UROXATRAL- alfuzosin hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Stat Rx USA

INN (International Name):

Alfuzosin Hydrochloride

Composition:

Alfuzosin Hydrochloride 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

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