Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
SCOPOLAMINE (UNII: DL48G20X8X) (scopolamine - UNII:DL48G20X8X)
Ingenus Pharmaceuticals, LLC
TRANSDERMAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
Ingenus Pharmaceuticals, LLC ---------- 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 Lire le document complet
SCOPOLAMINE- SCOPOLAMINE PATCH, EXTENDED RELEASE INGENUS PHARMACEUTICALS, LLC ---------- 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 Lire le document complet