PROCHLORPERAZINE EDISYLATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROCHLORPERAZINE EDISYLATE (UNII: PG20W5VQZS) (PROCHLORPERAZINE - UNII:YHP6YLT61T)

Available from:

Civica, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. 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.

Product summary:

Prochlorperazine Edisylate Injection, USP 5 mg/mL 2 mL (10 mg) vials packaged in 25s (NDC 72572-580-25) PROTECT FROM LIGHT.  Store in the box until ready to use. Discard if markedly discolored. Store at 20º -25º C (68º -77º F), excursions permitted to 15º -30º C (59º -86º F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROCHLORPERAZINE EDISYLATE- PROCHLORPERAZINE EDISYLATE INJECTION
CIVICA, INC.
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PROCHLORPERAZINE EDISYLATE INJECTION, USP
RX ONLY
WARNING
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. Analyses of seventeen placebo-controlled
trials (modal duration of 10
weeks), largely in patients taking atypical antipsychotic drugs,
revealed a risk of death in drug-
treated patients of between 1.6 to 1.7 times the risk of death in
placebo-treated patients. Over the
course of a typical 10-week controlled trial, the rate of death in
drug-treated patients was about
4.5%, compared to a rate of about 2.6% in the placebo group. Although
the causes of death were
varied, most of the deaths appeared to be either cardiovascular (e.g.,
heart failure, sudden death)
or infectious (e.g., pneumonia) in nature. Observational studies
suggest that, similar to atypical
antipsychotic drugs, treatment with conventional antipsychotic drugs
may increase mortality. The
extent to which the findings of increased mortality in observational
studies may be attributed to the
antipsychotic drug as opposed to some characteristic(s) of the
patients is not clear.
Prochlorperazine Edisylate Injection, USP is not approved for the
treatment of patients with
dementia-related psychosis (see WARNINGS).
DESCRIPTION
Prochlorperazine edisylate,
2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl] phenothiazine 1,2-
ethanedisulfonate (1:1), has the following structural formula:
Prochlorperazine Edisylate Injection, an antiemetic and antipsychotic,
is a sterile solution intended for
intramuscular or intravenous administration.
Each mL contains prochlorperazine 5 mg as the edisylate, monobasic
sodium phosphate monohydrate 5
mg, sodium tartrate dihydrate 12 mg, saccharin sodium 0.9 mg and
benzyl alcohol 7.5 mg in Water for
Injection. pH 4.2-6.2.
CLINICAL PHARMACOLOGY
Prochlorperazine is a propylpiperazine derivative of phenothiazin