- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of cariprazine.
Initial dose: 1.5mg once daily. The dose maybe increased by 1.5mg increments to a maximum dose of 6mg daily.
Due to the long half life of cariprazine, changes in dose may not be fully reflected for several weeks.
Additional Dosage Information
Switching from other antipsychotics to cariprazine
Gradual cross titration should be considered, with gradual discontinuation of the previous treatment while cariprazine treatment is initiated.
Switching to another antipsychotics from cariprazine
No gradual cross titration is needed, the new antipsychotic should be initiated in its lowest dose while cariprazine is discontinued. It should be considered that plasma concentration of cariprazine and its active metabolites will decline by 50% in 1 week.
Children under 18 years
Severe hepatic impairment
Severe renal impairment
Precautions and Warnings
Family history of long QT syndrome
Females of childbearing potential
Patients over 65 years
Predisposition to diabetes mellitus
Predisposition to orthostatic hypotension
Predisposition to venous thromboembolism
Risk of cerebrovascular accident
History of seizures
Consider preventative measures in patients at risk of thromboembolism
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Non-significant increase in QT interval at therapeutic doses
Monitor blood pressure
Monitor closely for symptoms of akathisia,especially during early treatment
Monitor patient's weight
Monitor patients with a history of depression and/or suicide attempts
Monitor patients with existing or tendency towards diabetes mellitus
Advise patient of the risk of weight gain
Consider discontinuation if signs of tardive dyskinesia occur
Discontinue if patient develops neuroleptic malignant syndrome
Maintain treatment at the lowest effective dose
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient to avoid grapefruit products
Female: Contraception required during and for 10 weeks after treatment
Akathesia and restlessness frequently occur with use of antipsychotics. Use caution in patients who are prone to or already exhibit symptoms of akathisia and monitor during the first phase of treatment. Dose can be modified based on patient response and tolerability.
Patients who would develop symptoms potentially related to cataracts should be advised to have a ophthalmologic examination and re-evaluation for treatment continuation.
Cariprazine has not been studied in elderly patients with dementia and is not recommended to treat elderly patients with dementia due to increased risk of overall mortality.
Pregnancy and Lactation
Cariprazine is contraindicated during pregnancy.
The manufacturer does not recommend using cariprazine during pregnancy and in women of childbearing potential not using effective contraception.
There is limited data regarding the use of cariprazine in pregnancy. Animal studies have shown reproductive toxicity.
Neonates exposed to cariprazine during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorder following antipsychotic use. These complications have varied in severity. Newborns should be monitored carefully.
Clinicians should also consider the risk of relapse and potential impact on maternal health if treatment is withdrawn, particularly with abrupt discontinuations.
Cariprazine is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking cariprazine.
There is limited data regarding the use of cariprazine in breastfeeding. It is unknown whether cariprazine or its active metabolites are excreted into human milk. A risk to the newborn or infants cannot be excluded.
Abnormal serum sodium levels
Cardiac conduction disturbances
Creatine phosphokinase increased
Disturbances in accommodation
Fine vermicular movement of the tongue
Gastroesophageal reflux disease
Increase in serum glucose
Increased intra-ocular pressure
Increases in hepatic enzymes
Neuroleptic malignant syndrome
Prolongation of QT interval
Reduced visual acuity
Serum bilirubin increased
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 ).
Last Full Review Date: November 2019
Summary of Product Characteristics: Reagila 1.5mg, 3mg, 4.5mg and 6mg hard capsules. Recordati Pharmaceuticals Ltd. Revised February 2022.
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
Cariprazine Last revised: 26 April 2018
Last accessed: 26 October 2018
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.