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
Parnate Indications, Dosage, Storage, Stability - Tranylcypromine
Parnate Indications, Dosage, Storage, Stability - Tranylcypromine
INDICATIONS
AND USES
For the treatment of Major Depressive Episode Without Melancholia.
Parnate (tranylcypromine sulfate) should be used in adult patients who can
be closely supervised. It should rarely be the first antidepressant drug given.
Rather, the drug is suited for patients who have failed to respond to the drugs
more commonly administered for depression.
The effectiveness of Parnate has been established in adult outpatients,
most of whom had a depressive illness which would correspond to a diagnosis
of Major Depressive Episode Without Melancholia. As described in the American
Psychiatric Association's Diagnostic and Statistical Manual, third edition (DSM
III), Major Depressive Episode 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 4 of the following 8
symptoms: change in appetite, change in sleep, psychomotor agitation or retardation,
loss of interest in usual activities or decrease in sexual drive, increased
fatigability, feelings of guilt or worthlessness, slowed thinking or impaired
concentration and suicidal ideation or attempts.
The effectiveness of Parnate in patients who meet the criteria for Major
Depressive Episode with Melancholia (endogenous features) has not been established.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted to the requirements of the individual patient. Improvement
should be seen within 48 hours to 3 weeks after starting therapy.
The usual effective dosage is 30 mg per day, usually given in divided doses.
If there are no signs of improvement after a reasonable period (up to 2 weeks),
then the dosage may be increased in 10 mg per day increments at intervals of
1 to 3 weeks; the dosage range may be extended to a maximum of 60 mg per day
from the usual 30 mg per day.
HOW SUPPLIED
Parnate is supplied as round, rose-red, film-coated tablets imprinted
with the product name PARNATE and SKF and contains tranylcypromine sulfate equivalent
to 10 mg of tranylcypromine, in bottles of 100 with a desiccant.
10 mg 100's: NDC 0007-4471-20
Store between 15° and 30°C (59° and 86°F).
*phentolamine mesylate USP, CibaGeneva.
** metrizamide, Sanofi Winthrop Pharmaceuticals.
*** disulfiram, Wyeth-Ayerst Laboratories.
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