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Prochlorperazine maleate

Oral
Rectal
Class
Antipsychotics
Subclass
Phenothiazines
Generic name
Prochlorperazine maleate
Common formulations
Tablet
Dosage and administration
Adults patients
Manifestations of psychotic disorders
•
5-10 mg PO q6-8h
Nausea and vomiting • Severe
•
5-10 mg PO q6-8h
Other off-label uses
•
Symptomatic relief of cyclic vomiting syndrome
Indications for use
Labeled indications
Adults
•
Treatment of manifestations of psychotic disorders
•
Treatment of nausea and vomiting (severe)
Children
•
Treatment of nausea and vomiting (severe)
Off-label indications
Adults
•
Symptomatic relief of cyclic vomiting syndrome
Safety risks
Boxed warnings
Neutropenia
•
Use extreme caution with a pre-existing low WBC count or a history of drug-induced leukopenia/neutropenia.
Tardive dyskinesia
•
Use extreme caution the use of prochlorperazine at higher doses or a history of movement disorders.
Contraindications
Comatose states (e.g., coma) or in the presence of large amounts of CNS depressants (alcohol, barbiturates, narcotics, etc.)
Known hypersensitivity to prochlorperazine or other phenothiazine hypersensitivity
Underlying cholestatic dysfunction
Warnings and precautions
Angina
•
Use caution with significant cardiac disease or pulmonary disease.
Ataxia
•
Use caution with neurological disease.
Hyperprolactinemia
•
Use caution with a history of breast cancer.
Orthostatic hypotension
•
Use caution with conditions, diseases, or concurrent medication use that could exacerbate orthostasis.
Prolonged QT interval
•
Use caution with conditions that may increase the risk of QT prolongation or receiving medications known to prolong the QT interval or cause electrolyte imbalances.
Seizures
•
Use caution with a seizure disorder.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
No guidance available.
Substantial chronic alcohol consumption
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in humans. Monitor neonates for extrapyramidal and/or withdrawal symptoms. The malformative risk with use of this drug in pregnant women is unknown. Patients have reported teratogenic effects; extrapyramidal and withdrawal symptoms have been reported in exposed neonates.
•
Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder, low Apgar score). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.
•
If used during labor, this drug should be withheld until the cervix is dilated 3 to 4 cm.
Breastfeeding
Use with caution during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Unknown frequency
•
Agranulocytosis, catatonia, cholestatic jaundice, death, ↓ WBC count, ↓ blood neutrophil count, ↓ serum sodium, drug withdrawal syndrome, drug-induced liver injury, dystonia, extrapyramidal signs, gynecomastia, hepatic steatosis, hypertension, hypotension, lip ulcers, neuroleptic malignant syndrome, oculogyric crisis, pulmonary embolism, parkinsonism, pituitary tumor, ↑QT interval, akathisia, amenorrhea, blurred vision, dizziness, erectile dysfunction, fever, galactorrhea, mastalgia, polydipsia, seizure, skin rash, somnolence, weight gain, syndrome of inappropriate antidiuretic hormone secretion, tardive dyskinesia, venous thromboembolism
Interactions
Drug(s)
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