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Abilify Mycite (Generic Aripiprazole)

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WARNING

Important word of caution for elderly people with dementia:

Studies have shown that older adults who take antipsychotics (medications for mental illness) like aripiprazole have an increased risk of dying while receiving treatment. Dementia is a brain disorder that affects memory, thinking clearly, communication, and daily activities as well as possibly causing changes in mood and personality. Additionally, older persons with dementia may be more likely to experience a stroke, ministroke, or other serious adverse effects while receiving medication.

The Food and Drug Administration (FDA) has not approved aripiprazole for the management of behavioural issues in dementia-affected older individuals. If you, a family member, or someone you care for has dementia and is taking aripiprazole, speak with the doctor who recommended it. Visit the FDA website at http://www.fda.gov/Drugs for further details.

Important word of caution for those who are depressed:

A few youngsters, teenagers, and young adults (up to 24 years old) who were given antidepressants during clinical research developed suicide thoughts (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental diseases may have a higher risk of committing suicide than those who do not take these medications. However, experts disagree on how significant this risk is and how much it has to be taken into account when determining whether or not a kid or adolescent should take an antidepressant. Aripiprazole is often not prescribed for use in treating depression in people under the age of 18, however in some circumstances, a doctor may determine that it is the most effective treatment option.

Even if you are an adult above the age of 24, you should be aware that taking aripiprazole or other antidepressants may cause unanticipated changes in your mental health. Suicidal thoughts may come to mind, especially at the start of treatment and whenever your dose is changed. Any of the following symptoms should prompt you, your family, or your carer to call your doctor immediately away: Depression that is either new or worsening, thoughts of self-harm or suicide, plans or attempts to do so, excessive worry, agitation, panic attacks, trouble falling or keeping asleep, aggressive behaviour, irritability, acting without thinking, intense restlessness, and mania (frenzied, abnormally excited mood). Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

While you are taking aripiprazole, your doctor will want to visit you frequently, especially at the start of your treatment. Be sure to show up for all of your doctor’s appointment times.

When you start aripiprazole therapy, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The FDA website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) also offers the Medication Guide.

No of your age, you, your parent, or your carer should discuss the advantages and disadvantages of treating your disease with an antidepressant or with alternative treatments with your doctor before starting an antidepressant. The dangers and advantages of not treating your ailment should also be discussed. You should be aware that your chance of committing suicide is significantly increased if you suffer from depression or any mental disorder. This risk is increased if you or a family member currently has, or previously had, mania, bipolar disorder (which causes mood swings between depression and extreme excitement), or if you have ever considered or really tried to commit suicide. Discuss your ailment, symptoms, and personal and family medical history with your doctor. What kind of treatment is best for you will be decided by both you and your doctor.

Why is this medication prescribed?

Aripiprazole is used to treat the symptoms of schizophrenia in adults and adolescents 13 years of age and older. Schizophrenia is a mental condition that causes disturbed or strange thinking, loss of interest in life, and strong or inappropriate emotions. Additionally, it is used to treat mixed episodes (manic and depressive symptoms co-occurring) in adults, adolescents, and children 10 years of age and older who have bipolar disorder, either by itself or in combination with other drugs (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). When an antidepressant is unable to control a patient’s symptoms on its own, aripiprazole is also used to treat depression. Children with autism disorder between the ages of 6 and 17 are also treated with aripiprazole (a developmental problem that causes difficulty communicating and interacting with others). These kids’ irritable behaviour, such as hostility, temper tantrums, and frequent mood swings, may be controlled by aripiprazole. Children with Tourette’s disorder aged 6 to 18 are also treated with aripiprazole (a condition characterised by the need to perform repeated motions or to repeat sounds or words). Atypical antipsychotics are a class of drugs that includes aripiprazole. It functions by altering the way that a few organic brain chemicals behave.

How should this medicine be used?

Aripiprazole is available in three different oral dosage forms: tablets, liquid solutions, and swiftly dissolving oral tablets. Typically, it is taken once day, with or without food. Aripiprazole should be taken every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Aripiprazole should be used as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

The orally disintegrating tablet should not be pushed through the foil. Instead, peel aside the foil wrapper with your dry hands. Take the tablet out right away, and put the entire thing on your tongue. Avoid attempting to break the tablet. Without a beverage, the tablet can be eaten and will immediately dissolve. The orally disintegrating pill can, if necessary, be taken with drink.

Do not divide, crush, or chew the tablets or the tablet with a sensor; instead, swallow them whole.

The wearable sensor patch that detects a signal from the tablet and the smartphone application (app) that displays information about how you are taking the medication are included with the tablets that include small sensors. Before you begin taking the prescription, you must download the app into your smartphone. Only when instructed to do so by the smartphone app, apply your patch to the left side of your body over the lower edge of your rib cage. Placement of the patch must not overlap the area of the most recent patch or be done in locations where the skin is scraped, cracked, inflammatory, or irritated. If necessary, change the patch every week or sooner. The software instructs you on how to properly instal and remove the patch and serves as a reminder when it needs to be changed. When taking a shower, swimming, or working out, keep the patch on. Remove the patch and replace it with a new one as soon as you can if you’re having an MRI (a medical test that utilises strong magnets to take photos of the inside of the body). Remove the patch and notify your doctor if it irritates your skin. Within 30 to 2 hours of taking the drug, the app can find the tablets in your body. Do not take another dose if the tablet is not found after intake. If you have any queries regarding how to use the patch, smartphone app, or tablets, consult your doctor.

Aripiprazole dosage may be progressively increased or decreased by your doctor based on how well the drug works for you and any side effects you encounter.

Although it won’t treat your disease, aripiprazole may help you manage your symptoms. You might not experience the full benefits of aripiprazole for two weeks or longer. Aripiprazole should be used even if you feel fine. Without consulting your doctor, do not discontinue taking aripiprazole.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking aripiprazole,

  • If you have an allergy to aripiprazole, any other drugs, or any of the ingredients in aripiprazole preparations, let your doctor and pharmacist know right away. For a list of the ingredients, ask your doctor or pharmacist or consult the Medication Guide.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: fluoxetine (Prozac, Sarafem), itraconazole (Onmel, Sporanox), ketoconazole, antihistamines, bupropion (Wellbutrin), clarithromycin (Biaxin), and ritonavir (Norvir) are HIV protease inhibitors. Other medications include antidepressants (mood elevators), antifungals, antifungal medications, antifungals, antifungals, antifungals; ipratropium (Atrovent); drugs for ulcers, irritable bowel syndrome, mental illness, motion sickness, Parkinson’s disease, or urinary issues; sedatives; some seizure drugs, such as carbamazepine (Carbatrol, Epitol, Tegretol, and others), phenobarbital, and phenytoin (Dilantin, Phenytek); sleeping pills; nefazodone; paroxetine (Paxil, Pexeva); pioglitazone (Actos, in Oseni); quinidine (in Nuedexta); tranquillizers; and telithromycin (Ketek; no longer sold in the United States). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all the drugs you are taking, including any not on this list, as many other drugs may also interact with aripiprazole.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • If you have persistent diarrhoea or vomiting or believe you may be dehydrated, contact your doctor right away. Additionally, let your doctor know if you currently or ever had any of the following conditions: difficulty staying balanced, dyslipidemia (high cholesterol levels), heart disease, heart failure, a heart attack, an irregular heartbeat, high or low blood pressure, a stroke, a ministroke, seizures, low white blood cell count, high blood pressure, high or low blood cholesterol, high blood sugar, or any condition that makes it difficult for you to swallow. Inform your doctor if you or any family members currently use or have previously used illicit substances, excessively abused alcohol or prescription medications, have diabetes, OCPD, ICD, bipolar disorder, or an impulsive personality. Additionally, let your doctor know if you’ve ever had to stop using a mental health medicine due to serious adverse effects.
  • If you are pregnant, particularly if you are in the last few months of your pregnancy, if you plan to get pregnant, or if you are breastfeeding, let your doctor know. Call your doctor if you get pregnant while taking aripiprazole. If aripiprazole is taken in the final months of pregnancy, it may have negative effects on babies after birth.
  • Inform your doctor or dentist that you are taking aripiprazole if you are undergoing surgery, including dental surgery.
  • You should be aware that aripiprazole may cause you to feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that drinking alcohol can make the drowsiness this medicine causes worse. When using aripiprazole, avoid drinking alcohol.
  • Even if you do not already have diabetes, you should be aware that taking this drug may cause hyperglycemia (increases in blood sugar). Aripiprazole and comparable drugs may increase the chance of developing diabetes if you have schizophrenia, which increases your risk compared to persons without the condition. If you experience any of the following side effects while taking aripiprazole: severe thirst, frequent urination, intense hunger, blurred vision, or weakness, call your doctor right once. Calling your doctor as soon as you experience any of these symptoms is crucial because untreated high blood sugar can result in the deadly disease known as ketoacidosis. If ketoacidosis is not treated right away, it could become life-threatening. Dry mouth, nausea, vomiting, shortness of breath, fruity-smelling breath, and diminished consciousness are all signs of ketoacidosis.
  • You should be aware that aripiprazole may result in lightheadedness, fainting, and dizziness if you stand up suddenly from a laying position. When you initially start taking aripiprazole, this happens more frequently. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • You ought to be aware that aripiprazole can make it more difficult for your body to cool off when it becomes extremely hot. If you want to engage in strenuous activity or be exposed to high temperatures, let your doctor know.
  • The orally disintegrating tablets contain phenylalanine, which should be noted if you have phenylketonuria (PKU), a genetic disorder that requires a particular diet to prevent mental retardation. You should be aware that aripiprazole solution contains sugar if you have diabetes.
  • It’s important to be aware that some people who used drugs like aripiprazole developed gambling issues or other strong compulsive or out-of-character desires or behaviours, like increased sexual urges or behaviours, excessive shopping, or binge eating. If you can’t control your behaviour or you have strong cravings to eat, shop, have sex, or gamble, call your doctor. Informing your family about this risk can enable them to seek medical attention even if you are unaware that your gambling or any other strong cravings or strange actions have become a problem.
  • You should be aware that aripiprazole should only be used as a component of a treatment plan that might also involve counselling and special education for treating youngsters. Make sure your child adheres to all the recommendations made by their physician or therapist.

What special dietary instructions should I follow?

If you plan to consume grapefruit juice while taking this medication, consult your doctor.

While using this medication, make sure you get enough water each day.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be negative effects from aripiprazole. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Nervousness
  • Restlessness
  • Feeling lightheaded, unstable, or having difficulties balancing
  • Heartburn
  • Constipation
  • Diarrhea
  • Abdominal pain
  • Gaining weight
  • Alterations in appetite
  • A rise in salivation
  • Pain, particularly in the joints, arms, or legs
  • Tiredness

Some adverse effects can be very harmful. Call your doctor right away if you notice any of the following symptoms or those detailed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Rash
  • Hives
  • Itching
  • Swelling of the hands, feet, ankles, throat, eyes, cheeks, lips, tongue, and lower legs
  • Breathing or swallowing challenges
  • Seizures
  • Alterations to vision
  • The face, the tongue, or other body parts shaking erratically
  • Perspiration, bewilderment, stiff muscles, or a rapid, thumping, or irregular pulse
  • Coordination issues or a rise in falls
  • Muscles in the neck contracting
  • Throat constriction

Other negative effects of aripiprazole are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. The oral disintegrating tablets, the solution, and the tablets should all be kept at room temperature and away from sources of extreme heat and moisture (not in the bathroom). Use the orally disintegrating pills right away after opening the sealed container in which they were packaged. The sensor-equipped tablets should be kept at room temperature and away from areas with significant humidity. Any unused aripiprazole solution should be thrown away six months after opening the bottle or as soon as the date on the bottle has expired, whichever comes first.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Drowsiness
  • Weakness
  • Widening eyes (black circles in the middle of the eyes)
  • Nausea
  • Vomiting
  • Alterations in heartbeat
  • Movements you’re unable to control
  • Confusion
  • Seizures
  • Consciousness loss

What other information should I know?

Keep all of your appointments with your physician and the lab. Prior to and throughout the course of your aripiprazole medication, your doctor may prescribe laboratory testing.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Abilify®
  • Abilify Mycite®
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