Prochlorperazine Edisylate

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Overview

What is Prochlorperazine Edisylate?

Prochlorperazine edisylate, 2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine 1,2-ethanedisulfonate (1:1), has the following structural formula:

CHClNS·CHOS 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.

What does Prochlorperazine Edisylate look like?

What are the available doses of Prochlorperazine Edisylate?

Sorry No records found.

What should I talk to my health care provider before I take Prochlorperazine Edisylate?

Sorry No records found

How should I use Prochlorperazine Edisylate?

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.

NOTE ON INJECTION:

Subcutaneous administration is not advisable because of local irritation.

Stability

Compatibility

Adults

IM Dosage

deeply

IV Dosage

Subcutaneous administration is not advisable because of local irritation.

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.

IM Dosage

deeply

Subcutaneous administration is not advisable because of local irritation.

Children

DO NOT USE IN PEDIATRIC SURGERY

IM Dosage

lb

IM Dosage

lb

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

PRECAUTIONS

Dystonia

What interacts with Prochlorperazine Edisylate?

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.

What are the warnings of Prochlorperazine Edisylate?

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What are the precautions of Prochlorperazine Edisylate?

Leukopenia, Neutropenia and Agranulocytosis

in vitro,

Long-Term Therapy

Children with acute illnesses (e.g., chickenpox, CNS infections, measles, gastroenteritis) or dehydration seem to be much more susceptible to neuromuscular reactions, particularly dystonias, than are adults. In such patients, the drug should be used only under close supervision.

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WARNINGS

What are the side effects of Prochlorperazine Edisylate?

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see ).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

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 treatment which patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described.There is no known effective treatment for tardive dyskinesia; antiparkinsonism agents do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment or increase the dosage of the agent or switch to a different antipsychotic agent, the syndrome may be masked.It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome, and if the medication is stopped at that time, the syndrome may not develop.

Contact Dermatitis

Avoid getting the injection solution on hands or clothing because of the possibility of contact dermatitis.

Adverse Reactions Reported with Prochlorperazine or Other Phenothiazine Derivatives

Adverse reactions with different phenothiazines vary in type, frequency, and the mechanism of occurrence, i.e., some are dose-related, while others involve individual patient sensitivity.Some adverse reactions may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses of certain phenothiazines.Not all of the following adverse reactions have been observed with every phenothiazine derivative but they have been reported with one or more and should be borne in mind when drugs of this class are administered: extrapyramidal symptoms (opisthotonos, oculogyric crisis, hyperreflexia, dystonias, akathisia, dyskinesia, parkinsonism), some of which have lasted months and even years, particularly in elderly patients with previous brain damage; grand mal and petit mal convulsions, particularly in patients with EEG abnormalities or history of such disorders; altered cerebrospinal fluid proteins; cerebral edema; intensification and prolongation of the action of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, alcohol), atropine, heat, organophosphorus insecticides; autonomic reactions (dryness of mouth, nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory disorders/impotence, priapism, atonic colon, urinary retention, miosis and mydriasis); reactivation of psychotic processes, catatonic-like states; hypotension (sometimes fatal); cardiac arrest; blood dyscrasias (pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia); liver damage (jaundice, biliary stasis); endocrine disturbances (hyperglycemia, hypoglycemia, glycosuria, lactation, galactorrhea, gynecomastia, menstrual irregularities, false-positive pregnancy tests); skin disorders (photosensitivity, itching, erythema, urticaria, eczema up to exfoliative dermatitis); other allergic reactions (asthma, laryngeal edema, angioneurotic edema, anaphylactoid reactions); peripheral edema; reversed epinephrine effect; hyperpyrexia; mild fever after large IM doses; increased appetite; increased weight; a systemic lupus erythematosus-like syndrome; pigmentary retinopathy; with prolonged administration of substantial doses, skin pigmentation, epithelial keratopathy, and lenticular and corneal deposits.EKG changes—particularly nonspecific, usually reversible Q- and T-wave distortions—have been observed in some patients receiving phenothiazines.Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuation in long-term psychiatric patients may cause temporary symptoms, e.g., nausea and vomiting, dizziness, tremulousness. There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.

What should I look out for while using Prochlorperazine Edisylate?

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.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

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

not

Neuroleptic Malignant Syndrome (NMS)

General

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.

Usage in Pregnancy

Nursing Mothers

BOXED WARNING

PRECAUTIONS

ADVERSE REACTIONS

What might happen if I take too much Prochlorperazine Edisylate?

(See also .) 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. 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 dialyzable.

How should I store and handle Prochlorperazine Edisylate?

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution.Prochlorperazine Edisylate Injection, USP is supplied as follows:StoragePROTECT FROM LIGHTStore 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]. Emcure Pharmaceuticals Ltd.,Heritage Pharmaceuticals Inc.Repackaged By:Cardinal HealthZanesville, OH 43701L50871430715

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Clinical Information

Chemical Structure

No Image found

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. It also has a clinically useful antipsychotic effect. Following intramuscular administration of prochlorperazine edisylate, the drug has an onset of action within ten to twenty minutes and a duration of action of three to four hours.

Non-Clinical Toxicology

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.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

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

not

Neuroleptic Malignant Syndrome (NMS)

General

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.

Usage in Pregnancy

Nursing Mothers

BOXED WARNING

PRECAUTIONS

ADVERSE REACTIONS

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see ).

Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QTprolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.

Leukopenia, Neutropenia and Agranulocytosis

in vitro,

Long-Term Therapy

Children with acute illnesses (e.g., chickenpox, CNS infections, measles, gastroenteritis) or dehydration seem to be much more susceptible to neuromuscular reactions, particularly dystonias, than are adults. In such patients, the drug should be used only under close supervision.

3

WARNINGS

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see ).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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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