Transderm Scop 1 mg/3d
Scopolamine · PATCH, EXTENDED RELEASE · Baxter Healthcare Corporation
Transderm Scop is a patch, extended release containing scopolamine at 1 mg/3d, taken transdermal. Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- Transderm Scop
- Generic Name
- Scopolamine
- NDC Code (Product)
10019-008- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 1 mg/3d
- Dosage Form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- NDA017874
- Drug Class
- Anticholinergic [EPC]
- Marketing Start
- 12/01/2016
Recall History
Sandoz Inc
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Sandoz Inc
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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
2 DOSAGE AND 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 …
Contraindications
4 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 )
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 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 …
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 )] • 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 clinica…
Frequently Asked Questions
What is Transderm Scop used for?
Transderm Scop contains Scopolamine. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.
Is Transderm Scop a controlled substance?
Transderm Scop is not classified as a controlled substance by the DEA.
What is the generic name for Transderm Scop?
The generic name for Transderm Scop is Scopolamine. There are 12 other brand versions of Scopolamine.
What is the NDC code for Transderm Scop 1 mg/3d?
The NDC (National Drug Code) for Transderm Scop 1 mg/3d is 10019-008, listed by Baxter Healthcare Corporation.