ABILIFY (Page 13 of 14)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ABILIFY® (aripiprazole) Tablets have markings on one side an are available in the strengths and packages listed in Table 32.
|Tablet Strength||Tablet Color/Shape||Tablet Markings||Pack Size||NDC Code|
|2 mg||greenmodified rectangle||“A-006” and “2”||Bottle of 30||59148-006-13|
|5 mg||bluemodified rectangle||“A-007” and “5”||Bottle of 30Blister of 100||59148-007-1359148-007-35|
|10 mg||pinkmodified rectangle||“A-008” and “10”||Bottle of 30Blister of 100||59148-008-1359148-008-35|
|15 mg||yellowround||“A-009” and “15”||Bottle of 30Blister of 100||59148-009-1359148-009-35|
|20 mg||whiteround||“A-010” and “20”||Bottle of 30Blister of 100||59148-010-1359148-010-35|
|30 mg||pinkround||“A-011” and “30”||Bottle of 30Blister of 100||59148-011-1359148-011-35|
ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets are round tablets with markings on either side. ABILIFY DISCMELT is available in the strengths and packages listed in Table 33.
|Tablet Strength||Tablet Color||Tablet Markings||Pack Size||NDC Code|
|10 mg||pink (with scattered specks)||“A” and “640””10″||Blister of 30||59148-640-23|
|15 mg||yellow (with scattered specks)||“A” and “641””15″||Blister of 30||59148-641-23|
ABILIFY® (aripiprazole) Oral Solution (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. ABILIFY Oral Solution is available as follows:
|150 mL bottle||NDC 59148-013-15|
ABILIFY® (aripiprazole) Injection for intramuscular use is available as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) solution in clear, Type 1 glass vials as follows:
|9.75 mg/1.3 mL single-dose vial||NDC 59148-016-65|
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Opened bottles of ABILIFY Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.
Store at 25ºC (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light by storing in the original container. Retain in carton until time of use.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Discuss the following issues with patients prescribed ABILIFY:
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 ABILIFY 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 ABILIFY. 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 ABILIFY 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)].
Use of Orally Disintegrating Tablet
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.
Interference with Cognitive and Motor Performance
Because ABILIFY 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 ABILIFY therapy does not affect them adversely [see Warnings and Precautions (5.12)].
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7)].
Heat Exposure and Dehydration
Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.13)].
Patients should be advised that each mL of ABILIFY Oral Solution contains 400 mg of sucrose and 200 mg of fructose.
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ABILIFY. Advise patients that ABILIFY may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ABILIFY during pregnancy [see Use in Specific Populations (8.1)].
Phenylalanine is a component of aspartame. Each ABILIFY DISCMELT Orally Disintegrating Tablet contains the following amounts: 10 mg, 1.12 mg phenylalanine and 15 mg, 1.68 mg phenylalanine.
Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
Orally Disintegrating Tablets, Oral Solution, and Injection manufactured by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA
ABILIFY is a registered trademark of Otsuka Pharmaceutical Co., Ltd.
© 2022, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
|ABILIFY® (a BIL ĭ fī) (aripiprazole) Tablets||ABILIFY® (a BIL ĭ fī) (aripiprazole)Orally Disintegrating Tablets||ABILIFY® (a BIL ĭ fī) (aripiprazole) Oral Solution||ABILIFY® (a BIL ĭ fī)(aripiprazole) Injection, for intramuscular use|
|This Medication Guide has been approved by the U.S. Food and Drug Administration||Revised: 08/2019|
|What is the most important information I should know about ABILIFY?(For other side effects, also see “What are the possible side effects of ABILIFY?“)Serious side effects may happen when you take ABILIFY, including: |
| What is ABILIFY? |
|Do not take ABILIFY if you are allergic to aripiprazole or any of the ingredients in ABILIFY. See the end of this Medication Guide for a complete list of ingredients in ABILIFY.|
|Before taking ABILIFY, tell your healthcare provider about all your medical conditions, including if you have or had: |
| How should I take ABILIFY? |
| What should I avoid while taking ABILIFY? |
| What are the possible side effects of ABILIFY?ABILIFY may cause serious side effects, including: |
| || |
|The most common side effects of ABILIFY in children include:|
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|These are not all the possible side effects of ABILIFY.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store ABILIFY? Store ABILIFY at room temperature, between 68°F to 77°F (20°C to 25°C). |
|General information about the safe and effective use of ABILIFY Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals.|
|What are the ingredients in ABILIFY?Active ingredient: aripiprazoleInactive ingredients:Tablets: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum LakeABILIFY DISCMELT Orally Disintegrating Tablets: acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum LakeABILIFY Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavorsFor more information about ABILIFY go to www.abilify.com or call 1-800-438-6055.Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 JapanOrally Disintegrating Tablets, Oral Solution, and Injection manufactured by Bristol-Myers Squibb Company, Princeton, NJ 08543 USADistributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USAABILIFY is a trademark of Otsuka Pharmaceutical Company.© Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan|
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