HALOPERIDOL solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

HALOPERIDOL LACTATE (UNII: 6387S86PK3) (HALOPERIDOL - UNII:J6292F8L3D)

Disponible depuis:

Lannett Company, Inc.

DCI (Dénomination commune internationale):

HALOPERIDOL LACTATE

Composition:

HALOPERIDOL 2 mg in 1 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Haloperidol Oral Solution is indicated for use in the management of manifestations of psychotic disorders. Haloperidol Oral Solution is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol Oral Solution 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 Oral Solution is contraindicated in severe toxic central nervous system depression or comatose states from any ca

Descriptif du produit:

Haloperidol Oral Solution USP (Concentrate) 2 mg per mL (as the lactate) is colorless, odorless, and tasteless solution. This product is available in 120 mL bottles (NDC 54838-501-40), with dropper graduated at 0.5 mg, and 1 mg, 1.5 mg, 2 mg, 3 mg, 4 mg, and 15 mL bottles (NDC 54838-501-15), with dropper graduated at 0.5 mg, and 1 mg. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from freezing. Protect from light. Dispense in a tight, light-resistant container as described in the USP. Distributed by: Lannett Company, Inc.  Philadelphia, PA 19136 10-1100 Rev. 02/20

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

HALOPERIDOL- HALOPERIDOL SOLUTION
LANNETT COMPANY, INC.
----------
HALOPERIDOL ORAL SOLUTION USP
(CONCENTRATE) 2 MG PER ML
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_-chlorophenyl)-4-hydroxypiperidino]-4′-fluorobutyrophenone
and it
has the following structural formula:
Haloperidol Oral Solution, USP (concentrate) contains 2 mg haloperidol
(as the lactate)
per mL.
Inactive ingredients: propylene glycol, methylparaben, propylparaben,
lactic acid, and
purified water.
CLINICAL PHARMACOLOGY
The precise mechanism of action has not been clearly established.
INDICATIONS AND USAGE
Haloperidol Oral Solution is indicated for use in the management of
manifestations of
psychotic disorders.
Haloperidol Oral