Prochlorperazine Maleate

Prochlorperazine Maleate

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Questions & Answers

Side Effects & Adverse Reactions

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).

The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye’s syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye’s syndrome.

Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic drug treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic drug treatment is withdrawn. Antipsychotic drug treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process.

The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia especially in the elderly. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome. For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONSand ADVERSE REACTIONS.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal syndrome complex sometimes referred to as neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous systems (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with lithium plus an antipsychotic. In some instances, the syndrome was followed by irreversible brain damage. Because of a possible causal relationship between these events and the concomitant administration of lithium and antipsychotics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).

Patients with bone marrow depression or who have previously demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not receive any phenothiazine, including Prochlorperazine, unless in the judgment of the physician the potential benefits of treatment outweigh the possible hazards.

Prochlorperazine may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, caution patients about activities requiring alertness (e.g., operating vehicles or machinery).

Phenothiazines may intensify or prolong the action of central nervous system depressants (e.g., alcohol, anesthetics, narcotics).

Usage in Pregnancy: Safety for the use of prochlorperazine during pregnancy has not been established. Therefore, prochlorperazine is not recommended for use in pregnant patients except in cases of severe nausea and vomiting that are so serious and intractable that, in the judgment of the physician, drug intervention is required and potential benefits outweigh possible hazards.

There have been reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia or hyporeflexia in newborn infants whose mothers received phenothiazines.

Non-teratogenic Effects
Neonates exposed to antipsychotic drugs, during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Prochlorperazine Maleate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: There is evidence that phenothiazines are excreted in the breast milk of nursing mothers. Caution should be exercised when prochlorperazine is administered to a nursing woman.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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 administered 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.

History

There is currently no drug history available for this drug.

Other Information

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

Structure of Prochlorperazine

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 equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.

Prochlorperazine Maleate Manufacturers


  • Blenheim Pharmacal, Inc.
    Prochlorperazine Maleate Tablet Prochlorperazine Maleate Tablet [Blenheim Pharmacal, Inc.]
  • A-s Medication Solutions Llc
    Prochlorperazine Maleate Tablet, Film Coated [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Prochlorperazine Maleate Tablet, Film Coated [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Prochlorperazine Maleate Tablet, Film Coated [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Prochlorperazine Maleate Tablet, Film Coated [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Prochlorperazine Maleate Tablet, Film Coated [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Prochlorperazine Maleate Tablet, Film Coated [A-s Medication Solutions Llc]
  • Cardinal Health
    Prochlorperazine Maleate Tablet, Film Coated [Cardinal Health]
  • Proficient Rx Lp
    Prochlorperazine Maleate Tablet [Proficient Rx Lp]
  • American Health Packaging
    Prochlorperazine Maleate Tablet, Film Coated [American Health Packaging]
  • Rebel Distributors Corp
    Prochlorperazine Maleate Tablet Prochlorperazine Maleate Tablet [Rebel Distributors Corp]
  • Remedyrepack Inc.
    Prochlorperazine Maleate Tablet [Remedyrepack Inc. ]
  • Physicians Total Care, Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Physicians Total Care, Inc.]
  • Remedyrepack Inc.
    Prochlorperazine Maleate Tablet [Remedyrepack Inc. ]
  • Jubilant Cadista Pharmaceuticals, Inc.
    Prochlorperazine Maleate (Prochlorperazine Maleate) Tablet Prochlorperazine Maleate (Prochlorperazine Maleate) Tablet [Jubilant Cadista Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Sandoz Inc
    Prochlorperazine Maleate Tablet, Film Coated [Sandoz Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Prodcuts Llc
    Prochlorperazine Maleate Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Prodcuts Llc]
  • Udl Laboratories, Inc.
    Prochlorperazine Maleate (Prochlorperazine) Tablet, Film Coated Prochlorperazine Maleate Tablet, Film Coated [Udl Laboratories, Inc.]
  • Dispensing Solutions, Inc.
    Prochlorperazine Maleate Tablet [Dispensing Solutions, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Prochlorperazine Maleate Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Preferred Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet [Preferred Pharmaceuticals, Inc.]
  • Teva Pharmaceuticals Usa Inc
    Prochlorperazine Maleate Tablet, Film Coated [Teva Pharmaceuticals Usa Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Prochlorperazine Maleate Tablet [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Prochlorperazine Maleate Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Prochlorperazine Maleate Tablet [Remedyrepack Inc. ]
  • A-s Medication Solutions Llc
    Prochlorperazine Maleate Tablet, Film Coated [A-s Medication Solutions Llc]
  • Cardinal Health
    Prochlorperazine Maleate Tablet, Film Coated [Cardinal Health]
  • Liberty Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet [Liberty Pharmaceuticals, Inc.]
  • Aidarex Pharmaceuticals Llc
    Prochlorperazine Maleate Tablet Prochlorperazine Maleate Tablet [Aidarex Pharmaceuticals Llc]
  • Northwind Pharmaceuticals
    Prochlorperazine Maleate Tablet [Northwind Pharmaceuticals]
  • Preferred Pharmaceuticals, Inc
    Prochlorperazine Maleate Tablet, Film Coated [Preferred Pharmaceuticals, Inc]
  • Preferred Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Prochlorperazine Maleate Tablet [Preferred Pharmaceuticals, Inc.]
  • Mylan Pharmaceuticals Inc.
    Prochlorperazine Maleate Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Bryant Ranch Prepack
    Prochlorperazine Maleate Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Prochlorperazine Maleate Tablet [Bryant Ranch Prepack]

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