neobookRx
DrugsLevel 4 LocalisationS5INJ · TAB · ODTEML

Aripiprazole

Quinolone derivativeAtypical antipsychotic

Indications

Registered South African indications:

  • Schizophrenia (inj, tab)
    - Treatment and maintenance of clinical improvement (tab)
    - Maintenance treatment in patients stabilised with oral aripiprazole (inj)
  • Acute manic episodes associated with bipolar I disorder (tab)
  • Prevention of recurrence of new manic episodes in patients who experienced predominantly manic episodes and who responded to aripiprazole treatment (tab)

Cautions

Contraindications 

South African recommendations

  • Hypersensitivity to the active ingredient or any of its excipients
  • Children below 18 years

Recommendations in other jurisdictions

  • Hypersensitivity to the active ingredient or any of its excipients

Cautions 

South African recommendations

  • Pregnancy
  • Breastfeeding
  • Severe hepatic impairment (inj)
  • Elderly 
    - Dementia-related psychosis
    - Psychosis associated with Alzheimer's disease
  • Known cardiovascular disease
    - History of myocardial infarction
    - Ischaemic heart disease
    - Heart failure
    - Conduction abnormalities
  • Cerebrovascular disease
  • Hypotension or risk factors thereof
    - Dehydration
    - Hypovolemia
    - Treatment with antihypertensive medicinal agents
  • Hypertension
    - Accelerated
    - Malignant
  • Risk factors for venous thromboembolism
  • Family history of QT prolongation (inj)
  • History of seizure disorder or conditions associated with seizures
  • Diabetes mellitus
    - Family history of diabetes
    - Risk factors for diabetes mellitus
  • Thyroid disorder
  • Pituitary adenoma
  • Risk of aspiration pneumonia
  • High risk for suicide
  • High risk for falls
    - Eldery
    - Debilitated patients
  • History of impulse control disorders
  • Conditions which may contribute to elevation in core body temperature (tab)
    - Strenuous exercise
    - Exposure to extreme heat
    - Dehydration 
  • Long-term exposure (tab)
  • Obesity (inj)
  • Acutely agitated or severely psychotic states (inj)
  • Coadministration with agents with anticholinergic activity 
  • Coadministration with stimulants for the treatment of attention deficient hyperactivity disorder (ADHD) (tab)
  • Galactose intolerance e.g. galactosaemia (tab)
  • Lapp lactase deficiency (tab)
  • Glucose-galactose malabsorption (tab)
  • May impair ability to drive and operate machinery 

Recommendations in other jurisdictions

  • Pregnancy
  • Breastfeeding
  • Severe hepatic impairment
  • Elderly 
    - Dementia-related psychosis
    - Psychosis associated with Alzheimer's disease
  • Known cardiovascular disease
    - History of myocardial infarction
    - Ischaemic heart disease
    - Heart failure
    - Conduction abnormalities
  • Cerebrovascular disease
  • Hypotension or risk factors thereof
    - Dehydration
    - Hypovolemia
    - Treatment with antihypertensive medicinal agents
  • Hypertension
    - Accelerated
    - Malignant
  • Risk factors for venous thromboembolism
  • Family history of QT prolongation
  • History of seizure disorder or conditions associated with seizures
  • Diabetes mellitus
    - Family history of diabetes
    - Risk factors for diabetes mellitus
  • Obesity 
  • Thyroid disorder
  • Pituitary adenoma
  • Risk of aspiration pneumonia
  • History of impulse control disorders
  • High risk for suicide
  • High risk for falls
    - Eldery
    - Debilitated patients
  • Acutely agitated or severely psychotic states (inj)
  • Coadministration with stimulants for the treatment of attention deficient hyperactivity disorder (ADHD) (tab) 
  • Galactose intolerance (tab) 
  • Total lactase deficiency (tab) 
  • Glucose-galactose malabsorption (tab) 
  • May impair ability to drive and operate machinery 

Adult dosage

Forms avail. in SA and covered in this monograph: tab, inj 

Dosages below include:

  • South African registered indications and dosages
  • Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Schizophrenia 
- Treatment and maintenance of clinical improvement

  • Oral (tab): Initial: 10-15mg, dly without regard to meals; Maintenance: 15mg, dly; Max: 30mg/24hrs

Aripiprazole is effective in a dose range of 10-30mg/day. Enhanced efficacy at doses higher than a daily dose of 15mg has not been demonstrated although individual patients may benefit from a higher dose 


- Maintenance treatment in patients stabilised with oral aripiprazole

  • IM: 400mg; Followed by: Oral (tab): 10-20mg, dly for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy; Maintenance: 400mg, monthly (no sooner than 26 days after the previous injection)

If there are adverse reactions with the 400mg dosage

  • IM: 300mg, monthly (no sooner than 26 days after the previous injection)

For IM use only. DO NOT administer IV or SC. Suspension should be injected slowly as a single injection into the gluteal or deltoid muscle. Care should be taken to avoid inadvertent injection into a blood vessel


For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with aripiprazole IM


Titration of the dose for aripiprazole IM is not required


See additional prescribing points for dosing guidance regarding missed doses and use with concomitant medications 


Acute manic episodes associated with bipolar I disorder
Prevention of recurrence of new manic episodes (Additional agent(s) may be required)
- As monotherapy or combination therapy in patients who experienced predominantly manic episodes and who responded to aripiprazole treatment

  • Oral (tab): Initial: 15mg, dly without regard to meals; Max: 30mg/24hrs 

Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status


Indications and dosages registered in other jurisdictions

Schizophrenia

  • Oral (tab): Initial: 10-15mg, dly without regard to meals; Maintenance: 15mg, dly; Max: 30mg/24hrs

Aripiprazole is effective in a dose range of 10-30mg/day. Enhanced efficacy at doses higher than a daily dose of 15mg has not been demonstrated although individual patients may benefit from a higher dose


- Maintenance treatment in patients stabilised with oral aripiprazole 

One injection start

  • IM: First inj: 400mg; Followed by: Oral (tab): 10-20mg, dly for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy; Maintenance: 400mg, monthly (no sooner than 26 days after the previous injection) 

Two injection start

  • IM: First inj: 800mg, as 2 separate injections of 400mg at separate injection sites; Followed by: Oral (tab): 20mg, as a single dose; Maintenance: 400mg, monthly (no sooner than 26 days after the previous injection)

If there are adverse reactions with the 400mg dosage

  • IM: 300mg, monthly (no sooner than 26 days after the previous injection)

For IM use only. DO NOT administer IV or SC. See additional prescribing points for administration instructions


For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with aripiprazole IM


Titration of the dose for aripiprazole IM is not required


Manic episodes in bipolar I disorder - moderate to severe
Prevention of a new manic episode in those who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment

  • Oral (tab): Initial: 15mg, dly; Max: 30mg/24hrs 

Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status


See additional prescribing points for dosing guidance regarding missed doses and use with concomitant medications 


Orodispersible tablets or oral solution may be used as an alternative to tablets for patients who have difficulty swallowing tablet

Paediatric dosage

Paed. forms avail. in SA and covered in this monograph: tab

Dosages below include:

  • South African registered indications and dosages
  • Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Not registered for use in South Africa for children below 18 years


Indications and dosages registered in other jurisdictions

Schizophrenia

Younger than 15 years

  • Not established for use

15 years and older

  • Oral (tab): Initial: 2mg (using aripiprazole oral solution 1mg/ml) for 2 days; Then: Titrate to 5mg, dly for 2 days until maintenance dose of 10mg, dly is reached; Max: 30mg/24hrs 

To be taken without regard to meals


When appropriate, subsequent dose increases should be administered in 5mg increments without exceeding the maximum daily dose of 30mg 


Aripiprazole is effective in a dose range of 10-30mg/day. Enhanced efficacy at doses higher than a daily dose of 10mg has not been demonstrated although individual patients may benefit from a higher dose 


The safety and efficacy of aripiprazole IM in children and adolescents aged 0 to 17 years have not been established. No data are available


Manic episodes associated with bipolar I disorder - moderate to severe

Younger than 13 years

  • Not recommended for use

13 years and older

  • Oral (tab): Initial: 2mg (using aripiprazole oral solution 1mg/ml) for 2 days; Then: Titrate to 5mg, dly for 2 days until maintenance dose of 10mg, dly is reached; Max: 30mg/24hrs; Treatment duration: ≤12 weeks

To be taken without regard to meals


Enhanced efficacy at doses higher than a daily dose of 10mg has not been demonstrated, and a daily dose of 30mg is associated with a substantially higher incidence of significant adverse reactions including extrapyramidal symptoms related events, somnolence, fatigue and weight gain. Doses higher than 10mg/day should therefore only be used in exceptional cases and with close clinical monitoring 


The safety and efficacy of aripiprazole IM in children and adolescents aged 0 to 17 years have not been established. No data are available


For irritability associated with autistic disorder, aripiprazole is not established for use in younger than 18 years


For use in tics associated with Tourette's disorder, aripiprazole is not established for use between 6-18 years, and no information is available for younger than 6 years 

Special populations

Pregnancy

South African recommendations

  • Caution; positive evidence for risk 
  • Safety during pregnancy has not been established
  • Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established. Animal studies could not exclude potential developmental toxicity (inj)
  • Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment
  • Neonates exposed to antipsychotics (including aripiprazole) during the third trimester of 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 should be monitored carefully
  • Prescribers need to be aware of the long-acting properties of aripiprazole IM

Recommendations in other jurisdictions

  • Caution; positive evidence for risk
  • There are no adequate and well-controlled trials of aripiprazole in pregnant women
  • Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established. Animal studies could not exclude potential developmental toxicity
  • Patients must be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole
  • Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus 
  • Newborn infants exposed to antipsychotics (including aripiprazole) during the third trimester of 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, newborn infants should be monitored carefully
  • Prescribers need to be aware of the long-acting properties of aripiprazole IM

Breastfeeding

South African recommendations

Recommendations in other jurisdictions

  • Caution; not recommended 
  • Aripiprazole/metabolites are excreted in human milk
  • A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

  • Aripiprazole did not impair fertility based on data from reproductive toxicity studies

Renal Impairment

Hepatic Impairment

South African recommendations

Recommendations in other jurisdictions

Elderly 

South African recommendations

Recommendations in other jurisdictions

Porphyria Information

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Central Nervous System Disorders

  • Akathisia
  • Extrapyramidal disorder
  • Tremor
  • Headache
  • Sedation
  • Somnolence
  • Dizziness
  • Dyskinesia
    - Tardive dyskinesia
  • Dystonia
    - Spasm of the neck muscles
    - Tightness of the throat
    - Difficulty swallowing
    - Difficulty breathing
    - Protrusion of the tongue
  • Restless legs syndrome
  • Parkinsonism
  • Neuroleptic malignant syndrome
    - Hyperpyrexia
    - Muscle rigidity
    - Altered mental status
    - Evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia)
    - Increased creatine phosphokinase
    - Myoglobinuria (rhabdomyolysis)
    - Acute renal failure
  • Grand mal seizures
  • Serotonin syndrome
  • Speech disorder
  • Syncope
  • Insomnia
  • Anxiety
  • Restlessness
  • Depression
  • Hypersexuality
  • Suicidal ideation
  • Suicide attempt
  • Completed suicide
  • Pathological gambling
  • Impulse-control disorder
  • Binge eating
  • Compulsive shopping
  • Poriomania
  • Aggression
  • Agitation
  • Nervousness
  • Fatigue
  • Neonatal drug withdrawal syndrome
  • Motor instability
  • Affect lability (inj) 
  • Apathy (inj)
  • Dysphoria (inj) 
  • Sleep disorder (inj)
  • Bruxism (inj)
  • Decreased libido (inj)
  • Altered mood (inj)
  • Movement disorder (inj) 
  • Psychomotor hyperactivity (inj)
  • Cogwheel rigidity (inj)
  • Hypertonia (inj)
  • Bradykinesia (inj)
  • Drooling (inj)
  • Parosmia (inj)
  • Gait disturbance (inj)
  • Sluggishness (inj)
  • Panic reaction (inj)
  • Psychotic disorder (inj)
  • Hallucinations (inj)
  • Delusion (inj)

Cardiovascular Disorders

  • Tachycardia
  • Sudden unexplained death
  • Torsades de pointes
  • Ventricular arrhythmia
  • Cardiac arrest
  • Bradycardia
  • Orthostatic hypotension
  • QT prolongation
  • Hypertension
  • Venous thromboembolism
    - Deep vein thrombosis
    - Pulmonary embolism 
  • Chest pain
  • Chest discomfort (inj)
  • Ventricular extrasystoles (inj)
  • Decreased electrocardiogram T wave amplitude (inj)
  • Abnormal electrocardiogram (inj)
  • Inversion of electrocardiogram T wave (inj)
  • Increased heart rate (tab)

Respiratory Disorders

  • Hiccups
  • Aspiration pneumonia
  • Laryngospasm
  • Oropharyngeal spasm
  • Cough (inj)

Gastrointestinal Disorders

  • Constipation
  • Dyspepsia
  • Nausea and vomiting
  • Salivary hypersecretion
  • Dry mouth
  • Dysphagia
  • Diarrhoea
  • Upper abdominal pain 
  • Abdominal discomfort
    - Stomach discomfort (tab)
  • Gastrooesophageal reflux disease (inj) 
  • Frequent bowel movements (inj) 

Hepatobiliary Disorders

  • Hepatic failure
  • Hepatitis
  • Jaundice
  • Increased alanine aminotransferase
  • Increased aspartate aminotransferase
  • Increased gamma-glutamyl transferase
  • Increased alkaline phosphatase
  • Pancreatitis
  • Abnormal hepatic function test (inj)
  • Increased hepatic enzyme (inj) 
  • Increased blood bilirubin (inj) 

Genitourinary Disorders

  • Priapism
  • Urinary incontinence
  • Urinary retention
  • Nephrolithiasis (inj)
  • Glycosuria (inj)
  • Erectile dysfunction (inj)
  • Gynaecomastia (inj)
  • Breast tenderness (inj)
  • Vulvovaginal dryness (inj)

Endocrine and Metabolic Disorders

  • Increase in serum prolactin
  • Decrease in serum prolactin
  • Diabetic hyperosmolar coma
  • Diabetic ketoacidosis
  • Hyperglycaemia
  • Diabetes mellitus
  • Hyponatremia
  • Anorexia
  • Decreased weight 
  • Increased weight
  • Fluctuation of blood glucose
    - Increased blood glucose
    - Decreased blood glucose (inj)
  • Increased appetite (tab)
  • Appetite disorder (inj) 
  • Increased blood insulin
  • Hypercholesterolaemia
  • Decreased blood cholesterol (inj)
  • Decreased blood triglycerides (inj)
  • Hyperlipidaemia
  • Hypertriglyceridaemia
  • Galactorrhoea (inj)
  • Thirst (inj)
  • Increased waist circumference (inj)

Musculoskeletal Disorders

  • Rhabdomyolysis
  • Myalgia
  • Musculoskeletal stiffness
  • Increased creatine phosphokinase
  • Muscle twitching
  • Muscle rigidity
  • Muscle spasms 
  • Muscle tightness
  • Pain in extremity (inj)
  • Arthralgia (inj)
  • Back pain (inj)
  • Decreased joint range of motion (inj)
  • Nuchal rigidity (inj)
  • Trismus (inj)

Skin and Subcutaneous Tissue Disorders

  • Rash
  • Photosensitivity reaction
  • Alopecia
  • Hyperhidrosis
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Acne (inj)
  • Rosacea (inj)
  • Eczema (inj)
  • Skin induration (inj)
  • Injection site pain (inj) 
  • Injection site induration (inj)
  • Injection site reactions (inj)
    - Erythema
    - Swelling
    - Discomfort
    - Pruritus

Immune, Blood and Lymphatic System Disorders

  • Anaemia (inj)
  • Leukopenia
  • Neutropenia
  • Thrombocytopenia
  • Allergic reaction
    - Anaphylactic reaction
  • Angioedema 
    - Swollen tongue
    - Tongue oedema 
    - Face oedema 
    - Pruritus
    - Urticaria
  • Temperature regulation disorder
    - Hypothermia
    - Pyrexia
  • Increased glycosylated haemoglobin
  • Hypersensitivity
  • Peripheral oedema
  • Decreased neutrophil count
  • Decreased white blood cell count

Sensory Disorders

  • Blurred vision
  • Diplopia
  • Photophobia
  • Oculogyric crisis
  • Sensory instability 
  • Dysgeusia (inj) 
  • Eye pain (inj) 

Interactions

  • Antihypertensive agents
  • Central nervous system agents
  • QT prolonging agents
  • Agents known to cause electrolyte imbalance
  • CYP2D6 inhibitors (particularly strong inhibitors)
  • Quinidine
  • Fluoxetine
  • Paroxetine
  • Escitalopram
  • CYP3A4 inhibitors (particularly strong inhibitors)
  • Ketoconazole
  • Itraconazole
  • HIV protease inhibitors
  • Diltiazem
  • Strong CYP3A4 inducers
  • Carbamazepine
  • Rifampicin
  • Rifabutin
  • Phenytoin
  • Phenobarbital
  • Primidone
  • Efavirenz
  • Nevirapine
  • Other serotonergic agents
  • Selective serotonin reuptake inhibitors
  • Serotonin-noradrenalin reuptake inhibitors

Other interactions

  • Alcohol
  • St John's wort

Monitoring

  • Electrolytes
  • Hepatic function
  • Renal function
  • Thyroid stimulating hormone
  • Fasting blood glucose/ HbA1c
  • Lipid profile
  • Vital signs
  • Weight
  • Height
  • Body mass index (BMI)

Specific cases may require

  • Full blood count
  • Prolactin
  • Waist circumference

Additional observations

  • Adherence
  • Extrapyramidal symptoms
  • Fall risk
  • Mental status
  • Metabolic syndrome history
    - Personal and family history of obesity, diabetes, dyslipidemia, hypertension, or cardiovascular disease
  • Symptoms of hyperprolactinemia
    - Changes in menstruation
    - Libido
    - Gynaecomastia
    - Development of galactorrhoea
    - Erectile and ejaculatory function
  • Tardive dyskinesia

Prescribing points

Missed doses (inj)

If 2nd or 3rd dose is missed and time since last injection is: Action

>4 weeks and <5 weeks

The injection should be administered as soon as possible and then the monthly injection schedule should be resumed

>5 weeks

Concomitant oral aripiprazole should be restarted for 14 days with next administered injection 

Or two separate injections given at one time, along with a single dose of 20mg oral aripiprazole. Monthly injection schedule should then resume (International manufacturer recommendations)

If 4th or subsequent doses are missed (i.e. after attainment of steady state) and time since last injection is:

Action

>4 weeks and <6 weeks

The injection should be administered as soon as possible and then the monthly injection schedule should be resumed

>6 weeks

Concomitant oral aripiprazole should be restarted for 14 days with next administered injection and then resume monthly injection schedule

Or two separate injections given at one time, along with a single dose of 20mg oral aripiprazole (International manufacturer recommendations)

Administration instructions (inj) 

  • The suspension should be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle. Care should be taken to avoid inadvertent injection into a blood vessel
  • If initiating with the two injection start, inject into two different sites in two different muscles. Do not inject both injections concomitantly into the same deltoid or gluteal muscle. For known CYP2D6 poor metabolisers administer in either two separate deltoid muscles or one deltoid and one gluteal muscle. Do not inject into two gluteal muscles (Recommendations in other jurisdictions)

Known CYP2D6 poor metabolisers (inj)

  • In patients who are known to be CYP2D6 poor metabolisers, the starting and maintenance dose should be 300mg. When used concomitantly with strong CYP3A4 inhibitors the dose should be reduced to 200mg
  • One injection start: The starting dose should be 300mg aripiprazole and continue treatment with prescribed dose of oral aripiprazole per day for 14 consecutive days (Recommendations in other jurisdictions)
  • Two injection start: The starting dose should be two separate injections of 300mg aripiprazole along with one single dose of the previous prescribed dose of oral aripiprazole (Recommendations in other jurisdictions) 

Known CYP2D6 poor metabolisers and concomitantly use a strong CYP3A4 inhibitor (inj) (Recommendations in other jurisdictions)

  • One injection start: The starting dose should be reduced to 200mg and continue treatment with the prescribed dose of oral aripiprazole per day for 14 consecutive days 
  • Two injection start is not to be used in patients who are known to be CYP2D6 poor metabolisers and concomitantly use a strong CYP3A4 inhibitor 

Dose adjustments due to coadministered medications

Oral

  • When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced (e.g halved). When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased
  • When concomitant administration of strong CYP3A4 inducers with aripiprazole occurs, the aripiprazole dose should be increased (e.g. doubled). When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced 

Injection

  • Dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers: 
    - Dosage adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors or strong CYP2D6 inhibitors for more than 14 days. If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the dosage may need to be increased to the previous dose 
    -  In case of adverse reactions despite dose adjustments of aripiprazole, the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed 
    - Coadministration of CYP3A4 inducers with aripiprazole should be avoided for more than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels 
  • Dose adjustments of aripiprazole in patients who are taking concomitant strong CYP2D6 inhibitors, strong CYP3A4 inhibitors, and/or CYP3A4 inducers for more than 14 days:

Aripiprazole (inj) - 400mg

Coadministered medicine Adjusted dose
Strong CYP2D6 or strong CYP3A4 inhibitors 300mg
Strong CYP2D6 and strong CYP3A4 inhibitors 200mg*
CYP3A4 inducers Avoid use

Aripiprazole (inj) - 300mg

Coadministered medicine Adjusted dose
Strong CYP2D6 or strong CYP3A4 inhibitors 200mg*
Strong CYP2D6 and strong CYP3A4 inhibitors 160mg*
CYP3A4 inducers Avoid use

*200mg and 160mg can be achieved via adjustment of the injection volume only by using aripiprazole powder and solvent for prolonged-release suspension for injection

Mechanism of action

It has been proposed that aripiprazole's efficacy in schizophrenia and bipolar I disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors. Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity. Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors. Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors. Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole. 

Dosage forms

  • Injection
  • Tablet
  • Oral dispersible tablet

Formulation

Tablet 5mg 

  • Abilify (H. Lundbeck) originator
  • Abipip 5 (Cipla Medpro)
  • Alebon 5mg (Aurogen)
  • Apripent 5 (Abex Pharmaceutica)
  • Aprizon 5 (Unicorn Pharmaceuticals)
  • Aripiprazole 5 Teva (Teva Pharmaceuticals)
  • Aripiprazole 5 Unichem (Unichem SA)
  • Arizofy (Sandoz)
  • Priptrin 5 (Unichem SA)
  • Prizal (Camox Pharm)
  • Thryve 5 (Innovata Pharmaceuticals)

Tablet 10mg 

  • Abilify (H. Lundbeck) originator
  • Abipip 10 (Cipla Medpro)
  • Apripent 10 (Abex Pharmaceutica)
  • Aprizon 10 (Unicorn Pharmaceuticals)
  • Alebon 10mg (Aurogen)
  • Aripiprazole 10mg Mylan (Mylan)
  • Aripiprazole 10 Teva (Teva Pharmaceuticals)
  • Aripiprazole 10 Unichem (Unichem SA)
  • Arizofy (Sandoz)
  • Priptrin 10 (Unichem SA)
  • Prizal (Camox Pharm)
  • Thryve 10 (Innovata Pharmaceuticals)

Tablet 15mg 

  • Abilify (H. Lundbeck) originator
  • Abipip 15 (Cipla Medpro)
  • Alebon 15mg (Aurogen)
  • Apripent 15 (Abex Pharmaceutica)
  • Aprizon 15 (Unicorn Pharmaceuticals)
  • Aripiprazole 15mg Mylan (Mylan)
  • Aripiprazole 15 Teva (Teva Pharmaceuticals)
  • Aripiprazole 15 Unichem (Unichem SA)
  • Arizofy (Sandoz)
  • Priptrin 15 (Unichem SA)
  • Prizal (Camox Pharm)

Injection (per vial) 300mg

  • Abilify Maintena (H. Lundbeck) originator

Injection (per vial) 400mg

  • Abilify Maintena (H. Lundbeck) originator

References

1. PI: Abilify 5mg, 10mg &15mg tablets, H Lundbeck: Date of Registration: 30 September 2011; Date of revision: 4 December 2020 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 2. PI: Abilify Maintena 400mg and 300mg lyophilised powder for prolonged release suspension for injection (IM), H Lundbeck: Date of Registration: 10 November 2020, Date of revision: 12 May 2021 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 3. SmPC: Aripiprazole Accord 10mg tablets, Accord Healthcare Limited: Last updated on eMC: 05-May-2022; Downloaded online 11 July 2022 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 4. SmPC: Aripiprazole Accord 15mg tablets, Accord Healthcare Limited: Last updated on eMC: 05-May-2022; Downloaded online 11 July 2022 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 5. SmPC: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe, Otsuka Pharmaceuticals: Last updated on eMC: 24-May-2022; Downloaded online 11 July 2022 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 6. SmPC: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe,Otsuka Pharmaceuticals: Last updated on eMC: 24-May-2022; Downloaded online 11 July 2022 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 7. U2D: Drug information; Aripiprazole; Uptodate; Downloaded online; 05 April 2022 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 8. NAPOS: Medication check: Aripiprazole; Downloaded online 5 April 2022 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] 9. SAID South African Institute for Drug Free Sport; Aripiprazole; Accessed online 25 May 2022 [https://drive.google.com/drive/u/0/folders/1SVDXatCyeANtXqck0Q_taPF4cUgWCuBV] OLD REFERENCES 1. SAMF_12th Edition_Page 480 2. SmPC: Aripiprazole 5mg, 10mg, 15mg and 30mg tablets, Zentiva: Last updated on eMC: 19 Feb 2018; Downloaded online 01 Aug 2018 https://www.medicines.org.uk/emc/medicine/31721 3. PI: Abilify 5mg, 10mg, 15mg, H Lundbeck: Date of Registration: 30 April 2017 [https://drive.google.com/drive/folders/1rO4ZD5PmMPVkhfzt3kHtJjhKHgfXWX8N] 4. U2D: Aripiprazole (short-acting oral and injectable; and long-acting injectable [Abilify Maintena]): Drug information; Uptodate; Downloaded online 01 Aug 2018 https://www.uptodate.com/contents/aripiprazole-short-acting-oral-and-injectable-and-long-acting-injectable-abilify-maintena-drug-information?source=search_result&search=aripiprazole%20drug%20information&selectedTitle=1~74 5. https://www.drugs.com/pregnancy/aripiprazole.html 6. NAPOS The Drug Database for Acute Porphyria: Aripiprazole; Accessed online 29 Nov 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=N05AX12] 7. South African Institute for Drug-Free Sport: Abilify; Accessed online 29 Nov 2018 [http://www.drugfreesport.org.za/online-medication-check/] 8. Afritox: Aripiprazole; Accessed online 18 June 2019 [http://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=14665] 9. SmPC: Aripiprazole 5 mg Tablets, Sciecure Pharma Ltd: Last updated on eMC: 05 Jan 2021; Downloaded online: 8 March 2021 [https://drive.google.com/drive/u/0/folders/1rO4ZD5PmMPVkhfzt3kHtJjhKHgfXWX8N] 10. SmPC: Aripiprazole 10 mg Tablets, Sciecure Pharma Ltd: Last updated om eMC: 05 Jan 2021; Downloaded online: 8 March 2021 [https://drive.google.com/drive/u/0/folders/1rO4ZD5PmMPVkhfzt3kHtJjhKHgfXWX8N] 11. SmPC: Aripiprazole 15 mg Tablets, Sciecure Pharma Ltd: Last updated on eMC: 05 Jan 2021; Downloaded online: 8 March 2021 [https://drive.google.com/drive/u/0/folders/1rO4ZD5PmMPVkhfzt3kHtJjhKHgfXWX8N] 12. SmPC: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe, Otsuka Pharmaceuticals (UK) Ltd: Last updated on eMC: 11 Nov 2020; Downloaded online: 8 March 2021 [https://drive.google.com/drive/u/0/folders/1rO4ZD5PmMPVkhfzt3kHtJjhKHgfXWX8N] 13: PI: Abilify Maintena, H. Lundbeck: Date of Registration: 10 November 2020 [https://drive.google.com/drive/u/0/folders/1rO4ZD5PmMPVkhfzt3kHtJjhKHgfXWX8N]

Brands & products

46 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days old

tabletGeneric· 39 products

from R9.42/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Apize 5 Mg5 mg30S5R282.67R9.42R102.973007643001
Abipip 55 mg30S5R295.50R9.85R106.503001454001
Arizofy5 mg30S5R295.50R9.85R106.50723961001
Radzil 5 Mg5 mg30S5R295.50R9.85R106.503005266001
Aprizon 55 mg30S5R295.50R9.85R106.503002934001
Alebon 5Mg5 mg30S5R295.51R9.85R106.503005146001
Thryve 55 mg30S5R298.87R9.96R107.433004438001
Priptrin 55 mg30S5R362.45R12.08R124.923003846001
Apripent 55 mg30S5R396.63R13.22R134.323002238001
Aripiprazole 5Mg Mylan5 mg30S5R419.93R14.00R140.733004213001
Aripiprazole 5 Kiara5 mg30S5R423.01R14.10R141.583004316001
Prizal 5Mg5 mg30S5R423.07R14.10R141.603001370001
Radzil 10 Mg10 mg30S5R469.31R15.64R154.323005267001
Apize 10 Mg10 mg30S5R499.32R16.64R157.923007644001
Aprizon 1010 mg30S5R521.12R17.37R161.133002935001
Alebon 10Mg10 mg30S5R521.13R17.37R161.133005147001
Abipip 1010 mg30S5R521.13R17.37R161.133001455001
Arizofy10 mg30S5R521.13R17.37R161.13723962001
Priptrin 1010 mg30S5R521.13R17.37R161.133003847001
Thryve 1010 mg30S5R524.59R17.49R161.643004439001
Apripent 1010 mg30S5R638.59R21.29R178.413002239001
Aripiprazole 10Mg Mylan10 mg30S5R646.97R21.57R179.643004214001
Aripiprazole 10 Kiara10 mg30S5R653.94R21.80R180.673004317001
Prizal 10Mg10 mg30S5R665.93R22.20R182.433001371001
Apize 15 Mg15 mg30S5R698.76R23.29R187.263007647001
Radzil 15 Mg15 mg30S5R720.45R24.02R190.453005268001
Alebon 15Mg15 mg30S5R732.18R24.41R192.183005148001
Abipip 1515 mg30S5R732.18R24.41R192.183001456001
Arizofy15 mg30S5R732.18R24.41R192.18723963001
Priptrin 1515 mg30S5R732.18R24.41R192.183003848001
+ 9 more tablet products (not shown)

OdtGeneric· 4 products

from R18.40/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Aridus 1010 mg30S5R552.15R18.40R165.693003431001
Abipip 10 Odt10 mg28S5R585.79R20.92R170.643003284001
Aridus 1515 mg30S5R765.69R25.52R197.113003440001
Abipip 15 Odt15 mg28S5R922.75R32.96R220.213003286001

injectionGeneric· 3 products

from R180.29/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Abilify im 1.3ml vial- mg/ml1S5R180.29R180.29R74.26716587001
Abilify Maintena 400 Mg (Pre-Filled Syringe)400 mg2S5R6805.98R3402.99R585.783002581001
Abilify Maintena 400 Mg (Vial Kit)400 mg2S5R6805.98R3402.99R585.783002583001
Trade names (13)
  • Abilify
  • Abipip
  • Apripent
  • Aprizon
  • Aridus
  • Aripiprazole Mylan
  • Aripiprazole Teva
  • Aripiprazole Unichem
  • Arizofy
  • Priptrin
  • Prizal
  • Thryve
  • Abilify Maintena

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Interacts with 14 known drugs

Check against other drugs →

Cited in 7 documents

NeoHealth® ID 15991 · updated 6/3/2024