Transderm Scop (Page 4 of 4)

13 NONCLINICAL PHARMACOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

14 CLINICAL STUDIES

14.1 Motion Sickness

In 195 adult subjects of different racial origins who participated in clinical efficacy studies at sea or in a controlled motion environment, there was a 75% reduction in the incidence of motion-induced nausea and vomiting.

14.2 Post-Operative Nausea and Vomiting

In two pivotal clinical efficacy studies in 391 adult female patients undergoing cesarean section or gynecological

surgery with anesthesia and opiate analgesia, 66% of those treated with Transderm Scōp® (compared to only 46% of

those receiving placebo) reported no retching/vomiting within the 24-hour period following administration of

anesthesia/opiate analgesia. When the need for additional antiemetic medication was assessed during the same

period, there was no need for medication in 76% of patients treated with Transderm Scōp as compared to 59% of

placebo-treated patients.

16 HOW SUPPLIED/STORAGE AND HANDLING

The Transderm Scōp® system is a tan-colored circular patch, 2.5 cm2 , on a clear, oversized, hexagonal peel strip,

which is removed prior to use.

Each Transderm Scōp system contains 1.5 mg of scopolamine and is formulated to deliver in-vivo approximately

1 mg of scopolamine over 3 days. Transderm Scōp is available in packages of four patches. Each patch is foil

wrapped. Patient instructions are included. [ see Patient Counseling Information (17)]

  • 1 Package (4 patches) NDC 0067-4345-04

Storage

The system should be stored at controlled room temperature between 20°C-25°C (68°F-77°F).

Handling

Since scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes,

patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling

the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.

[ see Dosage and Administration (2) , Warnings and Precautions (5.2), and Patient Counseling Information (17))]

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)
Please read this instruction sheet carefully before opening the system package.
Transderm Scōp® Transdermal System
Generic Name: scopolamine, pronounced skoe-POL-a-meen

  • Elderly patients should be informed that Transderm Scōp may cause a greater likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome and to seek immediate medical care if they become confused, disoriented or dizzy while wearing the patch or after removing.
  • Patients should be informed that since Transderm Scōp may cause drowsiness, disorientation and confusion they should avoid engaging in activities that require mental alertness such as driving a motor vehicle or operating dangerous machinery.
  • Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of Transderm Scop.
  • Because of the possibility of drowsiness, disorientation and confusion, patients should be informed that they should avoid drinking alcohol. In addition, patients should be informed that the following medications should be used with caution when taking Transderm Scop:
    • sedatives or tranquilizers
    • drugs with anticholinergic properties (e.g., other belladonna alkaloids),
    • antihistamines (including meclizine)
    • tricyclic antidepressants
    • muscle relaxants
  • Patients with the following conditions should be informed about the chance of developing serious reactions with Transderm Scōp:
    • patients with open angle glaucoma (may cause an increase in intraocular pressure)
    • patients with impaired kidney or liver function (increased likelihood of CNS effects)
    • patients with a history of seizures or psychosis (can potentially worsen both disorders)
    • patients with obstruction at the level of the pylorus, which is the outlet of the stomach, or urinary bladder neck obstruction (may cause difficulties in urinating)
    • patients suspected of having intestinal obstruction
    • pregnant or nursing mothers
  • Patients should be informed that if they remove the Transderm Scōp patch suddenly before treatment is complete, the following withdrawal symptoms may occur: dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, slow heart rate and low blood pressure. Patients should be instructed to seek immediate medical care if they develop any of these symptoms after removing Transderm Scōp.
  • Patients should be informed that Transderm Scop can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Patients should be informed to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, patients should be informed that used patches must be disposed of properly to avoid contact with children or pets.
  • Patients should be informed that skin burns have been reported at the patch site in several patients wearing an aluminized transdermal system during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp contains aluminum, patients should be advised to remove the system before undergoing an MRI.
  • Patients should be advised to use only one patch at a time.
  • Patients should be advised not to cut the patch.

FDA- Approved Patient Labeling

PATIENT INFORMATION

Transderm Scōp®, pronounced tran(t)s-derm skōp

(scopolamine)

transdermal system patch

Read this Patient Information before you start using Transderm Scōp® 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.

What is Transderm Scōp ®?

The Transderm Scōp® patch is a prescription medicine used for adults to:

  • help prevent nausea and vomiting from motion sickness
  • help prevent nausea and vomiting from anesthesia or taking opioid pain medicines after surgery

It is not known if Transderm Scōp® is safe or effective in children.

Who should not use Transderm Scōp ®?

Do not use Transderm Scōp ® if you:

  • have an eye problem called angle closure glaucoma
  • if you are allergic to any of the ingredients in Transderm Scōp® or other medicines called belladonna alkaloids. See the end of this leaflet for a list of the ingredients in Transderm Scōp®. Ask your doctor if you are not sure.

What should I tell my doctor before using Transderm Scōp ®?

Before you use Transderm Scōp®, tell your doctor if you:

  • are scheduled to have a gastric secretion test
  • have glaucoma (increased pressure in the eye)
  • have liver or kidney problems
  • have problems with your stomach or intestines
  • have trouble urinating
  • have a history of seizures or psychosis
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Transderm Scōp® can harm your unborn baby.
  • are breast-feeding or plan to breast-feed. Transderm Scōp® can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you use Transderm Scōp®.

Tell your doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins and herbal supplements. Transderm Scōp® may affect the way other medicines work, and other medicines may affect how Transderm Scōp® works. Medicines that you take by mouth may not be absorbed well while you use Transderm Scōp®.

Especially tell your doctor if you take:

  • a sedative or tranquilizer (medicines that make you sleepy)
  • an antidepressant medicine
  • an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, certain asthma medicines, or other medicines for motion sickness.

Ask your doctor if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I use Transderm Scōp ®?

Use Transderm Scōp ® exactly as your doctor tells you to use it.
Transderm Scōp ® is a tan-colored circle shaped patch.
Wear only one patch at any time.
Do not cut the patch.

To help prevent nausea and vomiting from motion sickness:

  • Apply one Transderm Scōp® patch to your skin on a hairless area behind one ear at least 4 hours before the activity to prevent nausea and vomiting.
  • If the treatment is needed for longer than 3 days, remove the patch from the hairless area behind your ear. Get a new Transderm Scōp® patch and place it on the hairless area behind your other ear.

To help prevent nausea and vomiting after surgery:

  • Follow your doctor’s instructions about when to apply Transderm Scōp® before your scheduled surgery.
  • The Transderm Scōp® patch should be left in place for 24 hours after surgery. After 24 hours the patch should be removed and thrown away.

Apply Transderm Scōp® as follows:

Inside the Transderm Scōp® package, you will find one Transderm Scōp® patch. A tan colored patch with a metallic (silver) sticky surface is adhered to a clear disposable backing (See Figure 1).

Figure 1
(click image for full-size original)

1. Select a hairless area of skin behind one of your ears. Avoid areas on your skin that may have cuts, pain or tenderness. Wipe the area of your skin with a clean, dry tissue.

2. Cut along dotted line on the Transderm Scōp® package to open (See Figure 2).

Figure 2
(click image for full-size original)

3. Remove the clear plastic backing from the tan-colored round patch (See Figure 3).

Figure 3
(click image for full-size original)

4. Avoid touching the metallic adhesive (sticky) surface on the patch with your hands (See Figure 4).

Figure 4
(click image for full-size original)

5. Apply the metallic adhesive surface of the patch firmly to the dry area of skin behind your ear. The tan-colored side of the patch should be facing up and showing (See Figure 5). Wash your hands with soap and water right away after applying the patch, so that any medicine from the patch that gets on your hands

will not get into your eyes.

Figure 5
(click image for full-size original)

After removing the patch, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Note that the used patch will still contain some of the active ingredient after use. To avoid accidental contact or ingestion by children or pets, fold the used patch in half with the sticky side together. Dispose in the trash out of the reach of children and pets.

If you use too much Transderm Scōp®, call your doctor or local poison control center, or go to the nearest hospital emergency room right away.

What should I avoid while using Transderm Scōp ®?

  • You should not drink alcohol while using Transderm Scōp®. It can increase your chances of having serious side effects.
  • You should not drive, operate heavy machinery, or do other dangerous activities until you know how Transderm Scōp® affects you.
  • You should not use Transderm Scōp® during a Magnetic Resonance Imaging scan (MRI). Remove Transderm Scōp® patch before undergoing an MRI; it can cause your skin to burn.
  • You should be careful if you use Transderm Scōp® while you participate in watersports because you may feel lost or confused (disoriented).
  • Limit contact with water while swimming and bathing because the Transderm Scōp® patch may fall off. If the patch falls off, throw it away and apply a new one on the hairless area behind your other ear.

What are the possible side effects of Transderm Scōp ®?

Transderm Scōp ® may cause serious side effects, including:

  • angle closure glaucoma. If you have open angle glaucoma and use Transderm Scōp®, remove the patch and call a doctor right away if you get pain and reddening of your eyes with an increase in the size of your pupil (the small dark circle in the eye).
  • temporary increase in the size of your pupil and blurry vision , especially if Transderm Scōp® comes in contact with your eyes
  • difficulties in urinating
  • difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea or vomiting.
  • worsening of seizures. Tell your doctor about any worsening of seizures while using Transderm Scōp®.
  • an unusual reaction called acute psychosis: Tell your doctor if you have any of these symptoms:
    • confusion
    • agitation
    • rambling speech
    • hallucinations (seeing or hearing things that are not there)
    • paranoid behaviors and delusions (false belief in something)
  • skin burns at the site of the patch. This can happen during a medical test called a Magnetic Resonance Imaging scan (MRI). Transderm Scōp® contains aluminum and should be removed from your skin before you have an MRI.

The most common side effects of using Transderm Scōp® include:

  • dry mouth
  • drowsiness
  • disorientation (confusion)
  • blurred vision
  • pharyngitis
  • memory trouble
  • dizziness
  • restlessness
  • agitation
  • problems urinating
  • skin rashes or redness, application site burning
  • dry itchy, or reddened whites of the eyes, and eye pain

Symptoms when removing Transderm Scōp ®. Some people may have certain symptoms 24 hours or more after removing Transderm Scōp®. These symptoms may include:

  • dizziness
  • nausea
  • vomiting
  • headache
  • problems with balance and walking
  • decrease in blood pressure
  • muscle weakness
  • decrease in heart rate

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Transderm Scōp®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may reports side effects to FDA at 1-800-FDA-1088.

How should I store Transderm Scōp®?

  • Store Transderm Scōp® at room temperature between 68°F and 77°F (20°C and 25°C) until you are ready to use it.
  • Keep Transderm Scōp® and all medicines out of reach of children.

General Information about Transderm Scōp ®

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Transderm Scōp® for a condition for which it was not prescribed. Do not give Transderm Scōp® to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about Transderm Scōp®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Transderm Scōp® that is written for the health professionals.

For more information, go to www. transdermscop.com or call 1-800-452-0051.

What are the ingredients in the Transderm Scōp ® patch?

Active ingredient: Scopolamine

Inactive ingredients: light mineral oil and polyisobutylene and aluminized polyester film

Manufactured by: ALZA Corporation

Vacaville, CA 95688

Distributed by:

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

©2013

Principle Display Panel

carton 4 ct
(click image for full-size original)
carton 4 ct

Package/Label Display Panel

NCH 1ct Pouch
(click image for full-size original)
TRANSDERM SCOP
scopolamine patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0067-4345
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCOPOLAMINE (scopolamine) SCOPOLAMINE 1 mg in 3 d
Inactive Ingredients
Ingredient Name Strength
POLYISOBUTYLENE (1100000 MW)
POLYISOBUTYLENE (35000 MW)
LIGHT MINERAL OIL
CHLOROFORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0067-4345-04 4 POUCH in 1 BOX contains a POUCH
1 1 PATCH in 1 POUCH This package is contained within the BOX (0067-4345-04) and contains a PATCH
1 3 d in 1 PATCH This package is contained within a POUCH and a BOX (0067-4345-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017874 10/02/2007
Labeler — Novatris Consumer Health, Inc. (879821635)

Revised: 04/2013 Novatris Consumer Health, Inc.

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