HALOPERIDOL solution, concentrate

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Atlantic Biologicals Corps

INN (International Nazwa):

HALOPERIDOL

Skład:

HALOPERIDOL 2 mg in 1 mL

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Product: 17856-0581 NDC: 17856-0581-5 2.5 mL in a SYRINGE, PLASTIC

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HALOPERIDOL- HALOPERIDOL SOLUTION, CONCENTRATE
ATLANTIC BIOLOGICALS CORPS
----------
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-hydroxy-piperidino]-4'-fluorobutyrophenone
and it has the following
structural formula:
Haloperidol oral solution USP (concentrate) contains 2 mg per mL
haloperidol (as the lactate).
INACTIVE INGREDIENTS: Lactic acid, methylparaben, propylparaben,
propylene glycol, purified water, and
sodium hydroxide to adjust pH.
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
manifestat