ABILIFY (Page 2 of 24)
2.6 Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)
Adults
The recommended dose in these patients is 9.75 mg. The recommended dosage range is 5.25 to 15 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 ABILIFY injection in agitated patients has not been systematically evaluated in controlled clinical trials. 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 [see CLINICAL STUDIES (14. 6)].
If ongoing ABILIFY therapy is clinically indicated, oral ABILIFY in a range of 10 to 30 mg/day should replace ABILIFY injection as soon as possible [see DOSAGE AND ADMINISTRATION (2.1 and 2.2)].
Administration of ABILIFY Injection
To administer ABILIFY Injection, draw up the required volume of solution into the syringe as shown in Table 1. Discard any unused portion.
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.
2.7 Dosage Adjustments for Cytochrome P450 Considerations
Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 2). When the coadministered drug is withdrawn from the combination therapy, ABILIFY dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, ABILIFY dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response.
Factors | Dosage Adjustments for ABILIFY |
Known CYP2D6 Poor Metabolizers | Administer half of usual dose |
Known CYP2D6 Poor Metabolizers taking concomitant strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) | Administer a quarter of usual dose |
Strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) | Administer half of usual dose |
Strong CYP2D6 and CYP3A4 inhibitors | Administer a quarter of usual dose |
Strong CYP3A4 inducers (e.g., carbamazepine, rifampin) | Double usual dose over 1 to 2 weeks |
When adjunctive ABILIFY is administered to patients with major depressive disorder, ABILIFY should be administered without dosage adjustment as specified in DOSAGE AND ADMINISTRATION (2.3).
2.8 Dosing of Oral Solution
The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution [see CLINICAL PHARMACOLOGY (12.3)].
2.9 Dosing of Orally Disintegrating Tablets
The dosing for ABILIFY Orally Disintegrating Tablets is the same as for the oral tablets [see DOSAGE AND ADMINISTRATION (2.1, 2.2, 2.3, and 2.4)].
3 DOSAGE FORMS AND STRENGTHS
ABILIFY® (aripiprazole) Tablets are available as described in Table 3.
Tablet Strength | Tablet Color/Shape | Tablet Markings |
2 mg | green modified rectangle | “A-006” and “2” |
5 mg | blue modified rectangle | “A-007” and “5” |
10 mg | pink modified rectangle | “A-008” and “10” |
15 mg | yellow round | “A-009” and “15” |
20 mg | white round | “A-010” and “20” |
30 mg | pink round | “A-011” and “30” |
ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets are available as described in Table 4.
Tablet Strength | Tablet Color/Shape | Tablet Markings |
10 mg | pink (with scattered specks) round | “A” and “640” “10” |
15 mg | yellow (with scattered specks) round | “A” and “641” “15” |
ABILIFY® (aripiprazole) Oral Solution (1 mg/mL) is a clear, colorless to light-yellow solution, supplied in child-resistant bottles along with a calibrated oral dosing cup.
ABILIFY® (aripiprazole) Injection for Intramuscular Use is a clear, colorless solution available as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) solution in clear, Type 1 glass vials.
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