Abilify Discmelt

Name: Abilify Discmelt

Uses For Abilify Discmelt

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 Abilify® oral solution was withdrawn from the market on May 15, 2015 and this dose form is not marketed by any generic manufacturers.

What do I need to tell my doctor BEFORE I take Abilify Discmelt?

  • If you have an allergy to aripiprazole or any other part of Abilify Discmelt.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Abilify Discmelt, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Abilify Discmelt. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Abilify Discmelt.

Review Date: October 4, 2017

Uses of Abilify Discmelt

Abilify Discmelt is a prescription medication used to treat:

  • schizophrenia in people age 13 years and older
  • bipolar I disorder in people age 10 years and older, including:
    • manic or mixed episodes that happen with bipolar I disorder
    • manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate
    • long-term treatment of bipolar I disorder
  • major depression in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone
  • irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old
  • agitation associated with schizophrenia or bipolar disorder

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Abilify Discmelt Precautions

Serious side effects have been reported with Abilify Discmelt including the following

  • neuroleptic malignant syndrome (NMS). Tell your healthcare provider right away if you have some or all of the following symptoms of this life-threatening nervous system disorder:
    • high fever
    • stiff muscles
    • confusion
    • sweating
    • changes in pulse, heart rate, and blood pressure
  • high blood sugar. Increases in blood sugar can happen in some people who take Abilify Discmelt.
    Call your healthcare provider if you have any of these symptoms of high blood sugar while taking Abilify Discmelt:
    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused, or your breath smells fruity
  • Increase in weight. Weight gain has been reported in patients taking medicines like Abilify Discmelt, so you and your healthcare provider should check your weight regularly. For children and adolescent patients (6 to 17 years of age) weight gain should be compared against that expected with normal growth.
  • difficulty swallowing. This may lead to aspiration and choking.
  • tardive dyskinesia. Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking Abilify Discmelt. Tardive dyskinesia may also start after you stop taking Abilify Discmelt.
  • orthostatic hypotension (decreased blood pressure). Lightheadedness or fainting can occur when rising too quickly from a sitting or lying position.
  • Low white blood cell count
  • Seizures (convulsions)
  • Problems controlling your body temperature so that you feel too warm. Avoid getting over-heated or dehydrated. Do not over-exercise. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much or heavy clothing. Drink plenty of water while taking Abilify Discmelt.

Important information about antidepressant medicines:

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how Abilify Discmelt affects you. Abilify Discmelt may make you drowsy. Do not drink alcohol while taking Abilify Discmelt.

Precautions

US BOXED WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS
-ELDERLY PATIENTS with dementia-related psychosis are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the 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 death appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., 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 finding 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. This drug is not approved for the treatment of patients with dementia-related psychosis.
-SUICIDALITY: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults compared to placebo in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of this drug in a child, adolescent, or young adult must balance this risk with the clinical need. Studies did not show an increase in the risk of suicidality in adults age 24 or older. 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 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.

Safety and efficacy of immediate-release aripiprazole have not been established:
-In patients younger than 18 years with major depressive disorder or agitation associated with schizophrenia or bipolar mania.
-In patients younger than 13 years with schizophrenia
-In patients younger than 10 years with bipolar I disorder
-In patients younger than 6 years with irritability associated with autistic disorder or Tourette's disorder

Safety and efficacy of extended-release IM aripiprazole have not been established in patients younger than 18 years.
Safety and efficacy of extended-release aripiprazole lauroxil have not been established in patients over 65 years.

Consult WARNINGS section for additional precautions.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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