DOSAGE AND ADMINISTRATION
ORAL
Schizophrenia
Usual Dose
The recommended starting and target dose for ABILIFY is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should not be made before 2 weeks, the time needed to achieve steady state.
Dosage in Special Populations
Dosage adjustments are not routinely indicated on the basis of age, gender, race, or renal or hepatic impairment status (see CLINICAL PHARMACOLOGY: Special Populations).
Dosage adjustment for patients taking aripiprazole concomitantly with potential CYP3A4 inhibitors: When concomitant administration of ketoconazole with aripiprazole occurs, aripiprazole dose should be reduced to one-half of the usual dose. When the CYP3A4 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased.
Dosage adjustment for patients taking aripiprazole concomitantly with potential CYP2D6 inhibitors: When concomitant administration of potential CYP2D6 inhibitors such as quinidine, fluoxetine, or paroxetine with aripiprazole occurs, aripiprazole dose should be reduced at least to one-half of its normal dose. When the CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased.
Dosage adjustment for patients taking potential CYP3A4 inducers: When a potential CYP3A4 inducer such as carbamazepine is added to aripiprazole therapy, the aripiprazole dose should be doubled (to 20 or 30 mg). Additional dose increases should be based on clinical evaluation. When carbamazepine is withdrawn from the combination therapy, the aripiprazole dose should be reduced to 10 to 15 mg.
Maintenance Therapy
While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, systematic evaluation of patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer, were discontinued from those medications, and were then administered ABILIFY 15 mg/day and observed for relapse during a period of up to 26 weeks, demonstrated a benefit of such maintenance treatment (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients should be periodically reassessed to determine the need for maintenance treatment.
Switching from Other Antipsychotics
There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to ABILIFY or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
Bipolar Disorder
Usual Dose
In clinical trials, the starting dose was 30 mg given once a day. A dose of 30 mg/day was found to be effective when administered as the tablet formulation. Approximately 15% of patients had their dose decreased to 15 mg based on assessment of tolerability. The safety of doses above 30 mg/day has not been evaluated in clinical trials.
Dosage in Special Populations
See Dosage in Special Populations under DOSAGE AND ADMINISTRATION: Schizophrenia.
Maintenance Therapy
While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, patients with Bipolar I Disorder who had been symptomatically stable on ABILIFY Tablets (15 mg/day or 30 mg/day with a starting dose of 30 mg/day) for at least 6 consecutive weeks and then randomized to ABILIFY Tablets (15 mg/day or 30 mg/day) or placebo and monitored for relapse, demonstrated a benefit of such maintenance treatment (see CLINICAL PHARMACOLOGY: Clinical Studies). While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of aripiprazole in such longer-term treatment (ie, beyond 6 weeks).
Oral Solution
The oral solution can be given on a mg-per-mg basis in place of the 5-, 10-, 15-, or 20-mg tablet strengths. Solution doses can be substituted for the tablet doses on a mg-per-mg basis up to 25 mg of the tablet. Patients receiving 30-mg tablets should receive 25 mg of the solution (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Directions for Use of ABILIFY DISCMELT Orally Disintegrating Tablets
Patients should be told the following:
Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT orally disintegrating tablet on the tongue. Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid. Do not attempt to split the tablet.
INTRAMUSCULAR INJECTION
Agitation Associated with Schizophrenia or Bipolar Mania
Usual Dose
The efficacy of aripiprazole injection in controlling agitation in these disorders was demonstrated in a dose range of 5.25 mg to 15 mg. The recommended dose in these patients is 9.75 mg. No additional benefit was demonstrated for 15 mg compared to 9.75 mg. A lower dose of 5.25 mg may be considered when clinical factors warrant. If agitation warranting a second dose persists following the initial dose, cumulative doses up to a total of 30 mg/day may be given. However, the efficacy of repeated doses of aripiprazole injection in agitated patients has not been systematically evaluated in controlled clinical trials. Also, the safety of total daily doses greater than 30 mg or injections given more frequently than every 2 hours have not been adequately evaluated in clinical trials.
If ongoing aripiprazole therapy is clinically indicated, oral aripiprazole in a range of 10 mg to 30 mg/day should replace aripiprazole injection as soon as possible (see PHARMACOLOGY and DOSAGE AND ADMINISTRATION: Schizophrenia or Bipolar Disorder).
Administration of ABILIFY Injection
To administer ABILIFY Injection, draw up the required volume of solution into the syringe as shown in Table 6. Discard any unused portion.
Table 6: ABILIFY Injection Dosing Recommendations | Single-Dose | Required Volume of Solution |
|---|
| 5.25 mg | 0.7 mL |
| 9.75 mg | 1.3 mL |
| 15 mg | 2 mL |
ABILIFY Injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage in Special Populations
See Dosage in Special Populations under DOSAGE AND ADMINISTRATION: Schizophrenia.
|
