FEXOFENADINE HYDROCHLORIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)

Tilgængelig fra:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Sammensætning:

FEXOFENADINE HYDROCHLORIDE 60 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fexofenadine Hydrochloride Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. Fexofenadine Hydrochloride Tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals. Fexofenadine Hydrochloride Tablets are contraindicated in patients with known hypersensitivity to any of its ingredients.

Produkt oversigt:

Fexofenadine Hydrochloride Tablets 60 mg are available in blisterpacks of 30 (NDC 0615-5620-39). Fexofenadine Hydrochloride Tablets 180 mg are available in blisterpacks of 30 (NDC 0615-5619-39) Fexofenadine Hydrochloride Tablets are coated with a peach colored film coating. Tablets have the following unique identifiers: 30 mg tablets have 03 on one side, 60 mg tablets have 06 on one side, and 180 mg tablets have 018 on one side. Store Fexofenadine Hydrochloride Tablets at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature). Fexofenadine Hydrochloride Tablets should be protected from excessive moisture.

Autorisation status:

New Drug Application

Produktets egenskaber

FEXOFENADINE HYDROCHLORIDE- FEXOFENADINE HYDROCHLORIDE TABLET, FILM
COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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FEXOFENADINE HYDROCHLORIDE TABLETS
DESCRIPTION
Fexofenadine hydrochloride is a histamine H -receptor antagonist with
the chemical name (±)-4-[1
hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α,α-dimethyl
benzeneacetic acid
hydrochloride. It has the following chemical structure
The molecular weight is 538.13 and the empirical formula is C
H NO •HCl.
Fexofenadine hydrochloride is a white to off-white crystalline powder.
It is freely soluble in methanol
and ethanol, slightly soluble in chloroform and water, and insoluble
in hexane. Fexofenadine
hydrochloride is a racemate and exists as a zwitterion in aqueous
media at physiological pH.
Fexofenadine hydrochloride is formulated as a tablet for oral
administration. Each tablet contains 30,
60, or 180 mg fexofenadine hydrochloride (depending on the dosage
strength) and the following
excipients: croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, and pregelatinized
starch. The aqueous tablet film coating is made from hypromellose,
iron oxide blends, polyethylene
glycol, povidone, silicone dioxide, and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Fexofenadine hydrochloride, the major active metabolite of
terfenadine, is an antihistamine with
selective peripheral H -receptor antagonist activity. Both enantiomers
of fexofenadine hydrochloride
displayed approximately equipotent antihistaminic effects.
Fexofenadine hydrochloride inhibited
antigen-induced bronchospasm in sensitized guinea pigs and histamine
release from peritoneal mast
cells in rats. The clinical significance of these findings is unknown.
In laboratory animals, no
anticholinergic or alpha -adrenergic blocking effects were observed.
Moreover, no sedative or other
central nervous system effects were observed. Radiolabeled tissue
distribution studies in rats indicated
that fexofenadine does not cross the blood-brain barrier.
PHARMACOKIN