TRANSDERM SCOP SIDE EFFECTS
- Generic Name: scopolamine
- Brand Name: Transderm Scop
- Drug Class: Antiemetic Agents
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.
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.
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
% (N = 461)
% (N = 457)
|*occurring in at least 3% of patients and at a rate higher than placebo|
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 .