HALOPERIDOL- haloperidol lactate injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

HALOPERIDOL LACTATE (UNII: 6387S86PK3) (HALOPERIDOL - UNII:J6292F8L3D)

Pieejams no:

Cardinal Health

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Haloperidol Injection, USP is indicated for use in the treatment of schizophrenia. Haloperidol Injection, USP is indicated for the control of tics and vocal utterances of Tourette's Disorder. Haloperidol Injection is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.

Produktu pārskats:

Haloperidol Injection, USP, equivalent to 5 mg/mL haloperidol (as the lactate), is supplied as follows: Overbagged with 5 vials per bag, NDC 55154-7478-5 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light . Do not freeze . To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: West-Ward Pharmaceuticals Eatontown, NJ 07724 USA Distributed by: Cardinal Health Dublin, OH 43017 L55235350419 Revised June 2018 PIN425-WES/7

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

HALOPERIDOL- HALOPERIDOL LACTATE INJECTION
CARDINAL HEALTH
----------
HALOPERIDOL INJECTION USP
(FOR IMMEDIATE RELEASE)
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:
M.F. =C
H ClFNO
M.W.=375.86
Haloperidol Injection, USP is available as a sterile parenteral form
for intramuscular injection. Each mL
of Haloperidol Injection, USP contains 5 mg haloperidol (as the
lactate) with 1.8 mg methylparaben and
0.2 mg propylparaben per mL, and lactic acid for pH adjustment between
3.0 to 3.8.
CLINICAL PHARMACOLOGY
The precise mechanism of action has not been clearly established.
INDICATIONS AND