HALOPERIDOL tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Mylan Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

HALOPERIDOL

Koostumus:

HALOPERIDOL 0.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any caus

Tuoteyhteenveto:

Haloperidol Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP. The 0.5 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 351 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0351-01 bottles of 100 tablets NDC 0378-0351-10 bottles of 1000 tablets The 1 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 257 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0257-01 bottles of 100 tablets NDC 0378-0257-10 bottles of 1000 tablets The 2 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 214 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0214-01 bottles of 100 tablets NDC 0378-0214-10 bottles of 1000 tablets The 5 mg tablets are orange, round, flat-faced, scored tablets debossed with MYLAN over 327 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0327-01 bottles of 100 tablets NDC 0378-0327-10 bottles of 1000 tablets The 10 mg tablets are light green, round, flat-faced, scored tablets debossed with MYLAN over 334 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0334-01 bottles of 100 tablets The 20 mg tablets are light blue, round, flat-faced, scored tablets debossed with MYLAN over 335 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0335-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75076829 Revised: 7/2020 MXI:HALO:R1

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

HALOPERIDOL- HALOPERIDOL TABLET
MYLAN PHARMACEUTICALS INC.
----------
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 (corn) and
sodium lauryl
sulfate. In addition, the 10 mg and 20 mg tablets also contain FD&C
Blue No. 1
Aluminum Lake.
21 23
2
CLINICAL PHARMACOLOGY
The precise mechani