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Scopolamine (Transderm Scop)

Trade Name : Transderm Scop

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

PATCH, EXTENDED RELEASE

Strength 1 mg/3d

SCOPOLAMINE Anticholinergic [EPC],Cholinergic Antagonists [MoA]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Scopolamine (Transderm Scop) which is also known as Transderm Scop and Manufactured by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. It is available in strength of 1 mg/3d per ml. Read more

Scopolamine (Transderm Scop) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a003/2019
  • Transderm Scu014dp is indicated in adults for the prevention of:
  • Transderm Scu014dp is an anticholinergic indicated in adults for the prevention of:
  • Application and Removal
  • Recommended Dosage
  • Transdermal system: a circular, flat, tan-colored transdermal system imprinted with u201cScopolamine 1 mg/3 daysu201d
  • Transdermal system: 1 mg/3 days ()
  • Transderm Scu014dp is contraindicated in patients with:
  • 4n- 6.2
  • 4n- 7
  • No data
  • Acute Angle Closure Glaucoma
  • Neuropsychiatric Adverse Reactions
  • Eclamptic Seizures in Pregnant Women
  • Gastrointestinal and Urinary Disorders
  • Drug Withdrawal/Post-Removal Symptoms
  • Blurred Vision
  • Magnetic Resonance Imaging (MRI) Skin Burns
  • The following serious adverse reactions are described elsewhere in labeling:
  • Most common adverse reactions are:
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline Consumer Healthcare at 1-800-398-5876 or FDA at 1-800-FDA-1088 or n
  • Motion Sickness
  • PONV
  • No data
  • Drugs Causing Central Nervous System (CNS) Adverse Reactions
  • Anticholinergic Drugs
  • Oral Drugs Absorbed in the Stomach
  • Interaction with Gastric Secretion Test
  • No data
  • Geriatric Patients
  • Renal or Hepatic Impairment
  • No data
  • The signs and symptoms of anticholinergic toxicity include: lethargy, somnolence, coma, confusion, agitation, hallucinations, convulsion, visual disturbance, dry flushed skin, dry mouth, decreased bowel sounds, urinary retention, tachycardia, hypertension, and supraventricular arrhythmias. These symptoms can be severe and may require medical intervention.
  • In cases of toxicity remove the Transderm Scu014dp transdermal system. Serious symptomatic cases of overdosage involving multiple transdermal system applications and/or ingestion may be managed by initially ensuring the patient has an adequate airway and supporting respiration and circulation. This should be rapidly followed by removal of all transdermal systems from the skin and the mouth. If there is evidence of transdermal system ingestion, endoscopic removal of swallowed transdermal systems, or administration of activated charcoal should be considered, as indicated by the clinical situation. In any case where there is serious overdosage or signs of evolving acute toxicity, continuous monitoring of vital signs and ECG, establishment of intravenous access, and administration of oxygen are all recommended.
  • The signs and symptoms of overdose/toxicity due to scopolamine should be carefully distinguished from the occasionally observed syndrome of withdrawal Although mental confusion and dizziness may be observed with both acute toxicity and withdrawal, other characteristic findings differ: tachyarrhythmias, dry skin, and decreased bowel sounds suggest anticholinergic toxicity, while bradycardia, headache, nausea and abdominal cramps, and sweating suggest post-removal withdrawal.
  • If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
  • Transderm Scu014dp (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 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is CHNO and its structural formula is:
  • Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scu014dp transdermal system is a circular, 0.2 mm thick, 2.5 cmfilm 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, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of 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:
  • No data
  • No long-term studies in animals have been conducted to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated.
  • Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system). However, fertility studies in male animals were not performed.
  • No data
  • Transderm Scu014dp (scopolamine transdermal system) 1 mg/3 days is available as the following:
  • Carton of 4 transdermal systems, packaged into individual foil pouches. NDC 0067-4346-04
  • Store at controlled room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
  • 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. 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 .
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Administration Instructions
  • Counsel patients on how to apply and remove the transdermal system:
  • Patients with Open-Angle Glaucoma
  • Advise patients with open-angle glaucoma to remove the Transderm Scu014dp transdermal system immediately and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma, including pain and reddening of the eyes, accompanied by dilated pupils, blurred vision and/or seeing halos around lights .
  • Neuropsychiatric Adverse Reactions
  • Decreased Gastrointestinal Motility and Urinary Retention
  • Instruct patients to remove the transdermal system if they develop symptoms of intestinal obstruction (abdominal pain, nausea or vomiting) or any difficulties in urinating .
  • Drug Withdrawal/Post-Removal Symptoms
  • Inform patients that if they remove the Transderm Scu014dp transdermal system before treatment is complete, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing Transderm Scu014dp .
  • Blurred Vision
  • Inform patients that temporary dilation of the pupils and blurred vision may occur if Transderm Scu014dp comes in contact with the eyes. Instruct patients to wash their hands thoroughly with soap and water immediately after handling the transdermal system .
  • MRI Skin Burns
  • Instruct patients to remove the Transderm Scu014dp transdermal system before undergoing an MRI n n n Manufactured by: ALZA Corporation, Vacaville, CA 95688 forn Warren, NJ 07059
  • Trademarks are owned by or licensed to the GSK group of companies.u00a92019 GSK group of companies or its licensor.
  • INSTRUCTIONS FOR USE
  • Transderm Scu014dp (trans-derm sku014dp)n- (scopolamine transdermal system)
  • Read this Instructions for Use before you start using Transderm Scu014dp and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
  • Information about Transderm Scu014dp:
  • To help prevent nausea and vomiting from motion sickness:
  • To help prevent nausea and vomiting after surgery:
  • How to use Transderm Scu014dp:
  • Inside the Transderm Scu014dp package, you will find one Transderm Scu014dp. An imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (See Figure 1).
  • How to remove Transderm Scu014dp:
  • After removing Transderm Scu014dp, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Please note that the used Transderm Scu014dp will still contain some of the active ingredient after use. To avoid accidental contact or ingestion by children, pets or others, fold the used Transderm Scu014dp in half with the sticky side together. Throw away (dispose of) Transderm Scu014dp in the household trash out of the reach of children, pets or others.
  • How should I store Transderm Scu014dp?
  • Keep Transderm Scu014dp and all medicines out of reach of children.
  • The Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: March 2019
  • NDC 0067-4346-04NSN 6505-456-2380
  • Transderm Scop
  • (scopolamine)
  • TRANSDERMAL SYSTEM, 1 mg/3 days
  • Formulated delivery of approximately 1 mg over three days
  • MOTION SICKNESS & POST-OPERATIVE NAUSEA & VOMITING PREVENTION TRANSDERMAL SYSTEMS
  • 4 Transdermal Systems
  • Rx ONLY

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