 )] . Either scopolamine transdermal system or the interacting drug should be chosen, depending on the importanc…
Adverse Reactions
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 Perrigo at 1-866-634-9120 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 trial…
Frequently Asked Questions
What is Scopolamine Trandermal System used for?
Scopolamine Transdermal System is a prescription patch that delivers medication through your skin to prevent nausea and vomiting, particularly from motion sickness or after surgery. It belongs to a class of drugs called anticholinergics that work by blocking certain nerve signals in the body.
Is Scopolamine Trandermal System a controlled substance?
Scopolamine Trandermal System is not classified as a controlled substance by the DEA.
What is the generic name for Scopolamine Trandermal System?
The generic name for Scopolamine Trandermal System is scolopamine transdermal system. There are no other listed brand versions of scolopamine transdermal system.
What is the NDC code for Scopolamine Trandermal System 1 mg/1?
The NDC (National Drug Code) for Scopolamine Trandermal System 1 mg/1 is 63629-8452, listed by Bryant Ranch Prepack.
Other Scopolamine Trandermal System Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)