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Prochlorperazine maleate
Overview
What is PROCHLORPERAZINE MALEATE?
Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure
Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform.
Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.
What does PROCHLORPERAZINE MALEATE look like?
What are the available doses of PROCHLORPERAZINE MALEATE?
Sorry No records found.
What should I talk to my health care provider before I take PROCHLORPERAZINE MALEATE?
Sorry No records found
How should I use PROCHLORPERAZINE MALEATE?
For control of severe nausea and vomiting.
For the treatment of schizophrenia.
Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).
When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see ).
The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).
Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.
Elderly Patients:
1.To Control Severe Nausea and Vomiting:
Oral Dosage-Tablets:
2.In Adult Psychiatric Disorders:
Oral Dosage:
Psychotic Disorders including Schizophrenia
Inrelatively mild conditions
In moderate to severe conditions,
In more severe dis‑turbances,
DOSAGE AND ADMINISTRATION--CHILDREN
Do not use in pediatric surgery.
1. Severe Nausea and Vomiting in Children:
Oral Dosage:
2. Children with schizophrenia:
Oral Dosage:
What interacts with PROCHLORPERAZINE MALEATE?
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 MALEATE?
DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING
Neuroleptic Malignant Syndrome (NMS):
Falls:
Usage in Pregnancy:
Non-teratogenic Effects
Prochlorperazine Maleate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
What are the precautions of PROCHLORPERAZINE MALEATE?
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.
Geriatric Use:
see and
see
What are the side effects of PROCHLORPERAZINE MALEATE?
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
Dystonia
Class effect:
Motor Restlessness:
Pseudo-Parkinsonism:
Tardive Dyskinesia:
Adverse Reactions Reported with Prochlorperazine or Other Phenothiazine Derivatives:
What should I look out for while using PROCHLORPERAZINE MALEATE?
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:
Neuroleptic Malignant Syndrome (NMS):
Falls:
Usage in Pregnancy:
Non-teratogenic Effects
Prochlorperazine Maleate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
What might happen if I take too much PROCHLORPERAZINE MALEATE?
(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.
TREATMENT--It is important to determine other medications taken by the patient since multiple-dose therapy is common in overdosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage. Extrapyramidal symptoms may be treated with antiparkinsonism drugs, barbiturates or Benadryl. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression.
If administration of a stimulant is desirable, amphetamine, dextroamphetamine or caffeine with sodium benzoate is recommended.
Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.
If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable to administer a vasoconstrictor, Levophed and Neo-Synephrine 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 further lowering of blood pressure.
Limited experience indicates that phenothiazines are not dialyzable.
How should I store and handle PROCHLORPERAZINE MALEATE?
Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes: 10mg Charteruse, round, film coated tablets debossed with ‘TL 115’ scored on one side and plain on the other side.Bottle of 10 - 68788-9414-1Bottle of 20 - 68788-9414-2Bottle of 30 - 68788-9414-3Bottle of 60 - 68788-9414-6 Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes: 10mg Charteruse, round, film coated tablets debossed with ‘TL 115’ scored on one side and plain on the other side.Bottle of 10 - 68788-9414-1Bottle of 20 - 68788-9414-2Bottle of 30 - 68788-9414-3Bottle of 60 - 68788-9414-6 Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes: 10mg Charteruse, round, film coated tablets debossed with ‘TL 115’ scored on one side and plain on the other side.Bottle of 10 - 68788-9414-1Bottle of 20 - 68788-9414-2Bottle of 30 - 68788-9414-3Bottle of 60 - 68788-9414-6 Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes: 10mg Charteruse, round, film coated tablets debossed with ‘TL 115’ scored on one side and plain on the other side.Bottle of 10 - 68788-9414-1Bottle of 20 - 68788-9414-2Bottle of 30 - 68788-9414-3Bottle of 60 - 68788-9414-6 Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes: 10mg Charteruse, round, film coated tablets debossed with ‘TL 115’ scored on one side and plain on the other side.Bottle of 10 - 68788-9414-1Bottle of 20 - 68788-9414-2Bottle of 30 - 68788-9414-3Bottle of 60 - 68788-9414-6
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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:
Neuroleptic Malignant Syndrome (NMS):
Falls:
Usage in Pregnancy:
Non-teratogenic Effects
Prochlorperazine Maleate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
Changes in contraceptive effectiveness associated with co-administration of other products:
a. Anti-infective agents and anticonvulsants
Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.
b. Anti-HIV protease inhibitors
Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of combination oral contraceptive products may be affected with co-administration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
c. Herbal products
Herbal products containing St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
Increase in plasma levels of estradiol associated with co-administered drugs:
Co-administration of atorvastatin and certain combination oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.
Changes in plasma levels of co-administered drugs:
Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of combination oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid, due to induction of conjugation have been noted when these drugs were administered with combination oral contraceptives.
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.
Geriatric Use:
see and
see
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
Dystonia
Class effect:
Motor Restlessness:
Pseudo-Parkinsonism:
Tardive Dyskinesia:
Adverse Reactions Reported with Prochlorperazine or Other Phenothiazine Derivatives:
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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