Dosing and uses of Alfutral, UroXatral (alfuzosin)
Adult dosage forms and strengths
tablet, extended release
- 10mg
Benign Prostatic Hyperplasia (BPH)
10 mg PO qDay taken after same meaL
Pediatric dosage forms and strengths
Safety & efficacy not established
Alfutral, UroXatral (alfuzosin) adverse (side) effects
1-10%
Abdominal pain (1-2%)
Back pain (1-2%)
Brochitis (1-2%)
Constipation (1-2%)
Dizziness (5.7%)
Dyspepsia (1-2%)
Fatigue (2.7%)
Headache (3%)
Impotence (1-2%)
Nausea (1-2%)
Pharyngitis (1-2%)
URT infection (3%)
Sinusitis (1-2%)
Upper respiratory infection (3%)
Postmarketing Reports
General disorders: Edema
Cardiac disorders: Tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease, atrial fibrillation
Gastrointestinal disorders: Diarrhea
Hepatobiliary disorders: Hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation)
Upper respiratory system: Rhinitis
Reproductive system: Priapism
Dermatology: Rash, pruritus, urticaria, angioedema, toxic epidermal necrolysis
Vascular disorders: Flushing
Blood and lymphatic system disorders: Thrombocytopenia
Warnings
Contraindications
Hypersensitivity
Moderate to severe liver impairment
Coadministration with potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) or other alpha1-blocking agents
Cautions
Caution in coronary artery disease, liver disease, symptomatic orthostatic hypotension or coadministration with other drugs that lower blood pressure
May cause syncope (first-dose effect)
Discontinue treatment if angina occurs or worsens
Rule out prostate cancer before initiating therapy (symptoms similar)
Priapism may occur with use
Rule out prostate cancer prior to treatment
Caution with renal impairment (ieg, CrCl <30 mL/min)
Caution with history of prolonged QT syndrome (shown to prolong QT interval)
Intraoperative floppy iris syndrome during cataract surgery reported Advise patient regarding risk of priapism
Do not chew or crush tablets
Not for use as antihypertensive drug
Pregnancy and lactation
Pregnancy category: B
Lactation: Not indicated for use in women
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Alfutral, UroXatral (alfuzosin)
Mechanism of action
Selective antagonist of postsynaptic alpha-1-adrenoceptors; blockade of adrenoreceptors in the prostate, prostatic capsule, bladder neck and prostatic urethra
Absorption
Bioavailability: 49%
Peak Plasma Time: 8 hr
Peak Plasma Concentration: 13.6 ng/mL
AUC: 194 ng.hr/mL
Distribution
Protein Bound: 82-90%
Vd: 3.2 L/kg
Metabolism
Hepatic P450 enzyme CYP3A4
Elimination
Half-life: 5-10 hr
Excretion: Feces (69%); urine (24%)
