Transderm Scop

TRANSDERM SCOP- scopolamine patch, extended release
Novatris Consumer Health, Inc.

1 INDICATIONS AND USAGE

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)]

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)]

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.

3 DOSAGE FORMS AND STRENGTHS

The Transderm Scōp system is a tan-colored circular flat patch which contains 1.5 mg of scopolamine base and is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days.

4 CONTRAINDICATIONS

Transderm Scōp is contraindicated in the following populations:

5 WARNINGS AND PRECAUTIONS

5.1 Open Angle Glaucoma

Patients currently being treated for Open Angle Glaucoma

Glaucoma therapy in patients with open angle glaucoma should be monitored and may need to be adjusted during Transderm Scōp use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure.

Patients should be advised to remove the patch immediately and promptly contact a physician in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).

5.2 Temporary Dilation of the Pupil

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. [ see Adverse Reactions (6)] In addition, it is important that used patches be disposed of properly to avoid contact with children or pets. [ see How Supplied/ Storage and Handling (16)]

5.3 Preexisting Gastrointestinal or Urinary Bladder Obstructions

Transderm Scōp should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or anticholinergic drug, including

Transderm Scōp, to patients suspected of having intestinal obstruction.

Patients should be instructed to remove the patch if they develop any difficulties in urinating. [see Adverse Reactions (6)]

5.4 History of Seizures or Psychosis

Transderm Scōp should be used with caution in patients with a history of seizures or psychosis since scopolamine can potentially aggravate both disorders.

5.5 Idiosyncratic Reactions

Idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, speech disorder, hallucinations, paranoia, and delusions. [ see Adverse Reactions (6)]

5.6 Specific Populations

Pediatric
A safe and effective dose has not been established in the pediatric population [ see Use in Specific Populations(8.4)]. Children are particularly susceptible to the side effects of belladonna alkaloids; including mydriasis, hallucinations, amyblyopia, and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported when one half or one quarter of a patch has been applied.

Elderly

Transderm Scōp should be used with caution in the elderly because of the increased likelihood of CNS effects, such

as hallucinations, confusion, dizziness and drug withdrawal syndrome. 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 Use in Specific Populations (8.5)]

Renal and Hepatic Impaired

Transderm Scōp should be used with caution in individuals with impaired renal or hepatic functions because of the

increased likelihood of CNS effects. Transderm Scop has not been studied in these populations. [ see Use in Specific Populations (8.6)]

5.7 Safety Hazards

Drowsiness
Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.

Disorienting Effects
Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine. [ see Patient Counseling Information (17)]

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