Abilify MEDICINE

 Generic Name: aripiprazole (AR i PIP ra zole)

Brand Name: Abilify, Abilify Discmelt

What is Abilify?

Abilify (aripiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Abilify is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression). It is not known if aripiprazole is safe or effective in children younger than 13 with schizophrenia, or children younger than 10 with bipolar disorder.

Abilify is also used together with other medicines to treat major depressive disorder in adults.

Abilify is also used in children 6 years or older who have Tourette's disorder, or symptoms of autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

Warnings

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

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor will need to check your progress at regular visits while you are using Abilify. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

Before taking this medicine

You should not take Abilify if you are allergic to aripiprazole.

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

To make sure Abilify is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• heart disease, high or low blood pressure, heart rhythm problems;

• high cholesterol or triglycerides (a type of fat in the blood);

• low white blood cell (WBC) counts;

• a heart attack or stroke;

• seizures or epilepsy;

• trouble swallowing;

• a personal or family history of diabetes; or

• an obsessive-compulsive disorder, impulse-control disorder, or addictive behaviors.

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

The liquid form (oral solution) of this medication may contain up to 15 grams of sugar per dose. Before taking Abilify oral solution, tell your doctor if you have diabetes.

Abilify may cause you to have high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking this medicine.

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant, do not stop taking Abilify without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of aripiprazole on the baby.

Aripiprazole can pass into breast milk. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take Abilify?

Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not take Abilify for longer than 6 weeks unless your doctor has told you to.

Abilify can be taken with or without food.

Swallow the regular tablet whole and do not crush, chew, or break the tablet. Do not split the Abilify Discmelt orally disintegrating tablet.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the orally disintegrating tablet (Discmelt):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

• Use dry hands to remove the tablet and place it in your mouth.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If needed, you may drink liquid to help swallow the dissolved tablet.

Use Abilify regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

You should not stop using Abilify suddenly. Stopping suddenly may make your condition worse.

Your doctor will need to check your progress while you are using this medicine.

Store at room temperature away from moisture and heat. Abilify liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), trouble breathing, or fainting.

What to avoid

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.

Abilify side effects

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

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• mask-like appearance of the face, trouble swallowing, problems with speech;

• seizure (convulsions);

• thoughts about suicide or hurting yourself;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• low blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, red or swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, weight loss.

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

Common Abilify side effects may include:

• blurred vision;

• increased saliva or drooling;

• muscle stiffness;

• uncontrolled muscle movements, shaking, anxiety, feeling restless;

• weight gain;

• nausea, vomiting, constipation;

• increased or decreased appetite;

• headache, dizziness, drowsiness, feeling tired;

• sleep problems (insomnia); or

• 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 

What other drugs will affect Abilify?

Taking Abilify with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many other drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Abilify.