Alfuzosin Hcl
Generic Name: alfuzosin hcl
Brand Names:
Uroxatral
11 DESCRIPTION Each UROXATRAL 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.
Overview
11 DESCRIPTION Each UROXATRAL 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.
Uses
1 INDICATIONS AND USAGE UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: UROXATRAL is not indicated for treatment of hypertension. ( 1.1 ) UROXATRAL is not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use UROXATRAL is not indicated for the treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, Uroxatral should be taken with food and with the same meal each day. The tablets should not be chewed or crushed. 10 mg once daily with food and with the same meal each day. ( 2 ) Tablets should not be chewed or crushed ( 2 , 12.3 )
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Interactions
7 DRUG INTERACTIONS Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including UROXATRAL, can potentially cause symptomatic hypotension ( 5.4 , 7.4 ) 7.1 CYP3A4 Inhibitors UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased [see Contraindications (4) , Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ] . 7.2 Alpha Adrenergic Antagonists The pharmacokinetic and pharmacodynamic interactions between UROXATRAL and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and UROXATRAL should not be used in combination with other alpha adrenergic antagonists [see Warnings and Precautions (5.4) ].
Warnings
5 WARNINGS AND PRECAUTIONS Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates ( 5.1 ) Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) ( 5.2 , 8.6 , 12.3 ) Use with caution in patients with mild hepatic impairment ( 5.3 , 8.7 , 12.3 ) Should not be used in combination with other alpha adrenergic antagonists ( 5.4 , 7.2 ) Prostate carcinoma should be ruled out prior to treatment ( 5.5 ) Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique ( 5.6 ) Discontinue UROXATRAL if symptoms of angina pectoris appear or wor... 4 CONTRAINDICATIONS UROXATRAL 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) ].
Pregnancy
8.1 Pregnancy Risk Summary Uroxatral is not indicated for use in women. There are no adequate data on the developmental risk associated with use of UROXATRAL in pregnant women. Based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at upto 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbit, via body surface area. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.
Storage
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP. Protect from light and moisture. Keep UROXATRAL out of reach of children.
Frequently Asked Questions
What is Alfuzosin Hcl used for?▼
1 INDICATIONS AND USAGE UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: UROXATRAL is not indicated for treatment of hypertension. ( 1.1 ) UROXATRAL is not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use UROXATRAL is not indicated for the treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population.
What are the side effects of Alfuzosin Hcl?▼
6 ADVERSE REACTIONS Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Can I take Alfuzosin Hcl during pregnancy?▼
8.1 Pregnancy Risk Summary Uroxatral is not indicated for use in women. There are no adequate data on the developmental risk associated with use of UROXATRAL in pregnant women. Based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at upto 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbit, via body surface area. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.
What are the important warnings for Alfuzosin Hcl?▼
5 WARNINGS AND PRECAUTIONS Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates ( 5.1 ) Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) ( 5.2 , 8.6 , 12.3 ) Use with caution in patients with mild hepatic impairment ( 5.3 , 8.7 , 12.3 ) Should not be used in combination with other alpha adrenergic antagonists ( 5.4 , 7.2 ) Prostate carcinoma should be ruled out prior to treatment ( 5.5 ) Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique ( 5.6 ) Discontinue UROXATRAL if symptoms of angina pectoris appear or wor... 4 CONTRAINDICATIONS UROXATRAL 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) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.