Silodosin capsules, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasi.
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Silodosin capsules, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsule is not indicated for the treatment of hypertension. ( 1 ) Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES ( 14 )] . Silodosin capsule is not indicated for the treatment of hypertension.
Capsules: 8 mg and 4 mg. ( 3 ) The 8 mg, size '1' capsules with white opaque cap and white opaque body imprinted with "LU" on the cap and "Q72" on the body in green ink. The 4 mg, size '3' capsules with white opaque cap and white opaque body imprinted with "LU" on the cap and "Q71" on the body in gold ink.
In double-blind, placebo-controlled, 12-week clinical studies of silodosin, 259 (55.6%) were under 65 years of age, 207 (44.4%) patients were 65 years of age and over, while 60 (12.9%) patients were 75 years of age and over. Orthostatic hypotension was reported in 2.3% of silodosin patients < 65 years of age (1.2% for placebo), 2.9% of silodosin patients ≥ 65 years of age (1.9% for placebo), and 5.0% of patients ≥ 75 years of age (0% for placebo) …
Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. ( 7.2 ) Alpha-blockers: Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. ( 7.3 ) Concomitant use of PDE5 inhibitors with alpha-blockers including silodosin can potentially cause symptomatic hypotension. …
Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning silodosin treatment. ( 5.1 ) In patients with moderate renal impairment, silodosin dose should be reduced to 4 mg once daily. ( 5.2 ) Silodosin should not be used in combination with other alpha-blockers. ( 5.5 ) Examine patients thought to have BPH prior to starting therapy with silodosin to rule out the presence of carcinoma of the prostate. ( 5.6 ) Inform patients planning cataract surgery to notify their ophthalmologist that they are taking silodosin because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS). …
Most common adverse reactions (incidence ≥ 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In U.S. …
8.1 Pregnancy Risk Summary Silodosin is not indicated for use in females.
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. …
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Products with Silodosin as the active ingredient. Names differ between countries.
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Silodosin capsules, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsule is not indicated for the treatment of hypertension. ( 1 ) Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDI (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: 8 mg capsules taken orally once daily with a meal. ( 2.1 ) 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30 mL/min to 50 mL/min]. ( 2.2 ) 2.1 Dosing Information The recommended dose is 8 mg orally once daily with a meal. Patients who have difficulty swallowing pills and capsules may carefully open the silo…
Usually yes. Silodosin is a prescription medicine in most countries. Rules differ by country.
Silodosin is sold under names such as Rapaflo. Brand names differ between countries.
The official label lists: Most common adverse reactions (incidence ≥ 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are c… Tell your doctor about any side effect that bothers you or does not go away.
Silodosin is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established. Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy Risk Summary Silodosin is not indicated for use in females. Ask your doctor or midwife first.
Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. ( 7.2 ) Alpha-blockers: Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. ( 7.3 ) Concomitant use of PDE5 inhibitors with alpha-blockers… Use the free interaction checker before combining medicines.
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 he… Get medical help right away.
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This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.