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
Motofen Side Effects, and Drug Interactions - Difenoxin and Atropine
Motofen Side Effects, and Drug Interactions - Difenoxin and Atropine
SIDE EFFECTS
In view of the small amount of atropine present (0.025 mg/tablet), effects
such as dryness of the skin and mucous membranes, flushing, hyperthermia, tachycardia
and urinary retention are very unlikely to occur, except perhaps in children.
Many of the adverse effects reported during clinical investigation of MOTOFEN®
are difficult to distinguish from symptoms associated with the diarrheal syndrome.
However, the following events were reported at the stated frequencies:
Gastrointestinal: Nausea, 1 in 15 patients; vomiting, 1
in 30 patients; dry mouth, 1 in 30 patients; epigastric distress, 1 in 100 patients;
and constipation, 1 in 300 patients.
Central Nervous System: Dizziness and light-headedness,
1 in 20 patients; drowsiness, 1 in 25 patients; and headache, 1 in 40 patients;
tiredness, nervousness, insomnia and confusion ranged from 1 in 200 to 1 in
600 patients.
Other less frequent reactions: Burning eyes and blurred
vision occurred in a few cases.
The following adverse reactions have been reported in patients receiving chemically-related
drugs: numbness of extremities, euphoria, depression, sedation, anaphylaxis,
angioneurotic edema, urticaria, swelling of the gums, pruritus, toxic megacolon,
paralytic ileus, pancreatitis, and anorexia.
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
MOTOFEN® (difenoxin hydrochloride with atropine sulfate) tablets are a Schedule
IV controlled substance.
Addiction to (dependence on) difenoxin hydrochloride is theoretically possible
at high dosage. Therefore, the recommended dosage should not be exceeded. Because
of the structural and pharmacological similarities of difenoxin hydrochloride
to drugs with a definite addiction potential, MOTOFEN® should be administered
with considerable caution to patients who are receiving addicting drugs, to
individuals known to be addiction prone, or to those in whom histories suggest
may increase the dosage on their own initiative.
DRUG INTERACTIONS
Since the chemical structure of difenoxin hydrochloride is similar to meperidine
hydrochloride, the concurrent use of MOTOFEN® with monoamine oxidase inhibitors
may, in theory, precipitate a hypertensive crisis.
MOTOFEN® may potentiate the action of barbiturates, tranquilizers, narcotics,
and alcohol. When these medications are used concomitantly with MOTOFEN®, the
patient should be closely monitored.
Diphenoxylate hydrochloride, from which the principal active metabolite difenoxin
is derived, was found to inhibit the hepatic microsomal enzyme system at a dose
of 2 mg/kg/day in studies conducted with male rats. Therefore, difenoxin 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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