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:

REMEDYREPACK 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

Rezumat produs:

Haloperidol decanoate injection, 100 mg/mL contains 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate, USP in: NDC: 70518-1809-00 NDC: 70518-1809-01 PACKAGING: 5 in 1 CARTON PACKAGING: 1 mL in 1 VIAL, TYPE 0 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

HALOPERIDOL DECANOATE- HALOPERIDOL DECANOATE INJECTION
REMEDYREPACK INC.
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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 clear, sligh