What is it used for?
- Schizophrenia in adults and adolescents aged 15 years and over.
- Treatment of moderate to severe manic episodes in adults and adolescents aged 13 years and over with bipolar disorder.
- As a mood stabiliser in adults aged 18 years and over with bipolar disorder. This medicine is used to prevent new manic episodes in those who experience mostly manic episodes that respond to aripiprazole treatment.
Aripiprazole may be given by injection into a muscle (intramuscularly) if there is a need for rapid control of agitation and disturbed behaviour in people with schizophrenia, or manic episodes in people with bipolar disorder. Once behaviour has been controlled, the treatment is usually switched to oral treatment with Abilify tablets or oral solution by mouth.
How does it work?
Abilify tablets, orodispersible tablets, oral solution and injection all contain the active ingredient aripiprazole, which is a type of medicine known as an atypical antipsychotic.
The way in which aripiprazole works is not fully understood, however, it does work in a slightly different way to other antipsychotic medicines.
Aripiprazole works by acting on various receptors in the brain, particularly dopamine receptors and serotonin (5HT) receptors. Dopamine and serotonin are natural compounds called neurotransmitters, and are involved in transmitting messages between brain cells. Psychotic illness is considered to be caused by disturbances in the activity of neurotransmitters (mainly dopamine) in the brain. Aripiprazole is thought to work mainly by stabilising the dopamine activity in the brain.
People with schizophrenia may experience 'positive symptoms' (such as hallucinations, delusions and hostility) and/or 'negative symptoms' (such as lack of emotion and social isolation).
The positive symptoms are thought to be due to overactivity of dopamine in certain areas of the brain. Aripiprazole blocks the dopamine receptors in these areas and so prevents the overactivity. This helps control the positive symptoms of the disease.
The negative symptoms, as well as cognitive symptoms such as memory loss and poor attention, are considered to be due to underactivity of dopamine in other areas of the brain. In these areas, aripiprazole stimulates the dopamine receptors. This mimics the activity of dopamine in these areas of the brain and so improves their activity. This helps improve the negative and cognitive symptoms of this illness.
Aripiprazole is also used to treat moderate to severe episodes of mania in people with bipolar affective disorder (manic depression). In people whose manic episode is controlled with aripiprazole, the medicine may also be used long-term as a mood stabiliser to prevent further manic episodes.
How do I take it?
- Abilify is usually taken once a day. The dose of this medicine that is prescribed will vary from person to person depending on the condition being treated. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the medicine. If you are unclear about anything you should ask your doctor or pharmacist for advice.
- Abilify tablets, orodispersible tablets and oral solution can be taken either with or without food.
- Abilify orodispersible tablets and oral solution are an alternative to the standard tablets for people who have difficulty swallowing the standard tablets. The orodispersible tablets are designed to dissolve on the tongue in the saliva without the need for a drink of water. These tablets are fragile and should be taken as soon as they are removed from the blister packet. Alternatively, these tablets can be dispersed in a glass of water.
- If you forget to take a dose take it as soon as you remember. If it is nearly time for your next dose leave it until then to take it. Don't take a double dose to make up for a missed dose.
- Unless your doctor tells you otherwise, you should not suddenly stop taking this medicine, even if you feel better and think you don't need it any more. This is because the medicine controls the symptoms of the illness but doesn't actually cure it. This means that if you suddenly stop treatment your symptoms could come back.
- This medicine may cause sleepiness and blurred vision and so may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
- This medicine can occasionally cause your blood pressure to drop when you move from a lying down or sitting position to sitting or standing. This may make you feel dizzy or unsteady and could make you faint. To avoid this try getting up slowly. If you do feel dizzy, sit or lie down until the symptoms pass.
- You should avoid drinking alcohol while taking this medicine, as this is likely to make any drowsiness or dizziness worse.
- Adolescents taking this medicine to treat bipolar mania should have their body weight regularly checked, as this medicine was shown to cause weight gain in clinical trials of this population. Your doctor may want you to stop taking this medicine if you gain a significant amount of weight.
- Antipsychotic medicines are associated with an increased risk of getting a blood clot in a vein (deep vein thrombosis) or in the lungs (pulmonary embolism). For this reason, you should consult a doctor immediately if you get any of the following symptoms, which could suggest you have a blood clot: stabbing pains and/or unusual redness or swelling in one leg, pain on breathing or coughing, coughing up blood or sudden breathlessness.
- Consult your doctor immediately if you experience abnormal movements, particularly of the face, lips, jaw and tongue, while taking this medicine. These symptoms may be indicative of a rare side effect known as tardive dyskinesia, and your doctor may ask you to stop taking this medicine, or decrease your dose.
- Consult your doctor immediately if you experience the following symptoms while taking this medicine: high fever, sweating, muscle stiffness, faster breathing and drowsiness or sleepiness. These symptoms may be due to a rare side effect known as the neuroleptic malignant syndrome, and your treatment may need to be stopped.
Use with caution in
- People over 65 years of age.
- Severely decreased liver function.
- People with disease involving the heart and blood vessels (cardiovascular disease) for example heart failure, angina, previous heart attack or an irregular heartbeat (arrhythmia).
- People with a personal or family history of an abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
- People with disease involving the blood vessels in the brain (cerebrovascular disease), eg history of stroke or mini-stroke (transient ischaemic attack).
- People with low blood pressure (hypotension), eg due to dehydration, blood loss, severe vomiting or diarrhoea, or treatment with diuretics or medicines for high blood pressure.
- High blood pressure (hypertension).
- People with a personal or family history of blood clots (venous thromboembolism), for example in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
- People with other risk factors for getting a blood clot, for example smoking, being overweight, taking the contraceptive pill, being over 40, recent major surgery or being immobile for prolonged periods.
- People with a history of fits (seizures), eg epilepsy.
- People with conditions that increase the risk of epilepsy or convulsions, eg brain damage or withdrawal from alcohol.
- People with diabetes or who are at risk of developing diabetes. (If you have diabetes your blood sugar levels should be monitored closely while you are having treatment with this medicine, because it may increase your blood sugar.)
- Parkinson's disease.
- People with a history of being unable to control urges to gamble.
- People taking stimulant medicines for ADHD.
Not to be used in
- Women who are breastfeeding.
- This medicine should not be used for treating manic episodes in children under 13 years of age, because younger children are at an increased risk of side effects.
- This medicine has not been studied for the treatment of schizophrenia in children and adolescents under 15 years of age and it is not recommended for this age group.
- This medicine is not licensed or recommended for treating psychosis in elderly people with dementia, eg Alzheimer's disease, as it may increase the risk of stroke or death in this group of people.
- Abilify tablets contain lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption.
- Abilify oral solution contains fructose and sucrose and should not be taken by people with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
- Abilify orodispersible tablets contain aspartame, which is a source of phenylalanine. This type of tablet should not be taken by people with an inherited disorder of protein metabolism called phenylketonuria.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor and the benefits to the mother outweigh any potential risks to the developing baby. If the medicine is used during the third trimester it could cause side effects or withdrawal symptoms in the baby after birth and the baby may need extra monitoring because of this. Seek further medical advice from your doctor.
- If you do get pregnant or want to plan a pregnancy while taking this medicine it is important to consult your doctor straight away for advice. You should not suddenly stop taking this medicine unless your doctor tells you to, as this could cause your symptoms to come back.
- Aripiprazole passes into breast milk. The manufacturer states that mothers who need to take this medicine should not breastfeed. Seek further medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Common (affect between 1 and 10 out of every 100 people)
- Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).
- Feeling restless, agitated and unable to sit still (akathisia).
- Difficulty sleeping (insomnia).
- Sleepiness (somnolence).
- Blurred vision.
- Gut disturbances such as constipation, indigestion, nausea and vomiting.
- Increased salivation.
Uncommon (affect between 1 and 10 out of every 1000 people)
- Increased heart rate (tachycardia).
- A drop in blood pressure that occurs when moving from a lying or sitting position to sitting or standing, causing dizziness and lightheadedness (postural hypotension).
- Increase or decrease in body weight.
- Prolonged erection (priapism). If you get an erection that lasts longer than four hours while taking this medicine, you should consult a doctor immediately. Treatment of this condition should not be delayed more than six hours, as this can cause damage to the erectile tissue in the penis and irreversible erectile dysfunction.
- Yellowing of the skin and whites of the eyes (jaundice).
- Inflammation of the liver (hepatitis).
- Inflammation of the pancreas (pancreatitis).
- Neuroleptic malignant syndrome (see warning section above).
- Tardive dyskinesia (see warning section above).
- Abnormal blood clot in the blood vessels (venous thromboembolism - see warning section above).
- Problems with regulation of body temperature.
- Increased blood glucose levels and diabetes. Tell your doctor if you notice you feel unusually hungry or thirsty, or need to pass urine more often than usual. People with diabetes should monitor their blood sugar closely.
- Decrease in the number of white blood cells or platelets in the blood (neutropenia or thrombocytopenia). You should consult your doctor if you experience any of the following symptoms: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness. Your doctor may want to take a blood test to check your blood cells.
- Pain in the muscles.
- Abnormal heartbeats, heart rate or rhythm.
- Chest pain.
- Swollen ankles.
- Skin reactions such as rash, hair loss, increased sweating, increased sensitivity of the skin to sunlight.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
There may be an increased risk of drowsiness and sedation if aripiprazole is taken with any of the following (which can also cause drowsiness):
- barbiturates, eg amobarbital, phenobarbital
- benzodiazepines, eg diazepam, temazepam
- MAOI antidepressants, eg phenelzine
- sedating antihistamines, eg chlorphenamine, hydroxyzine
- sleeping tablets, eg zopiclone
- strong opioid painkillers, eg morphine, codeine
- tricyclic antidepressants, eg amitriptyline.
Aripiprazole may enhance the blood pressure-lowering effects of medicines that lower blood pressure, including medicines used to treat high blood pressure (antihypertensives) and medicines that lower blood pressure as a side effect, eg benzodiazepines. If you are taking medicines that lower blood pressure you should tell your doctor if you feel dizzy or faint after starting treatment with this medicine, as your doses may need adjusting.
The following medicines may increase the amount of aripiprazole in your blood, and your doctor may need to prescribe you a lower dose of aripiprazole if you are taking any of these:
- protease inhibitors for HIV infection, eg ritonavir
If you stop treatment with any of these medicines while you are taking aripiprazole, your aripiprazole dose may need to be re-adjusted.
The following medicines may decrease the amount of aripiprazole in your blood. Your doctor may need to prescribe you a higher dose of aripiprazole if you are taking any of these:
- the herbal remedy St John's Wort (Hypericum perforatum).
If you stop treatment with any of these medicines while you are taking aripiprazole, your aripiprazole dose may need to be re-adjusted.
Aripiprazole may oppose the effect of anticonvulsant medicines used to treat epilepsy.
Aripiprazole may increase blood sugar levels and disturb the control of diabetes. People with diabetes may need an adjustment in the dose of their antidiabetic medication.
Aripiprazole may oppose the effect of histamine (used to treat leukaemia) and is not recommended for people having this treatment.
There may be an increased risk of abnormal heart rhythms (prolonged QT interval on a heart monitoring trace or ECG) if aripiprazole is taken in combination with any of the following medicines:
- antiarrhythmics (medicines to treat abnormal heart beats), eg amiodarone, procainamide, disopyramide, sotalol, dronedarone
- the antihistamines astemizole, mizolastine or terfenadine
- arsenic trioxide
- certain antidepressants, eg citalopram, escitalopram, clomipramine
- certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine, Riamet
- certain other antipsychotics, eg thioridazine, haloperidol, sertindole, pimozide
- intravenous erythromycin or pentamidine
There may also be an increased risk of a prolonged QT interval if medicines that can alter the levels of salts such as potassium or magnesium in the blood, eg diuretics such as furosemide, are taken in combination with aripiprazole.
Other medicines containing the same active ingredient
- Abilify maintena depot injection.