Scopolamine Trandermal System (Page 5 of 5)

Instructions for Use

INSTRUCTIONS FOR USE

Scopolamine (skoe pol’ a meen) Transdermal System

Read this Instructions for Use before you start using scopolamine transdermal system 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 scopolamine transdermal system:

Scopolamine transdermal system is a tan-colored, circle shaped transdermal system (patch) with “SCOP 1 mg/3 days” printed on it.
Wear only one scopolamine transdermal system at any time.
Do not cut scopolamine transdermal system.

To help prevent nausea and vomiting from motion sickness:

Apply one scopolamine transdermal system 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 scopolamine transdermal system from the hairless area behind your ear. Get a new scopolamine transdermal system 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 scopolamine transdermal system before your scheduled surgery.
Scopolamine transdermal system should be left in place for 24 hours after surgery. After 24 hours, scopolamine transdermal system should be removed and thrown away.

How to use scopolamine transdermal system:

Inside the scopolamine transdermal system package, you will find one scopolamine transdermal system. An imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (See Figure 1).

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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 the dashed line on the scopolamine transdermal system package to open (See Figure 2).
figure-2
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3.
Remove the clear plastic backing from the tan-colored round scopolamine transdermal system (See Figure 3).
figure-3
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4.
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermal system with your hands (See Figure 4).
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5.
Apply the metallic adhesive surface of scopolamine transdermal system firmly to the dry area of skin behind your ear. The imprinted, tan colored side of the transdermal system should be facing up and showing (See Figure 5). Wash your hands with soap and water right away after applying scopolamine transdermal system, so that any medicine from scopolamine transdermal system that gets on your hands will not get into your eyes.
figure-5
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How to remove scopolamine transdermal system:

After removing scopolamine transdermal system, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Please note that the used scopolamine transdermal system will still contain some of the active ingredient after use. To avoid accidental contact or ingestion by children, pets or others, fold the used scopolamine transdermal system in half with the sticky side together. Throw away (dispose of) scopolamine transdermal system in the household trash out of the reach of children, pets or others.

How should I store scopolamine transdermal system?

Store scopolamine transdermal system at room temperature between 68°F and 77°F (20°C and 25°C) until you are ready to use it.
Store scopolamine transdermal system in an upright position.
Do not bend or roll scopolamine transdermal system.

Keep scopolamine transdermal system 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 Administration Revised: April 2019

Package/Label Display Panel

Rx Only

Scopolamine Transdermal System

1 mg/3 days

Formulated delivery of approximately 1 mg over three days

Motion Sickness and Post-operative Nausea & Vomiting Prevention Transdermal Systems

24 Transdermal Systems

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The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

//medlibrary.org/lib/images-rx/scopolamine-trandermal-system/serialization-template-300x88.jpg
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SCOPOLAMINE TRANDERMAL SYSTEM
scolopamine transdermal system patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-580
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCOPOLAMINE (SCOPOLAMINE) SCOPOLAMINE 1 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
ISOPROPYL PALMITATE
LIGHT MINERAL OIL
POLYISOBUTYLENE (55000 MW)
POLYISOBUTYLENE (1100000 MW)
Product Characteristics
Color WHITE (TO ALMOST WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-580-84 4 POUCH in 1 CARTON contains a POUCH
1 1 PATCH, EXTENDED RELEASE in 1 POUCH This package is contained within the CARTON (45802-580-84)
2 NDC:45802-580-46 10 POUCH in 1 CARTON contains a POUCH
2 1 PATCH, EXTENDED RELEASE in 1 POUCH This package is contained within the CARTON (45802-580-46)
3 NDC:45802-580-62 24 POUCH in 1 CARTON contains a POUCH
3 1 PATCH, EXTENDED RELEASE in 1 POUCH This package is contained within the CARTON (45802-580-62)
4 NDC:45802-580-01 1 PATCH, EXTENDED RELEASE in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078830 06/13/2017
Labeler — Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021 Padagis Israel Pharmaceuticals Ltd

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