HALOPERIDOL tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)

Saatavilla:

McKesson Contract Packaging

INN (Kansainvälinen yleisnimi):

HALOPERIDOL

Koostumus:

HALOPERIDOL 5 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

HALOPERIDOL- HALOPERIDOL TABLET
MCKESSON CONTRACT PACKAGING
REFERENCE LABEL SET ID: 405EE4C4-394C-47DF-A6EC-9B4F4E7CA768
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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 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
tranquilizers. The chemical designation is
4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone
and it has the following
structural formula:
C H CLFNO 375.87
Haloperidol is supplied as tablets for oral administration containing
0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or
20 mg of haloperidol, USP and contains the following inactive
ingredients: colloidal silicon dioxide,
FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline
cellulose, pregelatinized
starch and sodium lauryl sulfate. In addition, the 10 mg and 20 mg
tablets also contain FD&C Blue No. 1
Aluminum