ARIPIPRAZOLE- aripiprazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Patient Information leaflet (PIL)

07-06-2019

Summary of Product characteristics (SPC)

07-06-2019

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aripiprazole oral 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 tablets are 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)] . Teratogenic Effects 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/pregnancyregistry/. Risk Summary

Product summary:

Aripiprazole tablets USP, 2 mg are light green to green, modified rectangular, bevel edged biconvex tablets debossed with 'I' on one side and '94' on other side. Bottles of 30 Tablets NDC 31722-819-30 Bottles of 100 Tablets NDC 31722-819-01 Blister card of 10 Unit dose tablets NDC 31722-819-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-819-32 Aripiprazole tablets USP, 5 mg are light blue to blue, modified rectangular, bevel edged biconvex tablets debossed with 'I' on one side and '95' on other side. Bottles of 30 Tablets NDC 31722-820-30 Bottles of 100 Tablets NDC 31722-820-01 Blister card of 10 Unit dose tablets NDC 31722-820-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-820-32 Aripiprazole tablets USP, 10 mg are light pink to pink, modified rectangular, bevel edged biconvex tablets debossed with 'I' on one side and '96' on other side. Bottles of 30 Tablets NDC 31722-827-30 Bottles of 100 Tablets NDC 31722-827-01 Blister card of 10 Unit dose tablets NDC 31722-827-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-827-32 Aripiprazole tablets USP, 15 mg are light yellow to yellow, round, bevel edged biconvex tablets debossed with 'I' on one side and '97' on other side. Bottles of 30 Tablets NDC 31722-828-30 Bottles of 100 Tablets NDC 31722-828-01 Blister card of 10 Unit dose tablets NDC 31722-828-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-828-32 Aripiprazole tablets USP, 20 mg are white to off-white, round, bevel edged biconvex tablets debossed with 'I' on one side and '98' on other side. Bottles of 30 Tablets NDC 31722-829-30 Bottles of 100 Tablets NDC 31722-829-01 Blister card of 10 Unit dose tablets NDC 31722-829-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-829-32 Aripiprazole tablets USP, 30 mg are light pink to pink, round, bevel edged biconvex tablets debossed with 'I' on one side and '99' on other side. Bottles of 30 Tablets NDC 31722-830-30 Bottles of 100 Tablets NDC 31722-830-01 Blister card of 10 Unit dose tablets NDC 31722-830-31 Blister pack of 250 (25 x 10) Unit dose tablets NDC 31722-830-32 Store at 20º to 25º C (68º to 77ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
REMEDYREPACK INC.
----------
SPL MEDGUIDE SECTION
Aripiprazole Tablets
(air-eh-PIP-rah-zole)
Read this Medication Guide before you start taking aripiprazole
tablets and each time you get a refill.
There may be new information. This Medication Guide does not take the
place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about
aripiprazole tablets?
(For other side effects, also see "What are the possible side effects
of aripiprazole tablets?").
Serious side effects may happen when you take aripiprazole tablets,
including:
• Increased risk of death in elderly patients with dementia-related
psychosis:
Medicines like aripiprazole 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 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) 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 vis

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Summary of Product characteristics

ARIPIPRAZOLE- ARIPIPRAZOLE TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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 TABLETS ARE 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. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Pathological Gambling and Other Compulsive
Behaviors (5.7) 08/2016
Warnings and Precautions, Falls (5.9) 02/2017
INDICATIONS AND USAGE
Aripiprazole tablets are an atypical antipsychotic. The oral
formulations are indicated for:
•Schizophrenia ( 14.1)
DOSAGE AND ADMINISTRATION
Initial
Dose
Recommended
Dose
Maximum Dose
Schizophrenia – adults (2.1)
10-15
mg/day
10-15
mg/day
30
mg/day
Schizophrenia - adolescents ( 2.1)
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 hypersensititivity to aripiprazole tablets ( 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.

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