Scopolamine
Generic: SCOPOLAMINE
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TRANSDERMAL
FDA Set ID
a472ee74-76a7-470f-8564-9018940a82e8
Indications & Usage
1 INDICATIONS AND USAGE Scopolamine Transdermal System is indicated in adults for the prevention of: nausea and vomiting associated with motion sickness.
post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.
Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: nausea and vomiting associated with motion sickness.
( 1 ) post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.
( 1 )
post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.
Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: nausea and vomiting associated with motion sickness.
( 1 ) post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Acute Angle Closure Glaucoma [see Warnings and Precautions (5.1) ] Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.2) ] Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (5.3) ] Gastrointestinal and Urinary Disorders [see Warnings and Precautions (5.4) ] Hyperthermia [see Warnings and Precautions (5.5) ] Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions (5.6) ] Blurred Vision [see Warnings and Precautions (5.7) ] MRI Skin Burns [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils.
( 6.1 ) PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis, and pharyngitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals at 1-888-873-5329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 occurring in at least 3% of patients and at a rate higher than placebo in Surgical Patients for the Prevention of PONV Scopolamine Transdermal System % (N=461) Placebo % (N=457) Dry mouth 29 16 Dizziness 12 7 Somnolence 8 4 Agitation 6 4 Visual Impairment 5 3 Confusion 4 3 Mydriasis 4 0 Pharyngitis 3 2 6.2 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: disorientation, hallucinations, and paranoia Nervous system disorders : amnesia, coordination abnormalities, disturbance in attention, headache, restlessness, speech disorder General disorders and administration site conditions : application site reactions (including blistering, burning, pruritus, and rash), and hyperthermia Eye disorders : amblyopia, angle closure glaucoma, dry eyes, eyelid irritation, eye pruritus Skin and subcutaneous tissue disorders : erythema, rash generalized, skin irritation Renal and urinary disorders : dysuria Ear and labyrinth disorders : vertigo
( 6.1 ) PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis, and pharyngitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals at 1-888-873-5329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 occurring in at least 3% of patients and at a rate higher than placebo in Surgical Patients for the Prevention of PONV Scopolamine Transdermal System % (N=461) Placebo % (N=457) Dry mouth 29 16 Dizziness 12 7 Somnolence 8 4 Agitation 6 4 Visual Impairment 5 3 Confusion 4 3 Mydriasis 4 0 Pharyngitis 3 2 6.2 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: disorientation, hallucinations, and paranoia Nervous system disorders : amnesia, coordination abnormalities, disturbance in attention, headache, restlessness, speech disorder General disorders and administration site conditions : application site reactions (including blistering, burning, pruritus, and rash), and hyperthermia Eye disorders : amblyopia, angle closure glaucoma, dry eyes, eyelid irritation, eye pruritus Skin and subcutaneous tissue disorders : erythema, rash generalized, skin irritation Renal and urinary disorders : dysuria Ear and labyrinth disorders : vertigo