Other antiemetics

Scopolamine

Approved 30 Jan 2015TransdermalSystem

The FDA lists this product in 7 strengths and forms.

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Indications

Scopolamine transdermal system is indicated in adults for 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 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 )

Contraindications

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 )] .
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 )

Warnings and precautions

Acute Angle Closure Glaucoma : Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop. ( 5.1 )
Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities. Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects. ( 5.2 , 7.1 )
Eclamptic Seizures in Pregnant Women : Avoid use in patients with severe preeclampsia. ( 5.3 )
Gastrointestinal and Urinary Disorders : Consider more frequent monitoring during treatment in patients suspected of having intestinal obstruction; patients with pyloric obstruction, urinary bladder neck obstruction or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. ( 5.4 , 7.2 )
Drug Withdrawal/Post-Removal Symptoms : Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.5 )

At a glance

Brand name: Scopolamine
Drug class: Other antiemetics, Other hypnotics and sedatives, Anticholinergics
Route: Transdermal
Dosage form: System
Applicant: Padagis US
Status: Prescription
FDA approval: 30 Jan 2015
Application: ANDA078830-001
RxCUI: 9601

Indications

Scopolamine transdermal system is indicated in adults for 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 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 )

Contraindications

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 )] .
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 )

Warnings and precautions

Acute Angle Closure Glaucoma : Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop. ( 5.1 )
Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities. Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects. ( 5.2 , 7.1 )
Eclamptic Seizures in Pregnant Women : Avoid use in patients with severe preeclampsia. ( 5.3 )
Gastrointestinal and Urinary Disorders : Consider more frequent monitoring during treatment in patients suspected of having intestinal obstruction; patients with pyloric obstruction, urinary bladder neck obstruction or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. ( 5.4 , 7.2 )
Drug Withdrawal/Post-Removal Symptoms : Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.5 )

Interactions

Drugs Causing Central Nervous System (CNS) Adverse Reactions : Monitor patients for CNS adverse reactions (drowsiness, dizziness or disorientations). ( 7.1 )
Anticholinergic Drugs : Consider more frequent monitoring during treatment in patients receiving other anticholinergic drugs. ( 7.2 )
Oral Drugs Absorbed in the Stomach : Monitor for increased or decreased therapeutic effect of the oral drug. ( 7.3 )
Interaction with Gastric Secretion Test : Discontinue use of scopolamine transdermal system 10 days prior to testing. ( 7.4 )

7.1Drugs Causing Central Nervous System (CNS) Adverse Reactions

The concurrent use of scopolamine transdermal system with other drugs that cause CNS adverse reactions of drowsiness, dizziness or disorientation (e.g., sedatives, hypnotics, opiates, anxiolytics and alcohol) or have anticholinergic properties (e.g., other belladonna alkaloids, sedating antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants) may potentiate the effects of scopolamine transdermal system [see Warnings and Precautions ( 5.2 )] .

Either scopolamine transdermal system or the interacting drug should be chosen, depending on the importance of the drug to the patient. If the interacting drug cannot be avoided, monitor patients for CNS adverse reactions.

7.2Anticholinergic Drugs

Concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of CNS adverse reactions [see Drug Interactions ( 7.1 )], intestinal obstruction and/or urinary retention. Consider more frequent monitoring during treatment with scopolamine transdermal system in patients receiving anticholinergic drugs [see Warnings and Precautions ( 5.2 , 5.4 )] .

7.3Oral Drugs Absorbed in the Stomach

Scopolamine transdermal system, as an anticholinergic, may delay gastric and upper gastrointestinal motility and, therefore, the rate of absorption of other orally administered drugs. Monitor patients for modified therapeutic effect of concomitant orally administered drugs with a narrow therapeutic index.

7.4Interaction with Gastric Secretion Test

Scopolamine will interfere with the gastric secretion test. Discontinue scopolamine transdermal system 10 days prior to testing.

Adverse reactions

The following serious adverse reactions are described elsewhere in labeling:

Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.1 )]
Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.2 )]
Eclamptic Seizures in Pregnant Women [see Warnings and Precautions ( 5.3 )]
Gastrointestinal and Urinary Disorders [see Warnings and Precautions ( 5.4 )]
Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions ( 5.5 )]
Blurred Vision [see Warnings and Precautions ( 5.6 )]
MRI Skin Burns [see Warnings and Precautions ( 5.7 )] Most common adverse reactions are:
Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils. ( 6.1 )
PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 practice. Motion Sickness The most common adverse reaction (approximately two thirds) was dry mouth. Less common adverse reactions, included drowsiness (less than one sixth), blurred vision and dilation of the pupils.

PONV Common adverse reactions, occurring in at least 3% of patients in PONV clinical trials are shown in Table 1. Scopolamine Transdermal System % (N = 461) Placebo % (N = 457) Dry mouth 29 16 Dizziness 12 7 Somnolence 8 4 Agitation 6 4 Visual Impairment 5 3 Confusion 4 3 Mydriasis 4 0 Pharyngitis 3 2 *occurring in at least 3% of patients and at a rate higher than placebo

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of scopolamine transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 pruritus, 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

Scopolamine

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Scopolamine

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Acute Angle Closure Glaucoma

5.2Neuropsychiatric Adverse Reactions Psychiatric Adverse Reactions

5.3Eclamptic Seizures in Pregnant Women

5.4Gastrointestinal and Urinary Disorders

5.5Drug Withdrawal/Post-Removal Symptoms Discontinuation

5.6Blurred Vision

5.7Magnetic Resonance Imaging (MRI) Skin Burns

Interactions

7.1Drugs Causing Central Nervous System (CNS) Adverse Reactions

7.2Anticholinergic Drugs

7.3Oral Drugs Absorbed in the Stomach

7.4Interaction with Gastric Secretion Test

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information