HYDROXYZINE HYDROCHLORIDE tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)

Commercializzato da:

McKesson Contract Packaging

INN (Nome Internazionale):

HYDROXYZINE HYDROCHLORIDE

Composizione:

HYDROXYZINE HYDROCHLORIDE 25 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
MCKESSON CONTRACT PACKAGING
----------
HYDROXYZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride has the chemical name of
2-[2-[4-(_p_-Chloro- -phenylbenzyl)-1-piperazinyl]
ethoxy] ethanol dihydrochloride.
Hydroxyzine hydrochloride occurs as a white, odorless powder which is
very soluble in water.
Each tablet for oral administration contains 10 mg, 25 mg or 50 mg
hydroxyzine hydrochloride. Inactive
ingredients include carnauba wax, colloidal silicon dioxide,
crospovidone, lactose monohydrate,
macrogol/polyethylene glycol 3350, magnesium stearate,
microcrystalline cellulose, polyvinyl alcohol
- part. hydrolyzed, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
Hydroxyzine hydrochloride is unrelated chemically to the
phenothiazines, reserpine, meprobamate or
the benzodiazepines. Hydroxyzine is not a cortical depressant, but its
action may be due to a suppression
of activity in certain key regions of the subcortical area of the
central nervous system.
Primary skeletal muscle relaxation has been demonstrated
experimentally. Bronchodilator activity, and
antihistaminic and analgesic effects have been demonstrated
experimentally and confirmed clinically. An
antiemetic effect, both by the apomorphine test and the veriloid test,
has been demonstrated.
Pharmacological and clinical studies indicate that hydroxyzine in
therapeutic dosage does not increase
gastric secretion or acidity and in most cases has mild antisecretory
activity.
Hydroxyzine is rapidly absorbed from the gastrointestinal tract and
hydroxyzine’s clinical effects are
usually noted within 15 to 30 minutes after oral administration.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with
psychoneurosis and as an adjunct in
organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such
as chronic urticaria and atopic and
contact dermatoses and in histamine-mediated pruritu