Opipza

Opipza is used to treat schizophrenia in adults and children who are at least 13 years old.

Opipza is also used in children who are at least 6 years old to treat Tourette's disorder, or irritability related to autistic disorder.

Opipza is also used alone or with a mood stabilizer to treat manic or mixed episodes of bipolar disorder in adults and children who are at least 10 years old.

Opipza is also used with antidepressant medication to treat major depressive disorder in adults.

Some forms of aripiprazole are only for specific conditions.

Opipza may also be used for other purposes not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

You may take Opipza with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Measure liquid medicine with the measuring device provided (not a kitchen spoon).

Remove an orally disintegrating tablet or oral film from the package with dry hands only when you are ready to use the medicine. Let the medicine dissolve in your mouth without chewing, do not split.

Your doctor will need to check your progress regularly.

Your blood sugar will need to be checked regularly, and you may need other medical tests.

If you are also using antidepressant medicine, do not stop using it suddenly or you could have unpleasant symptoms. Ask your doctor before stopping the antidepressant.

Store at room temperature away from moisture and heat. Discard any oral solution not used within 6 months after opening the bottle.

People with depression or mental illness may have thoughts about suicide. Some young people may have more suicidal thoughts when they first start taking a medicine for depression. Tell your doctor immediately if you notice any sudden changes in your mood or behavior, or if you have thoughts about suicide.

Opipza is not approved for use in older adults with dementia-related psychosis.

You should not take Opipza if you are allergic to it.

Opipza may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you have or have ever had:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures;
• low white blood cell (WBC) counts; or
• high cholesterol or triglycerides.

The oral solution (liquid) contains sugar.

The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU). Ask your doctor about your risk.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using Opipza.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use Opipza, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Opipza may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• seizure;
• feeling unusually hot;
• drops in blood pressure or feeling light-headed when standing up;
• trouble swallowing;
• weight gain;
• abnormal blood tests (high cholesterol or triglycerides);
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough; or
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Opipza. Talk with your doctor if this occurs.

Common side effects of Opipza may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• anxiety, uncontrolled muscle movements such as tremors or feeling restless;
• nausea, vomiting, constipation;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• fever, cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too quickly from a sitting or lying position, or you may feel dizzy. Avoid driving or doing dangerous activities until you know how Opipza will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Avoid getting too hot or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are taking Opipza.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect Opipza, especially:

• blood pressure medications; or
• a benzodiazepine sedative like lorazepam.

This list is not complete, and many other drugs may affect Opipza. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.