PROCHLORPERAZINE
DESCRIPTION:
INDICATIONS AND USAGE:
For control of severe nausea and vomiting.
For management of the manifestations of psychotic disorders.
Stemetil (prochlorperazine) is effective for the short-term treatment of
generalized non-psychotic anxiety. However, Stemetil 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, Stemetil should not be
administered at doses of more than 20 mg per day or for longer than 12 weeks,
because the use of Stemetil at higher doses or for longer intervals may cause
persistent tardive dyskinesia that may prove irreversible (see WARNINGS).
The effectiveness of Stemetil 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 Stemetil 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.).
Stemetil has not been shown effective in the management of behavioral
complications in patients with mental retardation.
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:
THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO STEMETIL
(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 STEMETIL (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 neuroleptic (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
neuroleptic treatment, which patients are likely to develop the syndrome.
Whether neuroleptic 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 neuroleptic 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 neuroleptic
treatment is withdrawn. Neuroleptic 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, neuroleptics should be prescribed in a manner that
is most likely to minimize the occurrence of tardive dyskinesia. Chronic
neuroleptic treatment should generally be reserved for patients who suffer from
a chronic illness that, 1) is known to respond to neuroleptic 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 neuroleptics,
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 a neuroleptic. 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 neuroleptics, 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 Stemetil, unless
in the judgment of the physician the potential benefits of treatment outweigh
the possible hazards.
Stemetil (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 Stemetil during pregnancy has not
been established. Therefore, Stemetil 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 Stemetil is
administered to a nursing woman.
PRECAUTIONS:
The antiemetic action of Stemetil (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 Stemetil is used with cancer chemotherapeutic drugs, vomiting as a sign of
the toxicity of these agents may be obscured by the antiemetic effect of
Stemetil.
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 1/2 hour. If hypotension occurs after parenteral or oral
dosing, place patient in head-low position with legs raised. If a
vasoconstrictor is required, Levophed(R)* and Neo-Synephrine(R)** are suitable.
Other pressor agents, including epinephrine, should not be used because they may
cause a paradoxical further lowering of blood pressure.
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Aspiration of vomitus has occurred in a few post- surgical patients who have
received Stemetil (prochlorperazine) as an antiemetic. 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.
Neuroleptic 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 neuroleptic 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 neuroleptics.
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(R)*/* and thus precipitate Dilantin toxicity.
----------
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The presence of phenothiazines may produce false- positive phenylketonuria (PKU)
test results.
LONG-TERM THERAPY: Given the likelihood that some patients exposed chronically
to neuroleptics 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 Stemetil (prochlorperazine)
and/or other neuroleptics 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.
Drugs which lower the seizure threshold, including phenothiazine derivatives,
should not be used with Amipaque(R)**/*. As with other phenothiazine
derivatives, Stemetil (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.
----------
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DRUG INTERACTIONS:
SEE PRECAUTIONS
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 WARNINGS).
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 Benadryl(R)# may be useful.) In more severe cases,
the administration of an anti- parkinsonism agent, except levodopa, usually
produces rapid reversal of symptoms. Suitable supportive measures such as
maintaining a clear airway and adequate hydration should be employed.
----------
#diphenhydramine hydrochloride, Parke-Davis.
----------
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 anti- parkinsonian agents,
benzodiazepines or propranolol may be helpful.
DYSTONIAS: 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.
In 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, 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.
PSEUDO-PARKINSONISM: 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 Stemetil (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 neuroleptic 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.
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 STEMETIL (PROCHLORPERAZINE) OR OTHER
PHENOTHIAZINE DERIVATIVES: 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.
EKG changes--particularly nonspecific, usually reversible Q and T wave
distortions--have been observed in some patients receiving phenothiazine
tranquilizers.
Although 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 Stemetil (prochlorperazine) Injection not
be mixed with other agents in the syringe.
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 40mg should be used only in resistant cases.
SPANSULE CAPSULES: 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.
RECTAL DOSAGE: 25 mg twice daily.
I.M. DOSAGE: Initially 5 to 10 mg (1 to 2 mL) injected Deeply into the upper
outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total
I.M. dosage should not exceed 40 mg per day.
I.V. DOSAGE: 2 1/2 to 10 mg (1/2 to 2 mL) by slow I.V. injection or infusion at
a rate not to exceed 5 mg per minute. Stemetil Injection may be administered
either undiluted or diluted in isotonic solution. A single dose of the drug
should not exceed 10 mg; total I.V. dosage should not exceed 40 mg per day. When
administered I.V., do not use bolus injection. Hypotension is a possibility if
the drug is given by I.V. injection or infusion.
SUBCUTANEOUS ADMINISTRATION IS NOT ADVISABLE BECAUSE OF LOCAL IRRITATION.
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 infusion.
I.M. DOSAGE: 5 to 10 mg (1 to 2 mL) 1 to 2 hours before induction of anesthesia
(repeat once in 30 minutes, if necessary), or to control acute symptoms during
and after surgery (repeat once if necessary).
I.V. DOSAGE: 5 to 10 mg (1 to 2 mL) as a slow I.V. injection or infusion 15 to
30 minutes before induction of anesthesia, or to control acute symptoms during
or after surgery. Repeat once if necessary. Stemetil (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.
ORAL DOSAGE: Non-Psychotic Anxiety--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--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.
I.M. DOSAGE: For immediate control of severely disturbed adults, inject an
initial dose of 10 to 20 mg (2 to 4 mL) Deeply into the upper outer quadrant of
the buttock. Many patients respond shortly after the first injection. If
necessary, however, repeat the initial dose every 2 to 4 hours (or, in resistant
cases, every hour) to gain control of the patient. More than three or four doses
are seldom necessary. After control is achieved, switch patient to an oral form
of the drug at the same dosage level or higher. If, in rare cases, parenteral
therapy is needed for a prolonged period, give 10 to 20 mg (2 to 4 mL) every 4
to 6 hours. Pain and irritation at the site of injection have seldom occurred.
SUBCUTANEOUS ADMINISTRATION IS NOT ADVISABLE BECAUSE OF LOCAL IRRITATION.
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.
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 Dystonias).
When writing a prescription for the 2 1/2 mg size suppository, write "2 1/2,"
not "2.5"; this will help avoid confusion with the 25 mg adult size.
1. SEVERE NAUSEA AND VOMITING IN CHILDREN: Stemetil (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 one day's therapy is seldom necessary.
---------------------------------------------------------------------------------------
Not to
Weight Usual Dosage Exceed
---------------------------------------------------------------------------------------
under 20 lbs not recommended
---------------------------------------------------------------------------------------
20 to 29 lbs 2 1/2 mg 1 or 2 7.5 mg
times a day per day
--------------------------------------------------------------------------------------
30 to 39 lbs 2 1/2 mg 2 or 3 10 mg
times a day per day
-------------------------------------------------------------------------------------
40 to 85 lbs 2 1/2 mg 3 times 15 mg
a day or 5 mg per day
2 times a day
-------------------------------------------------------------------------------------
I.M. DOSAGE: Calculate each dose on the basis of 0.06 mg of the drug per lb of
body weight; give by deep I.M. injection. Control is usually obtained with one
dose.
2. IN PSYCHOTIC CHILDREN:
ORAL OR RECTAL DOSAGE: For children 2 to 12 years, starting dosage is 2 1/2 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.
I.M. DOSAGE: For ages under 12, calculate each dose on the basis of 0.06 mg of
Stemetil (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.
OVERDOSAGE:
(See also ADVERSE REACTIONS.)
SYMPTOMS--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. 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.
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 a further lowering of blood
pressure.
Limited experience indicates that phenothiazines are Not dialyzable.
Special 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.
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