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INN monograph

Chlorpromazine

Therapeutic agent (verify pharmacological class) · POM

POM Source-linked Grade perfect

Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Professional class pharmacology (Therapeutic agent (verify pharmacological class))

Kenya market

Wholesale / list prices where loaded

From
KES 563
Median
KES 563
Brands
1
Boxed / critical warning

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 ).

Risk first

Contraindications

  • CONTRAINDICATIONS 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.).

Precautions

  • WARNINGS 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.
  • However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
  • There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
  • Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process.
  • The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Point of care

Dosing

Adult

DOSAGE AND ADMINISTRATION 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. Usually patient becomes quiet and cooperative within 24 to 48 hours and oral doses may be substituted and increased until the patient is calm. 500 mg a day is generally sufficient. While gradual increases to 2,000 mg a day or more may be necessary, there is usually little therapeutic gain to be achieved by exceeding 1,000 mg a day for extended periods. In general, dosage levels should be lower in the elderly, the emaciated and the debilitated. Less Acutely Disturbed Oral: 25 mg t.i.d. Increase gradually until effective dose is reached – usually 400 mg daily. Outpatients 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d. More Severe Cases 25 mg t.i.d. After 1 or 2 days, daily dosage may be increased by 20 to 50 mg at semiweekly intervals until patient becomes calm and cooperative. Prompt Control of Severe Symptoms Initial treatment should be with intramuscular chlorpromazine hydrochloride. Subsequent doses should be oral, 25 to 50 mg t.i.d. Nausea and Vomiting 10 to 25 mg q4 to 6h, p.r.n., increased, if necessary. Presurgical Apprehension 25 to 50 mg, 2 to 3 hours before the operation. Intractable Hiccups 25 to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, parenteral therapy is indicated. Acute Intermittent Porphyria 25 to 50 mg t.i.d. or q.i.d. Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients. Pediatric Patients (6 Months To 12 Years of Age) Chlorpromazine hydrochloride should generally not be used in pediatric patients under 6 months of age except where potentially lifesaving. It should not be used in conditions for which specific pediatric dosages have not been established. Severe Behavioral Problems Outpatients Select route of administration according to severity of patient's condition and increase dosage gradually as required. Oral: ¼ mg/lb body weight q4 to 6h, p.r.n. (e.g., for 40 lb child – 10 mg q4 to 6h). Hospitalized Patients As with outpatients, start with low doses and increase dosage gradually. In severe behavior disorders, higher dosages (50 to 100 mg daily, and in older children, 200 mg daily or more) may be necessary. There is little evidence that behavior improvement in severely disturbed mentally retarded patients is further enhanced by doses beyond 500 mg per day. Nausea and Vomiting Dosage and frequency of administration should be adjusted according to the severity of the symptoms and response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary. Oral: ¼ mg/lb body weight (e.g., 40 lb child – 10 mg q4 to 6h). Presurgical Apprehension ¼ mg/lb body weight, orally 2 to 3 hours before operation. Note on Concentrate When the Concentrate is to be used, add the desired dosage of Concentrate to 60 mL (2 fl oz) or more of diluent just prior to administration. This will insure palatability and stability. Vehicles suggested for dilution are: tomato or fruit juice, milk, simple syrup, orange syrup, carbonated beverages, coffee, tea or water. Semisolid foods (soups, puddings, etc.) may be used. The Oral Concentrate is light sensitive; it should be protected from light and dispensed in amber glass bottles. Refrigeration is not required.

Paediatric

See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.

Renal

Review renal impairment dosing; many agents need CrCl/eGFR adjustment.

  • CrCl 0–120: Confirm renal dosing in product SmPC / primary label.

Hepatic

Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.

Safety

Drug interactions

Open checker →
  • Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
  • Document allergy status and key interactions.

Safety

Adverse effects

  • ADVERSE REACTIONS 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.

Use

Indications

  • INDICATIONS AND USAGE For the management of manifestations of psychotic disorders.
  • For the treatment of schizophrenia.
  • To control nausea and vomiting.
  • For relief of restlessness and apprehension before surgery.
  • For acute intermittent porphyria.
  • As an adjunct in the treatment of tetanus.
  • To control the manifestations of the manic type of manic-depressive illness.
  • For relief of intractable hiccups.
  • For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.

Pharmacology

Mode of action

Mechanism is agent-specific.

Mechanism is agent-specific. At receptor, enzyme, ion channel, transpor… Confirm precise molecular mechanism in cur…
Full mechanism text

Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.

ADME

Pharmacokinetics & PD

Onset Product-specific
Duration Product-specific
Route See product SmPC
Full PK/PD text

CLINICAL PHARMACOLOGY The precise mechanism whereby the therapeutic effects of chlorpromazine hydrochloride are produced is not known. The principal pharmacological actions are psychotropic. It also exerts sedative and antiemetic activity. Chlorpromazine hydrochloride has actions at all levels of the central nervous system-primarily at subcortical levels-as well as on multiple organ systems. Chlorpromazine hydrochloride has strong antiadrenergic and weaker peripheral anticholinergic activity; ganglionic blocking action is relatively slight. It also possesses slight antihistaminic and antiserotonin activity.

Kenya

Brands & prices

1 listed
Brand Company Pack KES
CHLORPROMAZINE DAIMA BIASHARA / Wholesale Import 100MG TABS 100`S-DDA 563.30

Special populations

Pregnancy & lactation

Pregnancy

Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.

Lactation

Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.

Diet

Food & alcohol

  • Food
  • Food

Trust

Sources & disclaimer

Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Professional class pharmacology (Therapeutic agent (verify pharmacological class))

Open source link

Clinical review date not recorded.

Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.

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