Cariprazine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of cariprazine.
Drugs List
Therapeutic Indications
Uses
Schizophrenia
Dosage
Adults
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.
Contraindications
Children under 18 years
Breastfeeding
Dementia
Pregnancy
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
Cardiovascular disorder
Diabetes mellitus
History of seizures
Parkinson's disease
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
Pregnancy
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.
Lactation
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.
Side Effects
Abnormal serum sodium levels
Akathisia
Akinesia
Amnesia
Anaemia
Anxiety
Aphasia
Blurred vision
Bradyarrhythmias
Bradykinesia
Bruxism
Cardiac conduction disturbances
Cataracts
Constipation
Convulsions
Creatine phosphokinase increased
Decreased appetite
Decreased TSH
Delirium
Depression
Diabetes mellitus
Disturbances in accommodation
Dizziness
Dream abnormalities
Drooling
Dysaesthesia
Dysarthria
Dyskinesia
Dyslipidaemia
Dysphagia
Dystonia
Dysuria
Eosinophilia
Erectile dysfunction
Extrapyramidal effects
Eye irritation
Fatigue
Fine vermicular movement of the tongue
Gait abnormality
Gastroesophageal reflux disease
Hiccups
Hypersalivation
Hypersensitivity reactions
Hypersomnia
Hypertension
Hyporeflexia
Hypotension
Hypothyroidism
Increase in serum glucose
Increased appetite
Increased intra-ocular pressure
Increased libido
Increases in hepatic enzymes
Insomnia
Lethargy
Movement disturbances
Muscle rigidity
Muscle tension
Nausea
Neuroleptic malignant syndrome
Neutropenia
Oculogyric crisis
Parkinsonism
Photophobia
Pollakiuria
Prolongation of QT interval
Pruritus
Psychomotor hyperactivity
Rash
Reduced libido
Reduced visual acuity
Restless legs
Restlessness
Rhabdomyolysis
Sedation
Seizures
Serum bilirubin increased
Sleep disorders
Stiffness
Suicidal tendencies
T-wave changes
Tachyarrhythmia
Tardive dyskinesia
Thirst
Torticollis
Toxic hepatitis
Tremor
Trismus
Vertigo
Vomiting
Weight gain
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: November 2019
Reference Sources
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
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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