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:

Fresenius Kabi USA, LLC

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Haloperidol Decanoate Injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. Since the pharmacologic and clinical actions of haloperidol decanoate injection 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: - Severe toxic central nervous system depression or comatose states from any cause. - Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see WARNINGS, Hypersensitivity Reactions and ADVERSE REACTIONS). - Parkinson's disease (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies). - Dementia with Lewy bodies (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies).

Rezumat produs:

Haloperidol decanoate injection is supplied as: *as haloperidol Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from light. Keep out of reach of children. Keep in carton until empty. PREMERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured by: Fresenius Kabi Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451603A Revised: September 2021 PREMIER ProRx®

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

HALOPERIDOL DECANOATE - HALOPERIDOL DECANOATE INJECTION
FRESENIUS KABI USA, LLC
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HALOPERIDOL DECANOATE
Injection
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
INJECTION 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. It has a
markedly extended duration of effect. It is available as a
colorless/pink to yellow amber
solution in sesame oil in sterile form for intramuscular (IM)
injection. The structural
formula of haloperidol decanoate,
4-(4-chlorophenyl)-l-[4-(4-fluorophenyl)-4-oxobutyl]-4
piperidinyl decanoate, is:
C
H CIFNO M.W. 530.12
Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but
is soluble in most
31
41
3
organic solvents.
Each mL of haloperidol decanoate injection, 50 mg/mL, contains 50 mg
haloperidol
(