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
Prudoxin Side Effects, and Drug Interactions - Doxepin
Prudoxin Side Effects, and Drug Interactions - Doxepin
SIDE EFFECTS
CONTROLLED CLINICAL TRIALS:
Systemic Adverse Effects: In controlled clinical trials of patients
treated with PRUDOXIN Cream, the most common systemic adverse effect reported
was drowsiness. Drowsiness occurred in 22% of patients treated with PRUDOXIN
Cream (and 2% of patients treated with placebo cream) and resulted in the premature
discontinuation of the drug in approximately 5% of patients treated.
Other systemic adverse effects reported in approximately 1 to 10% of these
patients included: Dry mouth, dry lips, thirst, headache, fatigue, dizziness,
emotional changes, and taste changes.
Other systemic adverse effects reported in less than 1% of these patients included:
Nausea, anxiety, and fever.
Local Site Adverse Effects: In controlled clinical trials of patients
treated with PRUDOXIN Cream, the most common local site adverse effect reported
was burning and/or stinging at the site of application. These occurred in approximately
21% of these patients. Most of these reactions were categorized as "mild": however,
approximately 25% of patients who reported burning and/or stinging reported
the reaction as "severe." Four patients treated with PRUDOXIN Cream withdrew
from the study because of the burning and/or stinging.
Other local site adverse effects reported in approximately 1 to 10% of these
patients included: Pruritus exacerbation, eczema exacerbation, dryness and tightness
to skin, paresthesias, and edema.
Other local site adverse effects reported in less than 1% of these patients
included: Irritation, tingling, scaling, and cracking.
POST MARKETING EXPERIENCE
PRUDOXIN Cream has been associated with allergic contact dermatitis.
DRUG INTERACTIONS
Studies have not been performed examining drug interactions with PRUDOXIN Cream. However, data are available regarding
potentially significant drug interactions regarding doxepin. As plasma levels
of doxepin similar to therapeutic ranges for antidepressant therapy can be obtained
following topical application of PRUDOXIN Cream, it would not be unexpected
for the following drug interactions to be possible following topical PRUDOXIN
Cream application.
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