ALFUZOSIN HYDROCHLORIDE tablet, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F)

Доступно од:

DirectRX

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tabletsare not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. Alfuzosin hydrochloride extended-release tabletsare contraindicated for use: in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydrochlorid

Резиме производа:

Alfuzosin hydrochloride extended-release tablets 10 mg are available as white to off white, round shaped, biconvex, uncoated tablet debossed with ‘956’ on one side and plain on other side. Alfuzosin hydrochloride extended-release tablets are supplied as follows: Bottles of 30’s with Child Resistant Cap…....................NDC 47335-956-83 Bottles of 90’s with Child Resistant Cap…....................NDC 47335-956-81 Bottles of 100’s with Child Resistant Cap…..................NDC 47335-956-88 Bottles of 100’s with Non Child Resistant Cap…..........NDC 47335-956-08 Bottles of 1,000’s with Non Child Resistant Cap…........NDC 47335-956-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep alfuzosin hydrochloride extended-release tablets out of reach of children. Dispense in a tight, light-resistant container as defined in the USP.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ALFUZOSIN HYDROCHLORIDE- ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
DIRECTRX
----------
ALFUZOSIN HYDROCHLORIDE
INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablets are indicated for the
treatment of signs and symptoms
of benign prostatic hyperplasia.1.1 Important Limitations of Use
Alfuzosin hydrochloride extended-release tabletsare not indicated for
the treatment of hypertension.
Alfuzosin hydrochloride extended-release tablets are not indicated for
use in the pediatric population.
DOSAGE AND ADMINISTRATION
The recommended dosage is one 10 mg alfuzosin hydrochloride
extended-release tablet once daily.
The extent of absorption of alfuzosin is 50% lower under fasting
conditions. Therefore, alfuzosin
hydrochloride extended-release tablets should be taken with food and
with the same meal each day. The
tablets should not be chewed or crushed.
DOSAGE FORMS AND STRENGTHS
Alfuzosin hydrochloride extended-release tablets 10 mg are available
as white to off-white, round
shaped, biconvex, uncoated tablet debossed with ‘956’ on one side
and plain on other side.
CONTRAINDICATIONS
Alfuzosin hydrochloride extended-release tabletsare contraindicated
for use:
in patients with moderate or severe hepatic impairment (Childs-Pugh
categories B and C), since
alfuzosin blood levels are increased in these patients [see Use in
Specific Populations (8.7) and Clinical
Pharmacology (12.3)].
with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and
ritonavir, since alfuzosin blood
levels are increased [see Drug Interactions (7.1) and Clinical
Pharmacology (12.3)].
in patients with known hypersensitivity, such as urticaria and
angioedema, to alfuzosin hydrochloride or
any component of alfuzosin hydrochloride extended-release tablets [see
Adverse Reactions (6.2)].
WARNINGS AND PRECAUTIONS
5.1 Postural Hypotension
Postural hypotension with or without symptoms (e.g., dizziness) may
develop within a few hours
following administration of alfuzosin hydrochloride extended-release
tablets. As with other alpha