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The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies. In total, 1,581 patients have received silodosin at a dose
Apr 28, 2022 · The 24 mg dose of silodosin was selected to achieve blood levels of silodosin that may be seen in a “worst-case” scenario exposure (i.e. in the setting of concomitant renal disease or use of strong CYP3A4 inhibitors) [s ee Contraindications (4), Warnings and Precautions and Clinical Pharmacology (12.3)]. QT interval was measured during a 24 ...
Jun 5, 2024 · Silodosin is a white to pale yellowish white powder. It is sparingly soluble in methanol. Each silodosin capsule for oral administration contains 4 mg or 8 mg of silodosin, and the following inactive ingredients: gelatin, pregelatinized starch, sodium stearyl fumarate, sorbitol and titanium dioxide.
Sep 5, 2023 · Silodosin (Rapaflo) is used to treat symptoms of benign prostatic hyperplasia (BPH), or having an enlarged prostate. This medication is available as a brand-name and generic version, and it comes as a capsule that you take by mouth. The dosage is typically just once daily with a meal, but it can affect your ejaculation as a side effect (for ...
Mar 24, 2021 · The 24 mg dose of silodosin was selected to achieve blood levels of silodosin that may be seen in a “worst-case” scenario exposure (i.e. in the setting of concomitant renal disease or use of strong CYP3A4 inhibitors) [s ee Contraindications (4), Warnings and Precautions and Clinical Pharmacology (12.3)]. QT interval was measured during a 24 ...
Mechanism of Action: Silodosin is a selective antagonist of post-synaptic α 1 -adrenoreceptors in the prostate and bladder. Blockade of α 1 -adrenoreceptors causes relaxation of smooth muscle resulting to improved urine flow and reduced BPH symptoms. Pharmacokinetics: Absorption: Rapidly absorbed. Bioavailability: Approx 32%.
Silodosin is not indicated for use in the pediatric population. Safety and efficacy have not been established. Geriatric . Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of silodosin in the elderly.
