United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - 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 alfuzosin hydrochloride 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 s

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - 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

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride extended-release tablets are 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 tablets are contraindicated for use: alfuzosin hydrochloride extended-release tablets are not indicated for use in women, and there are no studies of alfuzosin in pregnant women. alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on auc of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (mrhd) of 10 mg. in rabbits administered up to 3 times the mrhd (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed. gestation was slightly prolonged in rats at exposure levels (bas

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride extended-release tablets are 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 tablets are contraindicated for use: alfuzosin hydrochloride extended-release tablets are not indicated for use in women, and there are no studies of alfuzosin in pregnant women. alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on auc of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (mrhd) of 10 mg. in rabbits administered up to 3 times the mrhd (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed. gestation was slightly prolonged in rats at exposure levels (bas

United States - English - NLM (National Library of Medicine)

cipla usa inc. - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride tablets usp, are 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 alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets [see adverse reactions (6.2) ]. risk summary alfuzosin hydrochloride extended-release tablets is not indicated for u

United States - English - NLM (National Library of Medicine)

wockhardt usa llc. - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride extended-release tablets, usp are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride extended-release tablets, usp are not indicated for the treatment of hypertension. alfuzosin hydrochloride extended-release tablets, usp are not indicated for use in the pediatric population. alfuzosin hydrochloride extended-release tablets are 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[seeuse in specific populations (8.7) andclinical 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 hydroch

United States - English - NLM (National Library of Medicine)

apotex corp. - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride extended-release tablets, usp are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride extended-release tablets, usp are not indicated for the treatment of hypertension. alfuzosin hydrochloride extended-release tablets, usp are not indicated for use in the pediatric population. alfuzosin hydrochloride extended-release tablets are 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) ].  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

United States - English - NLM (National Library of Medicine)

torrent pharmaceuticals limited - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride extended-release tablets, usp are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride extended-release tablets, usp are not indicated for the treatment of hypertension. alfuzosin hydrochloride extended-release tablets, usp are not indicated for use in the pediatric population. alfuzosin hydrochloride extended-release tablets are 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 angioedem

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride extended-release tablets are 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 tablets are 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. [s ee 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

United States - English - NLM (National Library of Medicine)

liberty pharmaceuticals, inc. - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - 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 alfuzosin hydrochloride 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 s