Anticholinergic

Scopolamine

Approved 24 Nov 2020TransdermalSystem

The FDA lists this product in 7 strengths and forms.

Indications

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 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 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, patients with impeded urine flow or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination.

( 5.4 , 7.2 ) Hyperthermia: Serious adverse reactions have been reported postmarketing in adult and pediatric patients, including fatal cases. If symptoms occur, remove the transdermal system, and contact a healthcare provider. ( 5.5 ) Drug Withdrawal/Post-Removal Symptoms: Anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.6 ) Blurred Vision: Avoid contact with the eyes.

At a glance

Brand name: Scopolamine
Pharmacologic class: Anticholinergic
Route: Transdermal
Dosage form: System
Applicant: Riconpharma LLC
Status: Prescription
FDA approval: 24 Nov 2020
Application: ANDA212342-001

Indications

( 1 )

Contraindications

( 4 , 7 )

Warnings and precautions

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.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. Avoid use of scopolamine transdermal system in patients with severe preeclampsia [see Warnings and Precautions ( 5.3 ) and Data] . 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.

In animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. Embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data In published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see Warnings and Precautions ( 5.3 )] .

Animal Data 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. Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by scopolamine transdermal system did not affect uterine contractions or increase the duration of labor.

Adverse reactions

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 Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 )] Hyperthermia [see Warnings and Precautions ( 5.5 )] Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions ( 5.6 )] Blurred Vision [see Warnings and Precautions ( 5.7 )] MRI Skin Burns [see Warnings and Precautions ( 5.8 )]

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. Table 1 Common Adverse Reactions occurring in at least 3% of patients and at a rate higher than placebo in Surgical Patients for the Prevention of PONV 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

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: disorientation, hallucinations, and paranoia Nervous system disorders: amnesia, coordination abnormalities, disturbance in attention, headache, restlessness, speech disorder General disorders and administration site conditions: application site reactions (including blistering, burning, pruritus, and rash) and hyperthermia Eye disorders: amblyopia, angle closure glaucoma, dry eyes, eyelid irritation, eye pruritus Skin and subcutaneous tissue disorders: erythema, rash generalized, skin irritation 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

5.5Hyperthermia

5.6Drug Withdrawal/Post-Removal Symptoms Discontinuation

5.7Blurred Vision

5.8Magnetic 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