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APO-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 ......................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
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 double-blind, placebo-controlled clinical studies (Studies 1 and 2) in which 466 patients were administered silodosin and 457 patients were administered placebo.
8% for placebo treated). 8%) for silodosin treated patients. Retrograde ejaculation is reversible upon discontinuation of treatment. The incidence of adverse treatment-emergent events listed in the following table were derived from two 12-week, multicenter, double-blind, placebo-controlled clinical studies of silodosin 8 mg daily in BPH patients.
Adverse events that occurred in at least 2% of patients treated with silodosin and more frequently than with placebo are shown in Table 1. 2) _____________________________________________________________________________ APO-SILODOSIN Product Monograph August, 2018 Page 7 of 36 In Studies 1 and 2, treatment-related adverse events that were reported as ≥ 1% and < 2% of patients receiving silodosin and occurred more frequently than with placebo are presented in Table 2.
S. 7% of those receiving placebo. A test for orthostatic hypotension was conducted 2 to 6 hours after the first dose in the two 12- week, double-blind, placebo-controlled clinical studies. After the patient had been at rest in a supine position for 5 minutes, the patient was asked to stand.
Blood pressure and heart rate were assessed at 1 minute and 3 minutes after standing. A positive result was defined as a > 30 mmHg decrease in systolic blood pressure, or a > 20 mmHg decrease in diastolic blood pressure, or a > 20 bpm increase in heart rate, as presented in Table 3.
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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4%) _____________________________________________________________________________ APO-SILODOSIN Product Monograph August, 2018 Page 8 of 36 Less Common Clinical Trial Adverse Drug Reactions (< 1%) Vascular Disorders One case of syncope in a patient taking prazosin concomitantly was reported in the silodosin treatment group.
In a 9-month open-label safety study, loss of consciousness was observed in one patient. Because the investigator who examined this patient could not rule out the possibility that silodosin was causative, this event was considered related to silodosin use.
Post-Market Adverse Drug Reactions The following adverse events have been identified during post-approval use of silodosin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Eye Disorders: Cases of Intraoperative Floppy Iris Syndrome have been reported (see WARNINGS AND PRECAUTIONS, Ophthalmologic).
Hepatobiliary Disorders:
Cases of jaundice, impaired hepatic function associated with increased transaminase values, and abnormal liver function tests have been reported.
Immune System Disorders:
Cases of allergic-type reactions, not limited to skin reactions including swollen tongue and pharyngeal edema resulting in hospitalization have been reported.
Skin and Subcutaneous Tissue Disorders:
Cases of toxic skin eruption (drug eruption), purpura, skin rash, pruritus, urticaria, angioedema, dermatitis exfoliative, swelling face, erythema and erythema multiforme have been reported.
Cardiac Disorders:
Cases of tachycardia and palpitations have been reported. Respiratory […]