aripiprazole 10 mg tablet with sensor and strip

Generic name:
Aripiprazole tablet with sensor and patch - kit

Pronunciation
(AR-i-PIP-ra-zole)

Brand name(s)
Abilify Mycite

If you are using aripiprazole in combination with other medication to treat depression, also carefully read the drug information for the other medication.

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

This product is a combination of aripiprazole tablets and a patch. Each tablet has an embedded sensor, and the patch detects the signal from the tablet sensor. You will use it with a smartphone application (app). Your health care professional or caregiver will also be able to see data from the tablet sensor in a web-based portal. Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazole belongs to a class of drugs known as atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for obsessive-compulsive disorder.

Read the Medication Guide provided by your pharmacist before you start taking aripiprazole and each time you get a refill. Before using this product, download the smartphone app and follow all the Instructions for Use. Make sure the app works with your smartphone. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole. Do not split, crush, or chew the tablets. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Apply the patch when instructed to do so by the smartphone app. The patch should be applied just above the lower edge of your rib cage. Do not place the patch on skin that is scraped, cracked, or irritated. Change the placement each time so the patch is not on the same spot where the last patch was placed. Leave the patch on when showering, swimming, or exercising. The smartphone app will tell you when to change the patch (weekly or sooner). If you have skin irritation, remove the patch and tell your doctor right away. If you are going to have an MRI test, you will need to remove your patch before the test and apply a new patch afterward. (See also Precautions section.)

The tablet is usually detected by the patch and smartphone app within 30 minutes after you take it, but it could take as long as 2 hours. Sometimes the tablet might not be detected at all. If this happens, do not repeat your dose.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It may take several weeks before you get the full benefit of this drug. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Dizziness, lightheadedness, drowsiness, nausea, vomiting, tiredness, excess saliva/drooling, blurred vision, weight gain, constipation, headache, and trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fainting
• mental/mood changes (such as increased anxiety, depression, suicidal thoughts)
• trouble swallowing
• restlessness (especially in the legs)
• shaking (tremor)
• muscle spasm
• mask-like expression of the face
• seizures
• trouble controlling certain urges (such as gambling, sex, eating or shopping)
• interrupted breathing during sleep

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may rarely cause a condition called tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms:

• fever
• muscle stiffness/pain/tenderness/weakness
• severe tiredness
• severe confusion
• sweating
• fast/irregular heartbeat
• dark urine
• signs of kidney problems (such as change in the amount of urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• problems with blood flow in the brain (such as cerebrovascular disease, stroke)
• diabetes (including family history)
• heart problems (such as low blood pressure, coronary artery disease, heart failure, irregular heartbeat)
• nervous system problems (such as dementia, NMS, seizures)
• obesity
• low white blood cell count (including history of low white blood cell count caused by medications)
• swallowing problems
• breathing trouble during sleep (sleep apnea)

This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

If you are going to have an MRI test, tell testing personnel that you are using this patch. This patch may contain metals that can cause serious burns during an MRI. You will need to remove your patch before the test and apply a new patch afterward.

Older adults may be more sensitive to the side effects of this drug, especially seizures, drowsiness, dizziness, lightheadedness, confusion, tardive dyskinesia, swallowing problems, and other serious (rarely fatal) side effects. (See also Warning section.) Drowsiness, dizziness, lightheadedness, and confusion can increase the risk of falling.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms such as muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor promptly.

Since untreated mental/mood problems (such as bipolar disorder, schizophrenia) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away about the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• metoclopramide

Tell your doctor or pharmacist if you are using other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: very fast heartbeat, loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as blood sugar, weight, cholesterol/triglyceride levels) may be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store the tablets at room temperature away from light and moisture. Store the patches (wearable sensor) in a cool place or at room temperature away from light and moisture. Check the manufacturer's information for recommended storage details. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.