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:

Teva Parenteral Medicines, Inc.

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: - 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, Neurolog

Rezumat produs:

Haloperidol Decanoate Injection is available as follows. 0703-7121-03 50 mg/mL 10 × 1 mL Single Dose vial 0703-7131-03 100 mg/mL 10 × 1 mL Single Dose vial 0703-7123-01 250 mg/5 mL (50 mg/mL) 5 mL Multiple Dose vial 0703-7133-01 500 mg/5 mL (100 mg/mL) 5 mL Multiple Dose vial 1 mL single dose vials are packaged 10 vials per shelf pack. 5 mL multiple dose vials are packaged in single unit cartons. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from light. Retain in carton until contents are used. Keep out of reach of children. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. I 11/2020

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

HALOPERIDOL DECANOATE- HALOPERIDOL DECANOATE INJECTION
TEVA PARENTERAL MEDICINES, INC.
----------
HALOPERIDOL DECANOATE INJECTION
RX ONLY
FOR INTRAMUSCULAR INJECTION 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, USP is the decanoate ester of the
butyrophenone, 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:
C
H
ClFNO M.W. 530.11
Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL),
but is soluble in
most organic solvents.
Haloperidol Decanoate Injection is a clear colorless to light pink or
light yellow viscous
liquid.
Each mL of Haloperi