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
Lomotil Side Effects, and Drug Interactions - Diphenoxylate & Atropine
Lomotil Side Effects, and Drug Interactions - Diphenoxylate & Atropine
SIDE EFFECTS
At therapeutic
doses, the following have been reported; they are listed in decreasing
order of severity, but
not of frequency:
Nervous system: numbness
of extremities, euphoria, depression, malaise/lethargy, confusion,
sedation/drowsiness, dizziness, restlessness, headache.
Allergic: anaphylaxis, angioneurotic edema, urticaria,
swelling of the gums, pruritus.
Gastrointestinal system: toxic megacolon, paralytic
ileus, pancreatitis, vomiting, nausea, anorexia, abdominal
discomfort.
The following atropine sulfate
effects are listed in decreasing order of severity, but not of frequency:
hyperthermia, tachycardia, urinary retention, flushing,
dryness of the skin and
mucous membranes. These
effects may occur especially in children.
THIS MEDICATION SHOULD BE KEPT IN A CHILD- RESISTANT CONTAINER
AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT
IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO
PERMANENT BRAIN DAMAGE OR
DEATH.
DRUG ABUSE AND DEPENDENCE
Controlled Substance
Diphenoxylate HCl and atropine sulfate
tablets are classified as a Schedule V controlled substance. Diphenoxylate
hydrochloride
is chemically related to the narcotic
analgesic meperidine.
Drug Abuse and Dependence
In doses used for the treatment
of diarrhea, whether acute
or chronic, diphenoxylate has not produced addiction.
Diphenoxylate hydrochloride
is devoid of morphine-like subjective
effects at therapeutic
doses. At high doses, it
exhibits codeine-like subjective effects. The dose
which produces antidiarrheal
action is widely separated
from the dose which causes
central nervous
system effects. The insolubility
of diphenoxylate hydrochloride
in commonly available aqueous
media precludes intravenous
self-administration. A dose
of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets,
administered to humans for 40 to 70 days, produced opiate
withdrawal symptoms.
Since addiction to
diphenoxylate hydrochloride is possible at high doses, the recommended
dosage should not be
exceeded.
DRUG INTERACTIONS
Known drug interactions
include barbiturates, tranquilizers, and alcohol. Diphenoxylate
HCl and atropine sulfate
may interact with MAO inhibitors
(see WARNINGS.)
In studies with male rats,
diphenoxylate hydrochloride
was found to inhibit the hepatic
microsomal enzyme system
at a dose of 2 mg/kg/day.
Therefore, diphenoxylate has the potential
to prolong the biological half-lives of drugs for which the rate
of elimination is
dependent on the microsomal drug
metabolizing enzyme system.
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