HALOPERIDOL- haloperidol lactate injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

haloperidol lactate (UNII: 6387S86PK3) (haloperidol - UNII:J6292F8L3D)

Verfügbar ab:

Sagent Pharmaceuticals

INN (Internationale Bezeichnung):

haloperidol lactate

Zusammensetzung:

haloperidol 5 mg in 1 mL

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Haloperidol Injection, USP is indicated for the treatment of patients with schizophrenia. Haloperidol injection 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 ).

Produktbesonderheiten:

Haloperidol Injection, USP (For Immediate Release) 5 mg per mL (as the lactate) is supplied in single-dose vials (preservative-free) and multi-dose vials as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in carton until time of use. *Discard unused portion. Keep out of reach of children. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Canada ©2020 Sagent Pharmaceuticals, Inc. Revised: December 2020 SAGENT Pharmaceuticals ®

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

HALOPERIDOL- HALOPERIDOL LACTATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
HALOPERIDOL INJECTION, USP
(FOR IMMEDIATE RELEASE)
(FOR INTRAMUSCULAR USE)
SAGENT
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 INJECTION IS NOT
APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
(SEE WARNINGS).
DESCRIPTION
Haloperidol is the first of the butyrophenone series of major
antipsychotics. The chemical designation
is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone
and it has the following
structural formula:
Haloperidol Injection, USP is available as a sterile parenteral form
for intramuscular injection in a 1 mL
single-dose vial, each mL containing 5 mg haloperidol (as the lactate)
and lactic acid for pH adjustment
between 3.0 to 3.8.
Haloperidol Injection, USP is also available as a sterile parenteral
form for intramuscular injection in a
10 mL multi-dose vial, each mL containing