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
Marplan Indications, Dosage, Storage, Stability - Isocarboxazid
Marplan Indications, Dosage, Storage, Stability - Isocarboxazid
INDICATIONS
Marplan is indicated for the treatment
of depression. Because of its potentially serious side
effects, Marplan is not an antidepressant
of first choice in the treatment
of newly diagnosed depressed
patients.
The efficacy of Marplan
in the treatment of
depression was established
in 6-week controlled trials of depressed
outpatients. These patients had symptoms that corresponded to the
DSM-IV category of major depressive disorder; however, they often
also had signs and symptoms of anxiety
(anxious mood, panic, and
or phobic symptoms).
(See CLINICAL PHARMACOLOGY)
A major depressive episode
(DSM-IV) implies a prominent and relatively persistent (nearly every
day for at least 2 weeks) depressed
or dysphoric mood that usually interferes with daily functioning,
and includes at least five of the following nine symptoms: depressed
mood, loss of interest
in usual activities, significant
change in weight and
or appetite, insomnia or hypersomnia, psychomotor
agitation or retardation,
increased fatigue, feelings of guilt
or worthlessness, slowed thinking
or impaired concentration, and a suicide
attempt or suicidal ideation.
The antidepressant
effectiveness
of Marplan in hospitalized depressed patients, or in endogenomorphically
retarded and delusionally depressed patients, has not been adequately
studied.
The effectiveness
of Marplan in long-term use, that is, for more than 6 weeks, has
not been systematically evaluated in controlled trials. Therefore,
the physician who
elects to use Marplan for extended periods should periodically evaluate
the long-term usefulness of the drug
for the individual patient.
DOSAGE AND ADMINISTRATION
For maximum therapeutic
effect, the dosage of
Marplan must be individually adjusted on the basis
of careful observation of the patient. Dosage should be started
with one tablet (10 mg)
of Marplan twice daily. If tolerated, dosage may be increased by
increments of one tablet
(10 mg) every 2 to 4 days to achieve a dosage
of four tablets daily (40 mg) by the end
of the first week of treatment. Dosage can then be increased by
increments of up to 20 mg/ week, if needed and tolerated, to a maximum
recommended dosage of 60 mg/ day. Daily dosage
should be divided into two to four doses. After maximum
clinical response
is achieved, an attempt should be made to reduce
the dosage slowly over
a period of several weeks
without jeopardizing the therapeutic
response. Beneficial effect
may not be seen in some patients for 3 to 6 weeks. If no
response is obtained
by then, continued administration is unlikely to help.
Because of the limited experience
with systematically monitored patients receiving Marplan at the
higher end of the currently
recommended dose range
of up to 60 mg/ day, caution is indicated in patients for whom a
dose of 40 mg/ day is exceeded
(see ADVERSE REACTIONS).
HOW SUPPLIED
Tablets, 10 mg isocarboxazid
each, peach-colored, scored— bottles of 100 (NDC 0004-0032-01).
Rx only
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