Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 24 October 2017

Indication(s)

1 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) 1.1 Motion Sickness Transderm Scōp® is indicated in adults for prevention of nausea and vomiting associated with motion sickness. [see Clinical Studies (14.1)] 1.2 Post Operative Nausea and Vomiting (PONV) 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) ]

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Advisory information

contraindications
4 CONTRAINDICATIONS 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)] •Patients with angle closure glaucoma (4, 6.2) •Persons who are hypersensitive to scopolamine or to other belladonna alkaloids (4, 7)
Adverse reactions
6 ADVERSE REACTIONS Most common adverse reactions during motion sickness clinical trials are dry mouth, drowsiness and blurred vision. (6.1) Most common adverse reactions during PONV trials (≥ than 3%) are dry mouth, dizziness, somnolence, urinary retention, agitation, visual impairment, confusion, mydriasis and pharyngitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-398-5876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Motion Sickness In motion sickness clinical studies of Transderm Scōp®, the most frequent adverse reaction was dry mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed. Post-Operative Nausea and Vomiting In a total of five clinical studies in which Transderm Scōp® was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥3% of patients treated with Transderm Scōp® and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1). Table 6.1 PONV: Adverse Drug Reactions in ≥3% of Patients Transderm Scōp® (N=461) Placebo (N=457) n % n % Adverse Drug Reactions 303 65.7 259 56.7 Dry mouth 133 28.9 72 15.8 Dizziness 57 12.4 33 7.2 Somnolence 36 7.8 16 3.5 Urinary Retention 33 7.2 30 6.6 Agitation 28 6.1 20 4.4 Visual Impairment 23 5.0 12 2.6 Confusion 18 3.9 14 3.1 Mydriasis 16 3.5 2 0.4 Pharyngitis 15 3.3 10 2.2 6.2 Postmarketing Experience The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scop®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship. In worldwide marketing with Transderm Scōp®, the following adverse drug reactions were reported by body system. Psychiatric disorders: acute psychosis including: hallucinations disorientation, and paranoia. Nervous system disorders: headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness. General disorders and administration site conditions: application site burning. Eye disorders: dry eyes, eye pruritis, angle closure glaucoma, amblyopia, eyelid irritation. Skin and subcutaneous tissue disorders: rash generalized, skin irritation, erythema. Renal and urinary disorders: dysuria. Ear and Labyrinth Disorders: vertigo. 6.3 Drug Withdrawal/Post-Removal Symptoms Symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache mental confusion, muscle weakness, bradycardia and hypotension may occur following abrupt discontinuation of anticholinergic drugs such as Transderm Scōp®. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scōp® system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. These symptoms can be severe and may require medical intervention. Some symptoms may be related to adaptation from a motion environment to a motion-free environment.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Each Transderm Scōp® patch is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days. Only one patch should be worn at any time. Do not cut the patch. The patch should be applied only to the skin in the postauricular (hairless area behind one ear) area. Handling After the patch is applied on the dry skin behind the ear, the hands should be washed thoroughly with soap and water and dried. Upon removal, the patch should be discarded. To prevent any traces of scopolamine from coming into direct contact with the eyes, after administration of the patch, the hands and the application site should be washed thoroughly with soap and water and dried. [see How Supplied/Storage and Handling (16) and Patient Counseling Information (17)] 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) 2.1 Initiation of Therapy Motion sickness •To prevent the nausea and vomiting associated with motion sickness, one Transderm Scōp® patch (formulated to deliver approximately 1mg of scopolamine over 3 days) should be applied to the hairless area behind one ear at least 4 hours before the antiemetic effect is required. Post Operative Nausea and Vomiting •To prevent post operative nausea and vomiting, one Transderm Scōp® patch should be applied the evening before scheduled surgery, except for caesarian section. •For caesarian section surgery, to minimize exposure of the newborn baby to the drug, apply the patch one hour prior to caesarian section. 2.2 Continuation of Therapy Should the patch become displaced, it should be discarded, and a fresh one placed on the hairless area behind the other ear. Motion Sickness If therapy is required for longer than 3 days, the first patch should be removed and a fresh one placed on the hairless area behind the other ear. Post Operative Nausea and Vomiting For perioperative use, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded.
Use in special populations
8 USE IN SPECIFIC POPULATIONS •Pregnancy: Based on animal data, may cause fetal harm (8.1) •Nursing mothers: Caution should be exercised when administered to a nursing woman (8.3) 8.1 Pregnancy 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 was the only adverse event occurring more frequently with Transderm Scōp® than placebo: 9 events (7.9%) versus 2 events (1.8%) (p=0.031). Jaundice, a common occurrence in newborns, resolved with ultraviolet light and did not prolong the hospital stay. There are no adequate and well-controlled studies of Transderm Scōp® use during pregnancy. 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. Transderm Scōp® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother. 8.2 Labor and Delivery During a clinical study among women undergoing cesarean section treated with Transderm Scōp® in conjunction with epidural anesthesia and opiate analgesia, no evidence of CNS depression was found in newborns. [see Clinical Studies (14.2)] Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by Transderm Scōp® did not affect uterine contractions or increase the duration of labor. Scopolamine does cross the placenta. 8.3 Nursing Mothers Scopolamine is excreted in human milk. Caution should be exercised when Transderm Scōp® is administered to a nursing woman. 8.4 Pediatric Use A safe and effective dose has not been established in the pediatric population. [see Warnings and Precautions (5.6)] 8.5 Geriatric Use Transderm Scōp® should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion and dizziness. Clinical trials of Transderm Scop did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. [see Warnings and Precautions (5.6)] 8.6 Renal or Hepatic Impairment Transderm Scōp® should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. [see Warnings and Precautions (5.6)]
Pregnancy and lactation
8.3 Nursing Mothers Scopolamine is excreted in human milk. Caution should be exercised when Transderm Scōp® is administered to a nursing woman.

Interactions

7 DRUG INTERACTIONS The absorption of oral medications may be decreased during the concurrent use of scopolamine because of decreased gastric motility and delayed gastric emptying. [see Warnings and Precautions (5.3)] Scopolamine should be used with caution in patients taking other drugs that are capable of causing CNS effects such as sedatives, tranquilizers, or alcohol. Special attention should be paid to potential interactions with drugs having anticholinergic properties; e.g., other belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants. In vitro studies indicated that the potential for scopolamine to alter the pharmacokinetics of other concomitant medications through inhibition of CYP 1A2, 2C8, 2C9, 2C19, 2D6 and 3A4 or induction of CYP 1A2 and 3A4 is low; however, in vivo studies have not been conducted. [see Clinical Pharmacology (12.3)] •Absorption of oral medications may be decreased (7) •Use with care while taking sedatives, tranquilizers or alcohol (7) •Potential interactions with drugs having anticholinergic properties (7) •Scopolamine interferes with the gastric secretion test (7.1) 7.1 Laboratory Test Interactions Scopolamine will interfere with the gastric secretion test.

More information

Category Value
Authorisation number NDA017874
Agency product number DL48G20X8X
Orphan designation No
Product NDC 66758-208
Date Last Revised 16-10-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 226552
Marketing authorisation holder Sandoz Inc