Uroxatral Information
Uroxatral (Alfuzosin hcl) Indications And Usage
Uroxatral (Alfuzosin hcl) is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Uroxatral (Alfuzosin hcl) is not indicated for the treatment of hypertension.
Uroxatral (Alfuzosin hcl) Dosage And Administration
The recommended dosage is one 10 mg Uroxatral (Alfuzosin hcl) extended-release tablet once daily. The extent of absorption of Uroxatral (Alfuzosin hcl) is 50% lower under fasting conditions. Therefore, Uroxatral (Alfuzosin hcl) should be taken immediately after the same meal each day. The tablets should not be chewed or crushed.
Uroxatral (Alfuzosin hcl) 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.
Uroxatral (Alfuzosin hcl) Contraindications
Uroxatral (Alfuzosin hcl) 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.
Uroxatral (Alfuzosin hcl) is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased. .
Uroxatral (Alfuzosin hcl) is contraindicated in patients known to be hypersensitive to alfuzosin hydrochloride or any component of Uroxatral (Alfuzosin hcl) tablets.
Uroxatral (Alfuzosin hcl) Warnings And Precautions
Uroxatral (Alfuzosin hcl) is a selective alpha-blocker and should not be used in combination with other alpha-blockers
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
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.
Uroxatral (Alfuzosin hcl) Adverse Reactions
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The incidence of treatment-emergent adverse events has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received Uroxatral (Alfuzosin hcl) 10 mg extended-release tablets. In these studies, 4% of patients taking Uroxatral (Alfuzosin hcl) 10 mg extended-release tablets withdrew from the study due to adverse events, compared with 3% in the placebo group.
Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving Uroxatral (Alfuzosin hcl) , and at an incidence numerically higher than that of the placebo group. In general, the adverse events seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.
The following adverse events, reported by between 1% and 2% of patients receiving Uroxatral (Alfuzosin hcl) and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system:
Body as a whole:
Gastrointestinal system:
Reproductive system:
Respiratory system:
The following adverse reactions have been identified during post approval use of Uroxatral (Alfuzosin hcl) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
General disorders:
Cardiac disorders:
Gastrointestinal disorders:
Hepatobiliary disorders:
Respiratory system disorders:
Reproductive system disorders:
Skin and subcutaneous tissue disorders:
Vascular disorders:
During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in some patients on or previously treated with alpha-1 blockers
Uroxatral (Alfuzosin hcl) Overdosage
Should overdose of Uroxatral (Alfuzosin hcl) lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.
Uroxatral (Alfuzosin hcl) Description
Each Uroxatral (Alfuzosin hcl) extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.
Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of alfuzosin hydrochloride is CHNO•HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is:
The tablet also contains the following inactive ingredients: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF).
Uroxatral (Alfuzosin hcl) Clinical Studies
Three randomized placebo-controlled, double-blind, parallel-arm, 12-week studies were conducted with the 10 mg daily dose of alfuzosin. In these three studies, 1,608 patients [mean age 64.2 years, range 49–92 years; Caucasian (96.1%), Black (1.6%), Asian (1.1%), Other (1.2%)] were randomized and 473 patients received Uroxatral (Alfuzosin hcl) 10 mg daily. Table 4 provides the results of the three studies that evaluated the 10 mg dose.
There were two primary efficacy variables in these three studies. The International Prostate Symptom Score (IPSS, or AUA Symptom Score) consists of seven questions that assess the severity of both irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with possible scores ranging from 0 to 35. The second efficacy variable was peak urinary flow rate. The peak flow rate was measured just prior to the next dose in study 2 and on average at 16 hours post-dosing in studies 1 and 3.
There was a statistically significant reduction from baseline to last assessment (Week 12) in the IPSS versus placebo in all three studies, indicating a reduction in symptom severity (Table 5 and Figures 2, 3, and 4).
Peak urinary flow rate was increased statistically significantly from baseline to last assessment (Week 12) versus placebo in studies 1 and 2 (Table 5 and Figures 5, 6, and 7).
Mean total IPSS decreased at the first scheduled observation at Day 28 and mean peak flow rate increased starting at the first scheduled observation at Day 14 in studies 2 and 3 and Day 28 in study 1.
Uroxatral (Alfuzosin hcl) How Supplied/storage And Handling
Uroxatral (Alfuzosin hcl) 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.
Uroxatral (Alfuzosin hcl) 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.
Uroxatral (Alfuzosin hcl)
Uroxatral (Alfuzosin hcl)
Uroxatral (Alfuzosin hcl)
Uroxatral (Alfuzosin hcl)
