Chlorpromazine

Chlorpromazine may be found in some form under the following brand names:

• Ormazine

• Thorazine

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of chlorpromazine, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The safe use of chlorpromazine during pregnancy has not been established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgment of the physician, it is essential. The potential benefits should clearly outweigh possible hazards.

Take chlorpromazine exactly as prescribed.

Oral:

Chlorpromazine comes in tablet form and is usually taken 2 to 4 times daily.

Injectable:

Chlorpromazine is also available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of chlorpromazine at the same time.

Oral/Injectable:

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

The dose and route of administration of chlorpromazine should be individualized according to the condition being treated, symptom severity, and patient response.

Chlorpromazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Chlorpromazine is used to treat psychotic disorders such as schizophrenia or manic-depression, and severe behavioral problems in children ages 1 through 12.

Chlorpromazine is also used to treat nausea and vomiting, anxiety before surgery, chronic hiccups, acute intermittent porphyria, and symptoms of tetanus.

Chlorpromazine may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dry mouth, bloating or stomach cramps, feeling restless or agitated, fever, muscle stiffness, jerky muscle movements, changes in heart rate, or seizure (convulsions).

The precise mechanism whereby the therapeutic effects of Chlorpromazine are produced is not known. The principal pharmacological actions are psychotropic. It also exerts sedative and antiemetic activity. Chlorpromazine has actions at all levels of the central nervous systemprimarily at subcortical levelsas well as on multiple organ systems.

Chlorpromazine has strong antiadrenergic and weaker peripheral anticholinergic activity; ganglionic blocking action is relatively slight. It also possesses slight antihistaminic and antiserotonin activity.

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.

Increase parenteral dosage only if hypotension has not occurred. Before using IM, see Important Notes On Injection.

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.

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

IM: 25 mg (1 mL). If necessary, give additional 25 to 50 mg injection in 1 hour. Increase subsequent IM doses gradually over several days–up to 400 mg q4-6h in exceptionally severe cases–until patient is controlled. Usually the patient becomes quiet and cooperative within 24 to 48 hours and oral doses may be substituted.

Prompt Control of Severe Symptoms

IM: 25 mg (1 mL). If necessary, repeat in 1 hour. Subsequent doses should be oral, 25-50 mg tid.

IM: 25 mg (1 mL). If no hypotension occurs, give 25 to 50 mg q3-4h prn, until vomiting stops. Then switch to oral dosage.

During Surgery

IM: 12.5 mg (0.5 mL). Repeat in 1/2 hour if necessary and if no hypotension occurs. 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.

IM: 12.5 to 25 mg (0.5-1 mL), 1 to 2 hours before operation.

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.

IM: 25 mg (1 mL) tid or qid until patient can take oral therapy.

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. It should not be used in conditions for which specific pediatric dosages have not been established.

Outpatients

Select route of administration according to severity of patient’s condition and increase dosage gradually as required. IM: 1/4 mg/lb body weight q6-8h, prn.

Hospitalized Patients

As with outpatients, start with low doses and increase dosage gradually. In severe behavior disorders, higher dosages (50-100 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. Maximum IM Dosage: Patients up to 5 years (or 50 lbs.), not over 40 mg/day; 5-12 years (or 50-100 lbs.), not over 75 mg/day except in unmanageable cases.

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. IM: 1/4 mg/lb body weight q6-8h, prn. Maximum IM Dosage: Pediatric patients 6 months to 5 years (or 50 lbs.), not over 40 mg/day; 5-12 years (or 50-100 lbs.), not over 75 mg/day except in severe cases.

During Surgery

IM: 1/8 mg/lb body weight. Repeat in 1/2 hour if necessary and if no hypotension occurs. IV: 1 mg per fractional injection at 2-minute intervals and not exceeding recommended IM dosage. Always dilute to 1 mg/mL, i.e., 1 mL (25 mg) mixed with 24 mL of saline.

1/4 mg/lb body weight IM 1 to 2 hours before operation.

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.

• Chlorpromazine HCl
• Chlorpromazine Hydrochloride
• CPZ
• Thorazine

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as hydrochloride:

Generic: 25 mg/mL (1 mL); 50 mg/2 mL (2 mL)

Tablet, Oral, as hydrochloride:

Generic: 10 mg, 25 mg, 50 mg, 100 mg, 200 mg

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Not dialyzable (0% to 5%)

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

SubQ: Do not administer SubQ (tissue damage and irritation may occur).

IV: For direct IV injection, administer diluted solution slow IV at a rate not to exceed 0.5 mg/minute in children and 1 mg/minute in adults. For the treatment of intractable hiccups, infuse as a slow IV infusion. To reduce the risk of hypotension, patients receiving IV chlorpromazine must remain lying down during and for 30 minutes after the injection.

IM: Inject slowly, deep into upper outer quadrant of buttock.

Note: Avoid skin contact with solution; may cause contact dermatitis.

Frequency not defined.

Cardiovascular: ECG abnormality (nonspecific QT changes), orthostatic hypotension, tachycardia

Central nervous system: Akathisia, dizziness, drowsiness, dystonia, neuroleptic malignant syndrome, parkinsonian-like syndrome, seizure, tardive dyskinesia

Dermatologic: Dermatitis, skin photosensitivity, skin pigmentation (slate gray)

Endocrine & metabolic: Amenorrhea, gynecomastia, hyperglycemia, hypoglycemia

Gastrointestinal: Constipation, nausea, xerostomia

Genitourinary: Breast engorgement, ejaculatory disorder, false positive pregnancy test, impotence, lactation, urinary retention

Hematologic & oncologic: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, immune thrombocytopenia, leukopenia

Hepatic: Jaundice

Ophthalmic: Blurred vision, corneal changes, epithelial keratopathy, retinitis pigmentosa

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 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 and 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 approximately 4.5%, compared with a rate of approximately 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, 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 is not approved for the treatment of patients with dementia-related psychosis.