ARIPIPRAZOLE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Healthcare Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aripiprazole orally disintegrating tablets are indicated for the treatment of: -   Schizophrenia [see Clinical Studies (14.1)] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY® (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 Exposure Registry   There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. Risk

Product summary:

Aripiprazole Orally Disintegrating Tablets USP,10 mg are white to off-white, capsule-shaped, uncoated tablets debossed with 'ZF 41' on one side and plain on the other side and are supplied as follows: NDC 70771-1432-3 in bottle of 30 tablets NDC 70771-1432-6 in bottle of 60 tablets NDC 70771-1432-9 in bottle of 90 tablets NDC 70771-1432-1 in bottle of 120 tablets Aripiprazole Orally Disintegrating Tablets USP, 15 mg are white to off-white, round-shaped, biconvex, uncoated tablets debossed with 'ZF 42' on one side and plain on other side and are supplied as follows: NDC 70771-1433-3 in bottle of 30 tablets NDC 70771-1433-6 in bottle of 60 tablets NDC 70771-1433-9 in bottle of 90 tablets NDC 70771-1433-1 in bottle of 120 tablets Aripiprazole Orally Disintegrating Tablets USP, 20 mg are white to off-white, barrel-shaped, uncoated tablets debossed with 'ZF 43' on one side and plain on the other side and are supplied as follows: NDC 70771-1434-3 in bottle of 30 tablets NDC 70771-1434-6 in bottle of 60 tablets NDC 70771-1434-9 in bottle of 90 tablets NDC 70771-1434-1 in bottle of 120 tablets Aripiprazole Orally Disintegrating Tablets USP, 30 mg are white to off-white, round-shaped, biconvex, uncoated tablets, debossed with 'ZF 44' on one side and plain on other side and are supplied as follows: NDC 70771-1435-3 in bottle of 30 tablets NDC 70771-1435-6 in bottle of 60 tablets NDC 70771-1435-9 in bottle of 90 tablets NDC 70771-1435-1 in bottle of 120 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
Cadila Healthcare Limited
----------
MEDICATION GUIDE
Aripiprazole (AR-i-PIP-ra-zole) Orally Disintegrating Tablets, USP
What is the most important information I should know about
aripiprazole orally disintegrating tablets?
(For other side effects, also see "What are the possible side effects
of aripiprazole orally disintegrating
tablets?").
Serious side effects may happen when you take aripiprazole orally
disintegrating tablets, including:
•
Increased risk of death in elderly patients with dementia-related
psychosis: Medicines like
aripiprazole orally disintegrating tablets can raise the risk of death
in elderly people who have lost
touch with reality (psychosis) due to confusion and memory loss
(dementia). Aripiprazole orally
disintegrating tablets are not approved for the treatment of patients
with dementia-related psychosis.
•
Risk of suicidal thoughts or actions: Antidepressant medicines,
depression and other serious mental
illnesses, and suicidal thoughts or actions:
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and
young adults within the first few months of treatment
2.
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is
changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts,
or feelings.
•
Keep all follow-up visits with the healthcare provider as schedule

Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
CADILA HEALTHCARE LIMITED
----------
ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1432-9
Aripiprazole Orally Disintegrating Tablets, 10 mg
90 tablets
Rx only
NDC 70771-1433-9
Aripiprazole Orally Disintegrating Tablets, 15 mg
90 tablets
Rx only
NDC 70771-1434-9
Aripiprazole Orally Disintegrating Tablets, 20 mg
90 tablets
Rx only
NDC 70771-1435-9
Aripiprazole Orally Disintegrating Tablets, 30 mg
90 tablets
Rx only
ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:70 771-1432
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ARIPIPRAZO LE (UNII: 8 2VFR53I78 ) (ARIPIPRAZOLE - UNII:8 2VFR53I78 )
ARIPIPRAZOLE
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ASPARTAME (UNII: Z0 H242BBR1)
CALCIUM STEARATE (UNII: 776 XM70 47L)
MANNITO L (UNII: 3OWL53L36 A)
PEPPERMINT (UNII: V9 5R5KMY2B)
CRO SPO VIDO NE (UNII: 2S78 30 E56 1)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
S CORE
no sco re
S HAP E
CAPSULE (CAPSULE)
S IZ E
8 mm
FLAVOR
PEPPERMINT (FLAVOR FIRMENICH POWDER PEPPERMINT)
IMPRINT CODE
ZF;41
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:70 771-1432-3
30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 2/0 6 /20 19
2
NDC:70 771-1432-6
6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 2/0 6 /20 19
3
NDC:70 771-1432-9
9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 2/0 6 /20 19
4
NDC:70 771-1432-1
120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 2/0 6 /20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
ANDA
ANDA0 9 0 16 5
0 2/0 6 /20 19
ARIPIPRAZOLE
aripiprazole tablet, orally disintegrating
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:70 771-1433
ROUTE OF ADMIN