HALOPERIDOL DECANOATE injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Zydus Pharmaceuticals USA Inc.

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 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

Ringkasan produk:

Haloperidol decanoate injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate is supplied as: *as haloperidol. Haloperidol decanoate injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate is supplied as: *as haloperidol. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. PROTECT FROM LIGHT. Keep out of reach of children. Retain in carton until contents are used. Please address medical inquiries to [e-mail] or Tel.: [phone]. Manufactured by: Zydus Lifesciences Ltd. Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 12/22

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

HALOPERIDOL DECANOATE- HALOPERIDOL DECANOATE INJECTION
ZYDUS PHARMACEUTICALS USA INC.
----------
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, 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:
Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL),
but is soluble in
most organic solvents.
Each mL of Haloperidol decanoate injection, 50 mg/mL for IM injection
contains 50 mg
haloperidol (present as haloperidol decanoate, USP 70.5