Chlorpromazine Hydrochloride (Page 4 of 4)

OVERDOSAGE

(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.

If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended. Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.

If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable to administer a vasoconstrictor, norepinephrine and phenylephrine are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating action of these agents and cause a further lowering of blood pressure.

Limited experience indicates that phenothiazines are not dialyzable.

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 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.

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Intended for institutional use. 30 mg/mL is available in 120 mL bottles and 100 mg/mL is available in 240 mL bottles.

The concentrate form is light-sensitive. For this reason, it should be protected from light and dispensed in amber bottles. Refrigeration is not required.

NDC 64950-240-12 30 mg/mL, 120 mL bottle

NDC 64950-241-24 100 mg/mL, 240 mL bottle

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured by:
Genus Lifesciences Inc.
514 N. 12th Street
Allentown, PA 18102
Rev. 10/20

PRINCIPAL DISPLAY PANEL — 120 mL Bottle Label

NDC 64950-240-12

chlorproMAZINE
Hydrochloride Oral
Concentrate, USP

30 mg/mL

Rx only
120 mL

Genus Lifesciences Inc.

PRINCIPAL DISPLAY PANEL -- 120 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 240 mL Bottle Label

NDC 64950-241-24

chlorproMAZINE
Hydrochloride Oral
Concentrate, USP

100 mg/mL

Rx only
240 mL

Genus Lifesciences Inc.

PRINCIPAL DISPLAY PANEL -- 240 mL Bottle Label
(click image for full-size original)
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64950-240
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
Edetate Disodium
Sodium Benzoate
SODIUM CITRATE, UNSPECIFIED FORM
Sucralose
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64950-240-12 120 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214542 08/10/2021
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64950-241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
Edetate Disodium
Sodium Benzoate
SODIUM CITRATE, UNSPECIFIED FORM
Sucralose
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64950-241-24 240 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214542 08/10/2021
Labeler — Genus Lifesciences Inc. (113290444)
Establishment
Name Address ID/FEI Operations
Genus Lifesciences Inc. 113290444 MANUFACTURE (64950-240), MANUFACTURE (64950-241), PACK (64950-240), PACK (64950-241), LABEL (64950-240), LABEL (64950-241)

Revised: 06/2021 Genus Lifesciences Inc.

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