Prescription Drug Name:

Fexofenadine Hydrochloride Tablets

ID:

cbebe8fd-aaea-4564-8e6d-0d35fcda8ac1

Code:

34391-3

DESCRIPTION


id: 6a878725-75a7-441b-abf0-50c6d751e807
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Fexofenadine hydrochloride is a histamine H1-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 C32H39NO4•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.

CONTRAINDICATIONS


id: b9a5bfdc-7f06-4de3-b27a-d1b83294d0f5
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Fexofenadine Hydrochloride
Tablets are contraindicated in patients with known hypersensitivity
to any of its ingredients.

OVERDOSAGE


id: c1d198a7-e37e-4582-98fa-4915c937570c
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Reports of fexofenadine
hydrochloride overdose have been infrequent and contain limited information.
However, dizziness, drowsiness, and dry mouth have been reported.
Single doses of fexofenadine hydrochloride up to 800 mg (6 healthy
volunteers at this dose level), and doses up to 690 mg twice daily
for 1 month (3 healthy volunteers at this dose level) or 240 mg once
daily for 1 year (234 healthy volunteers at this dose level) were
administered without the development of clinically significant adverse
events as compared to placebo. In the event of overdose, consider standard measures to remove any
unabsorbed drug. Symptomatic and supportive treatment is recommended.
Following administration of terfenadine, hemodialysis did not effectively
remove fexofenadine, the major active metabolite of terfenadine, from
blood (up to 1.7% removed). No deaths occurred at oral doses of fexofenadine hydrochloride up
to 5000 mg/kg in mice (110 times the maximum recommended human daily
oral dose in adults and 200 times the maximum recommended human daily
oral dose in children based on mg/m2) and up to 5000 mg/kg
in rats (230 times the maximum recommended human daily oral dose in
adults and 400 times the maximum recommended human daily oral dose
in children based on mg/m2). Additionally, no clinical
signs of toxicity or gross pathological findings were observed. In
dogs, no evidence of toxicity was observed at oral doses up to 2000
mg/kg (300 times the maximum recommended human daily oral dose in
adults and 530 times the maximum recommended human daily oral dose
in children based on mg/m2).

HOW SUPPLIED


id: 1dd5eefd-68be-4d3f-b973-80ef98637020
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL


id: eea9c813-8b88-4d1f-8778-dd1c9915be1e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Fexofenadine Hydrochloride Tablets, 60mg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL


id: dc1948b7-2b8c-4aa7-bd6f-c9c998d4f60e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Fexofenadine Hydrochloride Tablets, 180mg