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
Halcion Warnings, Precautions, Pregnancy, Nursing, Abuse - Triazolam
Halcion Warnings, Precautions, Pregnancy, Nursing, Abuse - Triazolam
WARNINGS
Sleep disturbance
may be the presenting manifestation
of a physical and/or psychiatric
disorder. Consequently, a decision to initiate symptomatic treatment
of insomnia should
only be made after the patient
has been carefully evaluated.
The failure of insomnia
to remit after 7-10 days of treatment
may indicate the presence of a primary
psychiatric and/or
medical illness.
Worsening of insomnia
or the emergence of new abnormalities of thinking or behavior
may be the consequence
of an unrecognized psychiatric
or physical disorder. These have also been reported to occur in
association with
the use of triazolam.
Because some of the adverse effects of triazolam appear to be dose
related(see PRECAUTIONS
and DOSAGE
AND ADMINISTRATION), it is important to use the smallest
possible effective dose. Elderly patients are especially susceptible
to dose related adverse
effects.
An increase in daytime anxiety
has been reported for triazolam after as few as 10 days of continuous
use. In some patients this
may be a manifestation of interdose withdrawal
(see CLINICAL PHARMACOLOGY.)
If increased daytime anxiety
is observed during treatment,
discontinuation of treatment
may be advisable.
A variety of abnormal
thinking and behavior
changes have been reported to occur in association
with the use of benzodiazepine
hypnotics including triazolam. Some of these changes may be characterized
by decreased inhibition, e.g. aggressiveness and extroversion
that seem excessive, similar to that seen with alcohol
and other CNS depressants
(e.g., sedative/hypnotics). Other kinds of behavioral changes
have also been reported, for example, bizarre behavior, agitation,
hallucinations, depersonalization. In
primarily depressed patients, the worsening of depression,
including suicidal thinking, has been reported in association
with the use of benzodiazepines.
It can rarely be determined with certainty whether a particular
instance of the abnormal
behaviors listed above is drug
induced, spontaneous
in origin, or a result of an underlying psychiatric
or physical disorder.
Nonetheless, the emergence of any new behavioral sign
or symptom of concern
requires careful and immediate
evaluation.
Because of its depressant
CNS effects, patients receiving
triazolam should be cautioned against engaging in hazardous occupations
requiring complete mental
alertness such as operating
machinery or driving a motor vehicle. For the same reason, patients
should be cautioned about the concomitant ingestion of alcohol
and other CNS depressant
drugs during treatment
with triazolam tablets.
As with some, but not all benzodiazepines, anterograde
amnesia of varying severity
and paradoxical reactions have been reported following therapeutic
doses of triazolam. Data from several sources suggest that anterograde
amnesia may occur at a higher rate
with triazolam than with other benzodiazepine hypnotics.
PRECAUTIONS
General
In elderly and/or debilitated
patients it is recommended that treatment
with triazolam tablets be initiated at 0.125 mg
to decrease the possibility of development
of oversedation, dizziness, or impaired coordination.
Some side effects reported
in association with
the use of triazolam appear to be dose
related. These include drowsiness,
dizziness, light-headedness,
and amnesia.
The relationship between dose
and what may be more serious behavioral phenomena is less certain.
Specifically, some evidence,
based on spontaneous marketing reports, suggests that confusion,
bizarre or abnormal
behavior, agitation, and hallucinations may also be dose
related, but this evidence is inconclusive. In
accordance with good medical
practice it is recommended
that therapy be initiated
at the lowest effective dose
(see DOSAGE AND ADMINISTRATION.)
Cases of "traveler's amnesia" have been reported by individuals
who have taken triazolam to induce sleep
while traveling, such as
during an airplane flight. In
some of these cases, insufficient time
was allowed for the sleep
period prior to awakening
and before beginning activity. Also, the concomitant
use of alcohol may have
been a factor in some
cases.
Caution should be exercised if triazolam is prescribed to patients
with signs or symptoms of depression
that could be intensified by hypnotic
drugs. Suicidal tendencies may be present
in such patients and protective
measures may be required. Intentional overdosage is more common
in these patients, and the least amount of drug
that is feasible should be available to the patient at any one time.
The usual precautions should be observed in patients with impaired
renal or hepatic function,
chronic pulmonary
insufficiency, and sleep
apnea. In patients with compromised respiratory
function, respiratory
depression and apnea have
been reported infrequently.
Information for the Patient
The text of a patient
package insert is printed at the end
of this insert. To assure safe and effective use of triazolam, the
information and instructions provided in this patient
package insert should be discussed with patients.
Laboratory Tests
Laboratory tests are not ordinarily required in otherwise healthy
patients.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No evidence
of carcinogenic
potential was observed
in mice during a 24-month study with triazolam in doses up to 4,000
times the human dose.
Pregnancy
Teratogenic effects: Pregnancy category X (see CONTRAINDICATIONS.)
Non-teratogenic effects: It is to be considered that the
child born of a mother
who is on benzodiazepines may be at some risk
for withdrawal symptoms from the drug,
during the postnatal
period. Also, neonatal
flaccidity has been reported in an infant
born of a mother who
had been receiving benzodiazepines.
Nursing Mothers
Human studies have not been performed; however, studies in rats
have indicated that triazolam and its metabolites are secreted in
milk. Therefore, administration
of triazolam to nursing
mothers is not recommended.
Pediatric Use
Safety and efficacy of triazolam in children below the age
of 18 have not been established.
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