HALOPERIDOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

HALOPERIDOL

Composition:

HALOPERIDOL 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is 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 should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. Haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this d

Product summary:

Haloperidol tablets, USP for oral administration are available as: 1 mg: round, yellow, partial scored tablets, debossed GG on one side and debossed 123 on the reverse side and supplied as: NDC 0904-5923-61 unit dose box of 100 2 mg: round, pink, partial scored tablets, debossed GG 124 on one side and plain on the reverse side and supplied as: NDC 0904-5924-61 unit dose box of 100 5 mg: round, green, partial scored tablets, debossed GG 125 on one side and plain on the reverse side and supplied as: NDC 0904-5925-61 unit dose box of 100 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOPERIDOL- HALOPERIDOL TABLET
MAJOR PHARMACEUTICALS
----------
HALOPERIDOL TABLETS, USP
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-chlorophenyl)-4-hydroxypiperidino]-4’-fluorobutyrophenone.
It has the following structural
formula.
Each tablet for oral administration contains haloperidol, USP, as 0.5
mg, 1 mg, 2 mg, 5 mg, 10 mg or 20
mg. Inactive ingredients for all strengths include lactose
(monohydrate), magnesium stearate, povidone
and starch (corn). The 1 MG also contains D & C Yellow #10 Aluminum
Lake and FD & C Yellow #6
Aluminum Lake; 2 MG: D & C Red Lake Blend (D & C Red #27 Aluminum Lake
and D & C Red #30
Aluminum Lake); 5 MG: D & C Yellow #10 Aluminum Lake and FD & C Blue
#1 Aluminum Lake; 10