Abilify

Abilify (aripiprazole) is an antipsychotic medication used to treat schizophrenia, bipolar I disorder, major depressive disorder, Tourette's disorder, and autistic disorder in certain patients. Abilify helps to improve symptoms in these conditions by changing the activity of dopamine and serotonin in the brain.

Abilify belongs to a class of medications called atypical antipsychotics.

Abilify is also available as Abilify Maintena, an injection given once a month, and Abilify Asimtufii, a long-acting injection administered every 2 months.

Abilify generic name is aripiprazole, and generic tablets and injections are available.

Abilify tablets are used to treat:

• Schizophrenia in adults and children at least 13 years old. Schizophrenia is a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions.
• Bipolar I disorder, to treat acute manic and mixed episodes in adults and children at least 10 years old.
• Major depressive disorder (MDD) in adults, when used together with antidepressant medication
• Tourette's disorder in patients 6 to 17 years old.
• Autistic disorder, to treat symptoms of irritability in patients 6 to 18 years old.

Abilify tablets can be taken with or without food. Swallow the tablet whole and do not crush, chew, or break it.

Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will need to check your progress on a regular basis.

If you also use 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.

Strengths available

Abilify 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets.

Abilify has a boxed warning for:

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis. In this group of patients, there is an increased risk of incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities). For this reason, Abilify is not approved for use in older adults with dementia-related psychosis.

• Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults. 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. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Warnings and precautions

Abilify has a warning for Neuroleptic Malignant Syndrome (NMS). 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.

Other warnings and precautions include tardive dyskinesia, metabolic changes (hyperglycemia, dyslipidemia, weight gain), pathological gambling, compulsive behaviors, orthostatic hypotension, leukopenia, neutropenia, agranulocytosis, seizures or convulsions, and potential for cognitive and motor impairment.

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

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

To make sure this medicine is safe for you, tell your doctor if you have:

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

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.

Aripiprazole can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Pregnancy

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.

Breastfeeding

Ask a doctor if it is safe to breastfeed while using this medicine. Using this medicine during pregnancy may reduce your breast milk supply. If you breastfeed, watch your baby closely for signs of dehydration and poor weight gain.

Common Abilify side effects

The most common side effects of Abilify may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• uncontrolled muscle movements, shaking, anxiety, feeling restless;
• weight gain;
• nausea, vomiting, constipation, or loss of bowel control;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat;

Serious Abilify side effects

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

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.

Other serious side effects can occur. 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);
• 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 - fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; 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 this medicine. Talk with your doctor if this occurs.

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 almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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), weak or shallow breathing, fainting, or coma.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking Abilify, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Taking Abilify with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many 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 other medicines you use.

Active ingredient: aripiprazole

Inactive ingredients: Cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Colorants: ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake