ARIPIPRAZOLE- aripiprazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

ARIPIPRAZOLE

Composition:

ARIPIPRAZOLE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aripiprazole Oral Tablets are indicated for the treatment of: - Schizophrenia[see CLINICAL STUDIES (14.1)] - Acute Treatment of Manic and Mixed Episodes Associated with Bipolar I Disorder[see CLINICAL STUDIES (14.2)] Pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s aripiprazole product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see ADVERSE REACTIONS (6.2) ]. Pregnancy Category C Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistr

Product summary:

Aripiprazole tablets 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with "2" on one side and "16" on other side. Aripiprazole tablets 5 mg are white to off-white, round, uncoated tablets, debossed with "5" on one side and "17" on other side.        55700-399-30 Aripiprazole tablets 10 mg are white to off-white, round, uncoated tablets, debossed with "10" on one side and "18" on other side. Aripiprazole tablets 15 mg are white to off-white, round, uncoated tablets, debossed with "15" on one side and "19" on other side. Aripiprazole tablets 20 mg are white to off-white, round, uncoated tablets, debossed with "20" on both sides. Aripiprazole tablets 30 mg are white to off-white, round, uncoated tablets, debossed with "30" on one side and "21" on other side. Tablets Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
Lake Erie Medical DBA Quality Care Products LLC
----------
17 PATIENT COUNSELING INFORMATION
See Medication Guide
Discuss the following issues with patients prescribed aripiprazole:
Clinical Worsening of Depression and Suicide Risk
Patients, their families, and their caregivers should be encouraged to
be alert to the emergence of anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia
(psychomotor restlessness), hypomania, mania, other unusual changes in
behavior, worsening of
depression, and suicidal ideation, especially early during
antidepressant treatment and when the dose is
adjusted up or down. Families and caregivers of patients should be
advised to look for the emergence of
such symptoms on a day-to-day basis, since changes may be abrupt. Such
symptoms should be reported
to the patient's prescriber or health professional, especially if they
are severe, abrupt in onset, or were not
part of the patient's presenting symptoms. Symptoms such as these may
be associated with an increased
risk for suicidal thinking and behavior and indicate a need for very
close monitoring and possibly changes
in the medication [see WARNINGS AND PRECAUTIONS (5.2)].
Prescribers or other health professionals should inform patients,
their families, and their caregivers about
the benefits and risks associated with treatment with aripiprazole and
should counsel them in its
appropriate use. A patient Medication Guide including information
about "Antidepressant Medicines,
Depression and other Serious Mental Illness, and Suicidal Thoughts or
Actions" is available for
aripiprazole. The prescriber or health professional should instruct
patients, their families, and their
caregivers to read the Medication Guide and should assist them in
understanding its contents. Patients
should be given the opportunity to discuss the contents of the
Medication Guide and to obtain answers to
any questions they may have. It should be noted that aripiprazole is
not approve

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIPIPRAZOLE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ARIPIPRAZOLE TABLETS.
ARIPIPRAZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED
PSYCHOSIS
AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS
_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death.
Aripiprazole is not approved for the treatment of patients with
dementia-related psychosis. (5.1 )
Increased risk of suicidal thinking and behavior in children,
adolescents, and young adults taking antidepressants.
Monitor for worsening and emergence of suicidal thoughts and
behaviors. (5.3 )
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes (5.6) 12/2014
INDICATIONS AND USAGE
Aripiprazole tablets are an atypical antipsychotic. The oral
formulations are indicated for: (1)
Schizophrenia (14.1 )
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I
(14.2 )
DOSAGE AND ADMINISTRATION
Initial
Dose
Recommended
Dose
Maximum
Dose
Schizophrenia – adults (2.1)
10 to 15 mg/day
10 to 15 mg/day
30 mg/day
Schizophrenia – adolescents
(2.1)
2 mg/day
10 mg/day
30 mg/day
Bipolar mania – adults:
monotherapy (2.2)
15 mg/day
15 mg/day
30 mg/day
Bipolar mania – adults:
adjunct to lithium or valproate (2.2)
10 to 15 mg/day
15 mg/day
30 mg/day
Bipolar mania – pediatric
patients: monotherapy or as an adjunct to lithium or
valproate (2.2)
2 mg/day
10 mg/day
30 mg/day
Oral formulations: Administer once daily without regard to meals (2 )
Known CYP2D6 poor metabolizers: Half of the usual dose (2.7 )
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3 )
CONTRAINDICATIONS
Known hypersensitivity to