ABILIFY DISCMELT(Aripiprazole) - America[美国药品]

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ABILIFY DISCMELT(Aripiprazole)

2015-08-29 10:18:38 来源: 作者: 【大中小】浏览:405次评论:0条

Generic Name and Formulations:
Aripiprazole 15mg; oral disintegrating tabs; vanilla flavor; contains phenylalanine.

Company:
Otsuka America Pharmaceutical, Inc.
Indications for ABILIFY DISCMELT:
Acute and maintenance treatment of manic or mixed episodes in bipolar I disorder as monotherapy; or as an adjunct to lithium or valproate. Adjunct to antidepressants for major depressive disorder (MDD). Irritability associated with autistic disorder.

Adult:
Discmelt: Dissolve on tongue; take without liquids. Bipolar disorder: initially 15mg once daily; may increase to max 30mg/day; maintenance: 15mg/day or 30mg/day (see full labeling for duration of therapy). Adjunct to MDD: initially 2–5mg/day; may adjust by 5mg/day increments at intervals of ≥1 week; usual range: 2–15mg/day. Reduce aripiprazole dose by at least ½ with CYP3A4 inhibitors or CYP2D6 inhibitors. Double aripiprazole dose (max 30mg/day) with CYP3A4 inducers. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.

Children:
<10yrs: not recommended. Bipolar disorder: 10–17yrs: initially 2mg/day, then increase to 5mg/day after 2 days, then increase to target dose of 10mg/day after 2 days. Subsequent dose increases may be adjusted by increments of 5mg/day; max 30mg/day. Maintenance: continue at lowest dose to maintain remission; see full labeling. Irritability w. autistic disorder: 6–17yrs: initially 2mg/day, then increase to 5mg/day; adjust dose by 5mg/day at ≥1 week intervals; usual range 5–15mg/day.

Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Reeva luate periodically. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Avoid alcohol. Caution with other centrally-acting drugs. Potentiates antihypertensives. Levels may be reduced by CYP3A4 inducers (eg, carbamazepine). Levels may be increased by CYP3A4 inhibitors (eg, ketoconazole) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

See Also:
ABILIFY

Aripiprazole Oral Solution

Pharmacological Class:
Atypical antipsychotic.

Adverse Reactions:
Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.

How Supplied:
Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Discmelt—30; Oral solution—contact supplier
Indications for ABILIFY DISCMELT:
Schizophrenia. Tourette's disorder.

Adult:
Discmelt: Dissolve on tongue; take without liquids. Initially 10mg or 15mg once daily; may increase at intervals of at least 2 weeks; usual maintenance 15mg/day; max 30mg/day. Reduce aripiprazole dose by at least ½ with CYP3A4 inhibitors or CYP2D6 inhibitors. Double aripiprazole dose (max 30mg/day) with CYP3A4 inducers. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.

Children:
<13yrs: not recommended. Schizophrenia: 13–17yrs: initially 2mg daily, then increase to 5mg after 2 days, then increase to target dose of 10mg after 2 days. Subsequent doses may be adjusted by increments of 5mg/day; max 30mg/day. Maintenance: continue at lowest dose to maintain remission; see full labeling. Tourette's disorder: 6–18yrs: <50kg: initially 2mg/day, then increase to target dose of 5mg/day after 2 days. May increase to 10mg/day if optimal control of tics not achieved. Adjust doses at intervals >1 week. ≥50kg: initially 2mg/day for 2 days, then increase to 5mg/day for 5 days, then increase to target dose of 10mg/day on day 8. May increase to 20mg/day if optimal control of tics not achieved. Adjust dose by 5mg/day at >1 week intervals.