"The US Food and Drug Administration (FDA) has approved a quarterly injection form of paliperidone (Invega Trinza, Janssen Pharmaceuticals) for schizophrenia, the company announced today.
Janssen Pharmaceuticals already markets a "...
(Generic versions may still be available.)
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 (prochlorperazine) 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 (prochlorperazine) should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of Compazine (prochlorperazine) at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).
The effectiveness of Compazine (prochlorperazine) 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 (prochlorperazine) 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 (prochlorperazine) has not been shown effective in the management of behavioral complications in patients with mental retardation.
DOSAGE AND ADMINISTRATION
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.
(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: 2½ 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 (prochlorperazine) 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
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 including Schizophrenia–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.
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 2½ mg size suppository, write “2½,” 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||2½ mg lor 2 times a day||7.5 mg per day|
|30 to 39 lbs||2½ mg 2 or 3 times a day||10 mg per day|
|40 to 85 lbs||2½ 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 2½ 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–2½ mg (for young children), 5 mg (for older children) and 25 mg (for adults), in boxes of 12.
2½ 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 oz 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.
Compazine® (prochlorperazine) Spansule capsules are manufactured by International Processing Corporation, Winchester, KY 40391. GlaxoSmithKline, Research Triangle Park, NC 27709.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/16/2009
Additional Compazine Information
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