HALOPERIDOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

HALOPERIDOL

Composition:

HALOPERIDOL 5 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 drug or have Parkinson’s disease.

Product summary:

Haloperidol Tablets USP, 0.5 mg are white to off white coloured, round, flat faced, bevel edged, uncoated tablets debossed with "15"' and "11" on either side of partial score line and plain on other side and are supplied as follows: NDC 68382-407-01 in bottles of 100 tablets NDC 68382-407-10 in bottles of 1,000 tablets NDC 68382-407-77 in carton of 100 tablets (10 x 10 unit-dose) Haloperidol Tablets USP, 1 mg are pale yellow to yellow coloured, round, flat faced, bevel edged, uncoated tablets debossed with "15" and "12" on either side of partial score line and plain on other side and are supplied as follows: NDC 68382-408-01 in bottles of 100 tablets NDC 68382-408-10 in bottles of 1,000 tablets NDC 68382-408-77 in carton of 100 tablets (10 x 10 unit-dose) Haloperidol Tablets USP, 2 mg are light pink coloured, round, flat faced, bevel edged, uncoated tablets debossed with "15" and "13" on either side of partial score line and plain on other side and are supplied as follows: NDC 68382-409-01 in bottles of 100 tablets NDC 68382-409-10 in bottles of 1,000 tablets NDC 68382-409-77 in carton of 100 tablets (10 x 10 unit-dose) Haloperidol Tablets USP, 5 mg are green, capsule-shaped, flat-faced, beveled-edge tablets debossed with the logo of 'ZC', '07' and partial bisect, on one side and plain on the other side and are supplied as follows: NDC 68382-079-01 in bottles of 100 tablets NDC 68382-079-10 in bottles of 1,000 tablets Haloperidol Tablets USP, 10 mg are light green, capsule-shaped, flat-faced, beveled-edge tablets debossed with the logo of 'ZC', '08' and partial bisect, on one side and plain on the other side and are supplied as follows: NDC 68382-080-06 in bottles of 30 tablets NDC 68382-080-01 in bottles of 100 tablets NDC 68382-080-10 in bottles of 1,000 tablets Haloperidol Tablets USP, 20 mg are coral, capsule-shaped, flat-faced, beveled-edge tablets debossed with the logo of 'ZC', '09' and bisect on one side and plain on the other side and are supplied as follows: NDC 68382-081-06 in bottles of 30 tablets NDC 68382-081-01 in bottles of 100 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOPERIDOL- HALOPERIDOL TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
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 haloperidol tablet, USP intended for oral administration contains
haloperidol, USP
0.5 mg or 1 mg or 2 mg or 5 mg or 10 mg or 20 mg. In addition each 0.5
mg, 1 mg, 2
mg tablet contains the following inactive ingredients: colloidal
silicon dioxide, magnesium
stearate, microcrystalline cellulose, pregelatinized starch (maize)
and each 5 mg, 10 mg,
20 mg tablet contains the following inactive ingredients: calcium
stearate, dibasic calcium
phosphate dihydrate, povido