HALOPERIDOL tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Medzinárodný Name):

HALOPERIDOL

Zloženie:

HALOPERIDOL 0.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets 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 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 should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any caus

Prehľad produktov:

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 orange round tablets debossed with MYLAN over 351 on one side of the tablet and scored on the other side. They are available as follows: NDC 0615-2594-39 blistercards of 30 tablets The 1 mg tablets are orange round tablets debossed with MYLAN over 257 on one side of the tablet and scored on the other side. They are available as follows: NDC 0615-2595-39 blistercards of 30 tablets The 2 mg tablets are orange round tablets debossed with MYLAN over 214 on one side of the tablet and scored on the other side. They are available as follows: NDC 0615-2596-39 blistercards of 30 tablets The 5 mg tablets are orange round tablets debossed with MYLAN over 327 on one side of the tablet and scored on the other side. They are available as follows: NDC 0615-2597-39 blistercards of 30 tablets The 10 mg tablets are light green round tablets debossed with MYLAN over 334 on one side of the tablet and scored on the other side. The 20 mg tablets are light blue round tablets debossed with MYLAN over 335 on one side of the tablet and scored on the other side. 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED DECEMBER 2011 HALO:R21

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

HALOPERIDOL- HALOPERIDOL TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HALOPERIDOL TABLET
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: colloidal silicon dioxide,
FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline
cellulose, pregelatinized
starch and sodium lauryl sulfate. In addition, the 10 mg and 20 mg
tablets also contain FD&C Blue No. 1
Aluminum Lake.
CLINICAL PHARMACOLOG