ARIPIPRAZOLE- aripiprazole tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

AvPAK

INN (Rahvusvaheline Nimetus):

ARIPIPRAZOLE

Koostis:

ARIPIPRAZOLE 2 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 Neonates exposed to antipsychotic drugs (including aripiprazole tablets) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Adequate and well controlled studies with aripiprazole tablets have not been conducted in pregnant women. Animal reproduction studies were conducted with aripiprazole in rats and rabbits during organogenesis, and in rats during the pre- and post-natal period. Oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses higher than the maximum recommended human dose (MRHD) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses higher than the maximum recommended human dose (MRHD) produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. Administer aripiprazole tablets during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including aripiprazole tablets) during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms. Data Animal Data In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. Pregnant rats were treated with oral doses of 3, 10, and  30 mg/kg/day (1, 3, and 10 times the maximum recommended human dose [MRHD] on a mg/m 2 basis) of aripiprazole during the period of organogenesis. Gestation was slightly prolonged at 30 mg/kg/day. Treatment at the high dose of 30 mg/kg/day caused a slight delay in fetal development (decreased fetal weight), undescended testes, and delayed skeletal ossification (also seen at 10 mg/kg/day). There were no adverse effects on embryofetal or pup survival. Delivered offspring had decreased body weights (10 and 30 mg/kg/day), and increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia at 30 mg/kg (the other dose groups were not examined for these findings). Postnatally, delayed vaginal opening was seen at 10 and 30 mg/kg/day and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) was seen at 30 mg/kg/day. Some maternal toxicity was seen at 30 mg/kg/day however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. Pregnant rabbits were treated with oral doses of 10, 30, and 100 mg/kg/day (2, 3, and 11 times human exposure at MRHD based on AUC and 6, 19, and 65 times the MRHD based on mg/m 2 ) of aripiprazole during the period of organogenesis. At the high dose of 100 mg/kg/day decreased maternal food consumption, and increased abortions were seen as well as increased fetal mortality, decreased fetal weight (also seen at 30 mg/kg/day), increased incidence of a skeletal abnormality (fused sternebrae) (also seen at 30 mg/kg/day). In a study in which rats were treated peri- and post-natally with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the MRHD on a mg/m 2 basis) of aripiprazole from day 17 through day 21 postpartum, slight maternal toxicity, slightly prolonged gestation an increase in stillbirths and, decreases in pup weight (persisting into adulthood) and survival were seen at 30 mg/kg/day. The effect of aripiprazole tablets on labor and delivery in humans is unknown. Aripiprazole is present in human breast milk. Because of the potential for serious adverse reactions in nursing infants from aripiprazole tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight [see CLINICAL PHARMACOLOGY ( 12.3)]. Schizophrenia Safety and effectiveness in pediatric patients with schizophrenia were established in a 6-week, placebo-controlled clinical trial in 202 pediatric patients aged 13 to 17 years [see DOSAGE AND ADMINISTRATION ( 2.1), ADVERSE REACTIONS ( 6.1), and CLINICAL STUDIES ( 14.1)]. Although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. Information describing a clinical study in which efficacy was not demonstrated in patients ages 6 to 17 years is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY® (aripiprazole). Additional pediatric use information in patients ages 6 to 18 years 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 pediatric information. Juvenile Animal Studies Aripiprazole in juvenile rats caused mortality, CNS clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40mg/kg/day from weaning (21 days old) through maturity (80 days old). At 40mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other CNS signs were observed in both genders. In addition, delayed sexual maturation was observed in males. At all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. A No Observed Adverse Effect Level (NOAEL) could not be determined and, at the lowest tested dose of 10mg/kg/day, there is no safety margin relative to the systemic exposures (AUC 0 to 24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. All drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. Aripiprazole in juvenile dogs (2 months old) caused CNS clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. Mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. A NOAEL could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (AUC 0 to 24) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. All drug-related effects were reversible after a 2-month recovery period. No dosage adjustment is recommended for elderly patients [see  BOXED WARNING, WARNINGS AND PRECAUTIONS ( 5.1), and CLINICAL PHARMACOLOGY ( 12.3)]. Of the 13,543 patients treated with oral aripiprazole tablets in clinical trials, 1073 (8%) were ≥65 years old and 799 (6%) were ≥75 years old. Placebo-controlled studies of oral aripiprazole in schizophrenia, other indications did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Aripiprazole tablets are not approved for the treatment of patients with psychosis associated with Alzheimer's disease [see  BOXED WARNINGand WARNINGS AND PRECAUTIONS ( 5.1)] . Dosage adjustment is recommended in known CYP2D6 poor metabolizers due to high aripiprazole concentrations. Approximately 8% of Caucasians and 3 to 8% of Black/African Americans cannot metabolize CYP2D6 substrates and are classified as poor metabolizers (PM) [see DOSAGE AND ADMINISTRATION ( 2.7) and CLINICAL PHARMACOLOGY ( 12.3)]. No dosage adjustment for aripiprazole tablets is required on the basis of a patient's hepatic function (mild to severe hepatic impairment, Child-Pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute) [see CLINICAL PHARMACOLOGY ( 12.3)]. No dosage adjustment for aripiprazole tablets are required on the basis of a patient's sex, race, or smoking status [see CLINICAL PHARMACOLOGY ( 12.3)] Aripiprazole tablet is not a controlled substance. Aripiprazole tablet has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of aripiprazole tablets misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). In physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed.

Toote kokkuvõte:

Aripiprazole tablets, 2 mg are light green to green, modified rectangular, bevel edged biconvex tablets debossed with 'I' on one side and '94' on other side. NDC 50268-087-12 10 Tablets per card, 2 cards per carton Aripiprazole tablets, 5 mg are light blue to blue, modified rectangular, bevel edged biconvex tablets debossed with 'I' on one side and '95' on other side. NDC 50268-088-15 10 Tablets per card, 5 cards per carton Aripiprazole tablets, 10 mg are light pink to pink, modified rectangular, bevel edged biconvex tablets debossed with 'I' on one side and '96' on other side. NDC 50268-089-15 10 Tablets per card, 5 cards per carton Aripiprazole tablets, 15 mg are light yellow to yellow, round, bevel edged biconvex tablets debossed with 'I' on one side and '97' on other side. NDC 50268-090-12 10 Tablets per card, 2 cards per carton Aripiprazole tablets, 20 mg are white to off-white, round, bevel edged biconvex tablets debossed with 'I' on one side and '98' on other side. NDC 50268-091-12 10 Tablets per card, 2 cards per carton Aripiprazole tablets, 30 mg are light pink to pink, round, bevel edged biconvex tablets debossed with 'I' on one side and '99' on other side. NDC 50268-092-12 10 Tablets per card, 2 cards per carton Dispensed in Unit Dose Package.  For Institutional Use Only. Store at 20º to 25º C (68º to 77ºF) [see USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

AvPAK
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MEDICATION GUIDE
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 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 visits with the healthcare provider as
scheduled. Call th

Toote omadused

ARIPIPRAZOLE - ARIPIPRAZOLE TABLET
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ARIPIPRAZOLE TABLETS
RX ONLY
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)
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
MaximumDose
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)
( 5.2)
• _Neuroleptic Malignant Syndrome:_ Manage with immediate
discontinuation and close monitoring ( 5.3)
• _Tardive Dyskinesia:_ Dis