What is Aripiprazole?

Warning: Increased Mortality In Elderly Patients With Dementia-Related Psychosis And Suicidal Thoughts And Behaviors With Antidepressant DrugsElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis .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 .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 .The safety and efficacy of aripiprazole have not been established in pediatric patients .

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 Abilify® oral solution was withdrawn from the market on May 15, 2015 and this dose form is not marketed by any generic manufacturers.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Swallow the tablets whole. Do not break, crush, or chew them.

Abilify Mycite® has a sensor in the tablet, which helps track it inside the stomach or bowels. The Abilify Mycite® System comes with a patch (wearable sensor), a smartphone application (app), and a web-based portal. Follow your doctor's instructions on how to use the medicine.

The Abilify Mycite® tablet is usually detected within 30 minutes after you take it, but there may be a delay of more than 2 hours for the smartphone app and web portal to detect that you have taken the medicine, and sometimes it might not be detected at all.

To apply the Abilify Mycite® patch:

• The app will tell you when to apply or remove the patch. It should be changed weekly or sooner as needed.
• Place the patch to the left side of your body just above the lower edge of your rib cage. Do not put the patch in areas where the skin is scraped, cracked, inflamed, or irritated, or near the area where you had removed the previous patch. The app will help you place the patch in the correct location.
• You may keep the patch on when showering, swimming, or exercising.

Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor's instructions.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets and orally disintegrating tablets):
  • For bipolar mania:
    • Abilify® and Abilify Discmelt®:
      • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    • Abilify Mycite®:
      • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For depression:
    • Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For irritability in children with autistic disorder:
    • Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For schizophrenia:
    • Abilify® and Abilify Discmelt®:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • Abilify Mycite®:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For Tourette's disorder:
    • Children 6 to 18 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If the Abilify Mycite® tablet is not detected on the app or portal after you take it, do not repeat the dose.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children younger than 13 years of age with schizophrenia and in children younger than 10 years of age with bipolar disorder. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Abilify Mycite® in children. Safety and efficacy have not been established.

Aripiprazole is not approved for use in children or teenagers with major depression.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children 6 to 17 years of age with autistic disorder.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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
• Ketoconazole
• 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
• Benzhydrocodone
• 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
• Deutetrabenazine
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fentanyl
• Fingolimod
• Flecainide
• Flibanserin
• Fluoxetine
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Leuprolide
• Levofloxacin
• Levorphanol
• Lofexidine
• Lopinavir
• Loxapine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mefloquine
• Meperidine
• Methadone
• Metronidazole
• Mifepristone
• Milnacipran
• Mitotane
• Mizolastine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osimertinib
• Oxycodone
• Oxymorphone
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Periciazine
• Perphenazine
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Remifentanil
• Ribociclib
• Rifampin
• Rilpivirine
• Risperidone
• Ritonavir
• Sertindole
• Sertraline
• 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
• Terbinafine
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zuclopenthixol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Depression or
• Diabetes, or family history of or
• Drug abuse or dependence, history of or
• Hyperglycemia (high blood sugar) or
• Neuroleptic malignant syndrome (NMS), history of or
• Neutropenia (low white blood cells) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Blood vessel disease or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (decrease in blood volume) or
• Ischemic heart disease, history of or
• Trouble with swallowing—Use with caution. May cause side effects to become worse.

• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may increase the amount of sugar in your blood. Also, the oral liquid form contains sugar. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Do not change the dose or stop taking this medicine without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.