For control of severe nausea and vomiting.

For the treatment of schizophrenia.

Compazine (prochlorperazine) is effective for the short-term treatment of generalized non-psychotic anxiety. However, Compazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).

When used in the treatment of non-psychotic anxiety, Compazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of Compazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ).

The effectiveness of Compazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that Compazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).

Compazine has not been shown effective in the management of behavioral complications in patients with mental retardation.

Notes on Injection:   Stability 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.

Compatibility  It is recommended that Compazine (prochlorperazine) Injection not be mixed with other agents in the syringe.

ADULTS

(For children's dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.

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.

1.   To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.
   Oral Dosage Tablets:   Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 40 mg should be used only in resistant cases.
   Spansule capsules:   Initially, usually one 15 mg capsule on arising or one 10 mg capsule q12h. Daily doses above 40 mg should be used only in resistant cases.
   Rectal Dosage:   25 mg twice daily.
   I.M. Dosage:   Initially 5 to 10 mg (1 to 2 mL) injected deeply into the upper outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total I.M. dosage should not exceed 40 mg per day.
   I.V. Dosage:   2 ½ to 10 mg ( ½ to 2 mL) by slow I.V. injection or infusion at a rate not to exceed 5 mg per minute. Compazine Injection may be administered either undiluted or diluted in isotonic solution. A single dose of the drug should not exceed 10 mg; total I.V. dosage should not exceed 40 mg per day. When administered I.V., do not use bolus injection. Hypotension is a possibility if the drug is given by I.V. injection or infusion.
   Subcutaneous administration is not advisable because of local irritation.
2.   Adult Surgery (for severe nausea and vomiting):   Total parenteral dosage should not exceed 40 mg per day. Hypotension is a possibility if the drug is given by I.V. injection or infusion.
   I.M. Dosage:   5 to 10 mg (1 to 2 mL) 1 to 2 hours before induction of anesthesia (repeat once in 30 minutes, if necessary), or to control acute symptoms during and after surgery (repeat once if necessary).
   I.V. Dosage: 5 to 10 mg (1 to 2 mL) as a slow I.V. injection or infusion 15 to 30 minutes before induction of anesthesia, or to control acute symptoms during or after surgery. Repeat once if necessary. Compazine (prochlorperazine) may be administered either undiluted or diluted in isotonic solution, but a single dose of the drug should not exceed 10 mg. The rate of administration should not exceed 5 mg per minute. When administered I.V., do not use bolus injection.
3.   In Adult Psychiatric Disorders including Schizophrenia:   Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen.
   Oral Dosage:   Non-Psychotic Anxiety  Usual dosage is 5 mg 3 or 4 times daily; by Spansule  capsule, usually one 15 mg capsule on arising or one 10 mg capsule q12h. Do not administer in doses of more than 20 mg per day or for longer than 12 weeks.
   Psychotic Disorders  In relatively mild conditions, as seen in private psychiatric practice or in outpatient clinics, dosage is 5 or 10 mg 3 or 4 times daily.
   In moderate to severe conditions, for hospitalized or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times daily. Increase dosage gradually until symptoms are controlled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75 mg daily.
   In more severe disturbances, optimum dosage is usually 100 to 150 mg daily.
   I.M. Dosage:   For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 to 20 mg (2 to 4 mL) deeply into the upper outer quadrant of the buttock. Many patients respond shortly after the first injection. If necessary, however, repeat the initial dose every 2 to 4 hours (or, in resistant cases, every hour) to gain control of the patient. More than three or four doses are seldom necessary. After control is achieved, switch patient to an oral form of the drug at the same dosage level or higher. If, in rare cases, parenteral therapy is needed for a prolonged period, give 10 to 20 mg (2 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.

Subcutaneous administration is not advisable because of local irritation.

CHILDREN

Do not use in pediatric surgery.

Children seem more prone to develop extrapyramidal reactions, even on moderate doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed dosage, since the possibility of adverse reactions increases as dosage rises.

Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under Dystonias).

When writing a prescription for the 2 ½ mg size suppository, write "2 ½ ," not "2.5"; this will help avoid confusion with the 25 mg adult size.

1.   Severe Nausea and Vomiting in Children: Compazine (prochlorperazine) should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children's dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the 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 or Rectal Dosage:   More than 1 day's therapy is seldom necessary.
   

    

   Weight	Usual Dosage	Not to Exceed
   under 20 lbs not recommended
   20 to 29 lbs	2 ½ mg 1 or 2 times a day	7.5 mg per day
   30 to 39 lbs	2 ½ mg 2 or 3 times a day	10 mg per day
   40 to 85 lbs	2 ½ mg 3 times a day or 5 mg 2 times a day	15 mg per day

   
   I.M. Dosage:   Calculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep I.M. injection. Control is usually obtained with one dose.
2.   In Children with schizophrenia:
   Oral or Rectal Dosage:   For children 2 to 12 years, starting dosage is 2 ½ mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient's response.
   FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.
   FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.
   I.M. Dosage:   For ages under 12, calculate each dose on the basis of 0.06 mg of Compazine (prochlorperazine) per lb of body weight; give by deep I.M. injection. Control is usually obtained with one dose. After control is achieved, switch the patient to an oral form of the drug at the same dosage level or higher.

Tablets 5 and 10 mg, in bottles of 100; in Single Unit Packages of 100 (intended for institutional use only).

5 mg 100's: NDC 0007-3366-20

5 mg SUP 100's: NDC 0007-3366-21

10 mg 100's: NDC 0007-3367-20

10 mg SUP 100's: NDC 0007-3367-21

Spansule capsules 10 and 15 mg, in bottles of 50.

10 mg 50's: NDC 0007-3344-15

15 mg 50's: NDC 0007-3346-15

Vials 2 mL (5 mg/mL), in boxes of 25 and 10 mL (5 mg/mL), in boxes of 1.

2 mL (5 mg/mL), in boxes of 25: NDC 0007-3352-16

10 mL (5 mg/mL), in boxes of 1: NDC 0007-3343-01

Suppositories 2 ½ mg (for young children), 5 mg (for older children) and 25 mg (for adults), in boxes of 12.

2 ½ mg, in boxes of 12: NDC 0007-3360-03

5 mg, in boxes of 12: NDC 0007-3361-03

25 mg, in boxes of 12: NDC 0007-3362-03

Syrup 5 mg/5 mL (1 teaspoonful) in 4 fl o bottles.

5 mg/5 mL, 4 fl oz: NDC 0007-3363-44

Store Compazine (prochlorperazine) vials below 30^° C (86^° F). Do not freeze. Other dosage forms can be stored between 15^° and 30^° C (59^° and 86^° F). Protect from light.

*norepinephrine bitartrate, Sanofi Pharmaceuticals.
** phenylephrine hydrochloride, Sanofi Pharmaceuticals.
*** phenytoin, Parke-Davis.
§metrizamide, Sanofi Pharmaceuticals.
^ll diphenhydramine hydrochloride, Parke-Davis.

Rx only

© 2002, GlaxoSmithKline, All rights reserved.

Compazine® Spansule capsules are manufactured by International Processing Corporation, Winchester, KY 40391

GlaxoSmithKline, Research Triangle Park, NC 27709, Revised 08/03/2005
CZ:L95

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