Maldemar Side Effects

Generic name: scopolamine

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

Some side effects of Maldemar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to scopolamine: oral tablet

Stop using scopolamine (the active ingredient contained in Maldemar) and seek emergency medical attention or contact your doctor immediately if you experience:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• pain and redness of the eyes with dilated pupils; or

• difficulty urinating.

In rare cases, unusual reactions to ordinary doses of scopolamine have occurred including confusion, agitation, rambling speech, hallucinations, paranoid behaviors, and delusions. In the case of such a reaction, stop using scopolamine and seek medical attention.

Other, less serious side effects may be more likely to occur. Continue to use scopolamine and talk to your doctor if you experience

• drowsiness;

• dizziness;

• dry mouth;

• restlessness;

• blurred vision;

• dilated pupils;

• dry or itchy eyes;

• flushing; or

• fast heartbeats.

Nausea, vomiting, dizziness, headache, and poor coordination have been reported when treatment that has lasted more than a few days is discontinued. If you use scopolamine for more than a few days, be aware that these side effects may occur when you stop.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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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