Prochlorperazine Edisylate

INDICATIONS AND USAGE 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.

DOSAGE AND ADMINISTRATION NOTE ON INJECTION: For intramuscular administration, inject deeply into the upper, outer quadrant of the buttock. Subcutaneous administration is not advisable because of local irritation. Stability This solution should be protected from light. Slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded. Compatibility It is recommended that prochlorperazine edisylate injection not be mixed with other agents in the syringe. 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. TO CONTROL SEVERE NAUSEA AND VOMITING Adjust dosage to the response of the individual. Begin with lowest recommended dosage. Intramuscular (IM) Dosage Initially 5 mg to 10 mg (1 mL to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total intramuscular (IM) dosage should not exceed 40 mg per day. Intravenous (IV) Dosage 2.5 mg to 10 mg (0.5 mL to 2 mL) by slow intravenous (IV) injection or infusion at a rate not to exceed 5 mg per minute. Prochlorperazine edisylate injection may be administered either undiluted or diluted in isotonic solution. A single dose of the drug should not exceed 10 mg; total intravenous (IV) dosage should not exceed 40 mg per day. When administered intravenously (IV), do not use bolus injection. Hypotension is a possibility if the drug is given by intravenous (IV) injection or infusion. Subcutaneous administration is not advisable because of local irritation. ADULT SURGERY (FOR SEVERE NAUSEA AND VOMITING) Total parenteral dosage should not exceed 40 mg per day. Hypotension is a possibility if the drug is given by intravenous (IV) injection or infusion. Intramuscular (IM) Dosage 5 mg to 10 mg (1 mL to 2 mL) 1 to 2 hours before induction of anesthesia (repeat once in 30 minutes, if necessary), or to control acute symptoms during and after surgery (repeat once if necessary). Intravenous (IV) Dosage 5 mg to 10 mg (1 mL to 2 mL) as a slow intravenous (IV) injection or infusion 15 to 30 minutes before induction of anesthesia, or to control acute symptoms during or after surgery. Repeat once if necessary. Prochlorperazine may be administered either undiluted or diluted in isotonic solution, but a single dose of the drug should not exceed 10 mg. The rate of administration should not exceed 5 mg per minute. When administered intravenously (IV), do not use bolus injection. 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 two, longer treatment is usually required before maximal improvement is seen. Intramuscular (IM) Dosage For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 mL to 4 mL) deeply into the upper, outer quadrant of the buttock. Many patients respond shortly after the first injection. If necessary, however, repeat the initial dose every 2 to 4 hours (or, in resistant cases, every hour) to gain control of the patient. More than 3 or 4 doses are seldom necessary. After control is achieved, switch patient to an oral form of the drug at the same dosage level or higher. If, in rare cases, parenteral therapy is needed for a prolonged period, give 10 mg to 20 mg (2 mL to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred. Subcutaneous administration i …

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.

ADVERSE REACTIONS Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see WARNINGS ). Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy. Neuromuscular (Extrapyramidal) Reactions These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases barbiturates by suitable route of administration will suffice, or injectable diphenhydramine may be useful. In more severe cases, the administration of an antiparkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed. Motor Restlessness Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms often disappear spontaneously. At times these symptoms may be similar to the original neurotic or psychotic symptoms. Dosage should not be increased until these side effects have subsided. If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug. Treatment with antiparkinsonian agents, benzodiazepines or propranolol may be helpful. Dystonia Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. Pseudoparkinsonism Symptoms may include mask-like facies, drooling, tremors, pillrolling motion, cogwheel rigidity, and shuffling gait. Reassurance and sedation are important. In most cases, these symptoms are readily controlled when an antiparkinsonism agent is administered concomitantly. Antiparkinsonism agents should be used only when required. Generally, therapy of a few weeks to two or three months will suffice. After this time, patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in pseudoparkinsonism.) Occasionally, it is necessary to lower the dosage of prochlorperazine or to discontinue the drug. Tardive Dyskinesia As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it is impossible to rely upon prevalence estimates to predict at the inception of antipsychotic t …

DESCRIPTION Prochlorperazine edisylate, 2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine 1,2-ethanedisulfonate (1:1), has the following structural formula: Molecular Formula: C 20 H 24 ClN 3 S.C 2 H 6 O 6 S 2 Molecular Weight: 564.14 g/mol Prochlorperazine edisylate is a white to very light yellow powder. It is freely soluble in water, insoluble in alcohol, ether and chloroform. Prochlorperazine edisylate injection, USP an antiemetic and antipsychotic, is a sterile solution intended for intramuscular or intravenous administration. Each mL contains prochlorperazine, USP 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 to 6.2. structure

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 drug therapy is common in overdosage situations. Treatment is essentially symptomatic and supportive. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage. Extrapyramidal symptoms may be treated with antiparkinsonism 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 and 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 or phenylephrine 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.

HOW SUPPLIED Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution. Prochlorperazine Edisylate Injection, USP is supplied as follows: NDC 55154-4183-5 Overbagged with 5 x 2 mL (10 mg) multiple-dose vials in each bag WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Storage PROTECT FROM LIGHT . Store in the box until ready to use. Discard if markedly discolored. Store at 20 ° to 25 ° C (68 ° to 77 ° F); excursions permitted between 15 ° to 30 ° C (59 ° to 86 ° F) [see USP Controlled Room Temperature]. Manufactured by: Emcure Pharmaceuticals Ltd., Sanand, Ahmedabad - 382110, India. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Distributed By: Cardinal Health Dublin, OH 43017 L50871430124 Revised: 11/2024 logo