Chlorpromazine injection

FDA label, Hikma Pharmaceuticals USA Inc., intramuscular, effective 2024-04-08. Full label on DailyMed

Other products: Chlorpromazine

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

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 Injection, USP is not approved for the treatment of patients with dementia-related psychosis ( see WARNINGS ).

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Preparation and administration

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IV: 2 mg per fractional injection, at 2-minute intervals. Do not exceed 25 mg. Dilute to 1 mg / mL, i.e., 1 mL (25 mg) mixed with 24 mL of saline. PRESURGICAL APPREHENSION IM : 12.5 to 25 mg (0.5-1 mL), 1 to 2 hours before operation. INTRACTABLE HICCUPS If symptoms persist for 2-3 days after trial with oral therapy, give 25 to 50 mg (1-2 mL) IM.

Should symptoms persist, use slow IV infusion with patient flat in bed: 25 to 50 mg (1-2 mL) in 500 to 1000 mL of saline. Follow blood pressure closely. ACUTE INTERMITTENT PORPHYRIA IM : 25 mg (1 mL) tid or qid until patient can take oral therapy. TETANUS IM : 25 to 50 mg (1-2 mL) given 3 or 4 times daily, usually in conjunction with barbiturates.

Total doses and frequency of administration must be determined by the patient’s response, starting with low doses and increasing gradually. IV: 25 to 50 mg (1-2 mL). Dilute to at least 1 mg per mL and administer at a rate of 1 mg per minute. Pediatric Patients (6 months to 12 years of age) Chlorpromazine should generally not be used in pediatric patients under 6 months of age except where potentially lifesaving.

Always dilute to 1 mg / mL, i.e., 1 mL (25 mg) mixed with 24 mL of saline. PRESURGICAL APPREHENSION 1 / 4 mg / lb body weight IM 1 to 2 hours before operation. TETANUS IM or IV: 1 / 4 mg / lb body weight q6-8h. When given IV, dilute to at least 1 mg / mL and administer at a rate of 1 mg per 2 minutes. In patients up to 50 lbs., do not exceed 40 mg daily; 50 to 100 lbs., do not exceed 75 mg except in severe cases.

Important Notes on Injection Inject slowly, deep into upper outer quadrant of buttock. Because of possible hypotensive effects, reserve parenteral administration for bedfast patients or for acute ambulatory cases, and keep patient lying down for at least 1 / 2 hour after injection. If irritation is a problem, dilute injection with saline or 2% procaine; mixing with other agents in the syringe is not recommended.

Subcutaneous injection is not advised. AVOID INJECTING UNDILUTED CHLORPROMAZINE HYDROCHLORIDE INJECTION INTO VEIN. IV ROUTE IS ONLY FOR SEVERE HICCUPS, SURGERY AND TETANUS. Because of the possibility of contact dermatitis, avoid getting solution on hands or clothing. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  • Chlorpromazine injection

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.).

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

A

Likelihood score A: Well known cause of clinically apparent liver injury.

Chlorpromazine is a phenothiazine that was once the most commonly prescribed antipsychotic agent, but that is now rarely used. Chlorpromazine can cause mild and transient serum enzyme elevations and is also a well known cause of clinically apparent acute and chronic cholestatic liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Chlorpromazine (NIDDK, public domain)Chapter updated Oct 5, 2017

Pregnancy and lactation

Pregnancy

Pregnancy NON-TERATOGENIC EFFECTS Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Chlorpromazine Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

Nursing Mothers There is evidence that chlorpromazine is excreted in the breast milk of nursing mothers. Because of the potential for serious adverse reactions in nursing infants from chlorpromazine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Breastfeeding (LactMed)

Chlorpromazine is detectable in the milk of some mothers during therapy, but levels appear not to correlate well with the maternal dose or serum level. Some breastfed infants become drowsy during maternal chlorpromazine therapy. Very limited long-term follow-up data indicate no adverse developmental effects when the drug is used alone. A safety scoring system finds chlorpromazine possible to use cautiously during breastfeeding. However, using it in combination with haloperidol can negatively affect development. Monitor the infant for excessive drowsiness during breastfeeding and for developmental milestones, especially if other antipsychotics are used concurrently.

Alternatives LactMed suggests considering:
Source: LactMed: Chlorpromazine (NICHD, public domain)Revised Mar 15, 2025

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