"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
For the treatment of schizophrenia.
To control nausea and vomiting.
For relief of restlessness and apprehension before surgery.
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
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.
In general, dosage recommendations for other oral forms of the drug may be applied to Spansule® brand sustained release capsules on the basis of total daily dosage in milligrams.
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 — I.M.: 25 mg (1 mL). If necessary, give additional 25 to 50 mg injection in 1 hour. Increase subsequent I.M. doses gradually over several days— up to 400 mg q4 to 6h in exceptionally severe cases— 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— Oral: 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d. MORE SEVERE CASES— Oral: 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— I.M.: 25 mg (1 mL). If necessary, repeat in 1 hour. Subsequent doses should be oral, 25 to 50 mg t.i.d.
Nausea and Vomiting — Oral: 10 to 25 mg q4 to 6h, p.r.n., increased, if necessary. I.M.: 25 mg (1 mL). If no hypotension occurs, give 25 to 50 mg q3 to 4h, p.r.n., until vomiting stops. Then switch to oral dosage. Rectal: One 100 mg suppository q6 to 8h, p.r.n. In some patients, half this dose will do.
DURING SURGERY— I.M.: 12.5 mg (0.5 mL). Repeat in 1 / 2 hour if necessary and if no hypotension occurs. I.V.: 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 — Oral: 25 to 50 mg, 2 to 3 hours before the operation. I.M.: 12.5 to 25 mg (0.5 to 1 mL), 1 to 2 hours before operation.
Intractable Hiccups — Oral: 25 to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, give 25 to 50 mg (1 to 2 mL) I.M. Should symptoms persist, use slow I.V. infusion with patient flat in bed: 25 to 50 mg (1 to 2 mL) in 500 to 1,000 mL of saline. Follow blood pressure closely.
Acute Intermittent Porphyria — Oral: 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. I.M.: 25 mg (1 mL) t.i.d. or q.i.d. until patient can take oral therapy.
Tetanus — I.M.: 25 to 50 mg (1 to 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. I.V.: 25 to 50 mg (1 to 2 mL). Dilute to at least 1 mg per mL and administer at a rate of 1 mg per minute.
DOSAGE AND ADMINISTRATION— PEDIATRIC PATIENTS (6 months to 12 years of age)
Thorazine (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: 1 / 4 mg/lb body weight q4 to 6h, p.r.n. (e.g., for 40 lb child— 10 mg q4 to 6h). Rectal: 1 / 2 mg/lb body weight q6 to 8h, p.r.n. (e.g., for 20 to 30 lb child— half a 25 mg suppository q6 to 8h). I.M.: 1 / 4 mg/lb body weight q6 to 8h, p.r.n.
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. Maximum I.M. Dosage: Children up to 5 years (or 50 lbs), not over 40 mg/day; 5 to 12 years (or 50 to 100 lbs), not over 75 mg/day except in unmanageable cases.
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: 1 / 4 mg/lb body weight (e.g., 40 lb child— 10 mg q4 to 6h). Rectal: 1 / 2 mg/lb body weight q6 to 8h, p.r.n. (e.g., 20 to 30 lb child— half of a 25 mg suppository q6 to 8h). I.M.: 1 / 4 mg/lb body weight q6 to 8h, p.r.n. Maximum I.M. Dosage: Pediatric patients 6 months to 5 yrs. (or 50 lbs), not over 40 mg/day; 5 to 12 yrs. (or 50 to 100 lbs), not over 75 mg/day except in severe cases. DURING SURGERY— I.M.: 1 / 8 mg/lb body weight. Repeat in 1 / 2 hour if necessary and if no hypotension occurs. I.V.: 1 mg per fractional injection at 2-minute intervals and not exceeding recommended I.M. dosage. 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, either orally 2 to 3 hours before operation, or I.M. 1 to 2 hours before.
Tetanus — I.M. or I.V.: 1 / 4 mg/lb body weight q6 to 8h. When given I.V., dilute to at least 1 mg/mL and administer at 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 Thorazine (chlorpromazine) into vein. I.V. route is only for severe hiccups, surgery and tetanus.
Because of the possibility of contact dermatitis, avoid getting solution on hands or clothing. This solution should be protected from light. This is a clear, colorless to pale yellow solution; a slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded. For information on sulfite sensitivity, see the WARNINGS section of this labeling.
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 also be used. The Concentrate is light sensitive; it should be protected from light and dispensed in amber glass bottles. Refrigeration is not required.
Tablets: 10 mg, in bottles of 100; 25 mg or 50 mg, in bottles of 100 and 1000. For use in severe neuropsychiatric conditions, 100 mg and 200 mg, in bottles of 100 and 1000.
NDC 0007-5073-20 10 mg 100's
NDC 0007-5074-20 25 mg 100's
NDC 0007-5074-30 25 mg 1000's
NDC 0007-5076-20 50 mg 100's
NDC 0007-5076-30 50 mg 1000's
NDC 0007-5077-20 100 mg 100's
NDC 0007-5077-30 100 mg 1000's
NDC 0007-5079-20 200 mg 100's
NDC 0007-5079-30 200 mg 1000's
Spansule® brand of sustained release capsules: 30 mg, 75 mg or 150 mg, in bottles of 50.
NDC 0007-5063-15 30 mg 50's
NDC 0007-5064-15 75 mg 50's
NDC 0007-5066-15 150 mg 50's
Ampuls: 1 mL and 2 mL (25 mg/mL), in boxes of 10.
NDC 0007-5060-11 25 mg/mL in 1 mL Ampuls (box of 10)
NDC 0007-5061-11 25 mg/mL in 2 mL Ampuls (box of 10)
Multi-Dose Vials: 10 mL (25 mg/mL), in boxes of 1.
NDC 0007-5062-01 25 mg/mL in 10 mL Multi-Dose Vials (box of 1)
Syrup: 10 mg/5 mL, in 4 fl oz bottles.
NDC 0007-5072-44 10 mg/5 mL 4 fl oz
Suppositories: 25 mg or 100 mg, in boxes of 12.
NDC 0007-5070-03 25 mg (box of 12)
NDC 0007-5071-03 100 mg (box of 12)
All dosage forms except Syrup should be stored between 15° and 30°C (59° and 86°F). Syrup should be stored below 25°C (77°F).
† metrizamide, Sanofi Winthrop Pharmaceuticals.
‡ norepinephrine bitartrate, Sanofi Winthrop Pharmaceuticals.
§phenylephrine hydrochloride, Sanofi Winthrop Pharmaceuticals.
||diphenhydramine hydrochloride, Parke-Davis.
WARNING: Thorazine® (chlorpromazine) Spansule capsules are manufactured with carbon tetrachloride and methyl chloroform, substances which harm public health and environment by destroying ozone in the upper atmosphere.
FDA revision date: 4/22/1998. Manufacturer information: n/a
Last reviewed on RxList: 6/2/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Thorazine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on therapy and treatment.