Aripiprazole oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of aripiprazole.
Drugs List
Therapeutic Indications
Uses
Bipolar disorder: prevention of recurrence
Treatment of moderate to severe manic episodes
Treatment of schizophrenia
Treatment of schizophrenia in adults and in adolescents 15 years and older.
Treatment of moderate to severe manic episodes in Bipolar I disorder in adults and adolescents 13 years and older.
Prevention of a new manic episode in adult patients who experienced predominantly manic episodes which responded to aripiprazole.
Dosage
Improvement in clinical condition may take several days to weeks and patients should be closely monitored during this period.
Adults
Schizophrenia
Initial dose: 10mg or 15mg once a day.
Maintenance dose: 15mg once a day.
Maximum 30mg once a day.
Enhanced efficacy of doses above 15mg has not been demonstrated, although some individuals may benefit from a higher dose.
Manic episodes
15mg once a day, as monotherapy or combination therapy.
Maximum 30mg once a day.
Recurrence prevention of manic episodes in Bipolar I Disorder
Continue therapy at the same dose used to treat manic episodes.
Adjust daily dosage including dose reduction on the basis of clinical status.
Maximum 30mg once a day.
Children
Schizophrenia
Children aged 15 years and above
Initial dose: 2mg once a day for 2 days. Increasing to 5mg once a day for 2 additional days.
Maintenance dose: 10mg once a day. Can be increased in 5mg increments if appropriate.
Maximum 30mg per day. Enhanced efficacy of doses above 10mg has not been demonstrated, although some individuals may benefit from a higher dose.
Children under 15 years: not recommended
Manic episodes in Bipolar I Disorder
Children aged 13 years and above
Initial dose: 2mg once a day for 2 days. Increasing to 5mg once a day for 2 additional days.
Maintenance dose: 10mg once a day.
Treatment duration should be the minimum required for symptom control and must not exceed 12 weeks.
Enhanced efficacy of doses above 10mg has not been demonstrated, a daily dose of 30mg has significantly higher incidence of undesirable effects including somnolence, fatigue and weight gain.
Children under 13 years: not recommended
Contraindications
Children under 13 years
Breastfeeding
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children aged 13 to 18 years
Family history of diabetes mellitus
Family history of long QT syndrome
Obesity
Patients over 65 years
Predisposition to hypotension
Predisposition to seizures
Predisposition to venous thromboembolism
Suicidal ideation
Cardiovascular disorder
Cerebrovascular disorder
Diabetes mellitus
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of ischaemic heart disease
History of myocardial infarction
History of seizures
History of torsade de pointes
Hypertension
Lactose intolerance
Phenylketonuria
Pregnancy
Severe hepatic impairment
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Oral solution contains sucrose and hydroxybenzoates
Some formulations contain fructose
Some formulations contain lactose
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor patients with existing or tendency towards diabetes mellitus
Monitor periodically for signs or symptoms of hyperglycaemia
Monitor serum electrolytes
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Symptoms of tardive dyskinesia can worsen or arise after discontinuation
Advise patient of the risk of weight gain
Consider discontinuation if signs of tardive dyskinesia occur
Discontinue in patients with unexplained high fever
Dysphagia & aspiration:caution in patients at risk for aspiration pneumonia
Advise patient to seek advice at first indications of pregnancy
Discontinue if patient develops neuroleptic malignant syndrome
Consider reducing initial dose in the elderly
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient/carer about symptoms of impulse control disorders
Weight gain should be monitored in adolescent patients with bipolar mania. If weight gain is clinically significant, dose reduction should be considered.
Pregnancy and Lactation
Pregnancy
Use aripiprazole with caution in pregnancy.
The manufacturer does not recommend using aripiprazole during pregnancy unless the benefit clearly outweighs the potential risk to the foetus.
At the time of writing, there is insufficient data regarding the use of aripiprazole in pregnancy, however, congenital abnormalities have been reported. Animal studies have not shown developmental toxicity.
Newborn infants exposed to aripiprazole during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms. There has been reports of agitation, hypertonia, tremor, somnolence, respiratory distress or feeding disorder, therefore newborns exposed to aripiprazole should be monitored carefully.
Lactation
Use of aripiprazole is contraindicated in breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking aripiprazole. Available data indicates aripiprazole is excreted in breastmilk.
Counselling
Advise patients to seek medical advice at first indications of pregnancy.
Advise patients of the possibility of weight gain during treatment.
Patients should be advised to use caution when driving or operating machines, until their susceptibility to adverse effects is known.
Advise patient to avoid alcohol consumption.
Side Effects
Abdominal discomfort
Aggression
Agitation
Akathisia
Alopecia
Angioedema
Anorexia
Anxiety
Arrhythmias
Aspiration pneumonia
Blood dyscrasias
Blood glucose disturbances
Blurred vision
Bradycardia
Cardiac arrest
Cerebrovascular accident
Chest pain
Constipation
Creatine phosphokinase increased
Depression
Diabetes mellitus
Diarrhoea
Diplopia
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dyspepsia
Dysphagia
Dystonia
Extrapyramidal effects
Fatigue
Gamma glutamyl transferase (GGT) increased
Grand mal seizure
Headache
Hepatitis
Hiccups
Hyperglycaemia
Hyperhidrosis
Hyperosmolar non-ketotic coma
Hyperprolactinaemia
Hypersalivation
Hypersensitivity reactions including anaphylaxis
Hypersexuality
Hypertension
Hyponatraemia
Hypoprolactinaemia
Hypothermia
Increase in alkaline phosphatase
Increase in blood levels of insulin
Increase in serum ALT/AST
Increased appetite
Increased heart rate
Insomnia
Interference with temperature regulation
Jaundice
Ketoacidosis
Laryngeal spasm
Leukopenia
Myalgia
Nausea
Nervousness
Neuroleptic malignant syndrome
Oropharyngeal spasm
Orthostatic hypotension
Pancreatitis
Pathological gambling
Peripheral oedema
Photosensitivity
Priapism
Prolongation of QT interval
Pruritus
Pyrexia
Rash
Restlessness
Rhabdomyolysis
Sedation
Seizures
Serotonin syndrome
Somnolence
Speech disturbances
Stiffness
Stomach pain
Sudden unexplained death
Suicidal tendencies
Syncope
Tachycardia
Tardive dyskinesia
Thromboembolic disorders
Tongue swelling
Torsades de pointes
Tremor
Urinary incontinence
Urinary retention
Urticaria
Ventricular arrhythmias
Vomiting
Weight changes
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2019
Reference Sources
Summary of Product Characteristics: Abilify 5mg tablets. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Abilify 10mg tablets. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Abilify 15mg tablets. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Abilify 30mg tablets. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Abilify 10mg orodispersible tablets. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Abilify 15mg orodispersible tablets. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Abilify 30mg orodispersible tablets. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Abilify oral solution 1mg ml. Otsuka and Bristol-Myers Squibb. Revised August 2018.
Summary of Product Characteristics: Aripiprazole 5mg tablets. Dr. Reddy's Laboratories Ltd. Revised January 2017.
Summary of Product Characteristics: Aripiprazole 10mg tablets. Dr. Reddy's Laboratories Ltd. Revised January 2017.
Summary of Product Characteristics: Aripiprazole 15mg tablets. Dr. Reddy's Laboratories Ltd. Revised January 2017.
Summary of Product Characteristics: Aripiprazole 30mg tablets. Dr. Reddy's Laboratories Ltd. Revised January 2017.
Summary of Product Characteristics: Aripiprazole 1mg/ml oral solution. Dr. Reddy's Laboratories Ltd. Revised November 2018.
Summary of Product Characteristics: Aripiprazole 1mg/ml oral solution. Thornton & Ross Ltd. Revised September 2017.
Summary of Product Characteristics: Aripiprazole 5mg tablets. Aspire Pharma Ltd. Revised June 2018.
Summary of Product Characteristics: Aripiprazole 10mg tablets. Aspire Pharma Ltd. Revised June 2018.
Summary of Product Characteristics: Aripiprazole 15mg tablets. Aspire Pharma Ltd. Revised June 2018.
Summary of Product Characteristics: Aripiprazole 30mg tablets. Aspire Pharma Ltd. Revised June 2018.
Summary of Product Characteristics: Arpoya 5mg tablets. Torrent Pharma Ltd. Revised March 2017.
Summary of Product Characteristics: Arpoya 10mg tablets. Torrent Pharma Ltd. Revised March 2017.
Summary of Product Characteristics: Arpoya 15mg tablets. Torrent Pharma Ltd. Revised March 2017.
Summary of Product Characteristics: Arpoya 30mg tablets. Torrent Pharma Ltd. Revised March 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 April 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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