ARIPIPRAZOLE tablet, orally disintegrating

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Zydus Pharmaceuticals (USA) Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 Sum

Tuoteyhteenveto:

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 68382-087-06 in bottle of 30 tablets NDC 68382-087-14 in bottle of 60 tablets NDC 68382-087-16 in bottle of 90 tablets NDC 68382-087-19 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 68382-088-06 in bottle of 30 tablets NDC 68382-088-14 in bottle of 60 tablets NDC 68382-088-16 in bottle of 90 tablets NDC 68382-088-19 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 68382-089-06 in bottle of 30 tablets NDC 68382-089-14 in bottle of 60 tablets NDC 68382-089-16 in bottle of 90 tablets NDC 68382-089-19 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 68382-090-06 in bottle of 30 tablets NDC 68382-090-14 in bottle of 60 tablets NDC 68382-090-16 in bottle of 90 tablets NDC 68382-090-19 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Zydus Pharmaceuticals (USA) Inc.
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MEDICATION GUIDE
Aripiprazole (ar" i pip' ra zole) Orally Disintegrating Tablets, USP
Phenylalanine is a component of aspartame. Each aripiprazole orally
disintegrating tablet
contains the following amounts: 10 mg - 1.12 mg phenylalanine, 15 mg -
1.68 mg
phenylalanine, 20 mg – 2.24 mg phenylalanine and 30 mg – 3.36 mg
phenylalanine.
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

Valmisteyhteenveto

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING
ZYDUS PHARMACEUTICALS (USA) INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIPIPRAZOLE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ARIPIPRAZOLE
ORALLY DISINTEGRATING TABLETS.
ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 2002
WARNING: 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)
INDICATIONS AND USAGE
Aripiprazole is an atypical antipsychotic. The oral formulation is
indicated for:
Schizophrenia (14.1)
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
Orally Disintegrating Tablets: Administer once daily without regard to
meals (2)
Known CYP2D6 poor metabolizers: Half of the usual dose (2.7)
DOSAGE FORMS AND STRENGTHS
Orally Disintegrating Tablets: 10 mg, 15 mg, 20 mg and 30 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to aripiprazole (4)
WARNINGS AND PRECAUTIONS
_Cerebrovascular Adverse Reactions in Elderly Patients with
Dementia-Related Psychosis: _ Increased incidence of
cerebrovascular adverse reactions (e.g., stroke, transient ischemic
attack, including fatalities) (5.2)
_Neuroleptic Malignant Syndrome: _ Manage with immediate
discontinuation and close monitoring (5.4)
_Tardive Dyskinesia: _ Discontinue if cl