Aripiprazole Solution for injection

What is this medicine?

ARIPIPRAZOLE (ay ri PIP ray zole) is an atypical antipsychotic. It is used to treat agitation associated with schizophrenia or bipolar disorder, also known as manic-depression.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dehydration
• dementia
• diabetes
• heart disease
• history of brain tumor, head injury or stroke
• Parkinson's disease
• previous heart attack
• seizures
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to aripiprazole, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• carbamazepine
• charcoal
• erythromycin
• fluoxetine
• grapefruit juice
• itraconazole
• ketoconazole
• paroxetine
• quinidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. It may be several weeks before you see the full effects of this medicine. Do not suddenly stop taking this medicine. You may need to gradually reduce the dose.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase dizziness and drowsiness. Avoid alcoholic drinks.

This medicine can reduce the response of your body to heat or cold. Try not to get overheated or dehydrated from exercise. Avoid temperature extremes, such as saunas, hot tubs, or very hot or cold baths or showers. Dress warmly in cold weather.

If you notice an increased hunger or thirst, different from your normal hunger or thirst, or if you find that you have to urinate more frequently, you should contact your health care provider as soon as possible. You may need to have your blood sugar monitored. This medicine may cause changes in your blood sugar levels. You should monitor your blood sugar frequently if you are a diabetic.

Do not treat yourself for colds, diarrhea or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• confusion
• feeling faint or lightheaded, falls
• fever or chills, sore throat
• increased hunger or thirst
• increased urination
• joint pain
• muscles pain, spasms
• problems with balance, talking, walking
• restlessness or need to keep moving
• seizures
• suicidal thoughts or other mood changes
• trouble swallowing
• uncontrollable head, mouth, neck, arm, or leg movements
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• blurred vision
• constipation
• headache
• nausea, vomiting
• trouble sleeping
• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.