Scopolamine: Package Insert and Label Information

SCOPOLAMINE- scopolamine system
Actavis Pharma, Inc.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Application and Removal Instructions

  • Each scopolamine transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days.
  • Only wear one transdermal system at any time.
  • Do not cut the transdermal system.
  • Apply the transdermal system to the skin in the postauricular area (hairless area behind one ear).
  • After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands [see Warnings and Precautions (5.6)].
  • If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear.
  • 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.

2.2 Recommended Adult Dosage

Motion Sickness

Apply one scopolamine transdermal system to the hairless area behind one ear at least 4 hours before the antiemetic effect is required – for use up to 3 days. If therapy is required for longer than 3 days, remove the first transdermal system and apply a new scopolamine transdermal system behind the other ear.

PONV

For surgeries other than cesarean section: Apply one scopolamine transdermal system the evening before scheduled surgery. Remove the transdermal system 24 hours following surgery.

3 DOSAGE FORMS AND STRENGTHS

Transdermal system: a circular, flat, tan-colored transdermal system imprinted with “Scopolamine 1mg/3 days”

4 CONTRAINDICATIONS

Scopolamine 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Acute Angle Closure Glaucoma

The mydriatic effect of scopolamine may cause an increase in intraocular pressure resulting in acute angle closure glaucoma. Monitor intraocular pressure in patients with open angle glaucoma and adjust glaucoma therapy during scopolamine transdermal system use, as needed. Advise patients to immediately remove the transdermal system and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema).

5.2 Neuropsychiatric Adverse Reactions

Psychiatric Adverse Reactions

Scopolamine has been reported to exacerbate psychosis. Other psychiatric reactions have also been reported, including acute toxic psychosis, agitation, speech disorder, hallucinations, paranoia, and delusions [see Adverse Reactions (6.2)]. Monitor patients for new or worsening psychiatric symptoms during treatment with scopolamine transdermal system. Also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects [see Drug Interactions (7.1)].

Seizures

Seizures and seizure-like activity have been reported in patients receiving scopolamine. Weigh this potential risk against the benefits before prescribing scopolamine transdermal system to patients with a history of seizures, including those receiving anti-epileptic medication or who have risk factors that can lower the seizure threshold.

Cognitive Adverse Reactions

Scopolamine can cause drowsiness, disorientation, and confusion. Discontinue scopolamine transdermal system if signs or symptoms of cognitive impairment develop. Elderly and pediatric patients may be more sensitive to the neurological and psychiatric effects of scopolamine transdermal system. Consider more frequent monitoring during treatment with scopolamine transdermal system in elderly patients [see Use in Specific Populations (8.5)]. Scopolamine transdermal system is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

Hazardous Activities

Scopolamine transdermal system may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery or participating in underwater sports. Concomitant use of other drugs that cause central nervous system (CNS) adverse reactions (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics) or have anticholinergic properties (e.g., other belladonna alkaloids, sedating antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants) may increase this effect [see Drug Interactions (7.1)]. Inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that scopolamine transdermal system does not affect them adversely.

5.3 Eclamptic Seizures in Pregnant Women

Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous and intramuscular scopolamine [see Use in Specific Populations (8.1)]. Avoid use of scopolamine transdermal system in patients with severe preeclampsia.

5.4 Gastrointestinal and Urinary Disorders

Scopolamine, due to its anticholinergic properties, can decrease gastrointestinal motility and cause urinary retention. Consider more frequent monitoring during treatment with scopolamine transdermal system in patients suspected of having intestinal obstruction, patients with pyloric obstruction or urinary bladder neck obstruction and patients receiving other anticholinergic drugs [see Drug Interactions (7.2) ]. Discontinue scopolamine transdermal system in patients who develop difficulty in urination.

5.5 Drug Withdrawal/Post-Removal Symptoms

Discontinuation of scopolamine transdermal system, usually after several days of use, may result in withdrawal symptoms, such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. The onset of these symptoms is generally 24 hours or more after the transdermal system has been removed. Instruct patients to seek medical attention if they experience severe symptoms.

5.6 Blurred Vision

Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes.

Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system [see Dosage and Administration (2.1)].

5.7 Magnetic Resonance Imaging (MRI) Skin Burns

Scopolamine transdermal system contains an aluminized film. Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during an MRI scan. Remove scopolamine transdermal system before undergoing an MRI.

6 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)]

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 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* in Surgical Patients for the Prevention of PONV

Scopolamine
Transdermal System


Placebo

% (N = 461)

% (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

6.2 Postmarketing 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

7 DRUG INTERACTIONS

7.1 Drugs 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.

7.2 Anticholinergic 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)].

7.3 Oral 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.

7.4 Interaction with Gastric Secretion Test

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

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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 Data).

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 estimated 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

Eclamptic Seizures

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.

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