SCOPOLAMINE patch

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

A-S Medication Solutions

Mode d'administration:

TRANSDERMAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Scopolamine transdermal system is indicated in adults for the prevention of: Scopolamine transdermal system is contraindicated in patients with: 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 defect, loss,

Descriptif du produit:

Product: 50090-5349 NDC: 50090-5349-0 1 d in a POUCH / 4 in a CARTON

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

A-S Medication Solutions
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MEDICATION GUIDE
Scopolamine Transdermal System
(skoe polʹ a meen)
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 and over-the-counter medicines,
vitamins and herbal supplements. Scopolamine transdermal syste

Résumé des caractéristiques du produit

SCOPOLAMINE- SCOPOLAMINE PATCH
A-S MEDICATION SOLUTIONS
----------
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:
•
•
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 other belladonna alkaloids or to
any ingredient or component of
the formulation or delivery system. (4, 7)
Acute Angle Closure Glaucoma: Monitor for increased intraocular
pressure in patients with open-angle
glaucoma