Abilify (aripiprazole)

Main use	Active ingredient	Manufacturer
Schizophrenia	Aripiprazole	Bristol-Myers Squibb

How does it work?

Abilify tablets, orodispersible tablets and oral solution 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.
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.
Abilify orodispersible tablets and oral solution can be used as an alternative to the standard tablets for people who have difficulty swallowing. 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.

What is it used for?

• Schizophrenia.
• Treatment of moderate to severe manic episodes in bipolar disorder, and as a mood stabiliser to prevent new manic episodes in people who experience mostly manic episodes that respond to aripiprazole treatment.

Warning!

• This medicine 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.
• If you feel sleepy or lightheaded while taking this medicine, these side effects are likely to be made worse by drinking alcohol.
• 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.
• 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.
• Disease involving the heart and blood vessels (cardiovascular disease), eg history of heart attack, angina, heart failure, heart block or abnormal heart beats.
• Family history of a type of abnormal heart beat seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• Disease involving the blood vessels in the brain (cerebrovascular disease), eg history of stroke.
• 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).
• History of fits (seizures), eg epilepsy.
• Diabetes or family history of diabetes.
• Obesity.
• Difficulty swallowing (dysphagia).

Not to be used in

• Breastfeeding.
• This medicine has not been studied in children and adolescents under the age of 18 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. Seek medical advice from your doctor if you get pregnant, think you could be pregnant, or want to plan a pregnancy while taking this medicine.
• It is not known if this medicine passes into breast milk. The manufacturer states that mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

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 (affects between 1 in 10 and 1 in 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).
• Anxiety.
• Dizziness.
• Sleepiness (somnolence).
• Headache.
• Blurred vision.
• Gut disturbances such as constipation, indigestion, nausea and vomiting.
• Increased salivation.
• Fatigue.
• Difficulty sleeping (insomnia).

Uncommon (affects between 1 in 100 and 1 in 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).
• Depression.

Unknown frequency

• Increase or decrease in body weight.
• Prolonged erection (priapism).
• Yellowing of the skin and whites of the eyes (jaundice).
• Inflammation of the liver (hepatitis) or pancreas (pancreatitis).
• Problems with regulation of body temperature.
• Increased blood sugar levels (hyperglycaemia) and diabetes.
• Pain in the muscles.
• Abnormal heart beats.
• Seizures.

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.
This medicine may enhance the blood pressure-lowering effects of certain medicines used to treat high blood pressure (antihypertensives). If you are taking medicines for high blood pressure you should tell your doctor if you feel dizzy or faint after starting treatment with this medicine, as the dose of your blood pressure medicines may need adjusting.
There may be an increased chance of feeling sleepy if this medicine is taken in combination with alcohol or medicines that can make you drowsy, such as the following:

• tricyclic antidepressants, eg amitriptyline
• strong opioid painkillers, eg morphine, codeine, dihydrocodeine
• benzodiazepines, eg diazepam, temazepam
• sedating antihistamines, eg chlorphenamine, promethazine, hydroxyzine
• sleeping tablets, eg zopiclone.

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:

• fluoxetine
• HIV protease inhibitors, eg ritonavir
• itraconazole
• ketoconazole
• paroxetine
• quinidine.

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:

• carbamazepine
• efavirenz
• nevirapine
• phenobarbital
• phenytoin
• primidone
• rifabutin
• rifampicin
• 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.
There may be an increased risk of abnormal heart rhythms (prolonged QT interval on a heart monitoring trace or ECG) if this medicine is taken in combination with any of the following medicines:

• medicines for abnormal heart beats (antiarrhythmics), eg amiodarone, procainamide, disopyramide, sotalol
• certain antidepressants, eg amitriptyline, imipramine, maprotiline
• the anthistamines astemizole (no longer available in the UK) or terfenadine
• certain antimalarials, eg halofantrine, chloroquine, quinine
• other antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol
• erythromycin or pentamidine given by injection into a vein
• cisapride
• medicines that can alter the levels of salts such as potassium in your blood, eg diuretics such as furosemide.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain aripiprazole as the active ingredient.