Aripiprazole (Injection)

Brand Name(s)

Abilify

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using medicine to lower blood pressure, such as hydrochlorothiazide [HCTZ], lisinopril, metoprolol, quinapril, Accupril®, Cozaar®, Diovan®, Lotrel®, Norvasc®, Toprol®, Zestril®.
• Tell your doctor if you are also using carbamazepine (Tegretol®), clarithromycin (Biaxin®), fluoxetine (Prozac®), ketoconazole (Nizoral®), paroxetine (Paxil®), or quinidine.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Introduction

Aripiprazole (ar-i-PIP-ra-zole)

Treats agitation associated with schizophrenia or bipolar disorder (manic or mixed).

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other trained health professional will give you this medicine.
• Your doctor will give you a few doses of this medicine 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.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, or if you have diabetes, heart or blood vessel disease, heart failure, heart rhythm problems, or low blood pressure. Tell your doctor if you have a history of heart attack, stroke, seizures, drug abuse, alcohol abuse, or if you have ever experienced symptoms of neuroleptic malignant syndrome (NMS) in the past.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic episodes with depression) or has tried to commit suicide.
• Do not breastfeed while you are using this medicine.
• Older adults may be more sensitive to the side effects of this medicine, including stroke. Make sure the doctor knows if the person who will be using this medicine has forgetfulness or confusion related to aging (such as Alzheimer's disease or dementia).
• This medicine may raise your blood sugar. Tell your doctor if you have diabetes. It may be necessary to measure your blood sugar more often.
• Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. 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.
• Stop using this medicine and 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 make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when standing or sitting up straight, so stand up or sit up slowly.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• You may get overheated more easily while you are using this medicine. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. Be careful if you exercise often or are in high heat or humidity. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Call your doctor if you drinking cool water and moving away from the heat does not cool you down.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, irritability, nervousness, restlessness, or trouble sleeping.
• Change in how much or how often you urinate.
• Chest pain, fast or slow heartbeat.
• Confusion, unusual behavior, depressed mood, or thoughts of hurting self or others.
• Dry mouth, increased thirst or hunger, or muscle cramps.
• Fever, sweating, confusion, uneven heartbeat, or muscle stiffness.
• Lightheadedness, dizziness, or fainting.
• Seizures or tremors.
• Severe drowsiness or sleepiness.
• Trouble swallowing.
• Twitching or muscle movements you cannot control (often in your face, tongue, or jaw).
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Headache or flu symptoms.
• Nausea, vomiting, or upset stomach.
• Redness, pain, swelling, itching, blistering, or rash where the shot was given.
• Weight gain or loss.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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