"The US Food and Drug Administration (FDA) has approved an injectable, long-acting version of Alkermes Inc's atypical antipsychotic aripiprazole to treat adults with schizophrenia.
Aripiprazole lauroxil (Aristada) is administere"...
(aripiprazole) Oral Administration and Intramuscular Injection
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS].
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS].
Aripiprazole is a psychotropic drug that is available as ABILIFY®(aripiprazole) Tablets, ABILIFY DISCMELT®(aripiprazole) Orally Disintegrating Tablets, ABILIFY®(aripiprazole) Oral Solution, and ABILIFY®(aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl23O2and its molecular weight is 448.38. The chemical structure is:
ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.
ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, 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 Lake.
ABILIFY Oral Solution is a clear, colorless to light-yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors.
ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 199.5 mg of sulfobutylether b-cyclodextrin (SBECD), 10.4 mg of tartaric acid, qs to pH 4.3 of sodium hydroxide, and qs to 1.33 mL of water for injection.
What are the possible side effects of aripiprazole (Abilify, Abilify Discmelt)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using aripiprazole and call your doctor at once if you have a serious side effect such as:
- fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
- jerky muscle movements you cannot control;
- sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
- fever, chills, body aches, flu symptoms, sores in your mouth and...
What are the precautions when taking aripiprazole (Abilify)?
See also Warning section.
Before taking aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as propylene glycol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems with blood flow in the brain (such as cerebrovascular disease, stroke), diabetes (including family history), heart problems (such as low blood pressure, coronary artery disease, heart failure, irregular heartbeat), nervous system problems (such as dementia, NMS, seizures), obesity, low white blood cell count (including history of low white blood cell count...
Last reviewed on RxList: 1/27/2016
This monograph has been modified to include the generic and brand name in many instances.
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