A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ditropan Side Effects, and Drug Interactions - Oxybutynin
Ditropan Side Effects, and Drug Interactions - Oxybutynin
SIDE EFFECTS
Adverse Events with DITROPAN ® XL
The safety and efficacy
of DITROPAN ®XL was evaluated in a total of 580 participants
who received DITROPAN ® XL in clinical
trials (429 patients, 151 healthy
volunteers). These participants were treated with 5-30 mg/day for
up to 4.5 months. Safety information is provided for 429 patients
from three controlled clinical
studies and one open label
study (Table 2). The adverse events are reported regardless of causality.
Table 2
Incidence (%) of Adverse Events Reported by ³5%
of Patients Using DITROPAN ® XL (5-30 mg/day)
|
Body System
|
Adverse Event
|
DITROPAN XL
5- 30 mg/ day
(n= 429)
|
| General
|
headache |
9.8
|
| asthenia |
6.8
|
| pain |
6.8
|
| Digestive
|
dry mouth |
60.8
|
| constipation |
13.1
|
| diarrhea |
9.1
|
| nausea |
8.9
|
| dyspepsia |
6.8
|
| Nervous
|
somnolence |
11.9
|
| dizziness |
6.3
|
| Respiratory |
rhinitis |
5.6
|
| Special
senses |
blurred vision |
7.7
|
| dry eyes |
6.1
|
| Urogenital |
urinary tract
infection |
5.1
|
The most common adverse events reported by patients receiving 5-30
mg/day DITROPAN ®XL were the expected side
effects of anticholinergic agents. The incidence
of dry mouth was dose-related.
The discontinuation rate for all adverse events was 6.8%. The most
frequent adverse event causing early discontinuation of study medication
was nausea (1.9%), while
discontinuation due to dry mouth
was 1.2%.
In addition, the following adverse events were reported by 2 to
< 5% of patients using DITROPAN ®XL (5-30 mg/day)
in all studies.
General: abdominal
pain, dry nasal
and sinus mucous
membranes, accidental injury, back
pain, flu
syndrome;
Cardiovascular: hypertension,
palpitation, vasodilatation;
Digestive: flatulence,
gastroesophageal
reflux;
Musculoskeletal: arthritis; Nervous: insomnia,
nervousness, confusion; Respiratory: upper respiratory
tract infection,
cough, sinusitis,
bronchitis, pharyngitis;
Skin: dry skin,
rash;
Urogenital: impaired urination (hesitancy), increased
post void
residual volume, urinary
retention, cystitis.
Adverse Events with Oxybutynin Chloride
Other adverse events have been reported with oxybutynin chloride:
tachycardia, hallucinations,
cycloplegia, mydriasis,
impotence, and suppression
of lactation.
DRUG INTERACTIONS
The concomitant
use of oxybutynin with other anticholinergic
drugs or with other agents which produce dry mouth,
constipation, somnolence
(drowsiness), and/or other anticholinergic-like effects may increase
the frequency and/or
severity of such effects.
Anticholinergic agents may potentially alter the absorption
of some concomitantly administered drugs due to anticholinergic
effects on gastrointestinal motility.
Pharmacokinetic studies with patients concomitantly receiving cytochrome
P450 enzyme inhibitors,
such as antimycotic
agents (e.g. ketoconazole, itraconazole, and miconazole) or macrolide
antibiotics (e.g. erythromycin and clarithromycin), have not been
performed.
No specific drug-drug
interaction studies have been performed with DITROPAN ®
XL.
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