SCOPOLAMINE TRANDERMAL SYSTEM- scolopamine transdermal system patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Eclamptic Seizures In published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see Warnings and Precautions (5.3)] . Animal Data In animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. An embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by scopolamine transdermal system did not affect uterine contractions or increase the duration of labor. Risk Summary Scopolamine is present in human milk. There are no available data on the effects of scopolamine on the breastfed infant or the effects on milk production. Because there have been no consistent reports of adverse events in breastfed infants over decades of use, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for scopolamine transdermal system and any potential adverse effects on the breastfed child from scopolamine transdermal system or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported. Clinical trials of scopolamine transdermal system did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. In other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome [see Warnings and Precautions (5.2, 5.5)]. Consider more frequent monitoring for CNS adverse reactions during treatment with scopolamine transdermal system in elderly patients [see Warnings and Precautions (5.2)] . Scopolamine transdermal system has not been studied in patients with renal or hepatic impairment. Consider more frequent monitoring during treatment with scopolamine transdermal system in patients with renal or hepatic impairment because of the increased risk of CNS adverse reactions [see Warnings and Precautions (5.2)]. Scopolamine transdermal system contains scopolamine, which is not a controlled substance. Termination of scopolamine transdermal system, usually after several days of use, may result in withdrawal symptoms such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. These withdrawal symptoms indicate that scopolamine, like other anticholinergic drugs, may produce physical dependence. The onset of these symptoms, generally 24 hours or more after the transdermal system has been removed, can be severe and may require medical intervention [see Warnings and Precautions (5.5)] . 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: To help prevent nausea and vomiting from motion sickness: To help prevent nausea and vomiting after surgery: 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). 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? 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

Product summary:

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)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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

Summary of Product characteristics

SCOPOLAMINE TRANDERMAL SYSTEM- SCOLOPAMINE TRANSDERMAL
SYSTEM PATCH, EXTENDED RELEASE
BRYANT RANCH PREPACK
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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 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