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
Tofranil Warnings, Precautions, Pregnancy, Nursing, Abuse - Imipramine
Tofranil Warnings, Precautions, Pregnancy, Nursing, Abuse - Imipramine
WARNINGS
Children
A dose of 2.5 mg/kg/day
of imipramine hydrochloride
should not be exceeded in childhood. ECG
changes of unknown significance have been reported in pediatric
patients with doses twice this amount.
Extreme caution should be used when this drug
is given to:
patients with cardiovascular
disease because of the
possibility of conduction defects, congestive heart
failure, arrhythmias, myocardial
infarction, strokes and tachycardia. These patients require cardiac
surveillance at
all dosage levels of
the drug;
patients with increased intraocular
pressure, history
of urinary retention
or history of narrow-angle
glaucoma because of
the drug’s anticholinergic properties;
hyperthyroid patients or those on thyroid
medication because
of the possibility of cardiovascular
toxicity;
patients with a history
of seizure disorder
because this drug has been
shown to lower the seizure
threshold;
patients receiving guanethidine, clonidine or similar agents since
imipramine hydrochloride
may block the pharmacologic
effects of these drugs;
patients receiving methylphenidate hydrochloride. Since methylphenidate
may inhibit the metabolism
of imipramine, downward dosage
adjustment of imipramine
may be required when given concomitantly with methylphenidate.
Imipramine may enhance the CNS
depressant effects
of alcohol. Therefore, it should be borne in mind
that the dangers inherent
in a suicide attempt
or accidental overdosage with the drug
may be increased for the patient who uses excessive amounts of alcohol.
(See PRECAUTIONS
.)
Since imipramine hydrochloride
may impair the mental
and/or physical abilities required for the performance
of potentially hazardous tasks, such as operating an automobile
or machinery, the patient
should be cautioned accordingly.
PRECAUTIONS
General
An ECG recording should
be made prior to the initiation of greater than usual doses of imipramine
hydrochloride
and at appropriate
intervals thereafter until steady state
is achieved. (Patients with any evidence
of cardiovascular disease require cardiac
surveillance at
all dosage levels of
the drug. See WARNINGS
.) Elderly patients
and patients with cardiac disease
or a past history of
cardiac disease
are at a special risk of developing the cardiac
abnormalities associated with the use of imipramine.
It should be kept in mind
that the possibility of suicide
in seriously depressed patients is inherent
in the illness and may
persist until significant remission occurs. Such patients should
be carefully supervised during the early phase
of treatment with
imipramine hydrochloride, and may require hospitalization. Prescriptions
should be written for the smallest amount feasible. Hypomanic or
manic episodes may occur,
particularly in patients with cyclic
disorders. Such reactions may necessitate discontinuation of the
drug. If needed, imipramine hydrochloride
may be resumed in lower dosage when these episodes are relieved.
Administration of a tranquilizer
may be useful in controlling such
episodes.
An activation of
the psychosis may
occasionally be observed in schizophrenic patients and may require
reduction of dosage
and the addition of
a phenothiazine.
Concurrent administration
of imipramine with electroshock
therapy may increase
the hazards; such treatment
should be limited to those patients for whom it is essential, since
there is limited clinical
experience.
Imipramine should be used with caution in patients with significantly
impaired renal or hepatic
function.
Patients who develop a fever
and a sore throat
during therapy with
imipramine hydrochloride should have leukocyte
and differential
blood counts performed.
Imipramine should be discontinued if there is evidence
of pathological neutrophil depression.
Prior to elective surgery,
imipramine hydrochloride
should be discontinued for as long as the clinical
situation will
allow.
Both elevation and
lowering of blood sugar
levels have been reported with imipramine use.
Usage During Pregnancy and Lactation
Animal reproduction
studies have yielded inconclusive results. (See also CLINICAL PHARMACOLOGY:
ANIMAL PHARMACOLOGY AND TOXICOLOGY.)
There have been no well-controlled
studies conducted with pregnant
women to determine the effect
of imipramine hydrochloride
on the fetus. However, there have been clinical
reports of congenital
malformations associated with the use of the drug. Although a causal
relationship between these effects and the drug
could not be established, the possibility of fetal risk from the
maternal ingestion
of imipramine hydrochloride
cannot be excluded. Therefore, imipramine hydrochloride
should be used in women who are or might become pregnant
only if the clinical
condition clearly
justifies potential risk
to the fetus.
Limited data suggest that imipramine hydrochloride
is likely to be excreted in human
breast milk. As
a general rule, a woman
taking a drug should not
nurse since the possibility exists that the drug
may be excreted in breast milk and be harmful to the child.
Usage in Children
The effectiveness
of the drug in children
for conditions other than nocturnal enuresis
has not been established.
The safety and effectiveness
of the drug as temporary
adjunctive therapy for nocturnal
enuresis in children
less than 6 years of age
have not been established.
The safety of the drug
for long term, chronic
use as adjunctive therapy for nocturnal
enuresis in children
6 years of age or older
has not been established; consideration should be given to instituting
a drug-free period following an adequate therapeutic
trial with a favorable response.
A dose of 2.5 mg/kg/day
should not be exceeded in childhood. ECG
changes of unknown significance have been reported in pediatric
patients with doses twice this amount.
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