Document
DailyMed Label: Prochlorperazine
Title
DailyMed Label: PROCHLORPERAZINE
Date
2009
Document type
DailyMed Prescription
Name
PROCHLORPERAZINE
Generic name
PROCHLORPERAZINE MALEATE
Manufacturer
STAT RX USA LLC
Product information
NDC: 16590-327
Product information
NDC: 16590-327
Description
DESCRIPTION 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 and has the following structural formula:
C 20 H 24 ClN 3 S•2C 4 H 4 O 4 M.W. 606.10 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: microcrystalline cellulose,
hypromellose, lactose monohydrate, magnesium stearate, polydextrose,
polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide,
triacetin, and yellow iron oxide
PROCHLORPERAZINE 10MG STRUCTURE
Indications
INDICATIONS AND USAGE 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 WARNINGS ).
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.
Dosage
DOSAGE AND ADMINISTRATION
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.
1. To Control Severe Nausea and Vomiting Adjust dosage to the response of the individual. Begin with the
lowest recommended dosage.
Oral Dosage - Tablets
Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 40
mg should be used only in resistant cases.
2. 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.
Oral Dosage
Non-Psychotic Anxiety – Usual dosage is 5 mg 3 or
4 times daily. Do not administer in doses of more than 20 mg per day or for
longer than 12 weeks.
Psychotic Disorders including Schizophrenia – In
relatively mild conditions , as seen in private psychiatric practice or in
outpatient clinics, dosage is 5 or 10 mg 3 or 4 times daily.
In moderate to severe conditions , for hospitalized
or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times
daily. Increase dosage gradually until symptoms are controlled or side effects
become bothersome. When dosage is increased by small increments every 2 or 3
days, side effects either do not occur or are easily controlled. Some patients
respond satisfactorily on 50 to 75 mg daily.
In more severe disturbances , optimum dosage is
usually 100 to 150 mg daily.
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
Dystonia
).
1. 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.
Oral Dosage
More than 1 day’s therapy is seldom necessary.
Weight
Usual
Dosage
Not to
Exceed
under 20 lbs not
recommended
20 to 29 lbs
2.5 mg 1 or 2 times a day
7.5 mg per day
30 to 39 lbs
2.5 mg 2 or 3 times a day
10 mg per day
40 to 85 lbs
2.5 mg 3 times a day or 5 mg 2 times
a day
15 mg per
day
2. In Children With Schizophrenia
Oral Dosage
For children 2 to 12 years, starting dosage is 2.5 mg 2 or 3 times daily. Do
not give more than 10 mg the first day. Then increase dosage according to
patient’s response.
FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.
FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.
Contraindications
CONTRAINDICATIONS Do not use in patients with known hypersensitivity to
phenothiazines.
Do not use in comatose states or in the presence of large amounts of central
nervous system depressants (alcohol, barbiturates, narcotics, etc.).
Do not use in pediatric surgery.
Do not use in pediatric patients under 2 years of age or under 20 lbs. Do not
use in children for conditions for which dosage has not been established.
Warnings
WARNINGS
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 maleate
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
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
treatment is withdrawn. Antipsychotic 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, antipsychotics should be prescribed in a manner
that is most likely to minimize the occurrence of tardive dyskinesia especially
in the elderly. 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.
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).
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.
PRECAUTIONS The anti-emetic action of prochlorperazine may mask the signs and
symptoms of overdosage of other drugs and may obscure the diagnosis and
treatment of other conditions such as intestinal obstruction, brain tumor and
Reye’s syndrome (see WARNINGS ).
When prochlorperazine is used with cancer chemotherapeutic drugs, vomiting as
a sign of the toxicity of these agents may be obscured by the anti-emetic effect
of prochlorperazine.
Because hypotension may occur, large doses and parenteral administration
should be used cautiously in patients with impaired cardiovascular systems. To
minimize the occurrence of hypotension after injection, keep patient lying down
and observe for at least ½ hour. If hypotension occurs after parenteral or oral
dosing, place patient in head-low position with legs raised. If a
vasoconstrictor is required, Levophed ® * (norepinephrine
bitartrate) and Neo-Synephrine ®
†
(phenylephrine hydrochloride) are suitable. Other pressor agents, including
epinephrine, should not be used because they may cause a paradoxical further
lowering of blood pressure.
Aspiration of vomitus has occurred in a few post-surgical patients who have
received prochlorperazine as an anti-emetic. Although no causal relationship has
been established, this possibility should be borne in mind during surgical
aftercare.
Deep sleep, from which patients can be aroused, and coma have been reported,
usually with overdosage.
Antipsychotic drugs elevate prolactin levels; the elevation persists during
chronic administration. Tissue culture experiments indicate that approximately
1/3 of human breast cancers are prolactin-dependent in
vitro , a factor of potential importance if the prescribing of these drugs
is contemplated in a patient with a previously detected breast cancer. Although
disturbances such as galactorrhea, amenorrhea, gynecomastia and impotence have
been reported, the clinical significance of elevated serum prolactin levels is
unknown for most patients. An increase in mammary neoplasms has been found in
rodents after chronic administration of antipsychotic drugs. Neither clinical
nor epidemiologic studies conducted to date, however, have shown an association
between chronic administration of these drugs and mammary tumorigenesis; the
available evidence is considered too limited to be conclusive at this time.
Chromosomal aberrations in spermatocytes and abnormal sperm have been
demonstrated in rodents treated with certain antipsychotics.
As with all drugs which exert an anticholinergic effect, and/or cause
mydriasis, prochlorperazine should be used with caution in patients with
glaucoma.
Because phenothiazines may interfere with thermoregulatory mechanisms, use
with caution in persons who will be exposed to extreme heat.
Phenothiazines can diminish the effect of oral anticoagulants.
Phenothiazines can produce alpha-adrenergic blockade.
Thiazide diuretics may accentuate the orthostatic hypotension that may occur
with phenothiazines.
Antihypertensive effects of guanethidine and related compounds may be
counteracted when phenothiazines are used concomitantly.
Concomitant administration of propranolol with phenothiazines results in
increased plasma levels of both drugs.
Phenothiazines may lower the convulsive threshold; dosage adjustments of
anticonvulsants may be necessary. Potentiation of anticonvulsant effects does
not occur. However, it has been reported that phenothiazines may interfere with
the metabolism of Dilantin ®
‡
(phenytoin) and thus precipitate Dilantin (phenytoin) toxicity.
The presence of phenothiazines may produce false-positive phenylketonuria
(PKU) test results.
Long-Term Therapy Given the likelihood that some patients exposed chronically to
antipsychotics will develop tardive dyskinesia, it is advised that all patients
in whom chronic use is contemplated be given, if possible, full information
about this risk. The decision to inform patients and/or their guardians must
obviously take into account the clinical circumstances and the competency of the
patient to understand the information provided.
To lessen the likelihood of adverse reactions related to cumulative drug
effect, patients with a history of long-term therapy with prochlorperazine
and/or other antipsychotics should be evaluated periodically to decide whether
the maintenance dosage could be lowered or drug therapy discontinued.
Children with acute illnesses (e.g., chicken-pox, 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.
Drugs which lower the seizure threshold, including phenothiazine derivatives,
should not be used with Amipaque ®
§
(metrizamide). As with other phenothiazine derivatives, prochlorperazine should
be discontinued at least 48 hours before myelography, should not be resumed for
at least 24 hours postprocedure, and should not be used for the control of
nausea and vomiting occurring either prior to myelography with Amipaque
(metrizamide), or postprocedure.
Leukopenia, Neutropenia and Agranulocytosis In clinical trial and postmarketing experience, events of
leukopenia/neutropenia and agranulocytosis have been reported temporally related
to antipsychotic agents.
Possible risk factors for leukopenia/neutropenia include preexisting low
white blood cell count (WBC) and history of drug induced leukopenia/neutropenia.
Patients with a preexisting low WBC or a history of drug induced
leukopenia/neutropenia should have their complete blood count (CBC) monitored
frequently during the first few months of therapy and should discontinue
prochlorperazine maleate tablets USP at the first sign of a decline in WBC in
the absence of other causative factors.
Patients with neutropenia should be carefully monitored for fever or other
symptoms or signs of infection and treated promptly if such symptoms or signs
occur. Patients with severe neutropenia (absolute neutrophil count less than
1000/mm 3 ) should discontinue prochlorperazine maleate
tablets USP and have their WBC followed until recovery.
Geriatric Use Clinical studies of prochlorperazine did not include sufficient
numbers of subjects aged 65 and over to determine whether elderly subjects
respond differently from younger subjects. Geriatric patients are more sensitive
to the side effects of antipsychotics, including prochlorperazine. These adverse
events include hypotension, anticholinergic effects (such as urinary retention,
constipation, and confusion), and neuromuscular reactions (such as parkinsonism
and tardive dyskinesia) (see PRECAUTIONS and ADVERSE REACTIONS ). Also, postmarketing safety experience
suggests that the incidence of agranulocytosis may be higher in geriatric
patients compared to younger individuals who received prochlorperazine. In
general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency of
decreased hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy (see DOSAGE AND ADMINISTRATION ).
Adverse reactions
Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions
and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been
reported in association with antipsychotic drugs (see
How supplied
HOW SUPPLIED Prochlorperazine maleate tablets USP are supplied as:
5 mg (as free base) tablets - yellow, round, film-coated; unscored on both
sides, debossed “93” on one side and debossed “9643” on the other side, in
bottles of 100.
10 mg (as free base) tablets - yellow, round, film-coated; unscored on both
sides, debossed “93” on one side and debossed “9652” on the other side, in
bottles of 100.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from light.
* Levophed ® is a registered
trademark of Abbott Laboratories.
† Neo-Synephrine ® is a
registered trademark of Abbott Laboratories.
‡ Dilantin ® is a registered
trademark of Parke-Davis.
§ Amipaque ® is a registered
trademark of Sanofi Pharmaceuticals.
# Benadryl ® is a registered
trademark of Parke-Davis.
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. G 5/2009
Package label
LABEL IMAGE
PROCHLORPERAZINE 10MG LABEL
4 organizations
2 products
Product
ProchlorperazineOrganization
Physicians Total Care, Inc.Product
Prochlorperazine EdisylateOrganization
PharmPak, Inc.Organization
Cosette Pharmaceuticals, Inc.Organization
STAT RX USA LLC