CHLORPROMAZINE HYDROCHLORIDE (Page 3 of 3)

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.

The 100 mg and 200 mg tablets are for use in severe neuropsychiatric conditions.

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 co-operative 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 – 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 semi-weekly intervals until patient becomes calm and cooperative.

Prompt Control of Severe Symptoms – Initial treatment should be with intramuscular chlorpromazine. Subsequent doses should be oral, 25 mg to 50 mg t.i.d.

Nausea and Vomiting – 10 mg to 25 mg q4 to 6h, p.r.n., increased, if necessary.

Presurgical Apprehension – 25 mg to 50 mg, 2 to 3 hours before the operation.

Intractable Hiccups – 25 mg 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 mg 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 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 mg 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.

HOW SUPPLIED

Chlorpromazine Hydrochloride Tablets USP, 10 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B” with black ink on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 69238-1054-1

Chlorpromazine Hydrochloride Tablets USP, 25 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B2” with black ink on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 69238-1056-1

Chlorpromazine Hydrochloride Tablets USP, 50 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B3” with black ink on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 69238-1058-1

THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS.

Chlorpromazine Hydrochloride Tablets USP, 100 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B4” with black ink on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 69238-1060-1

Chlorpromazine Hydrochloride Tablets USP, 200 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B5” with black ink on one side and plain on the other side.

They are available as follows:

Bottles of 100: NDC 69238-1062-1

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

Protect from light and moisture.

This package is not for household dispensing. If dispensed for outpatient use, a well closed, light-resistant, child-resistant container should be utilized.

Keep out of reach of children.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Oral Solid Dosage Unit

Ahmedabad 382213, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 12-2019-01

PRINCIPAL DISPLAY PANEL

NDC 69238-1054-1

Chlorpromazine Hydrochloride Tablets USP, 10 mg

Rx Only

100 Tablets

Amneal Pharmaceuticals LLC

10 mg
(click image for full-size original)

NDC 69238-1056-1

Chlorpromazine Hydrochloride Tablets USP, 25 mg

Rx Only

100 Tablets

Amneal Pharmaceuticals LLC

25 mg
(click image for full-size original)

NDC 69238-1058-1

Chlorpromazine Hydrochloride Tablets USP, 50 mg

Rx Only

100 Tablets

Amneal Pharmaceuticals LLC

50 mg
(click image for full-size original)

NDC 69238-1060-1

Chlorpromazine Hydrochloride Tablets USP, 100 mg

Rx Only

100 Tablets

Amneal Pharmaceuticals LLC

100 mg
(click image for full-size original)

NDC 69238-1062-1

Chlorpromazine Hydrochloride Tablets USP, 200 mg

Rx Only

100 Tablets

Amneal Pharmaceuticals LLC

200 mg
(click image for full-size original)

CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1054
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYPROMELLOSES
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1054-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209755 09/12/2018
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYPROMELLOSES
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code B2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1056-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209755 09/12/2018
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1058
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYPROMELLOSES
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code B3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1058-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209755 09/12/2018
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYPROMELLOSES
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code B4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1060-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209755 09/12/2018
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1062
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
HYPROMELLOSES
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 14mm
Flavor Imprint Code B5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1062-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209755 09/12/2018
Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 12/2023 Amneal Pharmaceuticals NY LLC

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