Maldemar Side Effects

Generic Name: scopolamine

Note: This page contains information about the side effects of scopolamine. Some of the dosage forms included on this document may not apply to the brand name Maldemar.

Not all side effects for Maldemar may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to scopolamine: transdermal patch extended release

In addition to its needed effects, some unwanted effects may be caused by scopolamine (the active ingredient contained in Maldemar). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking scopolamine:

Incidence not known
  • Blurred vision
  • chest pain or discomfort
  • difficulty with urinating
  • dilation of the pupils
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • eye pain
  • flushing or redness of the skin
  • mood or mental changes
  • muscle weakness
  • nausea or vomiting
  • rash
  • redness of the white part of the eyes
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • shortness of breath
  • slow or irregular heartbeat
  • sweating
  • unusual tiredness
  • unusually warm skin

If any of the following symptoms of overdose occur while taking scopolamine, get emergency help immediately:

Symptoms of overdose
  • Anxiety
  • blurred or loss of vision
  • change in consciousness
  • decrease in frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • disturbed color perception
  • double vision
  • dry mouth
  • dry, flushed skin
  • fast, pounding, or irregular heartbeat or pulse
  • halos around lights
  • headache
  • hyperventilation
  • irritability
  • loss of consciousness
  • nervousness
  • night blindness
  • overbright appearance of lights
  • painful urination
  • pounding in the ears
  • seizures
  • shaking
  • sleepiness
  • trouble with sleeping
  • tunnel vision
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to scopolamine: compounding powder, injectable solution, oral tablet, transdermal film extended release

Cardiovascular

Cardiovascular side effects are limited when scopolamine (the active ingredient contained in Maldemar) is delivered transdermally. Occasionally, there may be some clinically insignificant reductions in heart rate or blood pressure.

Dermatologic

Dermatologic side effects have included rash, dryness of the skin, and erythema. Dermatitis may occur at the site of application, in some cases due to the scopolamine (the active ingredient contained in Maldemar) itself.

Gastrointestinal

Gastrointestinal side effects reported have included dry mouth, which occurred in approximately two-thirds of the patients using the transdermal patch.

General

Most adverse effects of scopolamine (the active ingredient contained in Maldemar) are extensions of its pharmacologic activity and are anticholinergic in nature. Scopolamine delivered transdermally is associated with considerably less side effects than when administered by other routes.

Genitourinary

Genitourinary side effects have included retention. Urinary retention has been reported infrequently with the transdermal patch.

Nervous system

Nervous system side effects including drowsiness occurs quite frequently and is reported by about 17% of patients administered the scopolamine (the active ingredient contained in Maldemar) transdermal patch. Other nervous system side effects are sporadic, including dizziness, restlessness, insomnia, disorientation, memory disturbances, hallucinations, paranoia, and confusion. Most reports of scopolamine-induced psychosis and delirium have involved the elderly, although some behavioral and mental irregularities may also be seen in young children. Concomitant use of antihistamines and other anticholinergics may be predisposing factors.

Recurrent migraine attacks have been described in one individual following an apparent scopolamine intoxication characterized by weakness, blurred vision, drowsiness, confusion, motor incoordination, and a stuporous state lasting 2 hours.

Recurrent classic migraine attacks developed in a 20-year-old naval crew member who had been treated continuously with transdermal scopolamine for 5 months. The initial attack occurred within 24 hours of diagnosis of scopolamine intoxication. The patient had no self or family history of migraines. The attacks, presenting with prodrome and aura, followed by severe throbbing left headache, nausea, photophobia and sonophobia lasting 6 to 8 hours, recurred every 10 to 14 days for more than a year. Common triggers of migraines and other precipitating factors could not be identified in this case.

Ocular

Ocular side effects have included transient mydriasis and cycloplegia, resulting in blurred vision. Symptoms generally resolve within 2 days following removal of the patch but may take longer depending on the cumulative dose received. Unilateral dilation of the pupil and anisocoria have been reported, suggesting that some ocular events may be due to inadvertent contamination of the eye when there is failure to wash the hands after drug application. Narrow angle glaucoma resulting from bilateral mydriasis has been reported rarely but, in one case, required surgery. Esotropia has also occurred in a pediatric patient with neurodevelopmental disabilities but resolved several days after removal of the patch.

Other

Withdrawal symptoms may seldomly develop within 2 or 3 days following removal of the patch, usually in patients who have used it for more than 3 days. These symptoms are consistent with rebound cholinesterase activity and include dizziness, nausea, vomiting, paresthesias of the hands and feet, dysphoria, and hypotension.

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