ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE- alfuzosin hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Composition:

ALFUZOSIN HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride is not indicated for the treatment of hypertension. Alfuzosin hydrochloride is not indicated for use in the pediatric population. Alfuzosin hydrochloride 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 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 alfuzosinhydrochloride or any component of alfuzosin hydrochloride tablets [see Adverse Reactions (6.2)] Pregnancy Category B. Alfuzosin hydrochloride is not indicated for use in women, and there are no studie

Product summary:

Alfuzosin hydrochloride is supplied as follows: Alfuzosin hydrochloride extended-release tablets 10 mg are available as off white, round, biconvex tablets debossed with ‘IG’ on one side and “302” on other. Alfuzosin hydrochloride is supplied as follows: Package                       NDC Number Bottles of 30                    31722-302-30 Bottles of 100                   31722-302-01 Bottles of 500                   31722-302-05 Store at 20° to 25°C (68° to 77°F) [see USP]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Keep alfuzosin hydrochloride out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE- ALFUZOSIN HYDROCHLORIDE
TABLET
CAMBER PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALFUZOSIN HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALFUZOSIN
HYDROCHLORIDE.
ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Indications and Usage (1.1) 12/2010
Warnings and Precautions, PDE5 inhibitors (5.4) 04/2010
Warnings and Precautions, Priapism (5.7) 12/2010
INDICATIONS AND USAGE
Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated
for the treatment of signs and symptoms of benign
prostatic hyperplasia. (1)
Important Limitations of Use:
Alfuzosin hydrochloride is not indicated for the treatment of
hypertension. (1.1)
Alfuzosin hydrochloride is not indicated for use in the pediatric
population. (1.1, 8.4, 12.3)
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day. (2)
Tablets should not be chewed or crushed (2, 12.3)
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg (3)
CONTRAINDICATIONS
Moderate or severe hepatic impairment (4, 8.7, 12.3)
Co-administration with potent CYP3A4 inhibitors (e.g.ketoconazole,
itraconazole, ritonavir) (4, 5.4, 7.1, 12.3)
Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or
any of the ingredients (4, 6.2)
WARNINGS AND PRECAUTIONS
Postural hypotension/syncope: Care should be taken in patients with
symptomatic hypotension or who have had a
hypotensive response to other medications or are concomitantly treated
with antihypertensive medication or nitrates
(5.1)
Use with caution in patients with severe renal impairment (creatinine
clearance <30 mL/min) (5.2, 8.6, 12.3)
Use with caution in patients with mild hepatic impairment (5.3, 8.7,
12.3)
Should not be used in combination with other alpha adrenergic
antagonists (5.4, 7.2)
Prostate carcinoma should be ruled out prior to treatment (5.5)
Intraoperativ