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silodosin 4 mg capsule generic rapaflo

Out of Stock Manufacturer MACLEODS PHARMA 33342038407
Out of Stock

Uses

Benign Prostatic Hyperplasia

Silodosin is used for the symptomatic management of benign prostatic hyperplasia (BPH, benign prostatic hypertrophy). Silodosin relieves moderate to severe irritative (e.g., frequency, urgency, nocturia) and obstructive (e.g., hesitancy, weak stream, sensation of incomplete bladder emptying) symptoms and improves urinary flow rates in patients with BPH. Because silodosin has produced a substantial improvement in some patients with severe manifestations of BPH, the drug may be a useful alternative to surgery, particularly in those who are awaiting surgical correction of the hyperplasia (e.g., via transurethral resection of the prostate [TURP]) or who are not candidates for such surgery.

Results of several controlled studies indicate that silodosin is more effective than placebo in the management of BPH. In addition, results of a comparative study in patients with BPH suggest that the drug is at least as effective as the α1-adrenergic blocking agent tamsulosin. Symptomatic improvement has been maintained for up to 1 year of silodosin therapy in some patients.

Combination therapy with an α1-adrenergic blocking agent (e.g., doxazosin) and a 5α-reductase inhibitor (e.g., finasteride) has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression; combined therapy also can reduce the risks of long-term acute urinary retention and the need for invasive therapy compared with α-blocker monotherapy.

For additional information on the use of α1-blockers in the management of BPH,

Other Uses

The manufacturer states that silodosin should not be used in the management of hypertension.

Dosage and Administration

Administration

Silodosin is administered orally once daily with a meal. The manufacturer states that silodosin should be administered with a meal to reduce the risk of adverse effects.

Dosage

The usual adult dosage of silodosin for the management of benign prostatic hyperplasia (BPH) is 8 mg once daily.

Special Populations

The manufacturer states that use of silodosin is contraindicated in patients with severe hepatic impairment (Child-Pugh class C).(See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.) No dosage adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh class A or B).

The manufacturer states that use of silodosin is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). In patients with moderate renal impairment (creatinine clearance 30-50 mL/minute), the manufacturer recommends that the dosage be reduced to 4 mg once daily.(See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.) No dosage adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/minute).

Cautions

Contraindications

Severe hepatic impairment (Child-Pugh class C).

Severe renal impairment (creatinine clearance less than 30 mL/minute).

Concomitant use with potent inhibitors of cytochrome P-450 (CYP) isoenzyme 3A4 (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir).(See Drug Interactions.)

Warnings/Precautions

Warnings

Orthostatic Hypotension

Silodosin can cause orthostatic hypotension with or without symptoms (e.g., dizziness) during initiation of therapy. Like other α-adrenergic blocking agents, there is also potential for syncope to occur. During initiation of silodosin therapy, patients should exercise caution while driving, operating machinery, or performing hazardous tasks.(See Advice to Patients.)

General Precautions

Prostate Cancer

Because manifestations of prostate cancer may mimic those of benign prostatic hyperplasia (BPH), the possibility of prostate cancer should be excluded prior to initiation of silodosin therapy.

Intraoperative Floppy Iris Syndrome

Intraoperative floppy iris syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients currently receiving or previously treated with α1-adrenergic blocking agents. IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with mydriatics, and potential prolapse of the iris toward the phacoemulsification incisions. Male patients being considered for cataract surgery should be advised to inform their ophthalmologist of current or prior therapy with α1-adrenergic blockers, including silodosin. If a patient has received such agents, the ophthalmologist should consider use of corrective measures such as modification of the surgical technique through use of iris hooks or iris dilator rings or pharmacologic intervention with intracameral phenylephrine or preoperative administration of atropine. The benefit of discontinuing α1-blocker therapy prior to cataract surgery has not been established.

Specific Populations

Pregnancy

Category B. Silodosin is not intended for use in women.

Lactation

Silodosin is not intended for use in women.

Pediatric Use

Silodosin is not intended for use in pediatric patients.

Geriatric Use

In clinical studies with silodosin, a higher incidence of orthostatic hypotension was reported in geriatric patients 65 years of age and older relative to younger adults. No other substantial differences in safety and efficacy were observed between geriatric and younger adults.

Hepatic Impairment

Dosage adjustment is not required in patients with mild or moderate hepatic impairment. Silodosin has not been studied in patients with severe hepatic impairment. Therefore, use of the drug is contraindicated in patients with severe hepatic impairment.(See Cautions: Contraindications.)

Renal Impairment

Silodosin should be used with caution in patients with moderate renal impairment. In one study, plasma concentrations and half-life of silodosin increased threefold and twofold, respectively, in individuals with moderate renal impairment compared with those having normal renal function. Therefore, dosage reduction is recommended for patients with moderate renal impairment (creatinine clearance 30-50 mL/minute).(See Dosage and Administration: Special Populations.) Use of the drug is contraindicated in patients with severe renal impairment.(See Cautions: Contraindications.)

Common Adverse Effects

Adverse effects reported in 2% or more of patients receiving silodosin and at an incidence higher than that reported with placebo include retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.

Drug Interactions

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interaction (increased plasma silodosin concentrations) with potent inhibitors of the cytochrome P-450 (CYP) 3A4 isoenzyme. Concomitant use of potent inhibitors of the CYP3A4 isoenzyme (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) with silodosin is contraindicated. The effect of moderate CYP3A4 inhibitors on silodosin pharmacokinetics has not been evaluated. Concomitant use of moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) may increase silodosin concentrations. Caution is advised and patients should be monitored for adverse effects when silodosin is used concomitantly with moderate CYP3A4 inhibitors, particularly those that also inhibit P-glycoprotein.(See Drug Interactions: Drugs Affecting or Affected by P-glycoprotein Transport.)

In vitro studies indicate that silodosin does not have the potential to inhibit or induce CYP isoenzymes.

Drugs Affecting or Affected by P-glycoprotein Transport

Potential pharmacokinetic interaction (increased silodosin concentrations) with inhibitors of P-glycoprotein transport. Concomitant use of silodosin and ketoconazole (a CYP3A4 inhibitor and a P-glycoprotein inhibitor) resulted in substantially increased silodosin exposure. Studies evaluating concomitant use of silodosin and a potent P-glycoprotein inhibitor (e.g., cyclosporine) have not been conducted. Therefore, the manufacturer states that concomitant use of silodosin with a potent P-glycoprotein inhibitor is not recommended.

In vitro studies show that silodosin is a substrate for the P-glycoprotein transport system.

Drugs Affecting Uridine Diphosphate-glucuronosyltransferase

Potential pharmacokinetic interaction (increased silodosin exposure) with drugs that are inhibitors of uridine diphosphate-glucuronosyltransferase (UGT) 2B7 (e.g., fluconazole, probenecid, valproic acid).

α-Adrenergic Blocking Agents

Potential pharmacodynamic interaction (additive cardiovascular effects) with other α-adrenergic blocking agents. However, the interaction between silodosin and other α-adrenergic blocking agents has not been determined. Concomitant use is not recommended by the manufacturer.

Antihypertensive Agents

Potential pharmacodynamic interaction between silodosin and antihypertensive agents. Although the interaction has not been evaluated in a clinical study, one-third of patients in studies with silodosin used antihypertensive agents concomitantly. The incidence of dizziness and orthostatic hypotension in the patients receiving concomitant therapy was higher than that reported in those receiving silodosin alone. Caution is advised and patients should be monitored for adverse effects when silodosin is used concomitantly with antihypertensive agents.

Digoxin

Concomitant use of silodosin and digoxin in one study did not substantially alter the steady-state pharmacokinetics of digoxin. The manufacturer states that no dosage adjustment is required during concomitant use.

Phosphodiesterase Inhibitors

Concomitant use of silodosin with a phosphodiesterase (PDE) type 5 inhibitor (i.e., sildenafil, tadalafil) in one study showed a greater number of orthostatic effects in the group receiving silodosin and a PDE type 5 inhibitor compared with those receiving silodosin alone. However, symptomatic orthostasis or dizziness was not reported in individuals receiving concomitant therapy.

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