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
Tofranil Indications, Dosage, Storage, Stability - Imipramine
Tofranil Indications, Dosage, Storage, Stability - Imipramine
INDICATIONS
Depression
For the relief of symptoms
of depression. Endogenous depression
is more likely to be alleviated than other depressive states. One
to three weeks of treatment
may be needed before optimal therapeutic
effects are evident.
Childhood Enuresis
May be useful as temporary adjunctive therapy
in reducing enuresis
in children aged 6 years
and older, after possible organic
causes have been excluded by appropriate
tests. In patients having
daytime symptoms of frequency and urgency, examination
should include voiding cystourethrography
and cystoscopy, as necessary. The effectiveness
of treatment may decrease
with continued drug administration.
DOSAGE AND ADMINISTRATION
Depression
Lower dosages are recommended for elderly patients and adolescents.
Lower dosages are also recommended for outpatients as compared to
hospitalized patients who will
be under close supervision. Dosage should be initiated at a low
level and increased gradually, noting carefully the clinical
response and any evidence
of intolerance. Following remission, maintenance medication may
be required for a longer period
of time at the lowest dose
that will maintain remission.
Parenteral administration
should be used only for starting therapy
in patients unable or unwilling to use oral
medication. The oral form
should supplant the injectable
as soon as possible.
Oral
Usual Adult Dose:
Hospitalized patients - Initially, 100 mg/day in
divided doses gradually increased to 200 mg/day as required. If
no response
after two weeks, increase to 250-300 mg/day.
Outpatients - Initially, 75 mg/day increased to 150
mg/day. Dosages over 200 mg/day are not recommended. Maintenance,
50-150 mg/day.
Adolescent and geriatric patients:
Initially, 30- 40 mg/day; it is generally not necessary to exceed
100 mg/day.
Childhood Enuresis
Initially, an oral dose
of 25 mg/day should be tried in children aged 6 and older. Medication
should be given one hour before bedtime. If a satisfactory response
does not occur within one week, increase the dose
to 50 mg nightly in children
under 12 years; children over 12 may receive up to 75 mg
nightly. A daily dose greater
than 75 mg does not enhance
efficacy and tends
to increase side effects.
Evidence suggests that in early night bedwetters, the drug
is more effective given earlier and in divided amounts, i.e., 25
mg in midafternoon, repeated
at bedtime. Consideration should be given to instituting a drug-
free period following
an adequate therapeutic
trial with a favorable response. Dosage should be tapered off gradually
rather than abruptly discontinued; this may reduce
the tendency to relapse. Children who relapse
when the drug is discontinued
do not always respond to a subsequent course of treatment.
A dose of 2.5 mg/kg/day
should not be exceeded. ECG
changes of unknown significance have been reported in pediatric
patients with doses twice this amount.
The safety and effectiveness
of imipramine hydrochloride
as temporary adjunctive therapy
for nocturnal enuresis
in children less than 6 years of age
have not been established.
HOW SUPPLIED
Available in round, nonenteric-coated tablets.
10 mg - Yellow tablet
imprinted: “BL/19,” in bottles of 100 and 1000.
25 mg - Salmon tablet
imprinted: “BL/20,” in bottles of 100 and 1000.
50 mg - Green tablet
imprinted: “BL/21,” in bottles of 100 and 1000.
Store at controlled room
temperature 15°-30°
C (59-86° F).
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