- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution for injection containing aripiprazole.
Acute treatment of a manic episode associated with bipolar disorder
Agitation & disturbed behaviour in schizophrenic patients: acute treatment
Parenteral treatment with aripiprazole should be discontinued as soon as clinically appropriate, in favour of oral aripiprazole.
Recommended initial dose is 9.75mg (1.3ml) as a single intramuscular injection.
The effective dose range is 5.25mg to 15mg (0.7ml to 2ml) as a single injection. A lower dose of 5.25mg (0.7ml) may be given on an individual clinical status basis, taking into consideration other medicinal products already administered.
A second injection may be administered 2 hours after the first, on an individual clinical status basis.
No more than three injections should be given in any 24 hour period.
The maximum daily dose of aripiprazole is 30mg (including all formulations of aripiprazole).
Additional Dosage Information
Dose adjustments due to drug interactions
Use with CYP3A4 and CYP2D6 inhibitors:
Reduce the aripiprazole dose by approximately 50% when prescribed with drugs that are strong inhibitors of CYP3A4 or CYP2D6.
Upon discontinuation of the CYP3A4 or CYP3D6 inhibitor, return to the original dose of aripiprazole.
Use with CYP3A4 inducers:
Double the aripiprazole dose when prescribed with drugs that are strong inducers of CYP3A4.
Upon discontinuation of the CYP3A4 inducer, return to the original dose of aripiprazole.
For intramuscular use only.
To enhance absorption and minimise variability, it is recommended to inject into the deltoid or deep within the gluteus maximus muscle, avoiding adipose regions.
Children under 18 years
Precautions and Warnings
Family history of diabetes mellitus
Patients over 65 years
Predisposition to aspiration or regurgitation
Predisposition to hypotension
Predisposition to venous thromboembolism
Cardiac conduction defects
History of ischaemic heart disease
History of myocardial infarction
History of seizures
Severe hepatic impairment
May decrease glucose tolerance in patients with diabetes mellitus
Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Reduce initial dose in the elderly
Close medical supervision during initial dosing
Monitor BP, pulse, respiratory rate and level of consciousness regularly
Monitor for signs and symptoms of dystonia
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients at risk of pathological gambling
Monitor periodically for signs or symptoms of hyperglycaemia
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Refer women considering pregnancy for specialist advice and monitoring
Advise patient of the risk of weight gain
Advise patients/carers to seek medical advice if suicidal intent develops
Consider discontinuation if signs of tardive dyskinesia occur
Discontinue in patients with unexplained high fever
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient not to take St John's wort concurrently
Advise patient of increased risk of falls
The occurrence of suicidal behaviour is inherent in psychotic illness, and so patients at risk of suicide should be closely monitored, especially at initiation or switch or antipsychotic therapy.
Antipsychotic drug use is associated with oesophageal dysmotility and aspiration, and so aripiprazole should be used with caution in patients at risk of aspiration pneumonia such as patients with dysphagia.
Neonates exposed to antipsychotics during pregnancy are at risk of adverse reactions including extrapyramidal and or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently newborns exposed to antipsychotics during pregnancy should be appropriately monitored.
Pregnancy and Lactation
Use aripiprazole with caution in pregnancy.
At the time of writing, there are no adequate data on the use of aripiprazole in human pregnancy. It is not known if aripiprazole or its major metabolite cross the placenta, but it is thought likely due to their molecular weight, degree of protein binding and long elimination half lives. The extensive serum protein binding should limit foetal transfer. Congenital abnormalities have been reported; however, the manufacturer states that causal relationship with aripiprazole could not be established.
The animal data (rats and rabbits) from high dose studies suggest a possible risk of developmental toxicity and teratogenicity.
Schaefer (2007) concludes that atypical antipsychotics such as aripiprazole may be used during pregnancy where the treatment of acute psychosis or chronic psychotic illness is necessary. Olanzapine or quetiapine are the drugs of choice, due to the documented experience in pregnancy, but treatment with aripiprazole is not an indication for termination of the pregnancy, and antipsychotic medication should not be changed if patients are stable, as this may worsen the mother's health. However, consider a detailed foetal ultrasonography if used during the first trimester. If dose reduction or interruption in the days immediately preceding delivery is deemed appropriate, this may prevent neonatal adaption disorders. Pre-pregnancy dosage should be then started immediately after delivery to prevent relapse.
Briggs (2011) concludes that the safest course is to avoid aripiprazole during pregnancy, but recognises the importance of keeping maternal treatment stable. If used, it should be at the lowest effective dose, avoiding the first trimester if possible, and with long term evaluation of the neonate.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Aripiprazole is contraindicated in breastfeeding.
The molecular weight and prolonged elimination half life are consistent with excretion in human milk, but the extensive serum protein binding should limit foetal exposure.
The manufacturer does not recommend breastfeeding during treatment with aripiprazole, due to the lack of published human experience. LactMed agrees that other antipsychotic agents with more experience may be preferred, hence aripiprazole should only be administered if the mother and infant can be monitored. The effects of exposure on the nursing infant are unknown, but potent CNS effects and rare but potentially serious toxicities are possible. If breastfeeding during treatment, the infant should be monitored for somnolence, orthostatic hypotension, seizures, dysphagia, nausea, vomiting and other adverse effects. Briggs concludes that long term evaluation of the infant is warranted.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Blood glucose disturbances
Blood pressure changes
Creatine phosphokinase increased
Gamma glutamyl transferase (GGT) increased
Grand mal seizure
Hyperosmolar non-ketotic coma
Hypersensitivity reactions including anaphylaxis
Increase in alkaline phosphatase
Increase in blood levels of insulin
Increase in serum ALT/AST
Increased heart rate
Interference with temperature regulation
Neuroleptic malignant syndrome
Prolongation of QT interval
Sudden unexplained death
Torsades de pointes
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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Last Full Review Date: September 2014
British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.
BNF for Children (2013-2014) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
NICE guidance CG45 Antenatal and postnatal mental health; February 2007.
Summary of Product Characteristics: Abilify 7.5mg/ml solution for injection. Otsuka and Bristol Myers Squibb. Revised April 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Aripiprazole Last revised: January 24, 2013
Last accessed: August 08, 2013
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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