Prochlorperazine Maleate Tablets

Indications
Dosage
How Supplied

INDICATIONS

For control of severe nausea and vomiting.

For the treatment of schizophrenia.

Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, 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, prochlorperazine should not be adminis-tered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).

The effectiveness of 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 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.).

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

DOSAGE AND ADMINISTRATION

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.

2. 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; or one 10 mg tablet 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 out-patient 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.

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 for 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).

1. Severe Nausea and Vomiting in Children: 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 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 1/2 mg 1 or 2 times a day 7.5 mg per day
30 to 39 lbs 2 1/2 mg 2 or 3 times a day 10 mg per day
40 to 85 lbs 2 1/2 mg 3 times a day or 5 mg 2 times a day 15 mg per day

2. Children with schizophrenia:

Oral Dosage: For children 2 to 12 years, starting dosage is 21/2 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.

HOW SUPPLIED

Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes:

5 mg (Chartreuse, round, scored, film-coated, imprinted TL 113)

Bottles of 100..........................NDC 49884-549-01
Bottles of 1000..........................NDC 49884-549-10

10 mg (Chartreuse, round, scored, film-coated, imprinted TL 115)

Bottles of 100..........................NDC 49884-550-01
Bottles of 1000..........................NDC 49884-550-10

Store at 20°to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Manufactured for: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977, USA. Manufactured by: Jubilant Pharmaceuticals, Inc. Salisbury, MD 21801, USA. Revised: 12/05. FDA Rev date: n/a

Last reviewed on RxList: 8/15/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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