HALOPERIDOL DECANOATE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)

Disponibil de la:

Mylan Institutional LLC

INN (nume internaţional):

HALOPERIDOL DECANOATE

Compoziție:

HALOPERIDOL 50 mg in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. Since the pharmacologic and clinical actions of haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are attributed to haloperidol as the active medication, Contraindications, Warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. Haloperidol is contraindicated in patients with:

Rezumat produs:

Haloperidol decanoate injection, 50 mg/mL contains 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate, USP in: 5 mL multiple dose vials (NDC 67457-382-00) packaged in cartons of five - NDC 67457-382-58 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten - NDC 67457-410-13 Haloperidol decanoate injection, 100 mg/mL contains 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate, USP in: 5 mL multiple dose vials (NDC 67457-381-00) packaged in cartons of five - NDC 67457-381-58 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five - NDC 67457-409-13 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Do not refrigerate or freeze. Protect from light. Retain vial in carton until contents are used.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

HALOPERIDOL DECANOATE- HALOPERIDOL DECANOATE INJECTION
MYLAN INSTITUTIONAL LLC
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HALOPERIDOL DECANOATE INJECTION, 50 MG/ML
HALOPERIDOL DECANOATE INJECTION, 100 MG/ML
FOR INTRAMUSCULAR INJECTION ONLY
RX ONLY
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED
TRIALS (MODAL DURATION OF
10 WEEKS), LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS,
REVEALED A RISK OF DEATH IN
DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF DEATH IN
PLACEBO-TREATED
PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE
RATE OF DEATH IN DRUG-
TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN
THE PLACEBO GROUP.
ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED
TO BE EITHER
CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS
(E.G., PNEUMONIA) IN NATURE.
OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC
DRUGS, TREATMENT WITH
CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO
WHICH THE FINDINGS
OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE ATTRIBUTED TO
THE ANTIPSYCHOTIC DRUG
AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR.
HALOPERIDOL DECANOATE IS
NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (SEE
WARNINGS).
DESCRIPTION
Haloperidol decanoate is the decanoate ester of the butyrophenone,
haloperidol decanoate injection. 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, USP is a white or almost white powder. It very
soluble in alcohol, in methanol
and in methylene chloride, practically insoluble in water.
Haloperidol decanoate injection is clea