Prochlorperazine Suppository

Name: Prochlorperazine Suppository

Prochlorperazine Suppository - Clinical Pharmacology

Prochlorperazine is a propylpiperazine derivative of phenothiazine. Like other phenothiazines, it exerts an antiemetic effect through a depressant action on the chemoreceptor trigger zone.

Indications and Usage for Prochlorperazine Suppository

Prochlorperazine Suppositories, USP 25 mg are indicated in the control of severe nausea and vomiting in adults.

Contraindications

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 children under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.

Overdosage

(See also ADVERSE REACTIONS)

SYMPTOMS–Primarily involvement of the extrapyramidal mechanism producing some of the dystonic reactions described above.

Symptoms of central nervous system depression to the point of somnolence or coma. Agitation and restlessness may also occur. Other possible manifestations include convulsions, EKG changes and cardiac arrhythmias, fever, and autonomic reactions such as hypotension, dry mouth and ileus.

TREATMENT–It is important to determine other medications taken by the patient since multiple dose therapy is common in overdosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage. Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus. Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates, or diphenhydramine. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression.

If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended.

Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.

If hypotension occurs, the standard measures for managing circulatory shock should be initiated.  If it is desirable to administer a vasoconstrictor, norepinephrine bitartrate and phenylephrine hydrochloride are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating action of these agents and cause a further lowering of blood pressure.

Limited experience indicates that phenothiazines are not dialyzable.

Prochlorperazine Suppository Dosage and Administration

Adults: 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.

To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.

Rectal Dosage: 25 mg twice daily.

How is Prochlorperazine Suppository Supplied

For Adults, Prochlorperazine Suppositories, USP 25 mg in boxes of 12 and 1000 as follows:
Box of 12           NDC 0713-0135-12
Box of 1000       NDC 0713-0135-10

Rx only

Storage: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Do not remove from foil until ready to use.

Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080

Rev. 11/2016
8-0135GW11

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