Generic Name: aripiprazole (Intramuscular route)

ar-i-PIP-ra-zole

Intramuscular route(Powder for Suspension)

Elderly 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)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 years or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aripiprazole is not approved for use in pediatric patients with depression .

Commonly used brand name(s)

In the U.S.

  • Abilify
  • Abilify Maintena

Available Dosage Forms:

  • Solution
  • Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Uses For Abilify

Aripiprazole injection is used to treat schizophrenia (a mental disorder), agitation that occurs with schizophrenia, or bipolar I disorder (manic-depressive illness). It works in the brain to change how certain chemicals affect patients. Aripiprazole is an antipsychotic agent.

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This medicine is available only with your doctor's prescription.

Before Using Abilify

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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole injection in elderly patients.

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

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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.

  • Metoclopramide

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.

  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Citalopram
  • Cobicistat
  • Crizotinib
  • Dabrafenib
  • Eslicarbazepine Acetate
  • Hydromorphone
  • Milnacipran
  • Mitotane
  • Morphine
  • Morphine Sulfate Liposome
  • Oxymorphone
  • Piperaquine
  • Siltuximab

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clarithromycin
  • Ketoconazole
  • Quinidine

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 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
  • Seizures, history of—Use with caution. May make these conditions worse.

Proper Use of aripiprazole

This section provides information on the proper use of a number of products that contain aripiprazole. It may not be specific to Abilify. Please read with care.

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.

Your doctor will give you a few doses of the injection until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

The extended-release injection is given together with oral medicine for the first dose. The second dose is given one month later without oral medicine. The injections that follow are given once a month instead of oral medicine. Be sure to keep all appointments.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

The extended-release injection is given once a month instead of oral medicine. Be sure to keep all appointments.

Precautions While Using Abilify

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.

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 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 movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.

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). Stop using this medicine and check with your doctor right away if you have any of the following symptoms while using 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.

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.

Abilify Side Effects

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 with breathing or swallowing
  • unusual facial expressions
Rare
  • Convulsions
  • 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
  • severe muscle stiffness
  • sudden loss of consciousness
  • tiredness
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusually pale skin
Incidence not known
  • Hives or welts
  • itching skin
  • 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
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness

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
  • Acid or sour stomach
  • belching
  • difficulty having a bowel movement (stool)
  • dry mouth
  • fear
  • fever
  • headache
  • heartburn
  • hyperventilation
  • inability to sit still
  • indigestion
  • irritability
  • lightheadedness
  • need to keep moving
  • runny nose
  • shaking
  • sore throat
  • 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
  • coughing
  • difficulty with moving
  • dryness or soreness of the throat
  • 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

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.

See also: Side effects (in more detail)

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