SCOPOLAMINE patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SCOPOLAMINE (UNII: DL48G20X8X) (scopolamine - UNII:DL48G20X8X)

Available from:

Ingenus Pharmaceuticals, LLC

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Scopolamine transdermal system 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. 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)] . Risk Summary Available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. Avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see Dat

Product summary:

Scopolamine transdermal system 1 mg/3 days is available as the following: Carton of 4 transdermal systems, packaged into individual foil pouches. NDC 50742-505-04 Carton of 10 transdermal systems, packaged into individual foil pouches. NDC 50742-505-10 Carton of 24 transdermal systems, packaged into individual foil pouches. NDC 50742-505-24 Store at controlled room temperature between 68°F to 77°F (20°C to 25°C). 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 [see Dosage and Administration (2.1), Warnings and Precautions (5.6)] . PHARMACIST:  Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ingenus Pharmaceuticals, LLC
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Dispense with Medication Guide available at:
www.ingenus.com/medguide/scopolamine-tds.pdf
MEDICATION GUIDE
Scopolamine (skoe-POL-a-meen)
Transdermal System
Read this Medication Guide 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.
What is scopolamine transdermal system?
Scopolamine transdermal system is a prescription medicine used for
adults to help prevent:
•
nausea and vomiting from motion sickness
•
nausea and vomiting from anesthesia or taking opioid pain medicines
after surgery
It is not known if scopolamine transdermal system is safe or effective
in children.
Who should not use scopolamine transdermal system?
Do not use scopolamine transdermal system if you:
•
have an eye problem called angle closure glaucoma.
•
are allergic to scopolamine, belladonna alkaloids or any of the
ingredients in scopolamine transdermal
system. See the end of this leaflet for a list of the ingredients in
scopolamine transdermal system. Ask your
doctor if you are not sure.
What should I tell my doctor before using scopolamine transdermal
system?
Before you use scopolamine transdermal system, tell your doctor about
all of your medical conditions, including if
you:
•
have glaucoma (increased pressure in the eye).
•
have a history of seizures or psychosis.
•
have problems with your stomach or intestines.
•
have trouble urinating.
•
are scheduled to have a gastric secretion test.
•
have liver or kidney problems.
•
are pregnant or plan to become pregnant. It is not known if
scopolamine can harm your unborn baby.
•
are breastfeeding or plan to breastfeed. Scopolamine 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 scopolamine transdermal system.
Tell your doctor about all the medicines you take, including
prescription an

Summary of Product characteristics

SCOPOLAMINE- SCOPOLAMINE PATCH, EXTENDED RELEASE
INGENUS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SCOPOLAMINE
TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SCOPOLAMINE TRANSDERMAL SYSTEM.
SCOPOLAMINE TRANSDERMAL SYSTEM
INITIAL U.S. APPROVAL: 1979
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 03/2019
INDICATIONS AND USAGE
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 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)
DOSAGE FORMS AND STRENGTHS
Transdermal system: 1 mg/3 days (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Acute Angle Closure Glaucoma: Monitor for increased intraocular
pressure in patients with open-angle
glaucoma and adjust glaucoma therapy as needed. Dis