Silodel 8 8 mg

Uses of Silodel 8: - Benign prostatic hyperplasia Treating the signs and symptoms of enlarged prostate (benign prostatic hyperplasia [BPH]). Hypersensitivity.

BPH/ Urinary retention/ Urinary incontinence

Silodosin is a selective antagonist of post-synaptic alpha-1 adrenoreceptors, which are located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra. Blockade of these alpha-1 adrenoreceptors can cause smooth muscle in these tissues to relax, resulting in an improvement in urine flow and a reduction in BPH symptoms.

How to use Silodosin: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Silodosin is to be taken with food. Adult Dose: Benign Prostatic Hyperplasia Adults PO 8 mg once daily with a meal. Hepatic Impairment Mild-to-moderate impairment (Child-Pugh class A or B): Dose adjustment not necessary Severe Impairment: (Child-Pugh class C): Contraindicated (not studied) Renal Dose: Renal Impairment CrCl <50 mL/min: Dose adjustment not necessary CrCl 30-50 mL/min: 4 mg PO qDay CrCl <30 mL/min: Contraindicated

Ketoconazole, digoxin.

Hypersensitivity.

Common - Retrograde ejaculation - Orthostatic hypotension (sudden lowering of blood pressure on standing) - Dizziness - Headache - Nasal congestion (stuffy nose) - Diarrhea >10% Retrograde ejaculation (28%) 1-10% Diarrhea (3%),Headache (2%),Insomnia ((1-2%),Dizziness (3%),Orthostatic hypotension (3%; increased in patients >65 years),Nasopharyngitis (2%),Nasal congestion (2%),Sinusitis (1-2%)

Pregnancy Category B. Silodosin is not indicated for use in women. An embryo/fetal study in rabbits showed decreased maternal body weight at 200 mg/kg/day (approximately 13-25 times the maximum recommended human exposure or MRHE of Silodosin via AUC). No statistically significant teratogenicity was observed at this dose. Silodosin was not teratogenic when administered to pregnant rats during organogenesis at 1000 mg/kg/day (estimated to be approximately 20 times the MRHE). No maternal or fetal effects were observed at this dose. Rats and rabbits do not produce glucuronidated Silodosin, which is present in human serum at approximately 4 times the level of circulating Silodosin and which has similar pharmacological activity to Silodosin. No effects on physical or behavioral development of offspring were observed when rats were treated during pregnancy and lactation at up to 300 mg/kg/day.

Precaution: Impaired hepatic & renal function. Start treatment w/ a low dose (2 mg/dose).

Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse event was postural hypotension. Should overdose of Silodosin 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 maintaining the patient in the supine position. If this measure is inadequate, administration of intravenous fluid should be considered. If necessary, vasopressors could be used, and renal function should be monitored and supported as needed. Dialysis is unlikely to be of significant benefit since Silodosin is highly (97%) protein bound.

Store at below 30°C in a dry place protected from light. Keep out of reach of Children.

BPH/ Urinary retention/ Urinary incontinence

Selectively blocks postsynaptic alpha-1 adrenoreceptors located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.

Pregnancy Category B. Silodosin is not indicated for use in women. An embryo/fetal study in rabbits showed decreased maternal body weight at 200 mg/kg/day (approximately 13-25 times the maximum recommended human exposure or MRHE of Silodosin via AUC). No statistically significant teratogenicity was observed at this dose. Silodosin was not teratogenic when administered to pregnant rats during organogenesis at 1000 mg/kg/day (estimated to be approximately 20 times the MRHE). No maternal or fetal effects were observed at this dose. Rats and rabbits do not produce glucuronidated Silodosin, which is present in human serum at approximately 4 times the level of circulating Silodosin and which has similar pharmacological activity to Silodosin. No effects on physical or behavioral development of offspring were observed when rats were treated during pregnancy and lactation at up to 300 mg/kg/day.