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)

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)

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)

exelan pharmaceuticals 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 use

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

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)

wockhardt limited - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hcl extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hcl extended-release tablets are not indicated for the treatment of hypertension. alfuzosin hcl extended-release tablets are not indicated for use in the pediatric population. alfuzosin hcl 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 angioedema, to alfuzosin hydrochloride or any component of  alfuzosin hcl extended-release tablets [see adverse reactions (6.2)] pregnancy category b. alfuzosin hc

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

physicians total care, 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: - 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 drug interactio

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

rising pharma holdings, 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: - 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)] risk summary alfuzosin hydrochloride extended-release tablets are not indicated for use in women. there are no adequate data on the developmental risk associated with use of alfuzosin hydrochloride extended-release tablets in pregnant women. based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at up to 1200 times the mrhd of 10 mg via auc in rats and 3 times in rabbits, via body surface area. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancy is 2 to 4% and 15 to 20%, respectively. data animal data 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 (based on auc of unbound drug) approximately 12 times (greater than 5 mg/kg/day oral maternal dose) the mrhd, but difficulties with parturition were not observed. risk summary alfuzosin hydrochloride extended-release tablets are not indicated for use in women. there are no data on the presence of alfuzosin hydrochloride in human milk, the effect on the breastfed child, or effect on milk production. alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. efficacy of alfuzosin hydrochloride was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years with elevated detrusor leak point pressure (lpp≥40 cm h2 o) of neurologic origin treated with alfuzosin hydrochloride using pediatric formulations. the trial included a 12-week efficacy phase followed by a 40-week safety extension period. no statistically significant difference in the proportion of patients achieving a detrusor leak point pressure of <40 cm h2 o was observed between the alfuzosin and placebo groups. during the placebo-controlled trial, the adverse reactions reported in ≥2% of patients treated with alfuzosin and at a higher incidence than in the placebo group were: pyrexia, headache, respiratory tract infection, cough, epistaxis and diarrhea. the adverse reactions reported for the whole 12-month trial period, which included the open-label extension, were similar in type and frequency to the reactions observed during the 12-week period. alfuzosin hydrochloride was not studied in patients below the age of 2. of the total number of subjects in clinical studies of alfuzosin hydrochloride extended-release tablets, 48% were 65 years of age and over, whereas 11% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment [see clinical pharmacology (12.3)] . in phase 3 studies, the safety profile of patients with mild (n=172) or moderate (n=56) renal impairment was similar to the patients with normal renal function in those studies. safety data are available in only a limited number of patients (n=6) with creatinine clearance below 30 ml/min; therefore, caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered in patients with severe renal impairment [see warnings and precautions (5.2)] . the pharmacokinetics of alfuzosin hydrochloride extended-release tablets have not been studied in patients with mild hepatic impairment. alfuzosin hydrochloride extended-release tablets are contraindicated for use in patients with moderate or severe hepatic impairment [see contraindications (4), warnings and precautions (5.3) and clinical pharmacology (12.3)] .

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