TRANSDERM SCOP SIDE EFFECTS

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in labeling:

• Acute Angle Closure Glaucoma
• Neuropsychiatric Adverse Reactions
• Eclamptic Seizures in Pregnant Women
• Gastrointestinal and Urinary Disorders
• Drug Withdrawal/Post-Removal Symptoms
• Blurred Vision
• MRI Skin Burns

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

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

SRC: NLM .