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PMS-SILODOSIN is a brand name for Silodosin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
pms-SILODOSIN (silodosin) is contraindicated in patients known to have hypersensitivity to silodosin or any component of the pms-SILODOSIN formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
pms-SILODOSIN should not be administered to patients with severe hepatic impairment (Child-Pugh scores ≥ 10) (see WARNINGS AND PRECAUTIONS section). pms-SILODOSIN should not be administered to patients with severe renal impairment (CCr < 30 mL/min) (see WARNINGS AND PRECAUTIONS section).
, ketoconazole, clarithromycin, itraconazole, ritonavir) (see WARNINGS AND PRECAUTIONS section). , prazosin, terazosin, doxazosin) (see WARNINGS AND PRECAUTIONS section). WARNINGS AND PRECAUTIONS As with all α1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with silodosin, as a result of which, rarely, syncope can occur.
At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared (see WARNINGS AND PRECAUTIONS, Cardiovascular section and ADVERSE REACTIONS section). Patients beginning treatment with pms-SILODOSIN should be cautioned to avoid situations where injury could result should syncope occur.
General Prostatic carcinoma:
Carcinoma of the prostate and BPH cause many of the same symptoms. These two diseases frequently co-exist. Therefore, patients thought to have BPH should be examined prior to starting therapy with pms-SILODOSIN to rule out the presence of carcinoma of the prostate.
Carcinogenesis and Mutagenesis Carcinogenicity and mutagenicity studies have been performed in animals (see TOXICOLOGY section). Cardiovascular pms-SILODOSIN is not indicated for the treatment of hypertension. , dizziness) may develop when beginning silodosin treatment.
As with other alpha-blockers, there is potential for syncope. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating pms-SILODOSIN – Product Monograph page 5 of 38 therapy. pms-SILODOSIN should not be administered to patients using concomitant alpha-blockers.
pms- SILODOSIN should be administered with caution to patients using other concomitant pharmaceuticals known or suspected of inducing orthostatic hypotension or syncope (see ADVERSE REACTIONS, Vascular Disorders section and DRUG INTERACTIONS, Drug-Drug Interactions section).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Silodosin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Endocrine and Metabolism pms-SILODOSIN should not be administered to patients using concomitant potent CYP3A4 inhibitors. Hepatic pms-SILODOSIN should not be administered to patients with severe hepatic insufficiency (Child- Pugh scores ≥ 10).
Ophthalmologic Intraoperative Floppy Iris Syndrome has been observed during cataract surgery in some patients on alpha-1 blockers or previously treated with alpha-1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents; progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs; and potential prolapse of the iris toward the phacoemulsification incisions.
Patients planning cataract surgery should be told to inform their ophthalmologist that they are taking pms-SILODOSIN. Renal pms-SILODOSIN should not be administered to patients with severe renal insufficiency (CCr < 30 mL/min). In patients with moderate renal impairment (CCr 30 - 50 mL/min), the dose should be reduced to 4 mg once daily taken with a meal.
No dosage adjustment is needed in patients with mild renal impairment (CCr 50-80 mL/min). Special Populations Pregnant Women: pms-SILODOSIN is not indicated nor recommended for use in women. No embryotoxic and/or teratogenic effects in rats or rabbits were observed with silodosin.
Nursing Women: pms-SILODOSIN is not indicated nor recommended for use in women. It is unknown if the drug is excreted in human milk. Pediatrics (< 18 years of age): pms-SILODOSIN is not indicated for use in children. 9%) patients were 75 years of age and over.
0% of patients ≥ 75 years of age (0% for placebo). There were otherwise no significant differences in safety or effectiveness between older and younger patients. ADVERSE REACTIONS Adverse Drug Reaction Overview Retrograde ejaculation and dizziness are the most frequent adverse events with silodosin.
Retrograde ejaculation is reversible upon discontinuation of the drug. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. S. Phase 3 clinical trials, 897 patients with BPH were exposed to 8 mg silodosin daily. This includes 486 patients exposed for 6 months and 168 patients exposed for 1 year.
The population was 44 to 87 years of age, and predominantly Caucasian. 7% were 75 years of age or older. S. Phase 3 […]