SIDE EFFECTS
No side effects or manifestations not seen with either
compound alone have been reported with the administration of Librax. However,
since Librax contains chlordiazepoxide hydrochloride and clidinium bromide, the
possibility of untoward effects which may be seen with either of these two
compounds cannot be excluded.
When chlordiazepoxide hydrochloride has been used alone
the necessity of discontinuing therapy because of undesirable effects has been
rare. Drowsiness, ataxia and confusion have been reported in some patients -
particularly the elderly and debilitated. While these effects can be avoided in
almost all instances by proper dosage adjustment, they have occasionally been
observed at the lower dosage ranges. In a few instances syncope has been
reported.
Other adverse reactions reported during therapy with
chlordiazepoxide hydrochloride include isolated instances of skin eruptions,
edema, minor menstrual irregularities, nausea and constipation, extrapyramidal
symptoms, as well as increased and decreased libido. Such side effects have
been infrequent and are generally controlled with reduction of dosage. Changes
in EEG patterns (low-voltage fast activity) have been observed in patients
during and after chlordiazepoxide hydrochloride treatment.
Blood dyscrasias, including agranulocytosis, jaundice and
hepatic dysfunction have occasionally been reported during therapy with
chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride treatment
is protracted, periodic blood counts and liver function tests are advisable.
Adverse effects reported with use of Librax are those
typical of anticholinergic agents, i.e., dryness of the mouth, blurring of
vision, urinary hesitancy and constipation. Constipation has occurred most
often when Librax therapy has been combined with other spasmolytic agents
and/or a low residue diet.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant
Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Drug Abuse And Dependence
Withdrawal symptoms, similar in character to those noted
with barbiturates and alcohol (convulsions, tremor, abdominal and muscle
cramps, vomiting and sweating), have occurred following abrupt discontinuance
of chlordiazepoxide. The more severe withdrawal symptoms have usually been
limited to those patients who had received excessive doses over an extended
period of time. Generally milder withdrawal symptoms (e.g., dysphoria and
insomnia) have been reported following abrupt discontinuance of benzodiazepines
taken continuously at therapeutic levels for several months. Consequently,
after extended therapy, abrupt discontinuation should generally be avoided and
a gradual dosage tapering schedule followed. Addiction-prone individuals (such
as drug addicts or alcoholics) should be under careful surveillance when
receiving chlordiazepoxide or other psychotropic agents because of the
predisposition of such patients to habituation and dependence.
DRUG INTERACTIONS
The concomitant use of benzodiazepines and opioids
increases the risk of respiratory depression because of actions at different
receptor sites in the CNS that control respiration. Benzodiazepines interact at
GABAA sites and opioids interact primarily at mu receptors. When
benzodiazepines and opioids are combined, the potential for benzodiazepines to
significantly worsen opioid-related respiratory depression exists. Limit dosage
and duration of concomitant use of benzodiazepines and opioids, and follow
patients closely for respiratory depression and sedation.