Pronunciation:

ar-i-PIP-ra-zole

Brand Names:

• Abilify

Dosage Forms:

• Solution

Warnings:

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 with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and 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. Not approved for use in pediatric patients with depression .

Classifications:

Therapeutic—

Antipsychotic

Uses of This Medicine:

Aripiprazole is used to treat agitation that occurs with schizophrenia (a mental disorder) or bipolar I disorder (manic-depressive illness). This medicine should NOT be used to treat behavior problems in older adult patients who have dementia.

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

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 aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

Pregnancy—

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.

• 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.

• Hydromorphone
• Milnacipran

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.

• Carbamazepine
• Ketoconazole
• Quinidine

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. 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:

• Alcohol abuse, history of or
• Diabetes, or family history of or
• Drug abuse or dependence, history of or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures, history of—May make these conditions worse and cause serious side effects.

• Alzheimer's disease or
• Dementia—Should not be used in patients with these conditions. .

• Aspiration pneumonia, risk or history of—Use with caution. May increase risk of side effects.

• Blood vessel disease or
• Dehydration 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
• Myocardial infarction (heart attack), history of—Risk of hypotension is increased with this medicine, which can make these conditions worse.

• Exposure to extreme heat or
• Strenuous exercise—May increase the risk of heat stroke because aripiprazole changes the body's ability to cool itself.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It will be given as a shot into one of your muscles.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits to allow for changes in your dose and help reduce any unwanted effects.

Aripiprazole may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some children, teenagers, and young adults to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, 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; barbiturates; medicines for seizures; 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.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble in 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.

This medicine may cause tardive dyskinesia (a movement disorder). 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.

Dizziness, light-headedness, 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. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

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 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

high or low blood pressure

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

shortness of breath

skin rash

tightness in the chest

unusual tiredness or weakness

wheezing

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

Symptoms of overdose

Bigger, dilated, or enlarged pupils (black part of the eye)

diarrhea

increased sensitivity of eyes to light

lack or loss of strength

nausea

sleepiness or unusual drowsiness

vomiting

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

anxiety

belching

difficulty having a bowel movement (stool)

dry mouth

fear

fever

headache

heartburn

hyperventilation

inability to sit still

indigestion

irritability

light-headedness

need to keep moving

nervousness

rash

runny nose

shaking

sleeplessness

sore throat

stomach discomfort, upset, or pain

trouble sleeping

unable to sleep

weight gain

Less common

Accidental injury

bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

congestion

constipation

coughing

difficulty with moving

dryness or soreness of throat

hoarseness

increased appetite

increased salivation

joint pain

muscle aching or cramping

muscle pains or stiffness

rapid weight gain

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.