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
Abilify Indications, Dosage, Storage, Stability - Aripiprazole
Abilify Indications, Dosage, Storage, Stability - Aripiprazole
INDICATIONS AND USAGE
Schizophrenia
ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY in the treatment
of schizophrenia was established in short-term (4- and 6-week) controlled trials of schizophrenic
inpatients
(see CLINICAL
PHARMACOLOGY: Clinical Studies).
The efficacy of ABILIFY in maintaining stability in patients
with schizophrenia who had been symptomatically stable on other antipsychotic
medications for periods of 3 months or longer, were discontinued from those
other medications, and were then administered ABILIFY 15 mg/day and observed
for relapse during a period of up to 26 weeks was demonstrated in a placebo-controlled
trial (see CLINICAL PHARMACOLOGY: Clinical Studies).
The physician who elects to use ABILIFY for extended periods should periodically
re-evaluate the long-term usefulness of the drug for the individual patient
(see DOSAGE AND ADMINISTRATION).
Bipolar Mania
ABILIFY is indicated for the treatment of acute manic and mixed episodes associated with Bipolar
Disorder. The efficacy of ABILIFY was established in two placebo-controlled trials (3-week) of inpatients with DSM-IV
criteria for Bipolar I Disorder who were experiencing an acute manic or mixed episode with or without psychotic features
(see CLINICAL PHARMACOLOGY). However, the effectiveness of ABILIFY for longer-term use, that is, for more than 3 weeks
of treatment of an acute episode, and for prophylactic use in mania, has not been established in controlled clinical trials.
Therefore, physicians who elect to use ABILIFY for extended periods should periodically re-evaluate the long-term risks and
benefits of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
Usual Dose
The recommended starting and target dose for ABILIFY is 10
or 15 mg/day administered on a once-a-day schedule without regard to meals.
ABILIFY has been systematically evaluated and shown to be effective in a dose
range of 10 to 30 mg/day, however, doses higher than 10 or 15 mg/day, the lowest
doses in these trials, were not more effective than 10 or 15 mg/day. Dosage
increases should not be made before 2 weeks, the time needed to achieve steady
state.
Dosage in Special Populations
Dosage adjustments are not routinely indicated on the basis
of age, gender, race, or renal or hepatic impairment status (see CLINICAL
PHARMACOLOGY: Special Populations).
Dosage adjustment for patients taking aripiprazole concomitantly
with potential CYP3A4 inhibitors: When concomitant administration of ketoconazole
with aripiprazole occurs, aripiprazole dose should be reduced to one-half of
the usual dose. When the CYP3A4 inhibitor is withdrawn from the combination
therapy, aripiprazole dose should then be increased.
Dosage adjustment for patients taking aripiprazole concomitantly
with potential CYP2D6 inhibitors: When concomitant administration of potential
CYP2D6 inhibitors such as quinidine, fluoxetine, or paroxetine with aripiprazole
occurs, aripiprazole dose should be reduced at least to one-half of its normal
dose. When the CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole
dose should then be increased.
Dosage adjustment for patients taking potential CYP3A4 inducers:
When a potential CYP3A4 inducer such as carbamazepine is added to aripiprazole
therapy, the aripiprazole dose should be doubled (to 20 or 30 mg). Additional
dose increases should be based on clinical evaluation. When carbamazepine is
withdrawn from the combination therapy, the aripiprazole dose should be reduced
to 10 to 15 mg.
Maintenance Therapy
While there is no body of evidence available to answer the
question of how long a patient treated with aripiprazole should remain on it,
systematic evaluation of patients with schizophrenia who had been symptomatically
stable on other antipsychotic medications for periods of 3 months or longer,
were discontinued from those medications, and were then administered ABILIFY
15 mg/day and observed for relapse during a period of up to 26 weeks, demonstrated
a benefit of such maintenance treatment (see CLINICAL
PHARMACOLOGY: Clinical Studies). Patients should be periodically reassessed
to determine the need for maintenance treatment.
Switching from Other Antipsychotics
There are no systematically collected data to specifically
address switching patients with schizophrenia from other antipsychotics to ABILIFY
or concerning concomitant administration with other antipsychotics. While immediate
discontinuation of the previous antipsychotic treatment may be acceptable for
some patients with schizophrenia, more gradual discontinuation may be most appropriate
for others. In all cases, the period of overlapping antipsychotic administration
should be minimized.
ANIMAL TOXICOLOGY
Aripiprazole produced retinal degeneration in albino rats in
a 26-week chronic toxicity study at a dose of 60 mg/kg and in a 2-year carcinogenicity
study at doses of 40 and 60 mg/kg. The 40- and 60-mg/kg doses are 13 and 19
times the maximum recommended human dose (MRHD) based on mg/m2 and
7 to 14 times human exposure at MRHD based on AUC. Evaluation of the retinas
of albino mice and of monkeys did not reveal evidence of retinal degeneration.
Additional studies to further evaluate the mechanism have not been performed.
The relevance of this finding to human risk is unknown.
HOW SUPPLIED
ABILIFY (aripiprazole) Tablets are available in the following
strengths and packages.
The 5-mg ABILIFY tablets are blue, modified rectangular tablets,
debossed on one side with "A-007" and "5".
Bottles of 30 NDC 59148-007-13
Blister of 100 NDC 59148-007-35
The 10-mg ABILIFY tablets are pink, modified rectangular tablets,
debossed on one side with "A-008" and "10".
Bottles of 30 NDC 59148-008-13
Blister of 100 NDC 59148-008-35
The 15-mg ABILIFY tablets are yellow, round tablets, debossed
on one side with "A-009" and "15".
Bottles of 30 NDC 59148-009-13
Blister of 100 NDC 59148-009-35
The 20-mg ABILIFY tablets are white, round tablets, debossed
on one side with "A-010" and "20".
Bottles of 30 NDC 59148-010-13
Blister of 100 NDC 59148-010-35
The 30-mg ABILIFY tablets are pink, round tablets, debossed
on one side with "A-011" and "30".
Bottles of 30 NDC 59148-011-13
Blister of 100 NDC 59148-011-35
Storage
Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º
F) [see USP Controlled Room Temperature].
Marketed by Otsuka America Pharmaceutical,
Inc, Rockville, MD 20850 USA and Bristol-Myers Squibb Company, Princeton, NJ
08543 USA
Manufactured and Distributed by Bristol-Myers
Squibb Company, Princeton, NJ 08543 USA, U.S. Patent Nos. 4,734,416 and 5,006,528,
Revised March 2004,
2004, Otsuka Pharmaceutical Co, Ltd, Tokyo,
101-8535 Japan
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