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
Librax Warnings, Precautions, Pregnancy, Nursing, Abuse - Chlordiazepoxide and Clidinium
Librax Warnings, Precautions, Pregnancy, Nursing, Abuse - Chlordiazepoxide and Clidinium
WARNINGS
As in the case of other
preparations containing CNS-acting drugs, patients receiving Librax
should be cautioned about possible combined effects with alcohol
and other CNS depressants.
For the same reason, they should be cautioned against hazardous
occupations requiring complete mental
alertness such as operating machinery or driving a motor
vehicle.
Usage in Pregnancy
An increased risk of congenital
malformations associated with the use of minor
tranquilizers (chlordiazepoxide, diazepam
and meprobamate) during the first trimester
of pregnancy has been
suggested in several studies. Because use of these drugs is rarely
a matter of urgency,
their use during this period
should almost always be avoided. The possibility that a woman of
childbearing potential
may be pregnant at
the time of institution
of therapy should be considered. Patients should be advised that
if they become pregnant during therapy
or intend to become pregnant
they should communicate with their physicians about the desirability
of discontinuing the drug. As with all anticholinergic
drugs, an inhibiting effect
on lactation may occur
(see CLINICAL PHAMACOLOGY).
PRECAUTIONS
In elderly and debilitated patients, it is recommended that the
dosage be limited to the smallest effective amount to preclude the
development of ataxia,
oversedation or confusion
(not more than 2 Librax capsules per day initially, to be increased
gradually as needed and tolerated). In
general, the concomitant
administration
of Librax and other psychotropic agents is not recommended. If such
combination therapy
seems indicated, careful consideration should be given to the pharmacology
of the agents to be employed – particularly when the known potentiating
compounds such as the MAO
inhibitors and phenothiazines
are to be used. The usual precautions in treating patients with
impaired renal or hepatic
function should be
observed.
Paradoxical reactions to chlordiazepoxide hydrochloride, e.g. excitement,
stimulation and acute
rage, have been reported in psychiatric
patients and should be watched for during Librax therapy. The usual
precautions are indicated when chlordiazepoxide hydrochloride
is used in the treatment of anxiety
states where there is any evidence
of impending depression; it should be borne in mind
that suicidal tendencies may be present
and protective measures may be necessary. Although clinical
studies have not established a cause
and effect relationship,
physicians should be aware that variable
effects on blood coagulation
have been reported very rarely in patients receiving oral
anticoagulants and Librium (chlordiazepoxide hydrochloride).
Pediatric Use
Safety and effectiveness
in pediatric patients
have not been established.
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