Sandoz Aripiprazole
(aripiprazole)
How does this medication work? What will it do for me?
Aripiprazole belongs to the group of medications known as antipsychotics. It is used to treat schizophrenia and bipolar disorder. Aripiprazole may also be used in addition to other medications to treat major depressive disorder for adults who have not had enough of a response from previous treatments.
Aripiprazole does not cure these medical conditions, but helps to manage symptoms by affecting the actions of certain chemical messengers in the brain.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
How should I use this medication?
For schizophrenia, the recommended adult dose is 10 mg or 15 mg taken once a day, with or without food. Some people may require higher doses. If your doctor decides that a higher dose is needed, increases should only be made after 2 weeks. The maximum daily dose is 30 mg daily.
The recommended starting dose for adolescents (15 to 17 years) to treat schizophrenia is 2 mg daily, gradually increased to 10 mg daily, taken once a day.
For bipolar disorder, the recommended initial dose for adults is 15 mg daily with or without food. Based on response, the dose can be increased to a maximum of 30 mg daily.
The recommended starting dose for adolescents (13 to 17 years) to treat bipolar disorder is 2 mg daily, gradually increased to 10 mg daily, taken once a day.
For major depressive disorder, the recommended starting dose for adults is 2 mg to 5 mg taken once a day. Gradual increases in the dose can be made only after 1 week. The maximum dose is 15 mg daily.
Swallow the tablets whole with water.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What form(s) does this medication come in?
2 mg
Each green, modified rectangular, uncoated tablet, debossed with "251" on one side and plain on the other side, contains 2 mg of aripiprazole. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colouring agents: FD&C Blue No. 2/indigo carmine AL and iron oxide yellow.
5 mg
Each blue, modified rectangular, uncoated tablet, debossed with "250" on one side and plain on other side, contains 5 mg of aripiprazole. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colouring agents: FD&C Blue No. 2/indigo carmine AL.
10 mg
Each pink, modified rectangular, uncoated tablet, debossed with "252" on one side and plain on the other side, contains 10 mg of aripiprazole. Non-medicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colouring agents: iron oxide red.
15 mg
Each yellow, round, bevelled-edged, uncoated tablet, debossed with "253" on one side and plain on the other side, contains 15 mg of aripiprazole. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colouring agents: iron oxide yellow.
20 mg
Each white-to-off-white, round, bevelled-edged, uncoated tablet, debossed with "L254" on one side and plain on the other side, contains 20 mg of aripiprazole. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
30 mg
Each pink, round, bevelled-edged, uncoated tablet debossed with "L255" on one side and plain on other side, contains 30 mg of aripiprazole. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colouring agents: iron oxide red.
Who should NOT take this medication?
Do not take this medication if you are allergic to aripiprazole or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- anxiety
- constipation
- diarrhea
- dizziness
- drowsiness
- headache
- nausea
- restlessness
- skin rash (on its own)
- tremors
- trouble sleeping
- vomiting
- upset stomach
- weight gain
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- behaviour changes (e.g., uncontrolled and/or inappropriate sexual behaviour, or gambling)
- difficulty swallowing
- extrapyramidal symptoms (abnormal body movements, restlessness, shaking, or stiffness)
- muscle twitching or abnormal movements of the face or tongue
- signs of low blood pressure (dizziness or lightheadedness when rising from a lying or sitting position)
- sleep apnea (interrupted breathing during sleep)
- sleep walking and eating while asleep
- symptoms of an infection (e.g., sore throat, fever, chills, cough)
- symptoms of high blood sugar (excessive thirst or hunger, excessive urination, weight loss, tiredness)
- symptoms of restless leg syndrome (e.g., unpleasant sensations in the legs, uncontrollable urge to move legs when sitting or lying down)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- long-lasting (greater than 4 hours) and painful erection of the penis
- seizures
- signs of a blood clot in blood vessels, such as chest pain, abnormal heart rhythm, pain and swelling in one leg muscle
- signs of neuroleptic malignant syndrome (e.g., confusion, reduced consciousness, high fever, or muscle stiffness)
- signs of stroke (e.g., sudden weakness or numbness of the face, arms, or legs, and speech or vision problems)
- symptoms of a severe allergic reaction (hives; difficulty breathing; difficulty swallowing; swelling of the face, mouth, throat, or tongue)
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
- thoughts of suicide or self-harm
- very stiff muscles with high fever, rapid or irregular heartbeat, sweating, confusion, or reduced consciousness
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
Abnormal heart rhythms: This medication can cause an abnormal heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, heart attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.
Blood clots: Rarely, this medication increases the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting, you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.
Body temperature: Aripiprazole, like other antipsychotic medications, may interfere with your body's ability to regulate body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down.
Take care to avoid overheating during strenuous exercise or in hot temperatures, and avoid becoming dehydrated by drinking enough fluids.
Compulsive behaviour and impulse control: This medication has been known to cause changes in behaviour and impulse control. People who have a history of a gambling disorder may be at an increased risk of compulsive gambling. You may notice other compulsive behaviours, such binge eating, increased or inappropriate sexual thoughts or urges, or inappropriate spending. If you experience any of these behaviours or urges or notice compulsive behaviour in a family member, ensure that they see their doctor.
Diabetes: Aripiprazole may increase blood sugar for people with diabetes or those who are at risk for diabetes. If you have diabetes, monitor your blood sugar frequently as recommended by your doctor. If you experience symptoms of high blood sugar (e.g., increased urination, increased thirst, increased eating, and weakness) while taking this medication, contact your doctor.
Drowsiness/reduced alertness: Aripiprazole may cause drowsiness, lightheadedness, or impaired judgement, which could interfere with your ability to do activities requiring alertness, such as driving a car. Avoid these activities if the medication affects you in this way. Avoid alcohol while taking aripiprazole as it may increase your drowsiness.
Hypersensitivity reaction: Rarely, a severe allergic reaction called hypersensitivity syndrome or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) has been reported by some people using aripiprazole. This type of reaction can affect organ function and should be treated as an emergency. Get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.
Infection: Rarely, this medication will reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor if you notice more frequent signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Lactose: This medication contains lactose and should not be taken by people with rare problems of galactose intolerance or problems absorbing glucose or galactose.
Low blood pressure: Some people taking aripiprazole may experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor.
If you have or have had heart disease, stroke, "mini-stroke", or are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Neuroleptic malignant syndrome (NMS): This medication may cause a potentially fatal reaction called neuroleptic malignant syndrome (NMS). If you develop symptoms of NMS, such as muscle stiffness, fever, confusion, sweating, or irregular heartbeat, stop taking this medication and seek immediate medical attention.
Seizures: Seizures have occurred for people taking aripiprazole. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience a seizure while taking this medication, get immediate medical attention.
Suicidal behaviour: People taking this medication as part of treatment for depression may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Swallowing problems: People taking aripiprazole may have difficulty swallowing. Seniors and people on other antipsychotic medications should be closely monitored by their doctor for swallowing problems while they are using this medication. If you experience difficulty swallowing while taking this medication, contact your doctor.
Tardive dyskinesia: People taking this medication may develop tardive dyskinesia, a syndrome of uncontrolled body movements. This syndrome may be irreversible. If you develop uncontrolled or unusual body movements, contact your doctor as soon as possible.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Babies born to people that take this medication in the last 3 months of pregnancy may experience withdrawal symptoms after they are born, including breathing problems, difficulty feeding, or irritability. If you have been taking this medication during pregnancy, make sure that everyone involved in caring for you and your baby are aware.
Breast-feeding: This medication passes into breast milk. If you are breast-feeding and taking aripiprazole, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication have not been established for children less than 13 years of age. Aripiprazole may be used by adolescents 15 years and older to treat schizophrenia. It may also be used by adolescents 13 years and older to treat bipolar disorder. The use of aripiprazole to aid in the treatment of depression has not been studied for this age group and is therefore, not recommended. Movement disorders such as tardive dyskinesia are more likely to occur for this age group. Report any unusual body movements to your doctor as soon as possible.
Seniors: Seniors taking this medication for dementia-related psychosis have a higher risk of strokes and death compared to seniors who are not taking the medication. Aripiprazole is not approved or recommended for seniors for this purpose.
What other drugs could interact with this medication?
For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.
If you are taking any other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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