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WARNINGS AND PRECAUTIONS OF ALFUSIN-D

Evaluation for Other Urological Diseases

Prior to initiating treatment with Alfusin-D, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.

Postural Hypotension

Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of Alfusin-D tablets. 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 Alfusin-D tablets concomitantly with antihypertensive medication and nitrates. Care should be taken when Alfusin-D are administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.

Priapism

Rarely (probably less than 1 in 50,000), alfuzosin hcl, like other alpha-adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition.

Intraoperative Floppy Iris Syndrome (IFIS)

IFIS has been observed during cataract surgery in some patients on or previously treated with alpha-adrenergic antagonists. 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-adrenergic antagonist therapy prior to cataract surgery.

Increased Risk of High-grade Prostate Cancer

In men aged 50 to 75 years, with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng / mL and 10.0 ng / mL, who were taking dutasteride in the 4-year Reduction by Dutasteride of prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (dutasteride 1.0% versus placebo 0.5%). In a 7-year, placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (finasteride 5 mg), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%). The 5 alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. It has not been established as to whether the effect of 5 alpha-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies.

Exposure of Women - Risk to Male Foetus

Alfusin-D tablets should not be handled by a woman who is pregnant or who could become pregnant. Dutasteride is absorbed through the skin and could result in unintended foetal exposure. If a woman who is pregnant or who could become pregnant comes in contact with leaking Alfusin-D, the contact area should be washed immediately with soap and water.

Blood Donation

Men being treated with Alfusin-D tablets should not donate blood until at least 6 months have passed following their last dose, so as to prevent pregnant women from receiving dutasteride through blood transfusion.

Effects on Prostate-specific Antigen (PSA) and the use of PSA in Prostate Cancer Detection

In clinical studies, dutasteride reduced serum prostate-specific antigen (PSA) concentration by approximately 50% within 3-6 months of treatment. This decrease was predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. Dutasteride may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men taking dutasteride, a new PSA baseline should be established at least 3 months after starting treatment and the PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5 alpha-reductase inhibitor. Non-compliance with dutasteride may also affect PSA test results.

To interpret an isolated PSA value in a man treated with dutasteride for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men.

The free-to-total PSA ratio (percent-free PSA) remains constant, even under the influence of dutasteride. If clinicians elect to use percent-free PSA as an aid in the detection of prostate cancer in men receiving dutasteride, no adjustment to its value appears necessary.

Effect on Semen Characteristics

The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 years (n=27 dutasteride, n=23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume and sperm motility were 23%, 26% and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. Sperm concentration and sperm morphology were unaffected. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all-time points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride's effect on semen characteristics for an individual patient's fertility is not known.

Coronary Insufficiency

If symptoms of angina pectoris should newly appear or worsen, Alfusin-D tablets 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.

Drug Interactions

Potent CYP3A4 Inhibitors: CYP3A4 is the principal hepatic enzyme isoform involved in the metabolism of alfuzosin hydrochloride. Repeated administration of 400 mg of ketoconazole, a potent inhibitor of CYP3A4, increased the alfuzosin hydrochloride Cmax by 2.3-fold and the AUClast by 3.2-fold, following a single 10 mg dose of Alfuzosin HCl. In another study, repeated oral administration of a lower (200 mg/day) dose of ketoconazole increased the alfuzosin hydrochloride Cmax by 2.1-fold and the AUClast by 2.5-fold, following a single 10 mg dose of alfusion hydrochloride. Alfuzosin HCl should not be co-administered with potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole or ritonavir) because of increased alfuzosin hydrochloride exposure.

Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes. No clinical drug interaction trials have been performed to evaluate the impact of CYP3A enzyme inhibitors on dutasteride pharmacokinetics. However, based on in vitro data, blood concentrations of dutasteride may increase in the presence of inhibitors of CYP3A4/5 such as ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, and ciprofloxacin. Because of the potential for drug-drug interactions, use caution when prescribing dutasteride to patients taking potent, chronic CYP3A4 enzyme inhibitors.

Dutasteride does not inhibit the in vitro metabolism of model substrates for the major human CYP450 isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at a concentration of 1,000 ng/mL, 25 times greater than steady-state serum concentrations in humans.

Moderate CYP3A4 Inhibitors: Repeated co-administration of 240 mg/day of diltiazem, a moderately potent inhibitor of CYP3A4, with 7.5 mg/day (2.5 mg three times daily) alfuzosin hydrochloride increased the Cmax and AUC0-24 of alfuzosin hydrochloride 1.5- and 1.3-fold, respectively. Alfuzosin hydrochloride increased the Cmax and AUC0-12 of diltiazem 1.4-fold. Although no changes in blood pressure were observed in this study, diltiazem is an antihypertensive medication and the combination of alfuzosin hydrochloride and antihypertensive medications has the potential to cause hypotension in some patients.

In human liver microsomes, at concentrations that are achieved at the therapeutic dose, alfuzosin did not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6 or 3A4 isoenzymes. In primary culture of human hepatocytes, alfuzosin did not induce CYP1A, 2A6 or 3A4 isoenzymes.

Alpha-Adrenergic Antagonists: The pharmacokinetic and pharmacodynamic interactions between alfuzosin hydrochloride and other alpha-blockers have not been determined. However, interactions may be expected and Alfusin-D tablets should not be used in combination with other alpha-blockers.

The administration of dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha-adrenergic antagonist. The effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters was not evaluated; the percent change in DHT concentrations was similar for dutasteride alone compared with the combination treatment.

Phosphodiesterase-5 (PDE5) Inhibitors: Caution is advised when alpha-adrenergic antagonists, including alfuzosin hydrochloride, are co-administered with PDE5 inhibitors. Alpha-adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.

Antihypertensive Medication and Nitrates: There may be an increased risk of hypotension/postural hypotension and syncope when taking Alfusin-D tablets concomitantly with antihypertensive medication and nitrates.

Cimetidine: Repeated administration of 1 g/day cimetidine increased both the alfuzosin hydrochloride Cmax and AUC values by 20%.

Digoxin: Repeated co-administration of alfuzosin hydrochloride 10 mg and digoxin 0.25 mg/day for 7 days did not influence the steady-state pharmacokinetics of either drug. Dutasteride did not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks.

Warfarin: Multiple dose administration of an immediate-release tablet formulation of alfuzosin hydrochloride 5 mg twice daily for 6 days to 6 healthy male volunteers did not affect the pharmacological response to a single 25 mg oral dose of warfarin. Dutasteride 0.5 mg / day for 3 weeks did not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on the prothrombin time when administered with warfarin.

Atenolol: Single administration of 100 mg atenolol with a single dose of 2.5 mg of an immediate-release alfuzosin hydrochloride tablet in 8 healthy young male volunteers increased alfuzosin hydrochloride Cmax and AUC values by 28% and 21%, respectively. Alfuzosin HCl increased atenolol Cmax and AUC values by 26% and 14%, respectively. In this study, the combination of alfuzosin hydrochloride with atenolol caused significant reductions in the mean blood pressure and in mean heart rate.

Hydrochlorothiazide: Single administration of 25 mg hydrochlorothiazide did not modify the pharmacokinetic parameters of alfuzosin hydrochloride. There was no evidence of pharmacodynamic interaction between Alfuzosin HCl and HCTZ in the 8 patients in the study.

Calcium Channel Antagonists: In a population pharmacokinetics analysis, a decrease in clearance of dutasteride was noted when co-administered with the CYP3A4 inhibitors verapamil (37%, n=6) and diltiazem (44%, n=5). In contrast, no decrease in clearance was seen when amlodipine, another calcium channel antagonist that is not a CYP3A4 inhibitor, was co-administered with dutasteride (+7%, n=4).

The decrease in clearance and subsequent increase in exposure to dutasteride in the presence of verapamil and diltiazem is not considered to be clinically significant. No dose adjustment is recommended.

Cholestyramine: Administration of a single 5 mg dose of dutasteride followed 1 hour later by 12 g cholestyramine did not affect the relative bioavailability of dutasteride.

Other Concomitant Therapy: No clinically significant adverse interactions could be attributed to the combination of dutasteride and concurrent therapy when dutasteride was co-administered with anti-hyperlipidaemics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), PDE-5 inhibitors and quinolone antibiotics.

Information for Patients

  • Alfusin-D patient information

    Renal Impairment

    Caution should be exercised when alfuzosin hydrochloride is administered in patients with severe renal impairment (creatinine clearance < 30 mL / min). Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment. 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.

    The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, less than 0.1% of a steady-state 0.5-mg dose of dutasteride is recovered in human urine, so no adjustment in dosage is anticipated for patients with renal impairment.

    Hepatic Impairment

    Alfuzosin HCl is contraindicated for use in patients with moderate or severe hepatic impairment. Although the pharmacokinetics of alfuzosin hydrochloride has not been studied in patients with mild hepatic impairment, caution should be exercised when alfuzosin hydrochloride is administered to such patients.

    The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized, exposure could be higher in hepatically impaired patients. However, in a clinical study where 60 subjects received 5 mg (10 times the therapeutic dose) daily for 24 weeks, no additional adverse events were observed compared with those observed at the therapeutic dose of 0.5 mg.

    Pregnancy

    Pregnancy Category X

    Alfusin-D tablets are contraindicated for use in women of childbearing potential and during pregnancy. Dutasteride is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to DHT, a hormone necessary for the normal development of male genitalia. In animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male foetuses. Therefore, dutasteride may cause foetal harm when administered to a pregnant woman. If dutasteride is used during pregnancy or if the patient becomes pregnant while taking dutasteride, the patient should be apprised of the potential hazard to the foetus.

    Abnormalities in the genitalia of male foetuses is an expected physiological consequence of inhibition of the conversion of testosterone to DHT by 5 alpha-reductase inhibitors. These results are similar to observations in male infants with genetic 5 alpha-reductase deficiency. Dutasteride is absorbed through the skin. To avoid potential foetal exposure, women who are pregnant or may become pregnant should not handle dutasteride. If contact is made with broken Alfusin-D tablet, the contact area should be washed immediately with soap and water. Dutasteride is secreted into male semen. The highest measured semen concentration of dutasteride in treated men was 14 ng/mL. Assuming exposure of a 50 kg woman to 5 mL of semen and 100% absorption, the woman's dutasteride concentration would be about 0.175 ng/mL. This concentration is more than 100 times less than concentrations producing abnormalities of male genitalia in animal studies. Dutasteride is highly protein-bound in human semen (>96%), which may reduce the amount of dutasteride available for vaginal absorption.

    Lactation

    Alfusin-D is not indicated for use in nursing mothers. It is not known whether dutasteride is excreted in human milk.

    Paediatric Use

    Alfusin-D is not indicated for use in the paediatric 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 H2O) 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. No statistically significant difference in the proportion of patients achieving a detrusor leak point pressure of < 40 cm H20 was observed between the alfuzosin and placebo groups.

    During the placebo-controlled trial, the adverse reactions reported in #8805;2% of patients treated with alfuzosin and at a higher incidence than in the placebo group were: pyrexia, headache, respiratory tract infection, cough, epistaxis and diarrhea. The adverse reactions reported for the whole 12-month trial period, which included the open-label extension, were similar in type and frequency to the reactions observed during the 12-week period. Alfuzosin hydrochloride was not studied in patients below the age of 2. Safety and effectiveness of dutasteride in the paediatric population have not been established.

    Geriatric Use

    Of the total number of subjects in clinical studies of alfuzosin hydrochloride, 48% were 65 years of age and over, whereas 11% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but the greater sensitivity of some older individuals cannot be ruled out.

    Of 2167 male subjects treated with dutasteride in three clinical trials, 60% were aged 65 years and older and 15% were aged 75 years and older. No overall differences in safety or efficacy were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.


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