Tablets
Chemical Name: ARIPIPRAZOLE (AR-i-PIP-ra-zole)
Common uses Abilify is an atypical antipsychotic used
to treat schizophrenia, certain symptoms of bipolar disorder, and irritability associated with autistic disorder.
It is also used along with other medicines to treat depression. It may also be used to treat other conditions as
determined by your doctor.
Before using
WARNING: Abilify is an antipsychotic. It may increase the risk of death when used to treat mental problems
caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Abilify
is not approved to treat mental problems caused by dementia. Antidepressants may increase the risk of suicidal
thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems
may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Abilify
outweigh the risks. Family and caregivers must closely watch patients who take Abilify. It is important to keep in
close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened
depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor. Some
medicines or medical conditions may interact with Abilify. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and
over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you
are taking anticholinergics (such as methscopolamine, benztropine); benzodiazepines (such as lorazepam);
clarithromycin; imidazole antifungals (such as ketoconazole); quinidine; selective serotonin reuptake inhibitors
(SSRIs) (such as fluoxetine); voriconazole; carbamazepine; hydantoins (such as phenytoin); rifampin; alpha-blockers
(such as terazosin); or medicine for high blood pressure. DO NOT START OR STOP any medicine without doctor or
pharmacist approval. Inform your doctor of any other medical conditions including, if you or a family member has a
history of diabetes, you are very overweight, a history of phenylketonuria, a history of heart problems (such as
heart failure, irregular heartbeat, heart attack), low blood pressure, blood vessel problems, stroke, seizures,
dementia, Alzheimer disease, neuroleptic malignant syndrome (NMS), depression or other mental/mood disorders, or
suicidal thoughts or attempts. Inform your doctor of any other medical conditions including dehydration, low blood
volume, trouble swallowing, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of low
white blood cell levels (including low white blood cell levels caused by any medicine). Contact your doctor or
pharmacist if you have any questions or concerns about using Abilify.
Directions Follow the directions for using Abilify
provided by your doctor. Abilify comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration.
Read it carefully each time you refill Abilify. Ask your doctor, nurse, or pharmacist any questions that you may
have about Abilify. Abilify 5mg may be taken on an empty stomach or with food. STORE Abilify at room temperature at
77 degrees F (25 degrees C) in a tightly-closed container, away from heat and light. Brief storage between 59 to 86
degrees F (15 to 30 degrees C) is permitted. Do not store in bathroom. Use Abilify regularly in order to get the
most benefit from it. To help you remember, use it at the same time each day. If your symptoms do not improve or if
they become worse, check with your doctor. CONTINUE TO TAKE Abilify even if you feel well. Do not miss any doses.
IF YOU MISS A DOSE OF Abilify, take it as soon as possible. If it is almost time for your next dose, skip the
missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Cautions DO NOT USE Abilify if you have had an allergic
reaction to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or use more
often than prescribed without checking with your doctor. Lab and/or medical tests may be performed to monitor your
progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. Abilify MAY CAUSE drowsiness,
dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To
prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of these
effects. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react
to Abilify. DO NOT DRINK ALCOHOL while you are using Abilify. Check with your doctor before you use medicines that
may cause drowsiness. DO NOT BECOME OVERHEATED in hot weather, during exercise, or during other activities since
risk of heatstroke may be increased. Abilify MAY LOWER THE ABILITY OF YOUR BODY TO FIGHT INFECTION. Avoid contact
with people who have colds or infections. Tell your doctor if you notice signs of infection (eg, fever, chills,
sore throat). CHILDREN, TEENAGERS, AND YOUNG ADULTS WHO TAKE Abilify may be at increased risk for suicidal thoughts
or actions. Watch all patients who take Abilify closely. Contact the doctor at once if new, worsened, or sudden
symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in
mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
NEUROLEPTIC MALIGNANT SYNDROME (NMS) IS A POSSIBLY FATAL SYNDROME THAT CAN BE CAUSED BY Abilify. Contact your
doctor at once if you have fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and
sweating. SOME PATIENTS WHO USE Abilify MAY DEVELOP MUSCLE MOVEMENTS THAT THEY CANNOT CONTROL. Tell your doctor at
once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw while taking Abilify.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or
pharmacist. CAUTION IS ADVISED when using Abilify in the elderly; they may be more sensitive to its effects. FOR
WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using Abilify during
pregnancy. Using Abilify during the third trimester may result in uncontrolled muscle movements or withdrawal
symptoms in the newborn. Discuss any questions or concerns with your doctor. IT IS UNKNOWN IF Abilify IS EXCRETED
in breast milk. DO NOT BREAST-FEED while taking Abilify. DIABETICS: Abilify may affect your blood sugar. Check
blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Possible side effects SIDE EFFECTS that may occur while
taking Abilify include abnormal dreams; blurred vision; constipation; dizziness; drowsiness; headache; increased
appetite (in children); increased saliva production; lightheadedness; nausea; sore throat (in children); stomach
upset; tiredness; trouble sleeping; vomiting; or weight gain. ABILIFY 5mg MAY INCREASE YOUR RISK OF DEVELOPING
DIABETES or increase blood sugar levels. High blood sugar may make you feel confused, drowsy, or thirsty. It can
also cause increased urination and make you flush, breathe faster, or have a fruit-like breath odor. If these
symptoms occur, tell your doctor right away. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thinking;
chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased
sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, puffing of cheeks,
puckering of mouth, chewing movements); loss of control over urination; loss of coordination; muscle tremor,
jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks,
aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still);
one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or
attempts; swelling of the hands, ankles, or feet; trouble swallowing; trouble walking; unusual bruising; unusual
tiredness or weakness; or vision or speech changes. AN ALLERGIC REACTION TO Abilify IS UNLIKELY, but seek immediate
medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty
breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all
side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your
doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions Drug interactions can result in unwanted
side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your
medicines interact with each other.
If you take too
much OVERDOSE: If overdose is suspected, contact your local poison control center or emergency
room immediately. Symptoms of overdose may include aggression; confusion; fast, slow, or irregular heartbeat; loss
of consciousness; seizures; severe drowsiness, dizziness, or vomiting; tremor; trouble breathing; or unusual mental
changes