Abilify

Name: Abilify

Introduction

Quinolinone derivative;2 5 atypical or second-generation antipsychotic agent.1 2 7 28 89 98

Commonly used brand name(s)

In the U.S.

  • Abilify
  • Abilify Discmelt

Available Dosage Forms:

  • Tablet
  • Tablet, Disintegrating
  • Solution

Therapeutic Class: Antipsychotic

Indications and Usage for Abilify

Abilify Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for the treatment of:

• Schizophrenia [see CLINICAL STUDIES (14.1)] • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see CLINICAL STUDIES (14.2)] • Adjunctive Treatment of Major Depressive Disorder [see CLINICAL STUDIES (14.3)] • Irritability Associated with Autistic Disorder [see CLINICAL STUDIES (14.4)] • Treatment of Tourette’s Disorder [see CLINICAL STUDIES (14.5)]

Abilify Injection is indicated for the treatment of:

• Agitation associated with schizophrenia or bipolar mania [see CLINICAL STUDIES (14.6)]

Descriptions

Aripiprazole is used alone or together with other medicines to treat mental conditions such as bipolar I disorder (manic-depressive illness), major depressive disorder, and schizophrenia. It is also used in children to treat irritability associated with autistic disorder and Tourette syndrome. Aripiprazole works in the brain to change how certain chemicals affect patients. It is an antipsychotic agent.

This medicine is available only with your doctor's prescription. Abilify® oral solution was withdrawn from the market on May 15, 2015 and this dose form is not marketed by any generic manufacturers.

This product is available in the following dosage forms:

  • Tablet
  • Tablet, Disintegrating
  • Solution

What is Abilify, and how does it work (mechanism of action)?

Abilify (aripiprazole) is an anti-psychotic medicine used for the medical treatment of psychotic conditions and disorders such as schizophrenia and bipolar disorder. It also is used with other medications for the treatment of major depression in adults.

The exact mechanism of action of Abilify is unknown. However, like other anti-psychotics, it blocks receptors on nerves in the brain for several neurotransmitters (chemicals that nerves use to communicate with each other). It is thought that its beneficial effect is due to its effects on dopamine and serotonin receptors. Its effects on these receptors are complex, involving stimulation of the receptors but to a lesser degree than the naturally-occurring neurotransmitters (a process called partial agonism).

Why is this medication prescribed?

Aripiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used alone or with other medications to treat episodes of mania or mixed episodes (symptoms of mania and depression that happen together) in adults, teenagers, and children 10 years of age and older with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Aripiprazole is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Aripiprazole is also used to treat children 6 to 17 years of age who have autistic disorder (a developmental problem that causes difficulty communicating and interacting with others). Aripiprazole may help control irritable behavior such as aggression, temper tantrums, and frequent mood changes in these children. Aripiprazole is also used to treat children 6 to 18 years of age who have Tourette's disorder (a condition characterized by the need to perform repeated motions or to repeat sounds or words). Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking aripiprazole

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking aripiprazole it is important that your doctor knows:

  • If you are pregnant or breast-feeding.
  • If you have a heart condition or blood vessel disease.
  • If you have had a stroke, or if you have been told you have 'thickening' of the blood vessels to your brain.
  • If you have liver, kidney, or prostate problems.
  • If you have any problems with your breathing.
  • If you have any of the following: epilepsy, depression, Parkinson's disease, raised pressure in your eye (glaucoma) or a condition which causes muscle weakness, called myasthenia gravis.
  • If you have ever had yellowing of your skin or the whites of your eyes (jaundice) or a blood disorder.
  • If you have a tumour on your adrenal gland (a condition called phaeochromocytoma).
  • If you have had an allergic reaction to a medicine.
  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.

Description

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-(2,3dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and 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 199.5mg of sulfobutylether β-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.

Uses of Abilify

Oral and Immediate-Release Injectable:

Abilify is a prescription medication used to treat:

  • schizophrenia in people age 13 years and older
  • bipolar I disorder in people age 10 years and older, including:
    • manic or mixed episodes that happen with bipolar I disorder
    • manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate
    • long-term treatment of bipolar I disorder
  • major depression in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone
  • irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old
  • agitation associated with schizophrenia or bipolar disorder

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Abilify Food Interactions

Grapefruit and grapefruit juice may interact with Abilify and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Bromopride
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Boceprevir
  • Bromazepam
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Butorphanol
  • Carbamazepine
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Codeine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Dihydrocodeine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxylamine
  • Droperidol
  • Ebastine
  • Efavirenz
  • Enzalutamide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imipramine
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Meperidine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Milnacipran
  • Mitotane
  • Mizolastine
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Panobinostat
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Perflutren Lipid Microsphere
  • Periciazine
  • Perphenazine
  • Phenytoin
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Remifentanil
  • Rifampin
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zuclopenthixol

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), trouble breathing, or fainting.

What other drugs will affect Abilify?

Taking Abilify with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many other drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Abilify.

Upsides

  • Used to relieve symptoms of psychosis and agitation associated with schizophrenia and manic or mixed episodes of bipolar I disorder.
  • May also be used in addition to other medications in the treatment of depression.
  • May be used to reduce irritability associated with Autistic disorder.
  • Reduces tic severity in Tourette's syndrome.
  • Available as a tablet, an orally disintegrating tablet, an oral solution, and an extended-release intramuscular injection.
  • Generic aripiprazole is available.
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