Scopolamine (Systemic)

Concerns related to adverse effects:

• Anaphylaxis: Anaphylaxis including episodes of shock has been reported following parenteral administration; observe for signs/symptoms of hypersensitivity following parenteral administration. Patients with a history of allergies or asthma may be at increased risk of hypersensitivity reactions.

• Bradycardia (paradoxical): Lower doses (0.1mg) may have vagal mimetic effects (eg, increase vagal tone causing paradoxical bradycardia); these effects are likely mediated by blockade of muscarinic receptors at the level of the brain.

• CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Idiosyncratic reaction: Idiosyncratic reactions may rarely occur; patients may experience acute toxic psychosis, agitation, confusion, delusions, hallucinations, paranoid behavior, and rambling speech.

• Visual disturbances: Discontinue if patient reports unusual visual disturbances or pain within the eye.

• Withdrawal: Adverse events (including dizziness, headache, nausea, vomiting) may occur following abrupt discontinuation of large doses or in patients with Parkinson's disease; adverse events may also occur following removal of the transdermal patch although symptoms may not appear until ≥24 hours after removal.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with coronary artery disease, tachyarrhythmias, heart failure, or hypertension; evaluate tachycardia prior to administration.

• Gastrointestinal (GI) obstruction: Use with caution in patients with GI obstruction; when used for the treatment of smooth muscle spasm of the GI tract avoid continuous (daily) or prolonged use without evaluating source of abdominal pain. Patients should be instructed to report persistent or worsening abdominal pain with or without other symptoms (eg, nausea/vomiting, irregular bowel movements, bloody stool, hypotension).

• Genitourinary (GU) disease/obstruction: Use with caution in patients with GU obstruction, prostatic hyperplasia, or urinary retention; when used for the treatment of smooth muscle spasm of the GU tract avoid continuous (daily) or prolonged use without evaluating source of the spasm.

• Glaucoma: Use of the transdermal product in patients with open-angle glaucoma may necessitate adjustments in glaucoma therapy.

• Hepatic impairment: Use with caution in patients with hepatic impairment; adverse CNS effects occur more often in these patients.

• Hiatal hernia: Use with caution in patients with hiatal hernia with reflux esophagitis.

• Hyperthyroidism: Use caution in patients with hyperthyroidism; may have increased risk for arrhythmias.

• Psychosis: Use with caution in patients with a history of psychosis; may exacerbate condition.

• Renal impairment: Use with caution in patients with renal impairment; adverse CNS effects occur more often in these patients.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; may exacerbate condition.

• Ulcerative colitis: Use with caution in patients with ulcerative colitis; may precipitate/aggravate toxic megacolon.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Use with caution in infants and children since they may be more susceptible to adverse effects.

Dosage form specific issues:

• Fructose: Tablets may contain sucrose; avoid use of tablets in patients who are fructose intolerant.

• Product interchangeability: Scopolamine (hyoscine) hydrobromide should not be interchanged with scopolamine butylbromide formulations; dosages are not equivalent.

• Transdermal patch: May contain conducting metal (eg, aluminum); remove patch prior to MRI.