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Uroxatral

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Uroxatral

Uroxatral

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Postural Hypotension

Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of UROXATRAL (alfuzosin hcl) . 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 (alfuzosin hcl) concomitantly with anti-hypertensive medication and nitrates. Care should be taken when UROXATRAL (alfuzosin hcl) is administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.

Renal Impairment

Caution should be exercised when UROXATRAL (alfuzosin hcl) is administered in patients with severe renal impairment [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

Hepatic Impairment

UROXATRAL (alfuzosin hcl) is contraindicated for use in patients with moderate or severe hepatic impairment [see Use in Specific Populations and CONTRAINDICATIONS]. The pharmacokinetics of UROXATRAL (alfuzosin hcl) have not been studied in patients with mild hepatic impairment [see CLINICAL PHARMACOLOGY].

Pharmacodynamic Drug-Drug Interactions

UROXATRAL (alfuzosin hcl) is a selective alpha-blocker and should not be used in combination with other alpha-blockers [see DRUG INTERACTIONS].

Caution is advised when alpha adrenergic blocking agents, including UROXATRAL (alfuzosin hcl) , are co-administered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see DRUG INTERACTIONS].

Pharmacokinetic Drug-Drug Interactions

UROXATRAL (alfuzosin hcl) is contraindicated for use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) since alfuzosin blood levels are increased [see CONTRAINDICATIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Prostatic Carcinoma

Carcinoma of the prostate and benign prostatic hyperplasia (BPH) cause many of the same symptoms. These two diseases frequently coexist. Therefore, patients thought to have BPH should be examined prior to starting treatment with UROXATRAL (alfuzosin hcl) to rule out the presence of carcinoma of the prostate.

Intraoperative Floppy Iris Syndrome (IFIS)

IFIS has been observed during cataract surgery in some patients on or previously treated with alpha-1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

There does not appear to be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery.

Coronary Insufficiency

If symptoms of angina pectoris should appear or worsen, UROXATRAL (alfuzosin hcl) should be discontinued.

Patients with Congenital or Acquired QT Prolongation

Use with caution in patients with acquired or congenital QT prolongation or who are taking medications that prolong the QT interval [see CLINICAL PHARMACOLOGY].

Laboratory Test Interactions

No laboratory test interactions with UROXATRAL (alfuzosin hcl) tablets are known.

Patient Counseling Information

Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning UROXATRAL (alfuzosin hcl) , and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates.

Patients should be instructed to tell their ophthalmologist about their use of UROXATRAL (alfuzosin hcl) before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking UROXATRAL (alfuzosin hcl) .

UROXATRAL (alfuzosin hcl) should be taken with food and with the same meal each day. Patients should be advised not to crush or chew UROXATRAL (alfuzosin hcl) tablets.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of a drug-related increase in the incidence of tumors in mice following dietary administration of 100 mg/kg/day alfuzosin for 98 weeks (13 and 15 times the level of exposure to humans based on AUC of unbound drug) in females and males, respectively. The highest dose tested in female mice may not have constituted a maximally tolerated dose. Likewise, there was no evidence of a drug-related increase in the incidence of tumors in rats following dietary administration of 100 mg/kg/day alfuzosin for 104 weeks (53 and 37 times the level of exposure to humans based on AUC of unbound drug) in females and males, respectively. Alfuzosin showed no evidence of mutagenic effect in the Ames and mouse lymphoma assays, and was free of any clastogenic effects in the Chinese hamster ovary cell and in vivo mouse micronucleus assays. Alfuzosin treatment did not induce DNA repair in a human cell line. There was no evidence of reproductive organ toxicity when male rats were given alfuzosin at daily oral (gavage) doses of up to 250 mg/kg/day for 26 weeks, which corresponds to levels of exposure several hundred times that in humans. No impairment of fertility was observed following oral (gavage) administration to male rats at doses of up to 125 mg/kg/day for 70 days. Estrous cycling was inhibited in rats and dogs at doses of 25 mg/kg and 20 mg/kg, respectively, corresponding to levels of systemic exposure (based on AUC of unbound drug) 12- and 18-fold higher, respectively, than in humans, although this did not result in impaired fertility in rats.

Use In Specific Populations

Pregnancy

Pregnancy Category B. UROXATRAL (alfuzosin hcl) is not indicated for use in women.

There was no evidence of teratogenicity or embryotoxicity in rats at maternal (oral gavage) doses up to 250 mg/kg/day, corresponding to systemic exposure levels 1,200-fold higher than in humans. In rabbits, up to the dose of 100 mg/kg/day (approximately 3 times the clinical dose by body surface area) given orally (via gavage), no evidence of fetal toxicity or teratogenicity was seen.

Gestation was slightly prolonged in rats with a maternal dose > 5 mg/kg/day (oral gavage), which corresponds to systemic exposure levels (based on AUC of unbound drug) 12 times higher than human exposure levels, but there were no difficulties with parturition.

Pediatric Use

UROXATRAL (alfuzosin hcl) is not indicated for use in children.

Geriatric Use

Of the total number of subjects in clinical studies of UROXATRAL (alfuzosin hcl) , 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 [see CLINICAL PHARMACOLOGY]

Renal Impairment

Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment [see CLINICAL PHARMACOLOGY]. 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 UROXATRAL (alfuzosin hcl) is administered in patients with severe renal impairment [see WARNINGS AND PRECAUTIONS].

Hepatic Impairment

The pharmacokinetics of UROXATRAL (alfuzosin hcl) have not been studied in patients with mild hepatic impairment. UROXATRAL (alfuzosin hcl) is contraindicated for use in patients with moderate or severe hepatic impairment [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 5/3/2010
This monograph has been modified to include the generic and brand name in many instances.

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