pharmacopeia
GET
/api/v1/drug/prochlorperazine
2D structure
2-chloro-10-[3-(4-methylpiperazin-1-yl)propyl]phenothiazine
SMILES CN1CCN(CC1)CCCN2C3=CC=CC=C3SC4=C2C=C(C=C4)Cl
InChIKey WIKYUJGCLQQFNW-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Dopamine Antagonists.

Dopamine

Indications

Sourced from openFDA
  • For control of severe nausea and vomiting. For the treatment of schizophrenia.ICD-10: F20.9, R11.2

Contraindications

Sourced from openFDA
  • Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).contraindicated

Dosage & administration

Sourced from openFDA

(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients. Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reac­tions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully moni­tored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients. 1.To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage. Oral Dosage-Tablets: Usually one 5mg or 10mg tablet 3 or 4 times daily. Daily dosages above 40 mgs should be used only in resistant cases. 2.In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recom­mended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen. Oral Dosage: Non-Psychotic Anxiety--Usual dosage is 5 mg 3 or4 times daily. Do not administer in doses of more than 20mg per day or for longer than 12 weeks. Psychotic Disorders including Schizophrenia--In relatively mild conditions, as seen in private psychiatric practice or in out patient clinics, dosage is 5 or 10 mg 3 or 4 times daily. In moderate to severe conditions, for hospitalized or adequate­ly supervised patients, usual starting dosage is 10 mg 3 or 4 times daily.

Warnings & precautions

Sourced from openFDA

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye’s syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye’s syndrome. Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic drug treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.

Adverse reactions

Sourced from openFDA

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see WARNINGS). Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy. Neuromuscular (Extrapyramidal) Reactions These symptoms are seen in a significant number of hospitalized mental patients. They maybe characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases barbiturates by suitable route of administration will suffice. (Or, injectable BENADRYL®ll may be useful). In more severe cases, the administration of an anti-parkinsonism agent, except levodopa (See PDR), usually produces rapid reversal of symptoms.

Overdosage

Sourced from openFDA

(See also ADVERSE REACTIONS.) SYMPTOMS--Primarily involvement of the extrapyramidal mechanism producing some of the dystonic reactions described above. Symptoms of central nervous system depression to the point of somnolence or coma. Agitation and restlessness may also occur. Other possible manifestations include convulsions, EKG changes and cardiac arrhythmias, fever and autonomic reactions such as hypotension, dry mouth and ileus. TREATMENT--It is important to determine other medications taken by the patient since multiple-dose therapy is common in overdosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage. Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus. Extrapyramidal symptoms may be treated with antiparkinsonism drugs, barbiturates or Benadryl. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression.

Approval history

Sourced from openFDA
  • Aug 29, 1989ANDAANDA089903Hikma
  • Nov 24, 1993ANDAANDA040058Cosette
  • Jul 19, 1996ANDAANDA040101Chartwell Rx
  • Feb 27, 1998ANDAANDA040268Jubilant Cadista
  • Jun 28, 2000ANDAANDA040246Padagis Us
  • Oct 15, 2013ANDAANDA204147Avet Lifesciences
  • Oct 25, 2018ANDAANDA210710Mylan Labs Ltd
  • Apr 22, 2021ANDAANDA214379Caplin

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
37,077 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea4,70813%
  2. 2Fatigue4,11311%
  3. 3Diarrhoea3,3759.1%
  4. 4Vomiting2,5787.0%
  5. 5Death2,4786.7%
  6. 6Febrile Neutropenia2,0305.5%
  7. 7Off Label Use1,8775.1%
  8. 8Asthenia1,8585.0%
  9. 9Pneumonia1,5774.3%
  10. 10Dyspnoea1,5734.2%
  11. 11Decreased Appetite1,5704.2%
  12. 12Pain1,4383.9%
  13. 13Constipation1,3833.7%
  14. 14Pyrexia1,3813.7%
  15. 15Headache1,3703.7%

Literature

View JSON

Recent PubMed references pinned to Prochlorperazine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 50 ClinicalTrials.gov registrations naming Prochlorperazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Prochlorperazine work?
Mechanism-of-action class: Dopamine Antagonists.
What is Prochlorperazine used for?
According to FDA labeling, Prochlorperazine carries indications including: For control of severe nausea and vomiting. For the treatment of schizophrenia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Prochlorperazine?
Prochlorperazine is classified as Phenothiazines with piperazine structure, Phenothiazine, Dopamine Antagonists, Decreased Brain Stem Dopamine Activity, Decreased Central Nervous System Acetylcholine Activity, Decreased Central Nervous System Norepinephrine Activity, Decreased Central Nervous System Organized Electrical Activity, Emesis Suppression.
What are the brand names for Prochlorperazine?
Prochlorperazine is marketed under brand names including Compazine, Compro.
What are the contraindications for Prochlorperazine?
Prochlorperazine labeling lists contraindications including: Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).. Always consult the full prescribing information and a clinician.
Note. Data for prochlorperazine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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