FLUPHENAZINE DECANOATE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

FLUPHENAZINE DECANOATE (UNII: FMU62K1L3C) (FLUPHENAZINE - UNII:S79426A41Z)

זמין מ:

TYA Pharmaceuticals

INN (שם בינלאומי):

FLUPHENAZINE DECANOATE

הרכב:

FLUPHENAZINE DECANOATE 25 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation. Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage. Phenothiazine compounds should not be used in patients receiving large doses of hypnotics. Fluphenazine Decanoate Injection is contraindicated in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate. Fluphenazine Decanoate Injection is not intended for use in children under 12 years of age. Fluphenazine Decanoate Injection is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

leaflet_short:

NDC:64725-0272-1 in a CARTON of 1 INJECTION, SOLUTIONS

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

FLUPHENAZINE DECANOATE- FLUPHENAZINE DECANOATE INJECTION, SOLUTION
TYA PHARMACEUTICALS
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FLUPHENAZINE DECANOATE INJECTION, USP
DESCRIPTION
Fluphenazine decanoate is the decanoate ester of a trifluoromethyl
phenothiazine derivative. It is a
highly potent behavior modifier with a markedly extended duration of
effect and has the following
structural formula:
Fluphenazine Decanoate Injection, USP is available as a clear, pale
yellow solution for intramuscular
(IM) or subcutaneous (SC) use providing 25 mg fluphenazine decanoate
per mL in a sesame oil vehicle
with 12 mg benzyl alcohol as a preservative.
CLINICAL PHARMACOLOGY
The basic effects of fluphenazine decanoate appear to be no different
from those of fluphenazine
hydrochloride, with the exception of duration of action. The
esterification of fluphenazine markedly
prolongs the drug’s duration of effect without unduly attenuating
its beneficial action.
Fluphenazine decanoate has activity at all levels of the central
nervous system (CNS) as well as on
multiple organ systems. The mechanism whereby its therapeutic action
is exerted is unknown.
Fluphenazine differs from other phenothiazine derivatives in several
respects: it is more potent on a
milligram basis, it has less potentiating effect on CNS depressants
and anesthetics than do some of the
phenothiazines and appears to be less sedating, and it is less likely
than some of the older
phenothiazines to produce hypotension (nevertheless, appropriate
cautions should be observed, see and
). PRECAUTIONS ADVERSE REACTIONS
INDICATIONS AND USAGE
Fluphenazine Decanoate Injection is a long-acting parenteral
antipsychotic drug intended for use in the
management of patients requiring prolonged parenteral neuroleptic
therapy (e.g., chronic
schizophrenics).
Fluphenazine Decanoate Injection has not been shown effective in the
management of behavioral
complications in patients with mental retardation.
CONTRAINDICATIONS
Phenothiazines are contraindicated in patients with suspected or
established subcortical brain damage.