COMPAZINE® brand of prochlorperazine antiemetic• antipsychotic • tranquilizer
Compazine (prochlorperazine) is a phenothiazine derivative,
present in Compazine tablets and Spansule sustained release capsules as the maleate.
Its chemical name is 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-10H-phenothiazine (Z)-2-butenedioate (1:2).
and syrup contain prochlorperazine as the edisylate salt and Compazine suppositories contain prochlorperazine base. Empirical formulas
(and molecular weights) are: prochlorperazine maleate—C20H24CIN3S•2C4H4O4 (606.10); prochlorperazine edisylate—C20H24CIN3S•C2H6O6S2 (564.14); and prochlorperazine base—C20H24CIN3S
round, yellow-green, coated tablet contains prochlorperazine maleate equivalent
to prochlorperazine as follows: 5 mg imprinted SKF and C66; 10 mg
imprinted SKF and C67.
and 10 mg Tablets−Inactive ingredients consist of cellulose,
lactose, magnesium stearate, polyethylene glycol, sodium croscarmellose, titanium
dioxide, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Yellow
No. 6, FD&C Red No. 40, iron oxide, starch, stearic acid and
trace amounts of other inactive ingredients, including aluminum lake dyes.
Spansule® sustained release capsules−Each
Compazine®Spansule capsule is so prepared that an initial dose is released promptly
and the remaining medication is released gradually over a prolonged period.
Food slows absorption of prochlorperazine and decreases Cmax by
23% and AUC by 13%.
Each capsule, with black cap and
natural body, contains prochlorperazine maleate equivalent to prochlorperazine.
The 10 mg capsule is imprinted 10 mg and 3344 on the black cap and
is imprinted 10 mg and SB on the natural body. The 15 mg capsule
is imprinted 15 mg and 3346 on the black cap and is imprinted 15 mg
and SB on the natural body. Inactive ingredients consist of ammonio methacrylate
co-polymer, D&C Green No. 5, D&C Yellow No. 10, FD&C
Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40,
FD&C Yellow No. 6, gelatin, hydroxypropyl methylcellulose, propylene
glycol, silicon dioxide, simethicone emulsion, sodium lauryl sulfate, sorbic
acid, sugar spheres, talc, triethyl citrate, and trace amounts of other inactive
2 mL (5 mg/mL) and 10 mL (5 mg/mL)−Each mL contains,
in aqueous solution, 5 mg prochlorperazine as the edisylate, 5 mg
sodium biphosphate, 12 mg sodium tartrate, 0.9 mg sodium saccharin
and 0.75% benzyl alcohol as preservative.
Suppositories−Each suppository contains 2½ mg, 5 mg or
25 mg of prochlorperazine; with glycerin, glyceryl monopalmitate, glyceryl
monostearate, hydrogenated cocoanut oil fatty acids and hydrogenated palm
kernel oil fatty acids.
Syrup−Each 5 mL (1 teaspoonful) of clear, yellow-orange,
fruit-flavored liquid contains 5 mg of prochlorperazine as the edisylate.
Inactive ingredients consist of FD&C Yellow No. 6, flavors, polyoxyethylene
polyoxypropylene glycol, sodium benzoate, sodium citrate, sucrose and water.
For control of severe nausea and vomiting.
the treatment of schizophrenia.
is effective for the short-term treatment of generalized non-psychotic anxiety.
However, Compazine 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, Compazine should not be administered at doses of more than 20 mg per
day or for longer than 12 weeks, because the use of Compazine at higher doses or for longer intervals may cause persistent tardive
dyskinesia that may prove irreversible (see WARNINGS).
effectiveness of Compazine as treatmentfor non-psychotic anxiety was established in 4-week clinical studies of outpatients
with generalized anxiety disorder. This evidence does not predict that Compazine 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.).
Compazine has not been shown effective in the management of behavioral complications
in patients with mental retardation.
Do not use in patients with known hypersensitivity to phenothiazines.
not use in comatose states or in the presence of large amounts of central
nervous system depressants (alcohol, barbiturates, narcotics, etc.).
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.
The extrapyramidal symptoms which
can occur secondary to Compazine (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 Compazine (prochlorperazine) and other potential hepatotoxins should
be avoided in children and adolescents whose signs and symptoms suggest Reye’s
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.
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
The effect that symptomatic suppression
has upon the long-term course of the syndrome is unknown.
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
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.
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).
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
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.
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).
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 Compazine, 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).
may intensify or prolong the action of central nervous system depressants
(e.g., alcohol, anesthetics, narcotics).
Usage in Pregnancy
Safety for the use of Compazine during pregnancy has not been established. Therefore, Compazine 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.
have been reported instances of prolonged jaundice, extrapyramidal signs,
hyperreflexia or hyporeflexia in newborn infants whose mothers received phenothiazines.
There is evidence that phenothiazines are excreted in the
breast milk of nursing mothers. Caution should be exercised when Compazine is administered to a nursing woman.
The antiemetic action of Compazine (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 Compazine is used with cancer chemotherapeutic
drugs, vomiting as a sign of the toxicity of these agents may be obscured
by the antiemetic effect of Compazine.
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®* and Neo-Synephrine®† 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 Compazine (prochlorperazine)
as an antiemetic. Although no causal relationship has been established, this
possibility should be borne in mind during surgical aftercare.
sleep, from which patients can be aroused, and coma have been reported, usually
Antipsychotic drugs elevate prolactin
levels; the elevation persists during chronic administration. Tissue culture
experiments indicate that approximately one third 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.
aberrations in spermatocytes and abnormal sperm have been demonstrated in
rodents treated with certain antipsychotics.
all drugs which exert an anticholinergic effect, and/or cause mydriasis, prochlorperazine
should be used with caution in patients with glaucoma.
phenothiazines may interfere with thermoregulatory mechanisms, use with caution
in persons who will be exposed to extreme heat.
can diminish the effect of oral anticoagulants.
can produce alpha-adrenergic blockade.
may accentuate the orthostatic hypotension that may occur with phenothiazines.
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
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®‡ and thus precipitate Dilantin toxicity.
The presence of phenothiazines
may produce false-positive phenylketonuria (PKU) test results.
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.
lessen the likelihood of adverse reactions related to cumulative drug effect,
patients with a history of long-term therapy with Compazine (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., 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.
which lower the seizure threshold, including phenothiazine derivatives, should
not be used with Amipaque®§.
As with other phenothiazine derivatives, Compazine (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, or postprocedure.
Clinical studies of Compazine 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 Compazine. 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 Compazine.
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).
Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions
and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported
in association with antipsychotic drugs (see WARNINGS).
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
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.
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 Benadryl®║ may be useful.) In more severe cases, the administration
of an anti-parkinsonism agent, except levodopa (see PDR), usually produces rapid reversal of symptoms. Suitable supportive
measures such as maintaining a clear airway and adequate hydration should
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.
these symptoms become too troublesome, they can usually be controlled by a
reduction of dosage or change of drug. Treatment with anti-parkinsonian agents,
benzodiazepines or propranolol may be helpful.
Symptoms may include: spasm of the neck muscles, sometimes
progressing to torticollis; extensor rigidity of back muscles, sometimes progressing
to opisthotonos; carpopedal spasm, trismus, swallowing difficulty, oculogyric
crisis and protrusion of the tongue.
These usually subside
within a few hours, and almost always within 24 to 48 hours, after the
drug has been discontinued.
mild cases, reassurance or a barbiturate is often sufficient. In moderate cases, barbiturates will usually
bring rapid relief. In more severe adult cases, the administration of an anti-parkinsonism agent, except levodopa
(see PDR), usually produces rapid reversal
of symptoms. In children, reassurance
and barbiturates will usually control symptoms. (Or, injectable Benadryl may be useful. Note: See Benadryl prescribing information for appropriate children’s dosage.) If appropriate treatment with anti-parkinsonism agents
or Benadryl fails to reverse the signs
and symptoms, the diagnosis should be reevaluated.
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 anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism
agents should be used only when required. Generally, therapy of a few weeks
to 2 or 3 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 pseudo-parkinsonism.) Occasionally it is necessary to lower
the dosage of Compazine (prochlorperazine) or to discontinue the drug.
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; anti-parkinsonism agents do not alleviate
the symptoms of this syndrome. It is suggested that all antipsychotic agents
be discontinued if these symptoms appear.
be necessary to reinstitute treatment, or increase the dosage of the agent,
or switch to a different antipsychotic agent, the syndrome may be masked.
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.
Avoid getting the Injection solution on hands or clothing
because of the possibility of contact dermatitis.
Adverse Reactions Reported with Compazine (prochlorperazine) or Other
Adverse reactions with different phenothiazines vary in
type, frequency and 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 1 or more and should be borne in mind when
drugs of this class are administered: extrapyramidal symptoms (opisthotonos,
oculogyric crisis, hyperreflexia, dystonia, 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 I.M. 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.
nonspecific, usually reversible Q and T wave distortions−have been
observed in some patients receiving phenothiazines.
phenothiazines cause neither psychic nor physical dependence, sudden discontinuance
in long-term psychiatric patients may cause temporary symptoms, e.g., nausea
and vomiting, dizziness, tremulousness.
Note: 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.
DOSAGE AND ADMINISTRATION
Notes on Injection
Stability−This solution should be protected from light. This is a
clear, colorless to pale yellow solution; a slight yellowish discoloration
will not alter potency. If markedly discolored, solution should be discarded.
Compatibility−It is recommended that
Compazine (prochlorperazine) Injection not be mixed with other agents in the
DOSAGE AND ADMINISTRATION−ADULTS
(For children’s dosage and administration, see below.)
Dosage should be increased more gradually in debilitated or emaciated 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
1. To Control Severe Nausea and Vomiting
Adjust dosage to the response of the individual. Begin with
the lowest recommended dosage.
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.
Initially, usually one 15 mg capsule on arising or one
10 mg capsule q12h. Daily doses above 40 mg should be used only
in resistant cases.
25 mg twice daily.
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.
2½ to 10 mg (½ to 2 mL) by slow I.V.
injection or infusion at a rate not to exceed 5 mg per minute. Compazine 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
2. 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
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).
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. Compazine
(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.
3. 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.
−Usual dosage is 5 mg 3 or 4 times daily;
by Spansule capsule, usually one 15 mg
capsule on arising or one 10 mg capsule q12h. 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.
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
DOSAGE AND ADMINISTRATION−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.
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 Dystonias).
When writing a prescription for
the 2½ mg size suppository, write “2½,” not “2.5”;
this will help avoid confusion with the 25 mg adult size.
1. Severe Nausea and Vomiting in Children
Compazine (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 or Rectal Dosage
More than 1 day’s therapy is seldom necessary.
Not to Exceed
under 20 lbs not recommended
20 to 29 lbs
2½ mg 1 or 2 times a day
7.5 mg per day
30 to 39 lbs
2½ mg 2 or 3 times a day
10 mg per day
40 to 85 lbs
2½ mg 3 times a day or
mg 2 times a day
15 mg per day
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.
2. In Children with schizophrenia
Oral or Rectal Dosage
For children 2 to 12 years, starting dosage is 2½
mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then
increase dosage according to patient’s response.
AGES 2 to 5, total daily dosage usually does not exceed 20 mg.
AGES 6 to 12, total daily dosage usually does not exceed 25 mg.
For ages under 12, calculate each dose on the basis of 0.06 mg
of Compazine (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.
(See also ADVERSE REACTIONS.)
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. Do not attempt to induce emesis because a dystonic reaction
of the head or neck may develop that could result in aspiration of vomitus. Extrapyramidal symptoms may be treated with anti-parkinsonism
drugs, barbiturates or Benadryl. See
prescribing information for these products. Care should be taken to avoid
increasing respiratory depression.
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.
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 a further lowering of blood pressure.
experience indicates that phenothiazines are not dialyzable.
note on Spansule capsules −Since
much of the Spansule capsule medication
is coated for gradual release, therapy directed at reversing the effects of
the ingested drug and at supporting the patient should be continued for as
long as overdosage symptoms remain. Saline cathartics are useful for hastening
evacuation of pellets that have not already released medication.
−5 and 10 mg, in bottles of 100; in Single Unit
Packages of 100 (intended for institutional use only).
mg 100’s: NDC 0007-3366-20
5 mg SUP 100’s:
10 mg 100’s: NDC 0007-3367-20
mg SUP 100’s: NDC 0007-3367-21
−2 mL (5 mg/mL), in boxes of 25 and 10 mL (5 mg/mL),
in boxes of 1.
2 mL (5 mg/mL), in boxes of 25: NDC 0007-3352-16
mL (5 mg/mL), in boxes of 1: NDC 0007-3343-01
−2½ mg (for young children), 5 mg (for older
children) and 25 mg (for adults), in boxes of 12.
mg, in boxes of 12: NDC 0007-3360-03
5 mg, in boxes
of 12: NDC 0007-3361-03
25 mg, in boxes of 12: NDC 0007-3362-03
−5 mg/5 mL (1 teaspoonful) in 4 fl oz bottles.
mg/5 mL, 4 fl oz: NDC 0007-3363-44
Store Compazine (prochlorperazine)
vials below 30°C (86°F). Do not freeze. Other dosage forms can be
stored between 15° and 30°C (59° and 86°F). Protect from