ASOLAN TABLET 0.25 MG: A round
light blue, 7 mm diameter tablet with marking "DUOMA/DUOMA" and "DUO 2"
ASOLAN TABLET 0.5 MG: A round
pink, 7 mm diameter tablet with marking "DUOMADUOMA" and "DUO 2"
ASOLAN TABLET 1 MG: A round
apple green, 7 mm diameter tablet with marking "DUOMA/DUOMA" and "DUG' 2
ASOLAN TABLET 0.25 MG: Each
tablet contains Alprazolam 0.25 mg
ASOLAN TABLET 0.5 MG: Each tablet
contains Alprazolam 0.5 mg
ASOLAN TABLET 1 MG: Each tablet contains Alprazolam 1 mg
In general, benzodiazepines act
as depressants of the central nervous system (CNS). producing all levels of
CNS depression from mild sedation to hypnosis to coma depending on dose. The
precise sites and mechanisms of action have not been completely established.
Although various mechanisms of action have been proposed, it is believed
that benzodiazepines enhance or facilitate the inhibitory neurotransmitter
action of gamma-aminobutyric acid (GABA). which is one of the major
inhibitory neurotransmitters in the brain and mediates both pre- and
post-synaptic inhibition in all regions of the CNS, following interaction
between the benzodiazepine and a specific neuronal membrane receptor.
Pharmacological properties of alprazolam in animals appear similar to those
of other benzodiazepines. that is. it produces significant anxiolytic,
muscle relaxant, sleep promoting and anticonvulsant effects in appropriate
Following oral administration to fasting subjects, alprazolam is rapidly absorbed with nearly complete bioavailability.
Alprazolam exhibits linear kinetics; after single dose administration of 0.5
- 3.0 mg plasma levels of 8.0 p 40 mg/mL were observed; during multiple dose
administration of 1.5 -10 mg/day in divided doses, steady state plasma
levels of 18.3 -100 mg/mL were observed.
Peak plasma levels showed a two- to three-fold variation within individual
treatment groups. The plasma half life of alprazolam after single doses in
health subjects has ranged from 6 to 25 hours. The mean half life of
individual treatment groups ranged only from 10 to 14 hours. Alprazolam and
its metabolites are excreted primarily in the urine. About 50 percent of the
dose is excreted within 24 hours. and 94 percent after 72 hours. With
chronic dosing, the apparent elimination half life increases by about 50
percent, possibly because of compartmentalization effects.
Plasma levels of
drug reach steady state within 7 days after starting or altering dosage
size. The steady state level is 3 to 4 times that achieved with a single
Some 21 metabolites of alprazolam were detected in man. In addition to
alprazolam, the major drug-related materials excreted in urine are alpha-hydroxyalprazolam,
and a benzophenone analog. The biological activity of alpha-hydroxyalprazolam
is approximately one-half that of alprazolam. The benzophenone metabolite is
essentially inactive. Plasma level of these metabolites are extremely low.
However, their half-lives appear to be of the same order of magnitude as
that of alprazolam. In vitro alprazolam is bound (80%) to human serum
protein. When alprazolam-14C was administered to pregnant mice, drugrelated
materials appeared uniformly distributed in the foetus with 14C
concentration approximately the same as in the blood and skeletal muscle of
Of the known alprazolam metabolites, only alpha-hydroxy-alprazolam
shows significant pharmacologic activity (in animals); however, only very
low levels of this metabolite are found in human plasma. Alprazolam tablets
did not affect the prothrombin times or plasma warfarin levels in male
volunteers administered sodium warfarin orally.
Anxiety States (Anxiety Neuroses): Symptoms which occur in such
patients include anxiety, tension, agitation, insomnia, apprehension,
irritability and /or autonomic hyperactivity resulting in a variety of
Mixed Anxiety-Depression: Symptoms of both anxiety and depression occur
simultaneously in such patients.
Neurotic or Reactive Depression: Such patients primarily exhibit a depressed
mood or a pervasive loss of interest or pleasure. Symptoms of anxiety.
psychomotor agitation and insomnia are usually present. Other
characteristics include appetite disturbances, changes in weight, somatic
complaints, cognitive disturbances. decreased energy, feeling of
worthlessness or guilt or thoughts of death or suicide.
not be used in patients whose primary symptom of depression is psychomotor
retardation; with a diagnosis of bipolar depression; with psychotic
Anxiety states, mixed anxiety-depression or neurotic depression associated
with other diseases, eg. the chronic phase of alcohol withdrawal and
functional or organic disease, particularly certain gastrointestinal,
cardiovascular or dermatological disorders.
The effectiveness of alprazolam for long-term use exceeding 6 months has not
been established by systematic clinical trials. The physician should
periodically reassess the usefulness of the drug for the individual patient.
Dosage and Administration:
The optimum dosage of Alprazolam tablets should be individualised, based
upon the severity of the symptoms and individual patient response. The daily
dosage (see Table) will meet the needs of most patients. In the few patients
who require higher doses, dosage should be increased cautiously to avoid
adverse effects. When higher dosage is required, the evening dose should be
increased before the daytime doses. In general, patients who have not
previously received psychotropic medication will require lower doses than
those previously treated with minor tranquillisers, antidepressants, or
hypnotics or those with a history of chronic alcoholism. It is recommended
that the general principle of using the lowest effective dosage be followed
to preclude the development of oversedation or ataxia. In patients who
experience early morning anxiety and emergence of anxiety symptoms, it is
recommended that the same total daily dose be given divided as more frequent
administration. Patients should be periodically assessed and dosage
adjustments made, as appropriate:
Usual starting Dosage*
Usual Dosage Range
0.5 to 1.5 mg daily given
in divided doses
0.5 to 4.0 mg daily,
given in divided doses
*Anxiety with depressive
1.5 mg daily, given in
1.5 to 4.5 mg daily given
in divided doses
Geriatric patients or in
the presence of debilitating disease
0.5 to 0.75 mg daily
given in divided doses
0.5 to 0.75 mg daily,
given in divided doses; to be gradually increased if needed and
0.5 to 1.0 mg given at
bedtime, increasing at a rate of 0.25 mg to 1 mg every 3 days until
an adequate therapeutic dosage is achieved
The dose should be
adjusted to patient response. Dosage adjustments should be in
increments no greater than 1 mg every three to four days. additional
doses can be added until a TID** or QID** schedule is achieved. the
mean dose in a large multicentre study was 5.7 ± 2.27 mg with rare
patients requiring a maximum of 10 mg daily.
*If side effects occur,
the dose should be lowered.
**TID - three times
daily; QID - four times daily
Administration of Alprazolam tablets immediately after meals does not affect
the extent of Alprazolam tablets' absorption compared to administration on
an empty stomach. Food does, however, delay the onset of absorption and
decrease the rate of absorption of alprazolam tablets. As a direct
consequence, side effects, such as somnolence, are less pronounced.
Discontinuation therapy: The dosage should be reduced slowly in keeping with
good medical practice. It is suggested that the daily dosage of alprazolam
tablets be decreased by 0.25 to 0.5 mg every three days. It is important
that this rate of dosage reduction does_ not exceed 0.5 mg every 3 days in
order to minimize any possible withdrawal symptoms. Some patients may
require an even slower dosage reduction (see Precautions.)
Hypersensitivity to benzodiazepines; myasthenia gravis;
chronic obstructive airways disease with incipient respiratory failure.