INDICATIONS
HALDOL Decanoate 50 and HALDOL Decanoate 100 are long-acting
parenteral antipsychotic drugs intended for use in the
management of patients requiring prolonged parenteral
antipsychotic therapy (e. g., patients with chronic schizophrenia).
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 chronic
psychotic 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 psychotic symptoms, 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)
Elderly or Debilitated |
10 - 15 x
Daily
Oral Dose |
10 -15 x
Previous
Daily Oral Dose |
High dose
Risk of relapse
Tolerant to oral
HALDOL ® |
20 x Daily
Oral Dose |
10 -15 x
Previous
Daily Oral Dose |
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 SUPPLIED
HALDOL® (haloperidol) Decanoate 50 for IM injection,
50 mg haloperidol as 70.5 mg per mL haloperidol decanoate
- NDC 0045-0253, 10 x 1 mL ampuls, 3 x 1 mL ampuls and
5 mL multiple dose vials. HALDOL® (haloperidol) Decanoate
100 for IM injection, 100 mg haloperidol as 141.04 mg
per mL haloperidol decanoate - NDC 0045-0254, 5 x 1 mL
ampuls and 5 mL multiple dose vials.
Store at controlled room temperature (15°-30° C,
59°-86° F). Do not refrigerate or freeze. Protect
from light.
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