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Basic Drug Info
Drug Name:Prochlorperazine Edisylate
Manufacturer:Bedford Laboratories
Other Info:

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 PRECAUTIONS andDystonia).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.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.Children with Schizophrenia:I.M.

Dosage: For ages under 12, calculate each dose on the basis of 0.06 mg of 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.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.



Clinical Trials:


Indications and Usage

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.
Nausea -- An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Vomiting -- The forcible expulsion of the contents of the STOMACH through the MOUTH.

Tardive Dyskinesia -- iatrogenic extrapyramidal disorder produced by long-term administration of antipsychotic drugs; characterized by oral/lingual/buccal dyskinesias and choreoathetoid movements of the extremities.

Physical findings -- Objective evidence of disease perceptible to the examining physician.

Complication -- Any disease or disorder that occurs during the course of (or because of) another disease.

Complication Aspects -- Used with diseases to indicate conditions that co-exist or follow, i.e., co-existing diseases, complications, or sequelae.

Contraindications

Do not use in patients with known hypersensitivity to phenothiazines.Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).Do not use in pediatric surgery.Do not use in pediatric patients under 2 years of age or under 20 lbs.

Do not use in children for conditions for which dosage has not been established.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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.
Branded Drugs
The following US Branded drugs contain Prochlorperazine Edisylate


COMPAZINE -- GLAXOSMITHKLINE

PROCHLORPERAZINE -- ALPHARMA US PHARMACEUTICALS DIVISION

PROCHLORPERAZINE -- BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE


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