Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1732
Predicate | Object |
---|---|
rdf:type | |
rdfs:label |
COMPAZINE (Tablet, Coated)
|
dailymed-instance:dosage |
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
syringe.
|
dailymed-instance:descripti... |
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). prochlorperazine
maleate Compazine vials
and syrup contain prochlorperazine as the edisylate salt and Compazine suppositories contain prochlorperazine base. Empirical formulas
(and molecular weights) are: prochlorperazine maleate���CHCINS���2CHO(606.10); prochlorperazine edisylate���CHCINS���CHOS(564.14); and prochlorperazine base���CHCINS
(373.95). Tablets���Each
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. 5 mg
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
CompazineSpansule 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 Cby
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
ingredients. Vials,
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 2��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.
|
dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
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.
|
dailymed-instance:supply |
Tablets: ���5 and 10 mg, in bottles of 100; in Single Unit
Packages of 100 (intended for institutional use only). 5
mg 100's: NDC 0007-3366-20 5 mg SUP 100's:
NDC 0007-3366-21 10 mg 100's: NDC 0007-3367-20 10
mg SUP 100's: NDC 0007-3367-21<br/>Spansule capsules:<br/>Vials: ���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 10
mL (5 mg/mL), in boxes of 1: NDC 0007-3343-01<br/>Suppositories: ���2��mg (for young children), 5 mg (for older
children) and 25 mg (for adults), in boxes of 12. 2��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<br/>Syrup: ���5 mg/5 mL (1 teaspoonful) in 4 fl oz bottles. 5
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
light. norepinephrine bitartrate, Abbott
Laboratories. phenylephrine hydrochloride,
Abbott Laboratories. phenytoin, Parke-Davis. metrizamide,
Sanofi Pharmaceuticals. diphenhydramine
hydrochloride, Parke-Davis. DATE OF ISSUANCE July 2004 ��2004,
GlaxoSmithKline All rights reserved. CompazineSpansule capsules are manufactured by International
Processing Corporation, Winchester, KY 40391 GlaxoSmithKline Research
Triangle Park, NC 27709 CZ:L96
|
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... |
dailymed-ingredient:D&C_Yellow_No._10,
dailymed-ingredient:FD&C_Blue_No._2,
dailymed-ingredient:FD&C_Red_No._40,
dailymed-ingredient:FD&C_Yellow_No._6,
dailymed-ingredient:aluminum_lake_dyes,
dailymed-ingredient:cellulose,
dailymed-ingredient:iron_oxide,
dailymed-ingredient:lactose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:sodium_croscarmellose,
dailymed-ingredient:starch,
dailymed-ingredient:stearic_acid,
dailymed-ingredient:titanium_dioxide
|
dailymed-instance:overdosag... |
(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 havenot already released medication.
|
dailymed-instance:genericMe... |
prochlorperazine maleate
|
dailymed-instance:fullName |
COMPAZINE (Tablet, Coated)
|
dailymed-instance:adverseRe... |
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.<br/>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 Benadrylmay 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
be employed.<br/>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.<br/>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
(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.<br/>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 Compazine (prochlorperazine) or to discontinue the drug.<br/>Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may
appear in some patients on long-term therapy or may appear after drug therapy
has been discontinued. The syndrome can also develop, although much less frequently,
after relatively brief treatment periods at low doses. This syndrome appears
in all age groups. Although its prevalence appears to be highest among elderly
patients, especially elderly women, it is impossible to rely upon prevalence
estimates to predict at the inception of antipsychotic treatment which patients
are likely to develop the syndrome. The symptoms are persistent and in some
patients appear to be irreversible. The syndrome is characterized by rhythmical
involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion
of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes
these may be accompanied by involuntary movements of extremities. In rare
instances, these involuntary movements of the extremities are the only manifestations
of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia,
has also been described. There is no known effective
treatment for tardive dyskinesia; 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.<br/>Contact Dermatitis: Avoid getting the Injection solution on hands or clothing
because of the possibility of contact dermatitis.<br/>Adverse Reactions Reported with Compazine (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, aplasticanemia);
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 phenothiazines. 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.
|
dailymed-instance:warning |
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
syndrome.<br/>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.<br/>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 Compazine, unless in the judgment of the physician the potential benefits
of treatment outweigh the possible hazards. Compazine
(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).<br/>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. There
have been reported instances of prolonged jaundice, extrapyramidal signs,
hyperreflexia or hyporeflexia in newborn infants whose mothers received phenothiazines.<br/>Nursing Mothers: 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.
|
dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
COMPAZINE
|