Drug Catalog - Product Detail
PROCHLORPERAZINE MALEATE TB 5MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-5105-01 | MYLAN | 100 | 5MG | TABLET |
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Description
DESCRIPTION Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure: Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless, crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform. Each tablet for oral administration contains prochlorperazine maleate, USP equivalent to 5 mg or 10 mg of prochlorperazine and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, titanium dioxide, and triacetin. Prochlorperazine Structural Formula
How Supplied
HOW SUPPLIED Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP. The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with P1 on one side and M on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with P2 on one side and M on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2010 PCPZ:R12
Indications & Usage
INDICATIONS AND USAGE Prochlorperazine maleate tablets are indicated for the control of severe nausea and vomiting. Prochlorperazine maleate tablets are also indicated for the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are 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 maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets 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 maleate tablets 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
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. 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 mg 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 mg to 75 mg daily. In more severe disturbances, optimum dosage is usually 100 mg to 150 mg daily.