Flotral Tablets

Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. …

• The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily
• The extent of absorption of alfuzosin is 50% lower under fasting conditions
• Therefore, alfuzosin hydrochloride extended-release tablets 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
• Tablets should not be chewed or crushed

Alfuzosin hydrochloride extended-release tablet, USP 10 mg is available as a yellow, round, flat-faced beveled-edge tablet. Engraved "APO" on one side, "ALF" over "10" on the other side. Extended-release tablet: 10 mg ( 3 )

• 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 H 2 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. …

Of the total number of subjects in clinical studies of alfuzosin hydrochloride, 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) ].

• See FDA-approved patient labeling
• Hypotension/Syncope Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning alfuzosin hydrochloride extended-release tablets, 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 [ see Warnings and Precautions ]. …

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) ]. …

Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, can potentially cause symptomatic hypotension ( 5.4 , 7.4) 7.1 CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are 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) ]. …

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

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 Apotex Corp. at 1-800- 706-5575 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. …

8.1 Pregnancy 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 the use of alfuzosin hydrochloride extended-release tablets in pregnant women . …

Should overdose of alfuzosin hydrochloride extended-release tablets 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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.