Prescription Drug Information: ARIPIPRAZOLE (Page 9 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Aripiprazole tablets, USP have markings and are available in the strengths and packages listed in Table 32.

Table 32: Aripiprazole Tablet Presentations
Tablet Strength Tablet Color/Shape Tablet Markings Pack Size NDC Code

2 mg

Bottle of 30

43547-302-03

white to off-white

“2” on one side and

Bottle of 90

43547-302-09

capsule-shaped

“P” on the other side

Bottle of 100

43547-302-10

Bottle of 500

43547-302-50

5 mg

Bottle of 30

43547-303-03

pink

“5” on one side and

Bottle of 90

43547-303-09

capsule-shaped

“P” on the other side

Bottle of 100

43547-303-10

Bottle of 500

43547-303-50

10 mg

Bottle of 30

43547-304-03

beige

“10” on one side and

Bottle of 90

43547-304-09

capsule-shaped

“P” on the other side

Bottle of 100

43547-304-10

Bottle of 500

43547-304-50

15 mg

Bottle of 30

43547-305-03

pink

“15” on one side and

Bottle of 90

43547-305-09

round

“P” on the other side

Bottle of 100

43547-305-10

Bottle of 500

43547-305-50

20 mg

Bottle of 30

43547-306-03

beige

“20” on one side and

Bottle of 90

43547-306-09

round

“P” on the other side

Bottle of 100

43547-306-10

Bottle of 500

43547-306-50

30 mg

Bottle of 30

43547-307-03

white to off-white

“30” on one side and

Bottle of 90

43547-307-09

round

“P” on the other side

Bottle of 100

43547-307-10

Bottle of 500

43547-307-50

16.2 Storage

Tablets

Store at 20o C to 25o C (68o F to 77o F); excursions permitted between 15o C to 30o C (59o F to 86o F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Discuss the following issues with patients prescribed aripiprazole:

Clinical Worsening of Depression and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.3)].

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with aripiprazole and should counsel them in its appropriate use. A patient Medication Guide including information about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for aripiprazole. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that aripiprazole is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.

Pathological Gambling and Other Compulsive Behaviors

Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Warnings and Precautions (5.7)].

Interference with Cognitive and Motor Performance

Because aripiprazole may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that aripiprazole therapy does not affect them adversely [see Warnings and Precautions (5.12)].

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