UROXATRAL- alfuzosin hydrochloride tablet, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Alfuzosin Hydrochloride (UNII: 75046A1XTN) (Alfuzosin - UNII:90347YTW5F)

Disponível em:

Stat Rx USA

DCI (Denominação Comum Internacional):

Alfuzosin Hydrochloride

Composição:

Alfuzosin Hydrochloride 10 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is not indicated for the treatment of hypertension. The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of Uroxatral is 50% lower under fasting conditions. Therefore, Uroxatral should be taken immediately after the same meal each day. The tablets should not be chewed or crushed. UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10. UROXATRAL is 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 Clinical Pharmacology (12.3)]. UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased. [see

Resumo do produto:

UROXATRAL is supplied as follows: UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep UROXATRAL out of reach of children.

Status de autorização:

New Drug Application

Características técnicas

UROXATRAL - ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE
STAT RX USA
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UROXATRAL (ALFUZOSIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE
1 INDICATIONS AND USAGE
UROXATRAL is indicated for the treatment of signs and symptoms of
benign prostatic hyperplasia.
UROXATRAL is not indicated for the treatment of hypertension.
2 DOSAGE AND ADMINISTRATION
The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl)
extended-release tablet once
daily. The extent of absorption of Uroxatral is 50% lower under
fasting conditions. Therefore,
Uroxatral should be taken immediately after the same meal each day.
The tablets should not be chewed
or crushed.
3 DOSAGE FORMS AND STRENGTHS
UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available
as a round, three-layer tablet:
one white layer between two yellow layers, debossed with X10.
4 CONTRAINDICATIONS
UROXATRAL is 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_
_Clinical Pharmacology (12.3)]._
UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors
such as ketoconazole,
itraconazole, and ritonavir, since alfuzosin blood levels are
increased. _[see Clinical Pharmacology_
_(12.3)]_.
UROXATRAL is contraindicated in patients known to be hypersensitive to
alfuzosin hydrochloride or
any component of UROXATRAL tablets.
5 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 UROXATRAL. As with other alpha-blockers,
there is a potential for
syncope. Patients should be warned of the possible occurrence of such
events and should avoid
situations where injury could result should syncope occur. There may
be an increased risk of
hypotension/postural hypotension and syncope when taking UROXATRAL
concomitantly with anti-
hypertensive medication and nitrates. Care should be taken when
UROXATRAL is administered to
patie