Abilify Discmelt

Name: Abilify Discmelt

Precautions While Using Abilify Discmelt

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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • If you are planning to harm yourself or the want to harm yourself gets worse.
  • Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
  • Very bad dizziness or passing out.
  • Change in balance.
  • Feeling very tired or weak.
  • Seizures.
  • Blurred eyesight.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • Some people who take this medicine may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if Abilify Discmelt (aripiprazole orally disintegrating tablets) is stopped. Sometimes, signs may lessen or go away over time after this medicine is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take Abilify Discmelt or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

How do I store and/or throw out Abilify Discmelt?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Use oral-disintegrating tablet right after opening. Throw away any part of opened pouch that is not used.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Abilify Discmelt Food Interactions

Grapefruit and grapefruit juice may interact with Abilify Discmelt and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Abilify Discmelt and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Abilify Discmelt Dosage

Take Abilify Discmelt exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended dose varies depending upon which condition is being treated as well as other factors.

The recommended dose for Abilify Discmelt is 10 mg or 15 mg by mouth daily. The target dose for adolescents is 10 mg/day.

The dose may be increased to a maximum of 30 mg daily after 2 weeks.

Other Requirements

  • Store Abilify Discmelt at room temperature.
  • Keep Abilify Discmelt and all medicines out of the reach of children.

Abilify Discmelt FDA Warning

Talk to your doctor or your pharmacist about the following black box warning for this medication:

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive aripiprazole or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aripiprazole is not approved for use in pediatric patients with depression.

Usual Adult Dose for Schizophrenia

Immediate-release: The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
Initial Dose: 10 or 15 mg orally once a day
Target Dose: 10 to 15 mg per day; effective dose range 10 to 30 mg per day; however, clinical trials have not found doses exceeding 10 or 15 mg per day to be more effective; dose increases, if needed should be at 2-week intervals to allow time to achieve steady state
Maximum Dose: 30 mg per day

Aripiprazole Extended-Release IM Suspension [Abilify Maintena(R)]:
Initial dose: 400 mg IM; continue aripiprazole 10 to 20 mg orally once a day for 14 days
Maintenance Dose: 400 mg IM once a month; should not be given sooner than 26 days after the previous injection

Aripiprazole Lauroxil Extended-Release IM Suspension [Aristada(TM)]:
-For patients stable on oral aripiprazole 10 mg per day: Initial dose 441 mg IM; continue aripiprazole 10 mg orally once a day for 21 days
-For patients stable on oral aripiprazole 15 mg per day: Initial dose 662 mg IM; continue aripiprazole 15 mg orally once a day for 21 days
-For patients stable on oral aripiprazole 20 mg per day or higher: Initial dose 882 mg IM; continue aripiprazole dose orally once a day for 21 days
Maintenance Doses: 441 mg, 662 mg, or 882 mg IM monthly or 882 mg IM every 6 weeks; should not be given sooner than 14 days after the previous injection

Comments:
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and for patients taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.
-Prior to initiating therapy with extended-release IM formulations, establish tolerability with oral formulation; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
-Dose regimen adjustments (including addition of oral supplementation) will be needed for missed doses; see dose adjustments section.

Use: For the treatment of schizophrenia

Usual Pediatric Dose for Autism

Age: 6 to 17 years: Dose should be individualized according to tolerability and response.
Initial dose: 2 mg orally once a day
Dose titration: Increase dose to 5 mg orally once a day, with subsequent increases to 10 mg or 15 mg orally once a day if needed; dose adjustments in increments of up to 5 mg per day should occur at intervals of no less than 1 week.
Maximum Dose: 15 mg orally once a day

Comments: The efficacy of maintenance treatment of irritability associated with autistic disorder has not been evaluated; patients should be periodically reassessed to determine need for continued treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Use: Treatment of irritability associated with autistic disorder (including aggression, deliberate self injurious behavior, temper tantrums, and quickly changing moods):

Before taking this medicine

You should not take Abilify Discmelt if you are allergic to it.

Abilify Discmelt is not approved for use in psychotic conditions related to dementia. This medicine may increase the risk of death in older adults with dementia-related conditions.

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

  • 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);

  • a history of low white blood cell (WBC) counts;

  • a history of heart attack or stroke;

  • seizures or epilepsy;

  • trouble swallowing;

  • a personal or family history of diabetes; or

  • a history of 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 Discmelt oral solution, tell your doctor if you have diabetes.

Abilify Discmelt 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 Discmelt 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 Abilify Discmelt on the baby.

Aripiprazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

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.

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