pharmacopeia
GET
/api/v1/drug/chlorpromazine

Boxed warning

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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

2D structure
3-(2-chlorophenothiazin-10-yl)-N,N-dimethylpropan-1-amine
SMILES CN(C)CCCN1C2=CC=CC=C2SC3=C1C=C(C=C3)Cl
InChIKey ZPEIMTDSQAKGNT-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha-Antagonists; Dopamine Antagonists; Unknown Cellular or Molecular Interaction.

Dopamine

Indications

Sourced from openFDA
  • For the management of manifestations of psychotic disorders. For the treatment of schizophrenia.ICD-10: F20.9

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

Adults Adjust dosage to individual and the severity of his condition, recognizing that the milligram for milligram potency relationship among all dosage forms has not been precisely established clinically. It is important to increase dosage until symptoms are controlled. Dosage should be increased more gradually in debilitated or emaciated patients. In continued therapy, gradually reduce dosage to the lowest effective maintenance level, after symptoms have been controlled for a reasonable period. Elderly Patients In general, dosages in the lower range are sufficient for most elderly patients. Since theyappear 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. Psychotic Disorders Increase dosage gradually until symptoms are controlled. Maximum improvement may not be seen for weeks or even months. Continue optimum dosage for 2 weeks; then gradually reduce dosage to the lowest effective maintenance level. Daily dosage of 200 mg is not unusual. Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients). Hospitalized Patients Acute Schizophrenic or Manic States It is recommended that initial treatment be with chlorpromazine hydrochloride injection until patient is controlled.

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. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). The extrapyramidal symptoms which can occur secondary to chlorpromazine hydrochloride 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 chlorpromazine hydrochloride 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 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

Note: Some adverse effects of chlorpromazine hydrochloride may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses. Drowsiness: usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered. Jaundice: Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported. There is no conclusive evidence that pre-existing liver disease makes patients more susceptible to jaundice. Alcoholics with cirrhosis have been successfully treated with chlorpromazine hydrochloride without complications. Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have experienced jaundice with a phenothiazine should not, if possible, be reexposed to chlorpromazine hydrochloride or other phenothiazines. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment.

Overdosage

Sourced from openFDA

(See also ADVERSE REACTIONS .) Symptoms Primarily symptoms of central nervous system depression to the point of somnolence or coma. Hypotension and extrapyramidal symptoms. Other possible manifestations include agitation and restlessness, convulsions, fever, autonomic reactions such as dry mouth and ileus. EKG changes and cardiac arrhythmias. Treatment It is important to determine other medications taken by the patient since multiple drug therapy is common in over dosage 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 over dosage. 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 anti-parkinsonism drugs, barbiturates, or diphenhydramine hydrochloride. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression.

Approval history

Sourced from openFDA
  • Feb 13, 1974ANDAANDA080365Dr Reddys
  • Jul 9, 1974ANDAANDA083386Upsher Smith Labs
  • Jul 9, 1974ANDAANDA084113Upsher Smith Labs
  • Jul 9, 1974ANDAANDA084112Upsher Smith Labs
  • Jul 9, 1974ANDAANDA084114Upsher Smith Labs
  • Jul 9, 1974ANDAANDA084115Upsher Smith Labs
  • Jul 25, 1974ANDAANDA083329Hikma
  • Mar 1, 1976ANDAANDA080983Saptalis Pharms

FAERS reports

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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.
7,007 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. 1Drug Ineffective5367.6%
  2. 2Off Label Use4456.4%
  3. 3Toxicity To Various Agents4456.4%
  4. 4Overdose3565.1%
  5. 5Drug Interaction3244.6%
  6. 6Neuroleptic Malignant Syndrome2934.2%
  7. 7Nausea2753.9%
  8. 8Neutropenia2653.8%
  9. 9Diarrhoea2563.7%
  10. 10Fatigue2533.6%
  11. 11Vomiting2453.5%
  12. 12Somnolence2343.3%
  13. 13Psychotic Disorder2313.3%
  14. 14Suicide Attempt2163.1%
  15. 15Death2042.9%

Literature

View JSON

Recent PubMed references pinned to Chlorpromazine 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 33 ClinicalTrials.gov registrations naming Chlorpromazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Chlorpromazine work?
Mechanism-of-action classes: Adrenergic alpha-Antagonists; Dopamine Antagonists; Unknown Cellular or Molecular Interaction.
What is Chlorpromazine used for?
According to FDA labeling, Chlorpromazine carries indications including: For the management of manifestations of psychotic disorders. 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 Chlorpromazine?
Chlorpromazine is classified as Phenothiazines with aliphatic side-chain, Phenothiazine, Adrenergic alpha-Antagonists, Dopamine Antagonists, Unknown Cellular or Molecular Interaction, Decreased Central Nervous System Organized Electrical Activity, Decreased Dopamine Activity, Decreased Histamine Activity, Decreased Norepinephrine Activity, Decreased Serotonin Activity, Hypothalamic Endocrine Activity Alteration.
What are the contraindications for Chlorpromazine?
Chlorpromazine 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 chlorpromazine 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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