XYZAL levocetirizine dihydrochloride tablet film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3) (LEVOCARNITINE - UNII:0G389FZZ9M)

Предлага се от:

Lake Erie Medical DBA Quality Care Products LLC

INN (Международно Name):

LEVOCARNITINE HYDROCHLORIDE

Композиция:

LEVOCARNITINE HYDROCHLORIDE 5 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

XYZAL - LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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XYZAL 5 MG
11 DESCRIPTION
Levocetirizine dihydrochloride, the active component of XYZAL tablets
and oral solution, is an orally
active H - receptor antagonist. The chemical name is
(R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-
piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine
dihydrochloride is the R enantiomer of
cetirizine hydrochloride, a racemic compound with antihistaminic
properties. The empirical formula of
levocetirizine dihydrochloride is C
H ClN O •2HCl.
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1 INDICATIONS AND USAGE
1.1 Allergic Rhinitis
XYZAL is indicated for the relief of symptoms associated with allergic
rhinitis (seasonal and
perennial) in adults and children 6 years of age and older.
1.2 Chronic Idiopathic Urticaria
XYZAL is indicated for the treatment of the uncomplicated skin
manifestations of chronic idiopathic
urticaria in adults and children 6 years of age and older.
4 CONTRAINDICATIONSThe use of XYZAL is contraindicated in:
Patients with known hypersensitivity to levocetirizine or any of the
ingredients of XYZAL, or to
cetirizine. Observed reactions range from urticaria to anaphylaxis
[see _Adverse Reactions (6.2)_].
6 ADVERSE REACTIONS
Use of XYZAL has been associated with somnolence, fatigue, and
asthenia [see _Warnings and_
_Precautions (5.1)_].
6.1 Clinical Trials Experience
The safety data described below reflect exposure to XYZAL in 2549
patients with seasonal or
perennial allergic rhinitis and chronic idiopathic urticaria in 12
controlled clinical trials of 1 week to 6
months duration. The short-term (exposure up to 6 weeks) safety data
for adults and adolescents are
based upon eight clinical trials in which 1896 patients (825 males and
1071 females aged 12 years and
older) were treated with XYZAL 2.5, 5, or 10 mg once daily in the
evening. The short-term safety data
from pediatric patients are based upon two clinical trials in which
243 children with seasonal or
peren