Silodosin
Generic Name: silodosin
Brand Names:
Silodosin
11 DESCRIPTION Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2 R )-2-({2-[2-(2,2,2- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H -indole-7-carboxamide and the molecular formula is C 25 H 32 F 3 N 3 O 4 with a molecular weight of 495.53. The structural formula of silodosin is: Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C.
Overview
11 DESCRIPTION Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2 R )-2-({2-[2-(2,2,2- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H -indole-7-carboxamide and the molecular formula is C 25 H 32 F 3 N 3 O 4 with a molecular weight of 495.53. The structural formula of silodosin is: Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C.
Uses
1 INDICATIONS AND USAGE Silodosin, 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 capsules are not indicated for the treatment of hypertension. Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension. (1)
Dosage
2 DOSAGE AND ADMINISTRATION 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 silodosin capsule and sprinkle the powder inside on a tablespoonful of applesauce. The applesauce should be swallowed immediately (within 5 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing.
Side Effects
6 ADVERSE REACTIONS 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 AvKARE at 1-855-361-3993 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. 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.
Interactions
7 DRUG INTERACTIONS 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. ( 5.5 , 7.5 ) 7.1 Moderate and Strong CYP3A4 Inhibitors In a clinical metabolic inhibition study, a 3.8-fold increase in silodosin maximum plasma concentrations and 3.2-fold increase in silodosin exposure were observed with concurrent administration of a strong CYP3A4 inhibitor, 400 mg ketoconazole.
Warnings
5 WARNINGS AND PRECAUTIONS 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). ( 5.7 ) 5.1 Orthostatic Effects Postural hypotension, with or without symptoms (e.g., dizziness) may develop when beginning silodosin treatment. 4 CONTRAINDICATIONS Severe renal impairment (CCr 10). (4) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). (4) Patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin capsules. (4)
Pregnancy
8.1 Pregnancy Risk Summary Silodosin capsules are not indicated for use in females.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Silodosin Capsules, 4 mg are supplied as white, opaque, hard # 3 gelatin capsules imprinted with “AN” in gold on the cap and “1421” in gold on the body.
Frequently Asked Questions
What is Silodosin used for?▼
1 INDICATIONS AND USAGE Silodosin, 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 capsules are not indicated for the treatment of hypertension. Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension. (1)
What are the side effects of Silodosin?▼
6 ADVERSE REACTIONS 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 AvKARE at 1-855-361-3993 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. 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.
Can I take Silodosin during pregnancy?▼
8.1 Pregnancy Risk Summary Silodosin capsules are not indicated for use in females.
What are the important warnings for Silodosin?▼
5 WARNINGS AND PRECAUTIONS 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). ( 5.7 ) 5.1 Orthostatic Effects Postural hypotension, with or without symptoms (e.g., dizziness) may develop when beginning silodosin treatment. 4 CONTRAINDICATIONS Severe renal impairment (CCr 10). (4) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). (4) Patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin capsules. (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.