Aripiprazole (Oral route)
- Abilify Discmelt
- Tablet, Disintegrating
Warnings:Oral route(Tablet;Tablet, Disintegrating;Solution)
Aripiprazole is not indicated for treatment of dementia-related psychosis due to an increased risk of death seen in the elderly. Increased risk of suicidal thoughts and behavior with antidepressant use in children, adolescents, and young adults under the age of 24 years. Closely monitor patients of all ages for emerging suicidal thoughts and behaviors .
Uses of This Medicine:
Aripiprazole is used alone or together with other medicines to treat mental conditions such as bipolar I disorder (manic-depressive illness), major depressive disorder, and schizophrenia. It is also used in children to treat irritability associated with autistic disorder and Tourette syndrome. Aripiprazole works in the brain to change how certain chemicals affect patients. It is an antipsychotic agent.
This medicine is available only with your doctor's prescription. Abilify® oral solution was withdrawn from the market on May 15, 2015 and this dose form is not marketed by any generic manufacturers.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children younger than 13 years of age with schizophrenia and in children younger than 10 years of age with bipolar disorder. Safety and efficacy have not been established.
Aripiprazole is not approved for use in children or teenagers with major depression.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children 6 to 17 years of age with autistic disorder.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Arsenic Trioxide
- Inotuzumab Ozogamicin
- Morphine Sulfate Liposome
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Depression or
- Diabetes, or family history of or
- Drug abuse or dependence, history of or
- Hyperglycemia (high blood sugar) or
- Neuroleptic malignant syndrome (NMS), history of or
- Neutropenia (low white blood cells) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Blood vessel disease or
- Dehydration or
- Heart attack or stroke, history of or
- Heart disease or
- Heart failure or
- Heart rhythm problems or
- Hypotension (low blood pressure) or
- Hypovolemia (decrease in blood volume) or
- Ischemic heart disease, history of or
- Trouble with swallowing—Use with caution. May cause side effects to become worse.
- Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.
Swallow the tablets whole. Do not break, crush, or chew them.
Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor's instructions.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (tablets and orally disintegrating tablets):
- For bipolar mania:
- Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
- Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For depression:
- Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
- Children—Use and dose must be determined by your doctor.
- For irritability in children with autistic disorder:
- Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For schizophrenia:
- Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
- Children 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For Tourette's disorder:
- Children 6 to 18 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For bipolar mania:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.
For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.
This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.
Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.
Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.
This medicine may increase the amount of sugar in your blood. Also, the oral liquid form contains sugar. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.
This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.
Do not change the dose or stop taking this medicine without checking first with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Difficulty with speaking
- loss of balance control
- muscle trembling, jerking, or stiffness
- shuffling walk
- stiffness of the limbs
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- Less common
- Blurred vision
- inability to move the eyes
- increased blinking or spasms of the eyelid
- pounding in the ears
- slow or fast heartbeat
- sticking out the tongue
- trouble with breathing or swallowing
- unusual facial expressions
- fast heartbeat
- high fever
- high or low blood pressure
- increased sweating
- lip smacking or puckering
- loss of bladder control
- muscle spasm or jerking of all extremities
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- severe muscle stiffness
- sudden loss of consciousness
- uncontrolled chewing movements
- uncontrolled movements of the arms and legs
- unusually pale skin
- Incidence not known
- Hives or welts, itching, or skin rash
- itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- redness of the skin
- tightness in the chest
- unusual tiredness or weakness
- Symptoms of overdose
- Bigger, dilated, or enlarged pupils (black part of the eye)
- fast, pounding, or irregular heartbeat or pulse
- increased sensitivity of the eyes to light
- lack or loss of strength
- sleepiness or unusual drowsiness
- More common
- Acid or sour stomach
- blurred vision
- difficulty having a bowel movement (stool)
- dry mouth
- inability to sit still
- need to keep moving
- runny nose
- sore throat
- stomach discomfort, upset, or pain
- trouble sleeping
- weight gain
- Less common
- Accidental injury
- bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- difficulty with moving
- dryness or soreness of the throat
- increased appetite
- increased salivation
- joint pain
- muscle aching or cramping
- muscle pains or stiffness
- rapid weight gain
- stuffy nose
- swollen joints
- tender, swollen glands in the neck
- tingling of the hands or feet
- unusual weight gain or loss
- voice changes
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017