SCOPOLAMINE TRANDERMAL SYSTEM- scolopamine transdermal system patch, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Bryant Ranch Prepack

Mode d'administration:

TRANSDERMAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Scopolamine transdermal system is indicated in adults for prevention of: Scopolamine transdermal system is contraindicated in patients with: 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 Data). In animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. Embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defec

Descriptif du produit:

Scopolamine Transdermal System 1 mg/3 days is available as the following: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. 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)].

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Bryant Ranch Prepack
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MEDICATION GUIDE
MEDICATION GUIDE
Scopolamine (skoe pol’ a meen) Transdermal System
Read this Patient Information 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 Transderm Scōp 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 transdermal system 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 and over-the-counter medicines,
vitamins and herbal supplements. Scopolam

Résumé des caractéristiques du produit

SCOPOLAMINE TRANDERMAL SYSTEM- SCOLOPAMINE TRANSDERMAL
SYSTEM PATCH, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
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 1 MG/3 DAYS
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:
•
•
DOSAGE AND ADMINISTRATION
Application and Removal (2.1)
•
•
•
•
•
Recommended Dosage:
•
•
DOSAGE FORMS AND STRENGTHS
Transdermal system: 1 mg/3 days (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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)
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.
_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)
Angle closure glaucoma (4, 6.2)
Hypersensitivity to scopolamine or to other belladonna alkaloids or to
any ingredient or component of
the formulation or delivery system. (4, 7)
Acute Angle Closure Glaucoma: Monitor for incr