Prochlorperazine Edisylate
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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 Edisylate Injection, USP 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of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic drug treatment is withdrawn.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. 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 PRECAUTIONS and ADVERSE REACTIONS.
Neuroleptic Malignant Syndrome (NMS)
A potentially fatal symptom 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 system (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.
General
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).
Pregnancy
NON-TERATOGENIC EFFECTS
Neonates exposed to antipsychotic drugs, during the 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 Edisylate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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.
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
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.
History
There is currently no drug history available for this drug.
Other Information
Prochlorperazine edisylate, 2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine 1,2-ethanedisulfonate (1:1), has the following structural formula:
C20H24ClN3S C2H6O6S2 MW 564.14
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.
Sources
Prochlorperazine Edisylate Manufacturers
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Heritage Pharmaceuticals Inc.
![Prochlorperazine Edisylate Injection [Heritage Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Prochlorperazine Edisylate | Heritage Pharmaceuticals Inc.
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.
IM Dosage
Initially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day.
IV Dosage
2.5 mg to 10 mg (0.5 to 2 mL) by slow 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 IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by 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 IV injection or infusion.
IM Dosage
5 mg to 10 mg (1 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).
IV Dosage
5 mg to 10 mg (1 to 2 mL) as a slow 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 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.
IM Dosage
For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 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 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.
Children
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 and Dystonia ).
SEVERE NAUSEA AND VOMITING IN CHILDREN
Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or two 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.
IM Dosage
Calculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep IM injection. Control is usually obtained with one dose.
CHILDREN WITH SCHIZOPHRENIA
IM 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 IM 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.
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Remedyrepack Inc.
Prochlorperazine Edisylate | Remedyrepack Inc.
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.
IM Dosage
Initially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day.
IV Dosage
2.5 mg to 10 mg (0.5 to 2 mL) by slow 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 IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by 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 IV injection or infusion.
IM Dosage
5 mg to 10 mg (1 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).
IV Dosage
5 mg to 10 mg (1 to 2 mL) as a slow 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 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.
IM Dosage
For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 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 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.
Children
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 and Dystonia ).
SEVERE NAUSEA AND VOMITING IN CHILDREN
Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or two 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.
IM Dosage
Calculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep IM injection. Control is usually obtained with one dose.
CHILDREN WITH SCHIZOPHRENIA
IM 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 IM 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.
-
Heritage Pharmaceuticals Inc.
Prochlorperazine Edisylate | Heritage Pharmaceuticals Inc.
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.
IM Dosage
Initially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day.
IV Dosage
2.5 mg to 10 mg (0.5 to 2 mL) by slow 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 IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by 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 IV injection or infusion.
IM Dosage
5 mg to 10 mg (1 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).
IV Dosage
5 mg to 10 mg (1 to 2 mL) as a slow 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 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.
IM Dosage
For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 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 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.
Children
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 and Dystonia ).
SEVERE NAUSEA AND VOMITING IN CHILDREN
Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or two 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.
IM Dosage
Calculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep IM injection. Control is usually obtained with one dose.
CHILDREN WITH SCHIZOPHRENIA
IM 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 IM 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.
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General Injectables & Vaccines, Inc
Prochlorperazine Edisylate | General Injectables & Vaccines, Inc
Notes 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. A slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.Compatibility
It is recommended that prochlorperazine 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 the lowest recommended dosage.
I.M. Dosage: Initially 5 to 10 mg (1 to 2 mL) injected deeply into the upper outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total I.M. dosage should not exceed 40 mg per day.
I.V. Dosage: 2.5 to 10 mg (0.5 to 2 mL) by slow I.V. 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 I.V. dosage should not exceed 40 mg per day. When administered I.V., do not use bolus injection. Hypotension is a possibility if the drug is given by I.V. 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 I.V. injection or infusion.
I.M. Dosage: 5 to 10 mg (1 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).
I.V. Dosage: 5 to 10 mg (1 to 2 mL) as a slow I.V. 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 I.V., 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 2, longer treatment is usually required before maximal improvement is seen.
I.M. Dosage: For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 to 20 mg (2 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 three or four 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 to 20 mg (2 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.CHILDREN
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 and Dystonia).
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. -
Baxter Healthcare Corporation
Prochlorperazine Edisylate | Baxter Healthcare Corporation
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.
StabilityThis solution should be protected from light. Slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.
CompatibilityIt 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 PatientsIn 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 VomitingAdjust dosage to the response of the individual. Begin with lowest recommended dosage.
IM DosageInitially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day.
IV Dosage2.5 mg to 10 mg (0.5 to 2 mL) by slow 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 IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by 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 IV injection or infusion.
IM Dosage5 mg to 10 mg (1 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).
IV Dosage5 mg to 10 mg (1 to 2 mL) as a slow 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 IV, do not use bolus injection.
In Adult Psychiatric DisordersAdjust 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.
IM DosageFor immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 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 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.
ChildrenDO 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 and Dystonia).
Severe Nausea and Vomiting in ChildrenProchlorperazine should not be used in pediatric patients under 20 pounds in weight or two 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.
IM DosageCalculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep IM injection. Control is usually obtained with one dose.
Children with Schizophrenia IM DosageFor ages under 12, calculate each dose on the basis of 0.06 mg of prochlorperazine per lb of body weight; give by deep IM 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.
-
Physicians Total Care, Inc.
Prochlorperazine Edisylate | Physicians Total Care, Inc.
Notes on InjectionFor intramuscular administration, inject deeply into the upper, outer quadrant of the buttock. Subcutaneous administration is not advisable because of local irritation.
StabilityThis solution should be protected from light. A slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.
CompatibilityIt is recommended that prochlorperazine 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 PatientsIn 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.
I.M. Dosage: Initially 5 to 10 mg (1 to 2 mL) injected deeply into the upper outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total I.M. dosage should not exceed 40 mg per day.
I.V. Dosage: 2.5 to 10 mg (0.5 to 2 mL) by slow I.V. 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 I.V. dosage should not exceed 40 mg per day. When administered I.V., do not use bolus injection. Hypotension is a possibility if the drug is given by I.V. 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 I.V. injection or infusion.
I.M. Dosage: 5 to 10 mg (1 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).
I.V. Dosage: 5 to 10 mg (1 to 2 mL) as a slow I.V. 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 I.V., 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 2, longer treatment is usually required before maximal improvement is seen.
CHILDREN
I.M. Dosage: For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 to 20 mg (2 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 three or four 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 to 20 mg (2 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.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 and Dystonia).
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.
-
Heritage Pharmaceuticals Inc.
Prochlorperazine Edisylate | Heritage Pharmaceuticals Inc.
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.
IM Dosage
Initially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day.
IV Dosage
2.5 mg to 10 mg (0.5 to 2 mL) by slow 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 IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by 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 IV injection or infusion.
IM Dosage
5 mg to 10 mg (1 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).
IV Dosage
5 mg to 10 mg (1 to 2 mL) as a slow 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 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.
IM Dosage
For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 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 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.
Children
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 and Dystonia ).
SEVERE NAUSEA AND VOMITING IN CHILDREN
Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or two 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.
IM Dosage
Calculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep IM injection. Control is usually obtained with one dose.
CHILDREN WITH SCHIZOPHRENIA
IM 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 IM 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.
-
Bedford Laboratories
Prochlorperazine Edisylate | Bedford Laboratories
Notes on InjectionFor intramuscular administration, inject deeply into the upper, outer quadrant of the buttock. Subcutaneous administration is not advisable because of local irritation.
StabilityThis solution should be protected from light. A slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.
CompatibilityIt is recommended that prochlorperazine 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 PatientsIn 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.
I.M. Dosage: Initially 5 to 10 mg (1 to 2 mL) injected deeply into the upper outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total I.M. dosage should not exceed 40 mg per day.
I.V. Dosage: 2.5 to 10 mg (0.5 to 2 mL) by slow I.V. 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 I.V. dosage should not exceed 40 mg per day. When administered I.V., do not use bolus injection. Hypotension is a possibility if the drug is given by I.V. 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 I.V. injection or infusion.
I.M. Dosage: 5 to 10 mg (1 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).
I.V. Dosage: 5 to 10 mg (1 to 2 mL) as a slow I.V. 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 I.V., 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 2, longer treatment is usually required before maximal improvement is seen.
CHILDREN
I.M. Dosage: For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 to 20 mg (2 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 three or four 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 to 20 mg (2 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.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 and Dystonia).
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.
-
Cardinal Health
Prochlorperazine Edisylate | Cardinal Health
Notes on InjectionFor intramuscular administration, inject deeply into the upper, outer quadrant of the buttock. Subcutaneous administration is not advisable because of local irritation.
StabilityThis solution should be protected from light. A slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.
CompatibilityIt is recommended that prochlorperazine 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 PatientsIn 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.
I.M. Dosage: Initially 5 to 10 mg (1 to 2 mL) injected deeply into the upper outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total I.M. dosage should not exceed 40 mg per day.
I.V. Dosage: 2.5 to 10 mg (0.5 to 2 mL) by slow I.V. 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 I.V. dosage should not exceed 40 mg per day. When administered I.V., do not use bolus injection. Hypotension is a possibility if the drug is given by I.V. 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 I.V. injection or infusion.
I.M. Dosage: 5 to 10 mg (1 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).
I.V. Dosage: 5 to 10 mg (1 to 2 mL) as a slow I.V. 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 I.V., 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 2, longer treatment is usually required before maximal improvement is seen.
CHILDREN
I.M. Dosage: For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 to 20 mg (2 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 three or four 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 to 20 mg (2 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.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 and Dystonia).
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.
-
Cardinal Health
Prochlorperazine Edisylate | Cardinal Health
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.
IM Dosage
Initially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day.
IV Dosage
2.5 mg to 10 mg (0.5 to 2 mL) by slow 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 IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by 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 IV injection or infusion.
IM Dosage
5 mg to 10 mg (1 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).
IV Dosage
5 mg to 10 mg (1 to 2 mL) as a slow 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 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.
IM Dosage
For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 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 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.
Subcutaneous administration is not advisable because of local irritation.
Children
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 and Dystonia ).
SEVERE NAUSEA AND VOMITING IN CHILDREN
Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or two 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.
IM Dosage
Calculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep IM injection. Control is usually obtained with one dose.
CHILDREN WITH SCHIZOPHRENIA
IM 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 IM 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.
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