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Silodosin

Generic Name
Silodosin
Brand Names
Rapaflo, Silodyx, Urorec, Silodosin Recordati
Drug Type
Small Molecule
Chemical Formula
C25H32F3N3O4
CAS Number
160970-54-7
Unique Ingredient Identifier
CUZ39LUY82

Overview

Silodosin is a selective antagonist of alpha(α)-1 adrenergic receptors that binds to the α subtype with the highest affinity. α1-adrenergic receptors regulate smooth muscle tone in the bladder neck, prostate, and prostatic urethra: the α subtype accounts for approximately 75% of α1-adrenoceptors in the prostate. Silodosin was first approved by the FDA in October 2008 and it is also approved in Europe and Canada. Silodosin is available as oral capsules with common trade names Rapaflo and Urorec. It is indicated for the symptomatic treatment of benign prostatic hyperplasia in adults. Most commonly affecting males over the age of 40 years, benign prostatic hyperplasia is the non-malignant enlargement of the prostate gland, associated with lower urinary tract symptoms that have a negative impact on the quality of life of patients. Silodosin works by binding to α-adrenoceptors with high affinity and relaxing the lower urinary tract, thereby improving urinary symptoms and alleviating bladder outlet obstruction.

Indication

Silodosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). It is not indicated for the treatment of hypertension.

Associated Conditions

  • Benign Prostatic Hyperplasia (BPH)

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvKARE
42291-778
ORAL
8 mg in 1 1
1/10/2024
Alembic Pharmaceuticals Limited
46708-405
ORAL
4 mg in 1 1
1/30/2023
MSN LABORATORIES PRIVATE LIMITED
69539-053
ORAL
8 mg in 1 1
12/29/2020
Alembic Pharmaceuticals Inc.
62332-406
ORAL
8 mg in 1 1
7/15/2021
Novadoz Pharmaceuticals LLC
72205-009
ORAL
4 mg in 1 1
1/1/2021
PD-Rx Pharmaceuticals, Inc.
72789-351
ORAL
4 mg in 1 1
9/22/2023
Amneal Pharmaceuticals NY LLC
69238-1421
ORAL
4 mg in 1 1
12/30/2023
Alembic Pharmaceuticals Inc.
62332-405
ORAL
4 mg in 1 1
7/15/2021
Novadoz Pharmaceuticals LLC
72205-010
ORAL
8 mg in 1 1
1/1/2021
Camber Pharmaceuticals, Inc.
31722-635
ORAL
4 mg in 1 1
2/25/2020

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Silodosin Capsules
国药准字H20244076
化学药品
胶囊剂
6/18/2024
Silodosin Capsules
国药准字H20234393
化学药品
胶囊剂
10/27/2023
Silodosin Capsules
国药准字H20249444
化学药品
胶囊剂
11/22/2024
Silodosin Capsules
国药准字H20244313
化学药品
胶囊剂
6/28/2024
Silodosin Capsules
国药准字H20233954
化学药品
胶囊剂
7/25/2023
Silodosin Capsules
国药准字H20234269
化学药品
胶囊剂
10/12/2023
Silodosin Capsules
国药准字H20223105
化学药品
胶囊剂
3/1/2022
Silodosin Capsules
国药准字H20233605
化学药品
胶囊剂
5/26/2023
Silodosin Capsules
国药准字H20213612
化学药品
胶囊剂
7/28/2021
Silodosin Capsules
国药准字H20110100
化学药品
胶囊剂
8/11/2021

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
UROREC silodosin 8 mg hard capsule blister pack
275265
Medicine
A
5/23/2017
UROREC silodosin 4 mg hard capsule blister pack
275256
Medicine
A
5/23/2017

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