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Indications/Uses
Bladder outlet obstruction associated with benign prostatic hyperplasia.
Dosage/Direction for Use
The usual adult dose for oral use is 1 tablet (4 mg of silodosin) twice daily after breakfast and evening meal or as prescribed by the physician. The dose may be reduced according to the patient's conditions.
Overdosage
Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse reaction was postural hypotension. If ingestion is recent, induction of vomiting or gastric lavage may be considered. Should overdose of silodosin lead to hypotension, cardiovascular support has to be provided. Dialysis is unlikely to be of significant benefit since silodosin is highly protein bound.
Administration
Should be taken with food: Take after breakfast & evening meal.
Contraindications
Silodosin (Urief) is contraindicated in patients with known hypersensitivity to any of the ingredients of this product.
Special Precautions
Careful Administration [Silodosin (Urief) should be administered with care in the following patients]: Patients with orthostatic hypotension [Symptoms may be aggravated.]
Patients with impaired hepatic function [Elevated plasma drug concentrations may occur].
Patients with impaired renal function [Elevated plasma drug concentrations have been reported].
Patients treated with phosphodiesterase-5 inhibitors.
Important Precautions: Abnormal ejaculation (e.g., retrograde ejaculation) has been reported. Therefore, this drug should be used after obtaining the understanding of patients by carefully explaining the risk of abnormal ejaculation (see Adverse Reactions).
Orthostatic hypotension may occur. Therefore, caution should be exercised regarding fluctuations in blood pressure due to changes in body posture.
Dizziness may occur. Therefore, the patient should be advised to exercise caution when engaging in hazardous activities such as working at heights or driving a car.
Prior to commencement of treatment with Silodosin (Urief) the patient should be asked whether they are taking any hypotensive drugs and, in the event that any hypotensive drug is used, attention should be paid to changes in blood pressure while using Silodosin (Urief). If a decrease in blood pressure occurs, appropriate therapeutic actions, such as dosage reduction or discontinuation of treatment, should be taken.
It should be borne in mind that treatment with this drug does not eliminate the cause of the disease, but gives symptomatic relief. If treatment with Silodosin (Urief) does not result in the expected effect, consideration should be given to other appropriate therapeutic measures such as surgery.
Caution in Use: When this drug is supplied in press-through package (PTP), it should be removed from the PTP sheet for administration. It was reported that, when PTP sheet was accidentally swallowed by a patient, the hard and sharp edges of the PTP pierced the esophageal mucosa resulting to esophageal perforation, which led to serious complications such as mediastinitis.
Other Precautions: This drug is associated with a high incidence of adverse reactions and abnormal ejaculation is reported frequently as a characteristic adverse reaction. Silodosin (Urief) should be used after careful consideration is given to the risks associated with its use and carefully explaining the adverse reactions to the patient.
The plasma concentration of silodosin may be elevated in patients with impaired hepatic function. It has been reported that plasma concentration of silodosin is increased in patients with impaired renal function. Therefore, starting treatment at a low dose (2 mg/ dose) while observing the condition of the patient, for instance, should be considered.
It has been reported that intraoperative floppy iris syndrome (IFIS) attributable to α1-blocking effect had been observed in patients who are currently receiving treatment with an α1-blocker, or who have previously received such treatment.
In a 104-week administration study in mice, it has been reported that the frequency of seminal vesicle dilatation was increased at doses of 20 mg/kg/day or more.
In a study on fertility and early embryogenesis until implantation in rats, it has been reported that deciduation of sperm cells in seminiferous tubules was observed at doses of 200 mg/kg/day or more and atrophy/ degeneration of seminiferous tubules as well as decreased sperm survival and sperm count were observed at a dose of 600 mg/kg/day.
Use in Elderly: The elderly often have reduced physiological function. If hepatic or renal function is reduced, the elderly should be treated while carefully monitoring the condition of the patient, such as start administration at a low dose (2 mg/dose).
Patients with impaired hepatic function [Elevated plasma drug concentrations may occur].
Patients with impaired renal function [Elevated plasma drug concentrations have been reported].
Patients treated with phosphodiesterase-5 inhibitors.
Important Precautions: Abnormal ejaculation (e.g., retrograde ejaculation) has been reported. Therefore, this drug should be used after obtaining the understanding of patients by carefully explaining the risk of abnormal ejaculation (see Adverse Reactions).
Orthostatic hypotension may occur. Therefore, caution should be exercised regarding fluctuations in blood pressure due to changes in body posture.
Dizziness may occur. Therefore, the patient should be advised to exercise caution when engaging in hazardous activities such as working at heights or driving a car.
Prior to commencement of treatment with Silodosin (Urief) the patient should be asked whether they are taking any hypotensive drugs and, in the event that any hypotensive drug is used, attention should be paid to changes in blood pressure while using Silodosin (Urief). If a decrease in blood pressure occurs, appropriate therapeutic actions, such as dosage reduction or discontinuation of treatment, should be taken.
It should be borne in mind that treatment with this drug does not eliminate the cause of the disease, but gives symptomatic relief. If treatment with Silodosin (Urief) does not result in the expected effect, consideration should be given to other appropriate therapeutic measures such as surgery.
Caution in Use: When this drug is supplied in press-through package (PTP), it should be removed from the PTP sheet for administration. It was reported that, when PTP sheet was accidentally swallowed by a patient, the hard and sharp edges of the PTP pierced the esophageal mucosa resulting to esophageal perforation, which led to serious complications such as mediastinitis.
Other Precautions: This drug is associated with a high incidence of adverse reactions and abnormal ejaculation is reported frequently as a characteristic adverse reaction. Silodosin (Urief) should be used after careful consideration is given to the risks associated with its use and carefully explaining the adverse reactions to the patient.
The plasma concentration of silodosin may be elevated in patients with impaired hepatic function. It has been reported that plasma concentration of silodosin is increased in patients with impaired renal function. Therefore, starting treatment at a low dose (2 mg/ dose) while observing the condition of the patient, for instance, should be considered.
It has been reported that intraoperative floppy iris syndrome (IFIS) attributable to α1-blocking effect had been observed in patients who are currently receiving treatment with an α1-blocker, or who have previously received such treatment.
In a 104-week administration study in mice, it has been reported that the frequency of seminal vesicle dilatation was increased at doses of 20 mg/kg/day or more.
In a study on fertility and early embryogenesis until implantation in rats, it has been reported that deciduation of sperm cells in seminiferous tubules was observed at doses of 200 mg/kg/day or more and atrophy/ degeneration of seminiferous tubules as well as decreased sperm survival and sperm count were observed at a dose of 600 mg/kg/day.
Use in Elderly: The elderly often have reduced physiological function. If hepatic or renal function is reduced, the elderly should be treated while carefully monitoring the condition of the patient, such as start administration at a low dose (2 mg/dose).
Adverse Reactions
Adverse reactions of silodosin were reported in 391(44.8%) of a total of 873 patients with lower urinary tract symptoms in a clinical study conducted up to the time of approval. The most common adverse reactions included abnormal ejaculation (e.g., retrograde ejaculation) in 150 (17.2%) patients , thirst in 50 (5.7%) patients, diarrhea in 35 (4.0%) patients, loose stools in 34 (3.9%) patients, dizziness on standing up in 31 (3.6%) patients, nasal congestion in 29 (3.3%) patients, dizziness in 23 (2.6%) patients, light-headed feeling in 22 (2.5%) patients, and headache in 19 (2.2%) patients. Abnormal laboratory data were reported in 185 (21.7%) of a total of 853 patients. The most common events included increased triglycerides in 62 (7.4%) patients, increased CRP in 21 (3.9%) patients, increased ALT (GPT) in 20 (2.3%) patients, increased AST (GOT) in 19 (2.2%) patients, and increased γ-GTP in 19 (2.2%) patients. It should be noted that, in the phase III double-blind comparative study, abnormal ejaculation (e.g., retrograde ejaculation) was reported in 39 (22.3%) of 175 patients.
Clinically Significant Adverse Reactions: Syncope, unconsciousness (Incidence unknown): Since a transient unconsciousness associated with hypotension etc. may occur, patients should be carefully monitored and, in the event of any abnormalities, treatment with Silodosin (Urief ) should be discontinued and appropriate therapeutic action taken.
Impaired hepatic function, jaundice (Both incidence unknown): Impaired hepatic function associated with increased AST (GOT), increased ALT (GPT) etc. or jaundice may occur. Patients should be carefully monitored and, in the event of any abnormalities, appropriate measures, such as discontinuation of this drug should be taken.
Other adverse reactions: The following adverse reactions may occur. Therefore, if any abnormalities are observed, appropriate therapeutic measures such as dosage reduction or discontinuation of treatment should be taken. (See Table 9.)
Clinically Significant Adverse Reactions: Syncope, unconsciousness (Incidence unknown): Since a transient unconsciousness associated with hypotension etc. may occur, patients should be carefully monitored and, in the event of any abnormalities, treatment with Silodosin (Urief ) should be discontinued and appropriate therapeutic action taken.
Impaired hepatic function, jaundice (Both incidence unknown): Impaired hepatic function associated with increased AST (GOT), increased ALT (GPT) etc. or jaundice may occur. Patients should be carefully monitored and, in the event of any abnormalities, appropriate measures, such as discontinuation of this drug should be taken.
Other adverse reactions: The following adverse reactions may occur. Therefore, if any abnormalities are observed, appropriate therapeutic measures such as dosage reduction or discontinuation of treatment should be taken. (See Table 9.)
Drug Interactions
Silodosin is metabolised mainly by cytochrome P450 3A4 (CYP3A4), UDP-glucuronosyltransferases (UGTs), alcohol dehydrogenase (ADH), and aldehyde dehydrogenase (ALDH). Co-administration with potent inhibitors of CYP3A4 activity blocks the metabolism of silodosin. This may result in elevated plasma drug concentrations. (See Table 10.)
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Effects in human tissue: Affinity to α-adrenergic receptors in the sympathetic nervous system.
In a receptor-binding assay on human α1-adrenergic receptors, silodosin showed a high affinity to the α1A-adrenergic receptor subtype.
Effect on prostate gland: In a receptor-binding assay using human prostate membrane specimens, silodosin showed a high affinity to the α1A-adrenergic receptor subtype.
Silodosin inhibited noradrenalin-induced contractions of human prostate smooth muscle.
Effect in animals: Effect on lower urinary tract issue (prostate, urethra, and trigone of the urinary bladder).
Silodosin exhibited a potent antagonistic action against noradrenalin-induced contractions in isolated rabbit prostate, urethra, and trigone of the urinary bladder.
Effect on urethral pressure: In anesthesized male rats, phenylephrine-induced increases in urethral pressure in the region of the prostate were selectively inhibited by silodosin. The inhibitory dose was lower than hypotensive dose.
In anesthetized male dogs, increased urethral pressure in the region of the prostate due to electrical stimulation of the hypogastric nerve was also selectively inhibited by silodosin. The inhibitory dose was lower than the hypotensive model.
Effect in prostatic hypertrophy model: In a male rat prostatic hypertrophy model prepared by administration of sex hormone, bladder irritation symptoms associated with urinary retention were inhibited.
Mechanism of Action: By blocking the sympathetic nervous system, which mediates the α1A-adrenoreceptor subtype which is distributed in lower urinary tract issues (prostate, urethra, and trigone of the urinary bladder), silodosin reduces smooth muscle tone of lower urinary tract tissue and inhibits increases in urethral pressure, thereby improving lower urinary tract symptoms associated with benign prostatic hyperplasia.
Clinical Studies: Phase II-Double Blind Comparative Study: When silodosin at a dose of 2 or 4 mg, or placebo was administered orally twice daily for 4 weeks to patients with lower urinary tract symptoms (total I-PSS) were significantly improved in the 4-mg group compared to the placebo group. (See Table 2.)
In a receptor-binding assay on human α1-adrenergic receptors, silodosin showed a high affinity to the α1A-adrenergic receptor subtype.
Effect on prostate gland: In a receptor-binding assay using human prostate membrane specimens, silodosin showed a high affinity to the α1A-adrenergic receptor subtype.
Silodosin inhibited noradrenalin-induced contractions of human prostate smooth muscle.
Effect in animals: Effect on lower urinary tract issue (prostate, urethra, and trigone of the urinary bladder).
Silodosin exhibited a potent antagonistic action against noradrenalin-induced contractions in isolated rabbit prostate, urethra, and trigone of the urinary bladder.
Effect on urethral pressure: In anesthesized male rats, phenylephrine-induced increases in urethral pressure in the region of the prostate were selectively inhibited by silodosin. The inhibitory dose was lower than hypotensive dose.
In anesthetized male dogs, increased urethral pressure in the region of the prostate due to electrical stimulation of the hypogastric nerve was also selectively inhibited by silodosin. The inhibitory dose was lower than the hypotensive model.
Effect in prostatic hypertrophy model: In a male rat prostatic hypertrophy model prepared by administration of sex hormone, bladder irritation symptoms associated with urinary retention were inhibited.
Mechanism of Action: By blocking the sympathetic nervous system, which mediates the α1A-adrenoreceptor subtype which is distributed in lower urinary tract issues (prostate, urethra, and trigone of the urinary bladder), silodosin reduces smooth muscle tone of lower urinary tract tissue and inhibits increases in urethral pressure, thereby improving lower urinary tract symptoms associated with benign prostatic hyperplasia.
Clinical Studies: Phase II-Double Blind Comparative Study: When silodosin at a dose of 2 or 4 mg, or placebo was administered orally twice daily for 4 weeks to patients with lower urinary tract symptoms (total I-PSS) were significantly improved in the 4-mg group compared to the placebo group. (See Table 2.)
Phase III Double-blind Comparative Study: When silodosin at a dose of 4 mg or placebo was administered orally twice daily for 12 weeks to patients with lower urinary tract symptoms associated with benign prostatic hyperplasia, the total I-PSS in the silodosin and placebo groups on completion of the study showed a decrease of 8.3 and 5.3 points, respectively, compared to baseline (see Figure 1 and Table 3). The percentage (%) of patients in the silodosin and placebo groups whose total I-PSS improved by at least 25% compared to baseline was 76.4% (133/174 patients) and 50.6% (45/89 patients), respectively. The percentage (%) of patients in the silodosin and placebo groups whose symptoms improved to mild (total I-PSS: <8) was 47.7% (83/174 patients) and 31.5% (28/89 patients), respectively.
In the silodosin group, an improvement in subjective symptoms was seen from as early as wk 1 and an improvement effect was also observed in patients whose symptoms were severe. (See Figure 1 & Table 3.)
In the silodosin group, an improvement in subjective symptoms was seen from as early as wk 1 and an improvement effect was also observed in patients whose symptoms were severe. (See Figure 1 & Table 3.)
Long-term Administration Study: In a long-term administration study, silodosin was administered at a dose of 4 mg twice daily for 52 weeks of 364 patients with lower urinary tract symptoms associated with benign prostatic hypertrophy. A continuous improvement effect and drug safety were reported and stable subjective symptoms (total I-PSS) and improvement in maximum urine flow rate were observed.
Pharmacokinetics: Absorption and Plasma Concentrations: When a single 4 mg dose of silodosin tablet or capsule was administered orally to 27 healthy adult males, respectively, plasma concentrations and pharmacokinetic parameters of silodosin tablet are shown in Table 4 and Figure 2.
It was demonstrated that the silodosin tablet of 4 mg and capsule of 4 mg are biologically equivalent. (See Table 4 and Figure 2.)
Pharmacokinetics: Absorption and Plasma Concentrations: When a single 4 mg dose of silodosin tablet or capsule was administered orally to 27 healthy adult males, respectively, plasma concentrations and pharmacokinetic parameters of silodosin tablet are shown in Table 4 and Figure 2.
It was demonstrated that the silodosin tablet of 4 mg and capsule of 4 mg are biologically equivalent. (See Table 4 and Figure 2.)
When a single oral dose of this drug was administered to healthy adult male volunteers (6 subjects/group) at doses ranging from 0.5 to 12 mg, plasma concentrations of silodosin increased dose-dependently, and Cmax and AUC0-∞, showed linearity. The time course of changes in plasma concentrations of silodosin following a single oral administration of silodosin at a dose of 2 or 4 mg is shown in Figure 3. (See Figure 3.)
When silodosin was administered orally twice daily for 7 days (once daily on days 1 and 7) at a dose of 4 mg/dose in 5 healthy adult male volunteers, plasma concentrations of silodosin reached a steady state on day 3. The accumulation factor relative to the first dose was 1.1-fold. (See Table 5.)
Pharmacokinetic parameters following repeated administration are shown as the results obtained from the time course of changes in concentration on day 7 less the cumulative concentration from days 0-6.
When a single 4 mg dose of silodosin was administered orally to 12 elderly males (age range: 65 to 75 year) postprandially, no obvious differences in the pharmacokinetic profile were observed compared to that in 9 non-elderly (age range: 21 to 31 years) males. The pharmacokinetic parameters in elderly males who received treatment with silodosin are shown in Table 6. (See Table 6.)
When a single 4 mg dose of silodosin was administered orally to 12 elderly males (age range: 65 to 75 year) postprandially, no obvious differences in the pharmacokinetic profile were observed compared to that in 9 non-elderly (age range: 21 to 31 years) males. The pharmacokinetic parameters in elderly males who received treatment with silodosin are shown in Table 6. (See Table 6.)
When a single 4 mg dose of silodosin was administered orally to 11 healthy adult male volunteers 30 min postprandially or under fasting conditions, the Cmax, AUC0-48hr, Tmax, and t½ following postprandial administration (or under fasting conditions) were 23.0 (28.0) ng/mL, 128.8 (135.9) ng·hr/mL, 2.1 (1.4) hr, and 6.0 (4.7) hr, respectively (see Table 7.)
The clearance and distribution volume following administration of silodosin (2 mg) to 11 healthy adult male volunteers by intravenous infusion over 4 hr were 167.0 ± 33.8 mL/min and 49.5 ± 17.3L, respectively.
The bioavailability following a single oral administration of silidosin at a dose of 4 mg was 32.2%.
Protein Binding: In an in vitro study, the human plasma-protein binding rate of silodosin was 95.6% (at a concentration of 100 ng/mL) and the main binding protein was α1-acid glycoprotein.
Metabolism and Excretion: Silodosin was metabolised in plasma being a glucuronide and an oxidized metabolite of silidosin. When a single 8 dose of 14C-labeled silidosin solution was administered orally to 6 healthy male non-Japanese volunteers, the AUC0-12hr of silidosin and its glucuronide and oxidized metabolites relative to the AUC0-12hr of total radioactivity in plasma was 24.0, 21.9, and 34.9%, respectively. Other metabolites accounted for no more than 5%. In the 240-hour period after dosing 33.5 and 54.9% of administered radioactivity was excreted in urine and feces, respectively.
The cumulative excretion in urine 0-48 hr after a single 4 mg dose of silodosin was administered orally to 12 elderly and 9 non-elderly male volunteers was 2.3 and 2.4% for silodosin, 1.6 and 1.8% for its glucuronide metabolite, and 4.5 and 4.9% for its oxidised metabolite, respectively.
Pharmacokinetics in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: In an exploratory population pharmacokinetic analyses (n=258) of a long-term administration study with silodosin in patients with lower urinary tract symptoms associates with benign prostatic hyperplasia, the estimated plasma concentrations of silidosin (mean±SD) at steady state 2 and 12 hours post-dose were 24.8±8.0 and 7.4 ± 3.3 ng/mL, respectively. An analysis of variable factors in relation to plasma concentrations of silodosin suggested that silidosin clearance is affected by body weight, age, CRP, ALT (GPT). Of these factors, it was concluded that ALT (GPT) had the most effect on plasma concentrations of silodosin and it was suggested that, as a result of increased levels of ALT (GPT) (23→83 IU/L), silodosin clearance and distribution volume may decrease by approximately 47 and 27%, respectively.
Drug Interaction(s): Non-Japanese data: Ketoconazole (oral preparation not marketed in Japan) coadministration: When 16 healthy male volunteers ( non-Japanese) who were receiving 200 mg of ketoconazole (p.o) once daily for 4 days were coadministered a single 4 mg dose of silodosin (p.o) on day 2, Cmax and AUC0-∞ of silodosin alone was administered.
Digoxin coadministration: When silodosin (4 mg, twice daily) was administered orally with digoxin (0.25 mg, once daily) for 8 days to 16 healthy male volunteers (non-Japanese), it was confirmed that silodosin has no effect on the pharmacokinetic profile of digoxin.
Pharmacokinetics in Patients with Impaired Renal Function: When a single 4 mg dose of silodosin was administered orally to 6 patients with impaired renal function (creatinine clearance: 27-49 mL/min) and 7 volunteers with normal renal function (creatinine clearance: 125-176 mL/min), the total plasma concentration of silodosin was increased (Cmax 3.1-fold; AUC0-∞ : 3.2-fold) in patients with impaired renal function compared to that in the volunteer group. This increase in total plasma concentration of silodosin may be attributable to protein binding with serum α-1 acid glycoprotein, with a high correlation between total plasma concentration of silodosin and serum concentration of α1-acid glycoprotein observed. It should be noted that the increase in the plasma concentration of unbound silodosin (Cmax: 1.5-fold; AUC0-∞ : 2.0-fold), which is considered to have a direct bearing on the manifestation of drug effect and incidence of adverse reactions associated with silodosin, was less than that for the total drug concentration (see Table 8).
The bioavailability following a single oral administration of silidosin at a dose of 4 mg was 32.2%.
Protein Binding: In an in vitro study, the human plasma-protein binding rate of silodosin was 95.6% (at a concentration of 100 ng/mL) and the main binding protein was α1-acid glycoprotein.
Metabolism and Excretion: Silodosin was metabolised in plasma being a glucuronide and an oxidized metabolite of silidosin. When a single 8 dose of 14C-labeled silidosin solution was administered orally to 6 healthy male non-Japanese volunteers, the AUC0-12hr of silidosin and its glucuronide and oxidized metabolites relative to the AUC0-12hr of total radioactivity in plasma was 24.0, 21.9, and 34.9%, respectively. Other metabolites accounted for no more than 5%. In the 240-hour period after dosing 33.5 and 54.9% of administered radioactivity was excreted in urine and feces, respectively.
The cumulative excretion in urine 0-48 hr after a single 4 mg dose of silodosin was administered orally to 12 elderly and 9 non-elderly male volunteers was 2.3 and 2.4% for silodosin, 1.6 and 1.8% for its glucuronide metabolite, and 4.5 and 4.9% for its oxidised metabolite, respectively.
Pharmacokinetics in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: In an exploratory population pharmacokinetic analyses (n=258) of a long-term administration study with silodosin in patients with lower urinary tract symptoms associates with benign prostatic hyperplasia, the estimated plasma concentrations of silidosin (mean±SD) at steady state 2 and 12 hours post-dose were 24.8±8.0 and 7.4 ± 3.3 ng/mL, respectively. An analysis of variable factors in relation to plasma concentrations of silodosin suggested that silidosin clearance is affected by body weight, age, CRP, ALT (GPT). Of these factors, it was concluded that ALT (GPT) had the most effect on plasma concentrations of silodosin and it was suggested that, as a result of increased levels of ALT (GPT) (23→83 IU/L), silodosin clearance and distribution volume may decrease by approximately 47 and 27%, respectively.
Drug Interaction(s): Non-Japanese data: Ketoconazole (oral preparation not marketed in Japan) coadministration: When 16 healthy male volunteers ( non-Japanese) who were receiving 200 mg of ketoconazole (p.o) once daily for 4 days were coadministered a single 4 mg dose of silodosin (p.o) on day 2, Cmax and AUC0-∞ of silodosin alone was administered.
Digoxin coadministration: When silodosin (4 mg, twice daily) was administered orally with digoxin (0.25 mg, once daily) for 8 days to 16 healthy male volunteers (non-Japanese), it was confirmed that silodosin has no effect on the pharmacokinetic profile of digoxin.
Pharmacokinetics in Patients with Impaired Renal Function: When a single 4 mg dose of silodosin was administered orally to 6 patients with impaired renal function (creatinine clearance: 27-49 mL/min) and 7 volunteers with normal renal function (creatinine clearance: 125-176 mL/min), the total plasma concentration of silodosin was increased (Cmax 3.1-fold; AUC0-∞ : 3.2-fold) in patients with impaired renal function compared to that in the volunteer group. This increase in total plasma concentration of silodosin may be attributable to protein binding with serum α-1 acid glycoprotein, with a high correlation between total plasma concentration of silodosin and serum concentration of α1-acid glycoprotein observed. It should be noted that the increase in the plasma concentration of unbound silodosin (Cmax: 1.5-fold; AUC0-∞ : 2.0-fold), which is considered to have a direct bearing on the manifestation of drug effect and incidence of adverse reactions associated with silodosin, was less than that for the total drug concentration (see Table 8).
MedsGo Class
Drugs for Bladder & Prostate Disorders
Features
Brand
Urief
Full Details
Dosage Strength
4 mg
Drug Ingredients
- Silodosin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Silodosin
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY44043
Drug Classification
Prescription Drug (RX)