HALOPERIDOL tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Method Pharmaceuticals, LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP 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, USP 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, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. Haloperidol tablets, USP are 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.

Produktbesonderheiten:

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 white color, round, flat tablets with bevel edge, debossed “150” on one side and “I” on the other side. They are available as follows: NDC 58657-700-01 bottles of 100 tablets NDC 58657-700-10 bottles of 1000 tablets The 1 mg tablets are yellow color, round, flat tablets with bevel edge, debossed “151” on one side and “I” on the other side. They are available as follows: NDC 58657-701-01 bottles of 100 tablets NDC 58657-701-10 bottles of 1000 tablets The 2 mg tablets are white color, round, flat tablets with bevel edge, debossed “152” on one side and “I” on the other side. They are available as follows: NDC 58657-702-01 bottles of 100 tablets NDC 58657-702-10 bottles of 1000 tablets The 5 mg tablets are green color, round, flat tablets with bevel edge, debossed “153” on one side and “I” on the other side. They are available as follows: NDC 58657-703-01 bottles of 100 tablets NDC 58657-703-10 bottles of 1000 tablets The 10 mg tablets are aqua color, round, flat tablets with bevel edge, debossed “154” on one side and “I” on the other side. They are available as follows: NDC 58657-704-01 bottles of 100 tablets NDC 58657-704-10 bottles of 1000 tablets The 20 mg tablets are salmon color, round, flat tablets with bevel edge, debossed “155” on one side and “I” on the other side. They are available as follows: NDC 58657-705-01 bottles of 100 tablets NDC 58657-705-10 bottles of 1000 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 by: Innogenix, LLC. Amityville, NY 11701 Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev. 10/2019

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

HALOPERIDOL- HALOPERIDOL TABLET
METHOD PHARMACEUTICALS, LLC
----------
HALOPERIDOL TABLETS, USP
HALOPERIDOL TABLETS, USP
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 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: magnesium stearate, microcrystalline cellulose,
pregelatinized starch. In
21
23
2
addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10
Aluminum Lake.
The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20
mg t