What is Silodosin used for?

1 INDICATIONS AND USAGE 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

How does Silodosin work?

11 DESCRIPTION Silodosin capsule is a selective antagonist of alpha-1 adrenoreceptors.

What pharmaceutical form is Silodosin available in?

Silodosin: Kapsułki twarde 4 mg (doustna)

Is Silodosin OTC or prescription only?

Silodosin requires a doctor's prescription.

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 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 c

Who should NOT take Silodosin?

4 CONTRAINDICATIONS Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)]. ( 4 ) Patients with severe hepatic impairment (Child-Pugh score ≥ 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 ) Severe renal impairment (CCr < 30 mL/min) Sev

Does Silodosin interact with other medications?

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 )

Can Silodosin be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Renal impairment: Dose adjustment in moderate disease ( 2.2 ). Contraindicated in severe renal disease. ( 4 ) Hepatic impairment: Contraindicated in severe disease. ( 4 ) 8.1 Pregnancy Risk Summary Silodosin is not indicated for use in females. 8.2 Lactation Silodosin is not indicated for use in females. 8.3 Females and Males of Reproductive Potential Infertility Males Possible effects on male fertility could be observed based on findings in rats a

What precautions should be taken with Silodosin?

•Caution should be exercised in patients with history of low blood pressure, kidney or liver disease, elderly and children. Avoid driving a car or operating machinery, as it may cause dizziness and lightheadedness. Get up slowly from bed while taking this medication as silodosin can result in postural hypotension. Silodosin is prescribed only for men and is not advisable for women especially during pregnancy and breastfeeding.

Who manufactures Silodosin?

Recordati Ireland Limited (Francja)

What ATC class does Silodosin belong to?

Silodosin: ATC G04CA04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Silodosin

4 mg, Kapsułki twarde

INN: Silodosinum

Data updated: 2026-04-13

Available in:

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Form

Kapsułki twarde

Dosage

4 mg

Route

doustna

Storage

—

About This Product

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