Flosin 4

Silodosin selectively blocks post-synaptic alpha-1 adrenoreceptors found in the human prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. By blocking these receptors, it relaxes smooth muscle in these tissues, which improves urine flow and reduces BPH symptoms.

Pregnancy Category B. Silodosin is not indicated for use in women. In an embryo/fetal study, pregnant rabbits given 200 mg/kg/day (about 13 to 25 times the maximum recommended human exposure, or MRHE, of Silodosin by AUC) showed decreased maternal body weight; no statistically significant teratogenicity was seen at this dose. In pregnant rats, Silodosin given during organogenesis at 1000 mg/kg/day (about 20 times the MRHE) was not teratogenic, and no effects on the mother or fetus were observed at this dose. Rats and rabbits do not produce glucuronidated Silodosin, a compound found in human serum at roughly 4 times the level of circulating Silodosin and with pharmacological activity similar to Silodosin's. When rats were treated throughout pregnancy and lactation at doses up to 300 mg/kg/day, no effects on the offspring's physical or behavioral development were seen.

Silodosin is not indicated for children.

In older patients, the double-blind, placebo-controlled studies of Silodosin ran for 12 weeks. Of the patients, 259 (55.6%) were under 65 years of age, 207 (44.4%) were 65 or over, and 60 (12.9%) were 75 or over. Orthostatic hypotension was reported in 2.3% of Silodosin patients under 65 (1.2% for placebo), 2.9% of those over 65 (1.9% for placebo), and 5.0% of those over 75 (0% for placebo). Apart from this, there were no significant differences in safety or effectiveness between older and younger patients.

In kidney problems, Silodosin must not be used in patients with severe renal impairment (CrCl <30 mL/min). For moderate renal impairment (CrCl 30-50 mL/min), the dose should be reduced, and the medicine taken once daily with a meal. Patients with mild renal impairment (CrCl 50-80 mL/min) need no dose adjustment.

In liver problems, Silodosin has not been studied in patients with severe hepatic impairment (Child-Pugh score >10), so it is contra-indicated in these patients. No dose adjustment is needed in mild or moderate hepatic impairment.

Silodosin was tested in healthy men at doses of up to 48 mg/day. The dose-limiting adverse event was postural hypotension. If an overdose of Silodosin causes low blood pressure, the first priority is to support the cardiovascular system. Keeping the patient lying flat (in the supine position) may bring blood pressure back and settle the heart rate. If that isn't enough, intravenous fluid should be considered. Vasopressors could be used if necessary, and renal function should be monitored and supported as needed. Dialysis is unlikely to help much, because Silodosin is highly (97%) protein bound.

Keep Silodosin below 30°C, in a dry place and away from light. Keep it out of the reach of children.