Aripiprazole (Intramuscular route)

Pronunciation:

ar-i-PIP-ra-zole

Brand Names:

Abilify
Abilify Asimtufii
Abilify Maintena

Dosage Forms:

Powder for Suspension, Extended Release
Suspension, Extended Release

Warnings:

Intramuscular route(Powder for Suspension;Suspension, Extended Release)

Increased Mortality In Elderly Patients With Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.Aripiprazole extended-release suspension for IM injection is not approved for the treatment of patients with dementia-related psychosis .

Intramuscular route(Solution)

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.Closely monitor all anti-depressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber .

Classifications:

Therapeutic—

Antipsychotic

Uses of This Medicine:

Aripiprazole injection is used to treat agitation caused by schizophrenia or bipolar mania.

Aripiprazole extended-release injection is used to treat schizophrenia (a mental disorder) and bipolar disorder (manic-depressive illness). It works in the brain to change how certain chemicals affect patients. Aripiprazole is an antipsychotic agent.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of this medicine in elderly patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving aripiprazole injection. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

Breast-feeding—

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.

Other medicines—

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 receiving 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.

Bepridil
Bromopride
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Levoketoconazole
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.

Abametapir
Abiraterone Acetate
Adagrasib
Alfentanil
Alfuzosin
Alprazolam
Amiodarone
Amisulpride
Amitriptyline
Anagrelide
Apalutamide
Apomorphine
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Bedaquiline
Bentazepam
Benzhydrocodone
Boceprevir
Bromazepam
Buprenorphine
Bupropion
Buserelin
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Carbamazepine
Ceritinib
Cetirizine
Chlordiazepoxide
Chloroquine
Chlorpromazine
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clorazepate
Clothiapine
Cloxazolam
Clozapine
Cobicistat
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Dabrafenib
Daridorexant
Darunavir
Dasatinib
Degarelix
Delamanid
Delorazepam
Desipramine
Deslorelin
Desvenlafaxine
Deutetrabenazine
Dexmedetomidine
Diazepam
Dihydrocodeine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Droperidol
Duloxetine
Ebastine
Efavirenz
Encorafenib
Entrectinib
Enzalutamide
Eribulin
Erythromycin
Escitalopram
Esketamine
Estazolam
Famotidine
Fedratinib
Felbamate
Fentanyl
Fexinidazole
Fingolimod
Flecainide
Flibanserin
Flunitrazepam
Fluoxetine
Flurazepam
Formoterol
Foscarnet
Fosnetupitant
Fosphenytoin
Fostemsavir
Gabapentin
Gabapentin Enacarbil
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halazepam
Halofantrine
Haloperidol
Histrelin
Hydrocodone
Hydromorphone
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Idelalisib
Iloperidone
Imipramine
Indinavir
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Josamycin
Ketamine
Ketazolam
Lacosamide
Lapatinib
Lefamulin
Lemborexant
Lenvatinib
Leuprolide
Levocetirizine
Levofloxacin
Levorphanol
Lofexidine
Lonafarnib
Lopinavir
Loprazolam
Lorazepam
Lormetazepam
Loxapine
Lumacaftor
Lumefantrine
Macimorelin
Magnesium Oxybate
Mavacamten
Medazepam
Mefloquine
Meperidine
Metaclazepam
Methadone
Metronidazole
Mibefradil
Midazolam
Mifepristone
Mirtazapine
Mitotane
Mizolastine
Mobocertinib
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nalbuphine
Nefazodone
Nelfinavir
Netupitant
Nilotinib
Nitrazepam
Nordazepam
Norfloxacin
Octreotide
Ofloxacin
Olanzapine
Omaveloxolone
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxazepam
Oxycodone
Oxymorphone
Ozanimod
Pacritinib
Paliperidone
Panobinostat
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Periciazine
Perphenazine
Phenobarbital
Phenytoin
Pimavanserin
Pinazepam
Pipamperone
Pitolisant
Ponesimod
Potassium Oxybate
Prazepam
Pregabalin
Primidone
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quazepam
Quetiapine
Quinidine
Quinine
Quizartinib
Ranolazine
Relugolix
Remifentanil
Remimazolam
Ribociclib
Rifampin
Rifapentine
Rilpivirine
Risperidone
Ritonavir
Ropeginterferon Alfa-2b-njft
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John's Wort
Sufentanil
Sulpiride
Sunitinib
Tacrolimus
Tamoxifen
Tapentadol
Telaprevir
Telavancin
Telithromycin
Temazepam
Terbinafine
Tetrabenazine
Tetrazepam
Tolterodine
Topiramate
Toremifene
Tramadol
Trazodone
Triazolam
Triclabendazole
Trimipramine
Triptorelin
Troleandomycin
Tucatinib
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Zolpidem
Zuclopenthixol
Zuranolone

Other interactions—

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

Other medical problems—

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:

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

Depression or
Diabetes, or family history of or
Dyslipidemia (high cholesterol or fats in the blood) or
Hyperglycemia (high blood sugar) or
Neuroleptic malignant syndrome (NMS), history of or
Neutropenia (low white blood cells) or
Reduced white blood cell count, history of or
Seizures, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It will be given as a shot into a muscle in your arm or buttock.

This injection is given together with the oral medicine for the first dose. The second dose and the injections that follow are given instead of the oral medicine. Be sure to keep all appointments for the injections.

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

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Be sure to keep all appointments for the injections.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and help reduce any unwanted effects. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase risk for stroke in elderly patients with dementia. Tell your doctor right away if you have confusion, difficulty in speaking, slow speech, inability to speak, inability to move the arms, legs, or facial muscles, double vision, or headache while using this medicine.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may add to the effects of alcohol and other medicines that make you drowsy or less alert. Some examples of these medicines are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics (medicines that numb), including some dental anesthetics. If you are taking any of these medicines, make sure you tell your doctor before you receive aripiprazole injection.

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

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, 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). Check with your doctor right away if you have 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, including 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 suddenly 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. Avoid places that are very hot. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

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 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common: Difficulty with speaking; drooling; loss of balance control; muscle trembling, jerking, or stiffness; restlessness; shuffling walk; stiffness of the limbs; twisting movements of the body; uncontrolled movements, especially of the face, neck, and back

Less common: Blurred vision; dizziness; fast, pounding, or irregular heartbeat or pulse; headache; inability to move the eyes; increased blinking or spasms of the eyelid; nervousness; pounding in the ears; sticking out the tongue; trouble breathing or swallowing; unusual facial expressions

Rare: Fast heartbeat; high fever; increased sweating; lip smacking or puckering; loss of bladder control; muscle spasm or jerking of all extremities; puffing of the cheeks; rapid or worm-like movements of the tongue; seizures; severe muscle stiffness; sudden loss of consciousness; tiredness; uncontrolled chewing movements; uncontrolled movements of the arms and legs; unusually pale skin

Incidence not known: Black, tarry stools; chest pain or tightness; cough; hives or welts, itching, or skin rash; itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; redness of the skin; sore throat; sores, ulcers, or white spots on the lips or in the mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose: Infection from breathing foreign substance into the lungs; seizure that will not stop; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Belching; difficulty having a bowel movement; dry mouth; fear; fever; heartburn; hyperventilation; inability to sit still; indigestion; irritability; lightheadedness; need to keep moving; runny nose; shaking; stomach discomfort, upset, or pain; trouble sleeping; weight gain

Less common: Accidental injury; bloating or swelling of the face, arms, hands, lower legs, or feet; body aches or pain; congestion; difficulty with moving; hoarseness; increased appetite; joint pain; muscle aching or cramping; muscle pains or stiffness; sneezing; stuffy nose; swollen joints; tender, swollen glands in the neck; tingling of the hands or feet; tremor; unusual weight gain or loss; voice changes

Incidence not known: Hiccups

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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