Drug Catalog - Product Detail
CHLORPROMAZINE HCL TB 100MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-5916-01 | SANDOZ | 100 | 100MG | TABLET |
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Description
DESCRIPTION Chlorpromazine hydrochloride, USP a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula: Chlorpromazine hydrochloride, USP occurs as white or slightly creamy white, odorless, crystalline powder which darkens on prolonged exposure to light. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive Ingredients: acacia, black iron oxide, calcium sulfate, carnauba wax, D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, anhydrous lactose, magnesium stearate, methylparaben, pharmaceutical glaze, povidone, propylparaben, sodium benzoate, sucrose and titanium dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Chlorpromazine hydrochloride tablets, USP, 10 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "201" and no print on the reverse side. They are supplied as follows: Bottles of 100 tablets, NDC 0781-5913-01 Chlorpromazine hydrochloride tablets, USP, 25 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "202" and no print on the reverse side. They are supplied as follows: Bottles of 100 tablets, NDC 0781-5914-01 Chlorpromazine hydrochloride tablets, USP, 50 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "203" and no print on the reverse side. They are supplied as follows: Bottles of 100 tablets, NDC 0781-5915-01 THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine hydrochloride tablets, USP, 100 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "225" and no print on the reverse side. They are supplied as follows: Bottles of 100 tablets, NDC 0781-5916-01 Chlorpromazine hydrochloride tablets, USP, 200 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "249" and no print on the reverse side. Thy are supplied as follows: Bottles of 100 tablets, NDC 0781-5917-01 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]. Protect from light and moisture. This is a pharmacy bulk package that is NOT CHILD RESISTANT . Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Indications & Usage
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.
Dosage and Administration
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 HCl 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 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 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.