An oval, scored tablet blue in colour with markings 'DUO 861' and 'd/d'.
Each tablet contains Triazolam 0.25mg
Triazolam is a potent short-acting benzodiazepines with general properties
similar to those of diazepam.
Triazolam is rapidly and nearly completely absorbed from the
gastrointestinal tract, peak plasma concentrations being achieved within 2
hours of administration by mouth. Triazolam has a plasma elimination
half-life ranging from 1.5 to 5.5 hours. It is reported to be about 89%
bound to plasma proteins. Hydroxylation of Triazolam in the liver is
mediated by the cytochrome P450 isozyme CYP3A4. Triazolam is excreted in the
urine mainly in the form of its conjugated metabolites with only small
amounts appearing unchanged.
Inzolam is useful in the management of patients with transient and short
term insomnia. It is also useful as a short term adjunctive treatment in the
management of selected patients with long-term insomnia.
RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF ADMINISTRATION
It is important to individualised dosage of Triazolam in patients within
various population groups in order to obtain maximum therapeutic effect
while using the smallest effective dose. The recommended dose for most
adults is 0.25 mg before retiring. A dose of 0.125 mg may be found
sufficient for some patients (e.g. low body weight). A dose of 0.5 mg should
be used only for exceptional patients who do not respond adequately to a
trial of a lower dose since the risk of several adverse reactions increases
with the size of the dose administered. A dose of 0.5 mg should not be
exceeded. In geriatric and/or debilitated patients the recommended dosage
range is 0.125mg to 0.25 mg. Therapy should be initiated at 0.125 mg in this
group and the 0.25 mg dose should be used only for exceptional patients who
do not respond to a trial of the lower dose. A total dose of 0.25 mg should
not be exceeded in these patients.
Triazolam is contraindicated with ketoconazole, itraconazole, and nefazodone,
medications that significantly impair the oxidative metabolism mediated by
cytochrome P450 3A (CYP 3A), pregnancy, lactation (breast feeding),
depressed patients with suicidal tendencies, hypersensitivity to
benzodiazepines, Myasthenia gravis, chronic obstructive airways disease with
incipient respiratory failure.
PRECAUTIONS / WARNINGS
Warning: May be habit forming on prolonged used
Caution to patients not to take Inzolam in circumstances where a full
night's sleep and clearance of the drug from the body are not possible
before they would again need to be active and functional, e.g. an overnight
flight of less than 7-8 hours, since amnetic episodes have been reported in
Depression, Psychosis and Schizophrenia: Triazolam is not recommended
as primary therapy for patients with depression and psychosis. In such
conditions, psychiatric assessment and supervision are necessary if
benzodiazepines are indicated. Benzodiazepines may increase depression in
some patients and may contribute to deterioration in severely disturbed
schizophrenics with confusion and with withdrawal. Suicidal tendencies may
be present or uncovered and protective measures may be required.
Paradoxical Reactions: Paradoxical reactions such as acute rage,
stimulation or excitement may occur; should such reactions occur, Triazolam
should be discontinued.
Geriatric or Debilitated Patients: Such patients may be particularly
susceptible to the sedative effects of benzodiazepines and associated
giddiness, ataxia and confusion, which may increase the possibility of a
fall. For this reason, the dosage should be limited to the smallest
effective amount to preclude such effects. The systemic availability of oral
Triazolam is increased in geriatric patients probably due to a diminished
firstpass hepatic metabolism.
Impaired Renal/Liver Function: Patients with impaired renal or liver
function should use benzodiazepine medication with caution and a reduction
in dosage, or decision not to prescribe, may be necessary in such patients.
In rare instances some patients taking benzodiazepines have developed blood
dyscrasias, and some have had elevations of liver enzymes. As with other
benzodiazepines, periodic blood counts and liver function tests are
recommended. Caution must be used in treating patients with impaired hepatic
function, severe pulmonary insufficiency, or sleep apnoea.
Impaired Respiratory Function: Caution in the use of Triazolam is
recommended inpatients with respiratory depression. In patients with chronic
obstructive pulmonary disease, benzodiazepines can cause increased arterial
carbon dioxide tension and decreased oxygen tension. In patients with
compromised respiratory function, respiratory depression and apnoea have
been reported infrequently.
Hypotension: Although hypotension may occur only rarely,
benzodiazepines should be administered with caution to patients in whom a
drop in blood pressure might lead to cardiac or cerebral complications. This
is particularly important in the elderly patient.
Abuse: Caution must be exercised in administering Triazolam to
individuals known to be addiction prone, or those whose history suggests
they may increase the dosage on their own initiative. It is desirable to
limit repeat prescriptions without adequate medical supervision.
Dependence: The use of benzodiazepines may lead to dependence as
defined by the presence of a withdrawal syndrome on discontinuation of the
drug Tolerance as defined by a need to increase the dose in order to achieve
the same therapeutic effect seldom occurs in patients receiving the
recommended dose under medical supervision. Tolerance to sedation may occur
with benzodiazepines, especially in those with drug seeking behaviour.
Tolerance may develop during 1 to 2 weeks of therapy. Withdrawal symptoms,
similar in character to those noted with barbiturates and alcohol have
occurred following abrupt discontinuance with benzodiazepines, including
Triazolam. These symptoms range from insomnia, anxiety, dysphoria,
palpitations, panic attacks, vertigo, myoclonus, akinesia, hypersensitivity
to light, sound and touch, abnormal body sensations (eg. feelings of motion,
metallic taste), depersonalisation, derealisation, delusional beliefs,
hyperreflexia and loss of short term memory, to a major syndrome which may
include convulsions, seizures, tremor, abdominal and muscle cramps,
confusional state, delirium, hallucinations, hyperthermia, psychosis,
vomiting and sweating. Such manifestations of withdrawal, especially the
more serious ones are more common in patients who have received excessive
doses over a prolonged period. However, withdrawal symptoms have been
reported following abrupt discontinuation of benzodiazepines taken
continuously at therapeutic levels. Accordingly, Triazolam should be
terminated by tapering the dose to minimise occurrence of withdrawal
symptoms. Patients should be advised to consult with their physician before
either increasing the dose or abruptly discontinuing the medication. Rebound
phenomena have been described in the context of benzodiazepine use Rebound
insomnia and anxiety mean an increase in the severity of these symptoms
beyond pre-treatment levels following the cessation of benzodiazepines
Rebound phenomena in general possible reflect there-emergence of
pre-existing symptoms combined with withdrawal symptoms described earlier.
Some patients prescribed benzodiazepines with very short half-lives (in the
order of 2 to 4 hours) may experience relatively mild rebound symptoms
between their regular doses. Withdrawal/rebound symptoms may follow the use
of high doses for relatively short periods.
Acute Narrow-Angle Glaucoma: Caution should be used in the treatment
of patients with acute-narrow glaucoma (because of atropine-like side
Epilepsy: Abrupt withdrawal of
benzodiazepines in persons with convulsive disorders may be associated with
a temporary increase in the frequency and/or severity of seizures. Patients
with convulsive disorder should not be abruptly withdrawn from Triazolam.
Use in Paediatrics: Benzodiazepines and other hypnotic drugs may impair
mental alertness in children. Triazolam is not recommended as safety and
effectiveness in patients under the age of 18 has not been established.