TRANSDERM SCOP- scopolamine patch, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Novatris Consumer Health, Inc.

DCI (Dénomination commune internationale):

SCOPOLAMINE

Composition:

SCOPOLAMINE 1 mg in 3 d

Mode d'administration:

TRANSDERMAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Transderm Scōp® is indicated in adults for prevention of nausea and vomiting associated with motion sickness. [see Clinical Studies (14.1)] Transderm Scōp® is indicated in adults for prevention of nausea and vomiting associated with recovery from anesthesia and/or opiate analgesia and surgery. [ see Clinical Studies (14.2)] Transderm Scōp is contraindicated in the following populations: - Patients with angle closure glaucoma. [see Adverse Reactions (6)] - Persons who are hypersensitive to the drug scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. [see Drug Interactions (7) and Description (11)] Pregnancy Category C Based on data from one prospective study of Transderm Scōp in cesarean delivery, the rate of newborn adverse events in both the Transderm Scōp and placebo groups were the same. The rates were 10.5% (12 events in 114 newborns) in both treatment groups. None of these events were considered life threatening or drug related. Jaundice

Descriptif du produit:

The Transderm Scōp® system is a tan-colored circular patch, 2.5 cm2 , on a clear, oversized, hexagonal peel strip, which is removed prior to use. Each Transderm Scōp system contains 1.5 mg of scopolamine and is formulated to deliver in-vivo approximately 1 mg of scopolamine over 3 days. Transderm Scōp is available in packages of four patches. Each patch is foil wrapped. Patient instructions are included. [ see Patient Counseling Information (17) ] Storage The system should be stored at controlled room temperature between 20°C-25°C (68°F-77°F). Handling Since scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets. [ see Dosage and Administration (2) , Warnings and Precautions (5.2), and Patient Counseling Information (17))]

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

TRANSDERM SCOP- SCOPOLAMINE PATCH, EXTENDED RELEASE
NOVATRIS CONSUMER HEALTH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRANSDERM SCŌP SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TRANSDERM SCŌP
.
TRANSDERM SCŌP
(SCOPOLAMINE) TRANSDERMAL SYSTEM PATCH
INITIAL U.S. APPROVAL: 1979
INDICATIONS AND USAGE
TRANSDERM SCŌP IS AN ANTICHOLINERGIC AGENT INDICATED IN ADULTS FOR
THE PREVENTION OF NAUSEA AND VOMITING
ASSOCIATED WITH:
Motion Sickness (1.1)
Post Operative Nausea and Vomiting (PONV) (1.2)
DOSAGE AND ADMINISTRATION
DO NOT CUT THE PATCH. APPLY ONE PATCH IN THE POSTAURICULAR AREA TO
PREVENT:
Motion Sickness
Apply 4 hrs before antiemetic effect is required- for use up to 3
days. (2.1)
For use longer than 3 days, remove current patch and place new patch
behind other ear. (2.2)
Post Operative Nausea and Vomiting
(PONV)
Apply evening before scheduled surgery. (2.1)
For cesarean section, apply 1 hour prior to surgery. (2.1)
Discard 24 hrs after surgery. (2.2)
DOSAGE FORMS AND STRENGTHS
Continuous release, circular, flat, tan colored patch (1.5 mg
scopolamine) (3)
CONTRAINDICATIONS
Patients with angle closure glaucoma (4, 6.2)
Persons who are hypersensitive to scopolamine or to other belladonna
alkaloids (4, 7)
WARNINGS AND PRECAUTIONS
Use with caution in patients with open angle glaucoma (5.1)
Stop use if patient experiences symptoms of angle closure glaucoma
(5.1, 6.2)
Can cause temporary dilation and blurred vision if scopolamine
contacts the eyes (5.2, 6, 16)
Use caution in patients with a history of seizures or psychosis (5.4)
Use with caution in patients with pyloric obstruction, urinary bladder
neck obstruction, or patients suspected of having
intestinal obstruction (5.3)
Stop use if patient has difficulty urinating (5.3, 6)
Idiosyncratic reactions, such as confusion, agitation, speech
disorder, hallucinations, paranoia and delusions, may occur
with therapeutic doses of scopolamine (5.5, 6.2)
A safe and effective dose h