Haldol Decanoate
Generic Name: haloperidol
Dosage Form: Injection
Rx Only
Haldol Decanoate Description
Haloperidol decanoate is the decanoate ester of the
butyrophenone, HALDOL (haloperidol). It has a markedly extended duration of
effect. It is available in sesame oil in sterile form for intramuscular (IM)
injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4
piperidinyl decanoate, is:
Haloperidol decanoate is almost insoluble
in water (0.01 mg/mL), but is soluble in most organic solvents.
Each mL of Haldol Decanoate 50 for IM injection contains 50
mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil
vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.
Each mL of Haldol Decanoate 100 for IM injection contains 100
mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil
vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.
Haldol Decanoate - Clinical Pharmacology
Haldol Decanoate 50 and Haldol Decanoate 100 are the
long-acting forms of HALDOL (haloperidol). The basic effects of haloperidol
decanoate are no different from those of HALDOL with the exception of duration
of action. Haloperidol blocks the effects of dopamine and increases its turnover
rate; however, the precise mechanism of action is unknown.
Administration of haloperidol decanoate in sesame oil results
in slow and sustained release of haloperidol. The plasma concentrations of
haloperidol gradually rise, reaching a peak at about 6 days after the injection,
and falling thereafter, with an apparent half-life of about 3 weeks. Steady
state plasma concentrations are achieved after the third or fourth dose. The
relationship between dose of haloperidol decanoate and plasma haloperidol
concentration is roughly linear for doses below 450 mg. It should be noted,
however, that the pharmacokinetics of haloperidol decanoate following intramuscular
injections can be quite variable between subjects.
Indications and Usage for Haldol Decanoate
Haldol Decanoate 50 and Haldol Decanoate 100 are indicated
for the treatment of schizophrenic patients who require prolonged parenteral
antipsychotic therapy.
Contraindications
Since the pharmacologic and clinical actions of HALDOL
Decanoate 50 and Haldol Decanoate 100 are attributed to HALDOL (haloperidol)
as the active medication, CONTRAINDICATIONS, WARNINGS, and additional information
are those of HALDOL, modified only to reflect the prolonged action.
HALDOL is contraindicated in severe toxic central nervous
system depression or comatose states from any cause and in individuals who
are hypersensitive to this drug or have Parkinson"s disease.
Warnings
Cardiovascular Effects
Cases of sudden death have been reported in psychiatric patients
receiving antipsychotic drugs, including Haldol Decanoate.
Since
QT-prolongation has been observed during Haldol Decanoate treatment, it is
advised to be cautious in patients with QT-prolonging conditions (long QT-syndrome,
hypokalaemia, electrolyte imbalance, drugs known to prolong QT, cardiovascular
diseases, family history of QT prolongation). Haldol Decanoate MUST NOT BE
ADMINISTERED INTRAVENOUSLY.
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 tardive dyskinesia 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 process. The effect that symptomatic suppression
has upon the long-term course of the syndrome is unknown.
Given these considerations, antipsychotic drugs should be prescribed
in a manner that is most likely to minimize the occurrence of tardive dyskinesia.
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 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 (including catatonic signs) and evidence
of autonomic instability (irregular pulse or blood pressure, tachycardia,
diaphoresis, and cardiac dysrhythmias). Additional signs may include elevated
creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.
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.
Hyperpyrexia and heat stroke, not
associated with the above symptom complex, have also been reported with HALDOL.
General
A number of cases of bronchopneumonia, some fatal,
have followed the use of antipsychotic drugs, including HALDOL (haloperidol).
It has been postulated that lethargy and decreased sensation of thirst due
to central inhibition may lead to dehydration, hemoconcentration and reduced
pulmonary ventilation. Therefore, if the above signs and symptoms appear,
especially in the elderly, the physician should institute remedial therapy
promptly.
Although not reported with HALDOL,
decreased serum cholesterol and/or cutaneous and ocular changes have been
reported in patients receiving chemically-related drugs.
Precautions
Haldol Decanoate 50 and Haldol Decanoate 100 should
be administered cautiously to patients:
- –
- with severe cardiovascular disorders,
because of the possibility of transient hypotension and/or precipitation of
anginal pain. Should hypotension occur and a vasopressor be required, epinephrine
should not be used since HALDOL (haloperidol) may block its vasopressor activity,
and paradoxical further lowering of the blood pressure may occur. Instead,
metaraminol, phenylephrine or norepinephrine should be used.
- –
- receiving anticonvulsant medications,
with a history of seizures, or with EEG abnormalities, because HALDOL may
lower the convulsive threshold. If indicated, adequate anticonvulsant therapy
should be concomitantly maintained.
- –
- with known allergies, or with a
history of allergic reactions to drugs.
- –
- receiving anticoagulants, since
an isolated instance of interference occurred with the effects of one anticoagulant
(phenindione).
If concomitant antiparkinson medication is required,
it may have to be continued after Haldol Decanoate 50 or Haldol Decanoate
100 is discontinued because of the prolonged action of haloperidol decanoate.
If both drugs are discontinued simultaneously, extrapyramidal symptoms may
occur. The physician should keep in mind the possible increase in intraocular
pressure when anticholinergic drugs, including antiparkinson agents, are administered
concomitantly with haloperidol decanoate.
In
patients with thyrotoxicosis who are also receiving antipsychotic medication,
including haloperidol decanoate, severe neurotoxicity (rigidity, inability
to walk or talk) may occur.
When HALDOL is used
to control mania in bipolar disorders, there may be a rapid mood swing to
depression.
Information for Patients
Haloperidol decanoate may impair the mental and/or
physical abilities required for the performance of hazardous tasks such as
operating machinery or driving a motor vehicle. The ambulatory patient should
be warned accordingly.
The use of alcohol with
this drug should be avoided due to possible additive effects and hypotension.
Drug Interactions
An encephalopathic syndrome (characterized by weakness,
lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis,
elevated serum enzymes, BUN, and FBS) followed by irreversible brain damage
has occurred in a few patients treated with lithium plus HALDOL. A causal
relationship between these events and the concomitant administration of lithium
and HALDOL has not been established; however, patients receiving such combined
therapy should be monitored closely for early evidence of neurological toxicity
and treatment discontinued promptly if such signs appear.
As with other antipsychotic agents, it should be noted that
HALDOL may be capable of potentiating CNS depressants such as anesthetics,
opiates, and alcohol.
In a study of 12 schizophrenic
patients coadministered oral haloperidol and rifampin, plasma haloperidol
levels were decreased by a mean of 70% and mean scores on the Brief Psychiatric
Rating Scale were increased from baseline. In 5 other schizophrenic patients
treated with oral haloperidol and rifampin, discontinuation of rifampin produced
a mean 3.3-fold increase in haloperidol concentrations. Thus, careful monitoring
of clinical status is warranted when rifampin is administered or discontinued
in haloperidol-treated patients.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No mutagenic potential of haloperidol decanoate
was found in the Ames Salmonella microsomal activation assay. Negative or
inconsistent positive findings have been obtained in in
vitro and in vivo studies
of effects of short-acting haloperidol on chromosome structure and number.
The available cytogenetic evidence is considered too inconsistent to be conclusive
at this time.
Carcinogenicity studies using
oral haloperidol were conducted in Wistar rats (dosed at up to 5 mg/kg daily
for 24 months) and in Albino Swiss mice (dosed at up to 5 mg/kg daily for
18 months). In the rat study survival was less than optimal in all dose groups,
reducing the number of rats at risk for developing tumors. However, although
a relatively greater number of rats survived to the end of the study in high-dose
male and female groups, these animals did not have a greater incidence of
tumors than control animals. Therefore, although not optimal, this study does
suggest the absence of a haloperidol related increase in the incidence of
neoplasia in rats at doses up to 20 times the usual daily human dose for chronic
or resistant patients.
In female mice at 5
and 20 times the highest initial daily dose for chronic or resistant patients,
there was a statistically significant increase in mammary gland neoplasia
and total tumor incidence; at 20 times the same daily dose there was a statistically
significant increase in pituitary gland neoplasia. In male mice, no statistically
significant differences in incidences of total tumors or specific tumor types
were noted.
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 prescription 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 studies 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.
Usage in Pregnancy
Pregnancy Category C. Rodents given up to 3 times
the usual maximum human dose of haloperidol decanoate showed an increase in
incidence of resorption, fetal mortality, and pup mortality. No fetal abnormalities
were observed.
Cleft palate has been observed
in mice given oral haloperidol at 15 times the usual maximum human dose. Cleft
palate in mice appears to be a nonspecific response to stress or nutritional
imbalance as well as to a variety of drugs, and there is no evidence to relate
this phenomenon to predictable human risk for most of these agents.
There are no adequate and well-controlled studies in pregnant
women. There are reports, however, of cases of limb malformations observed
following maternal use of HALDOL along with other drugs which have suspected
teratogenic potential during the first trimester of pregnancy. Causal relationships
were not established with these cases. Since such experience does not exclude
the possibility of fetal damage due to HALDOL, haloperidol decanoate should
be used during pregnancy or in women likely to become pregnant only if the
benefit clearly justifies a potential risk to the fetus.
Nursing Mothers
Since haloperidol is excreted in human breast milk,
infants should not be nursed during drug treatment with haloperidol decanoate.
Pediatric Use
Safety and effectiveness of haloperidol decanoate
in children have not been established.
Geriatric Use
Clinical studies of haloperidol did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience
has not consistently identified differences in responses between the elderly
and younger patients. However, the prevalence of tardive dyskinesia appears
to be highest among the elderly, especially elderly women (see WARNINGS,
Tardive dyskinesia). Also, the pharmacokinetics of haloperidol
in geriatric patients generally warrants the use of lower doses (see DOSAGE AND ADMINISTRATION).
Adverse Reactions
Adverse reactions following the administration of
Haldol Decanoate 50 or Haldol Decanoate 100 are those of HALDOL (haloperidol).
Since vast experience has accumulated with HALDOL, the adverse reactions are
reported for that compound as well as for haloperidol decanoate. As with all
injectable medications, local tissue reactions have been reported with haloperidol
decanoate.
Cardiovascular Effects
Tachycardia, hypotension, and hypertension have
been reported. QT prolongation and/or ventricular arrhythmias have also been
reported, in addition to ECG pattern changes compatible with the polymorphous
configuration of torsade de pointes, and may occur more frequently with high
doses and in predisposed patients (see WARNINGS and PRECAUTIONS).
Cases
of sudden and unexpected death have been reported in association with the
administration of HALDOL. The nature of the evidence makes it impossible to
determine definitively what role, if any, HALDOL played in the outcome of
the reported cases. The possibility that HALDOL caused death cannot, of course,
be excluded, but it is to be kept in mind that sudden and unexpected death
may occur in psychotic patients when they go untreated or when they are treated
with other antipsychotic drugs.
CNS Effects
Extrapyramidal Symptoms (EPS)
EPS during the administration of HALDOL (haloperidol)
have been reported frequently, often during the first few days of treatment.
EPS can be categorized generally as Parkinson-like symptoms, akathisia, or
dystonia (including opisthotonos and oculogyric crisis). While all can occur
at relatively low doses, they occur more frequently and with greater severity
at higher doses. The symptoms may be controlled with dose reductions or administration
of antiparkinson drugs such as benztropine mesylate USP or trihexyphenidyl
hydrochloride USP. It should be noted that persistent EPS have been reported;
the drug may have to be discontinued in such cases.
Withdrawal Emergent Neurological Signs
Generally, patients receiving short-term therapy
experience no problems with abrupt discontinuation of antipsychotic drugs.
However, some patients on maintenance treatment experience transient dyskinetic
signs after abrupt withdrawal. In certain of these cases the dyskinetic movements
are indistinguishable from the syndrome described below under "Tardive Dyskinesia"
except for duration. Although the long-acting properties of haloperidol decanoate
provide gradual withdrawal, it is not known whether gradual withdrawal of
antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent
neurological signs.
Tardive Dyskinesia
As with all antipsychotic agents HALDOL has been
associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting
of potentially irreversible, involuntary, dyskinetic movements, may appear
in some patients on long-term therapy with haloperidol decanoate or may occur
after drug therapy has been discontinued. The risk appears to be greater in
elderly patients on high-dose therapy, especially females. The symptoms are
persistent and in some patients appear irreversible. The syndrome is characterized
by rhythmical involuntary movements of 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 and the trunk.
There is no known effective treatment for tardive dyskinesia;
antiparkinson agents usually 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, this syndrome
may be masked.
It has been reported that
fine vermicular movement of the tongue may be an early sign of tardive dyskinesia
and if the medication is stopped at that time the full syndrome may not develop.
Tardive Dystonia
Tardive dystonia, not associated with the above
syndrome, has also been reported. Tardive dystonia is characterized by delayed
onset of choreic or dystonic movements, is often persistent, and has the potential
of becoming irreversible.
Other CNS Effects
Insomnia, restlessness, anxiety, euphoria, agitation,
drowsiness, depression, lethargy, headache, confusion, vertigo, grand mal
seizures, exacerbation of psychotic symptoms including hallucinations, and
catatonic-like behavioral states which may be responsive to drug withdrawal
and/or treatment with anticholinergic drugs.
Body as a Whole
Neuroleptic malignant syndrome (NMS), hyperpyrexia
and heat stroke have been reported with HALDOL. (See WARNINGS
for further information concerning NMS.)
Hematologic Effects
Reports have appeared citing the occurrence of mild
and usually transient leukopenia and leukocytosis, minimal decreases in red
blood cell counts, anemia, or a tendency toward lymphomonocytosis. Agranulocytosis
has rarely been reported to have occurred with the use of HALDOL, and then
only in association with other medication.
Liver Effects
Impaired liver function and/or jaundice have been
reported.
Dermatologic Reactions
Maculopapular and acneiform skin reactions and isolated
cases of photosensitivity and loss of hair.
Endocrine Disorders
Lactation, breast engorgement, mastalgia, menstrual
irregularities, gynecomastia, impotence, increased libido, hyperglycemia,
hypoglycemia and hyponatremia.
Gastrointestinal Effects
Anorexia, constipation, diarrhea, hypersalivation,
dyspepsia, nausea and vomiting.
Autonomic Reactions
Dry mouth, blurred vision, urinary retention, diaphoresis
and priapism.
Respiratory Effects
Laryngospasm, bronchospasm and increased depth of
respiration.
Special Senses
Cataracts, retinopathy and visual disturbances.
Postmarketing Events
Hyperammonemia has been reported in a 5 1 /2 year
old child with citrullinemia, an inherited disorder of ammonia excretion,
following treatment with HALDOL.
Cardiovascular Effects
Overdosage
While overdosage is less likely to occur with a parenteral
than with an oral medication, information pertaining to HALDOL (haloperidol)
is presented, modified only to reflect the extended duration of action of
haloperidol decanoate.
Manifestations
In general, the symptoms of overdosage would be
an exaggeration of known pharmacologic effects and adverse reactions, the
most prominent of which would be: 1) severe extrapyramidal reactions, 2) hypotension,
or 3) sedation. The patient would appear comatose with respiratory depression
and hypotension which could be severe enough to produce a shock-like state.
The extrapyramidal reactions would be manifested by muscular weakness or rigidity
and a generalized or localized tremor, as demonstrated by the akinetic or
agitans types, respectively. With accidental overdosage, hypertension rather
than hypotension occurred in a two-year old child. The risk of ECG changes
associated with torsade de pointes should be considered.
(For further information regarding torsade de pointes, please
refer to ADVERSE REACTIONS.)
Treatment
Since there is no specific antidote, treatment is
primarily supportive. A patent airway must be established by use of an oropharyngeal
airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy.
Respiratory depression may be counteracted by artificial respiration and mechanical
respirators. Hypotension and circulatory collapse may be counteracted by use
of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents
such as metaraminol, phenylephrine and norepinephrine. Epinephrine should
not be used. In case of severe extrapyramidal reactions, antiparkinson medication
should be administered, and should be continued for several weeks, and then
withdrawn gradually as extrapyramidal symptoms may emerge. ECG and vital signs
should be monitored especially for signs of Q-T prolongation or dysrhythmias
and monitoring should continue until the ECG is normal. Severe arrhythmias
should be treated with appropriate anti-arrhythmic measures.
Haldol Decanoate Dosage and Administration
Haldol Decanoate 50 and Haldol Decanoate 100 should
be administered by deep intramuscular injection. A 21 gauge needle is recommended.
The maximum volume per injection site should not exceed 3 mL. DO NOT ADMINISTER
INTRAVENOUSLY.
Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit.
HALDOL
Decanoate 50 and Haldol Decanoate 100 are intended for use in schizophrenic
patients who require prolonged parenteral antipsychotic therapy. These patients
should be previously stabilized on antipsychotic medication before considering
a conversion to haloperidol decanoate. Furthermore, it is recommended that
patients being considered for haloperidol decanoate therapy have been treated
with, and tolerate well, short-acting HALDOL (haloperidol) in order to reduce
the possibility of an unexpected adverse sensitivity to haloperidol. Close
clinical supervision is required during the initial period of dose adjustment
in order to minimize the risk of overdosage or reappearance of psychotic symptoms
before the next injection. During dose adjustment or episodes of exacerbation
of symptoms of schizophrenia, haloperidol decanoate therapy can be supplemented
with short-acting forms of haloperidol.
The dose
of Haldol Decanoate 50 or Haldol Decanoate 100 should be expressed in terms
of its haloperidol content. The starting dose of haloperidol decanoate should
be based on the patient"s age, clinical history, physical condition,
and response to previous antipsychotic therapy. The preferred approach to
determining the minimum effective dose is to begin with lower initial doses
and to adjust the dose upward as needed. For patients previously maintained
on low doses of antipsychotics (e.g. up to the equivalent of 10 mg/day oral
haloperidol), it is recommended that the initial dose of haloperidol decanoate
be 10–15 times the previous daily dose in oral haloperidol equivalents;
limited clinical experience suggests that lower initial doses may be adequate.
Initial Therapy
Conversion from oral haloperidol to haloperidol
decanoate can be achieved by using an initial dose of haloperidol decanoate
that is 10 to 20 times the previous daily dose in oral haloperidol equivalents.
In patients who are elderly, debilitated, or stable on low
doses of oral haloperidol (e.g. up to the equivalent of 10 mg/day oral haloperidol),
a range of 10 to 15 times the previous daily dose in oral haloperidol equivalents
is appropriate for initial conversion.
In patients
previously maintained on higher doses of antipsychotics for whom a low dose
approach risks recurrence of psychiatric decompensation and in patients whose
long-term use of haloperidol has resulted in a tolerance to the drug, 20 times
the previous daily dose in oral haloperidol equivalents should be considered
for initial conversion, with downward titration on succeeding injections.
The initial dose of haloperidol decanoate should not exceed
100 mg regardless of previous antipsychotic dose requirements. If, therefore,
conversion requires more than 100 mg of haloperidol decanoate as an initial
dose, that dose should be administered in two injections, i.e. a maximum of
100 mg initially followed by the balance in 3 to 7 days.
Maintenance Therapy
The maintenance dosage of haloperidol decanoate
must be individualized with titration upward or downward based on therapeutic
response. The usual maintenance range is 10 to 15 times the previous daily
dose in oral haloperidol equivalents dependent on the clinical response of
the patient.
Haldol Decanoate
Dosing Recommendations
| Patients |
Monthly
1st Month |
Maintenance |
Stabilized on low daily oral doses
(up to 10 mg/day)
|
10–15 × Daily Oral Dose |
10–15 × Previous Daily Oral Dose
|
| Elderly or Debilitated |
|
|
| High Dose |
20 × Daily Oral Dose |
10–15 × Previous Daily Oral Dose |
| Risk of relapse |
|
|
| Tolerant to oral haloperidol |
|
|
Close clinical supervision is required during
initiation and stabilization of haloperidol decanoate therapy. Haloperidol
decanoate is usually administered monthly or every 4 weeks. However, variation
in patient response may dictate a need for adjustment of the dosing interval
as well as the dose (See CLINICAL
PHARMACOLOGY).
Clinical experience
with haloperidol decanoate at doses greater than 450 mg per month has been
limited.
How is Haldol Decanoate Supplied
HALDOL® (haloperidol) Decanoate 50
for IM injection, 50 mg haloperidol as 70.5 mg per mL haloperidol decanoate—NDC
0045-0253, 10 × 1 mL ampuls and 3 × 1 mL ampuls.
HALDOL® (haloperidol) Decanoate 100 for IM injection,
100 mg haloperidol as 141.04 mg per mL haloperidol decanoate—NDC 0045-0254,
5 × 1 mL ampuls.
Store at controlled room
temperature (15°–30° C, 59°–86° F). Do not
refrigerate or freeze.
Protect from light.
Manufactured by:
Janssen
Pharmaceutica N.V.
Beerse, Belgium
Distributed by:
Ortho-McNeil
Pharmaceutical, Inc.
Raritan, NJ 08869
(ORTHO-McNEIL LOGO)
May 2007
©OMP
2005
| Haldol Decanoate (Haloperidol Decanoate) |
|
|
|
|
| Haldol Decanoate (Haloperidol Decanoate) |
|
|
|
|
Revised: 05/2007
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