SILODOSIN 8 MG TABLET

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Description

Silodosin Tablets (8 mg)

Healthy Inc is a specialized global supplier and exporter of advanced urological, geriatric, and men’s health therapeutics. We provide ultra-high-purity, kinetically stabilized Silodosin Film-Coated Tablets (8 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Highly Selective Alpha-1A Adrenergic Receptor Antagonist” is a premium, high-value export to urology centers, specialized geriatric clinics, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, highly tolerable intervention for the rapid relief of Benign Prostatic Hyperplasia (BPH).


Product Overview

This formulation contains Silodosin, a highly advanced, next-generation alpha-blocker that provides massive improvements in urinary flow without the dangerous cardiovascular side effects associated with older BPH medications.

The “Ultra-Selective Prostate Relaxant” Specialist:

  • Mechanism 1 (The Prostate Checkpoint): In men with BPH, the enlarged prostate physically squeezes the urethra, making urination extremely difficult and painful. The smooth muscle in the prostate and bladder neck is controlled by Alpha-1A receptors. Silodosin acts as a highly targeted chemical key, aggressively binding to and blocking these specific receptors. This physically relaxes the smooth muscle, opening the urethra and allowing urine to flow freely and forcefully.
  • The “No-Fainting” Advantage (Uro-Selectivity): Older drugs (like Terazosin, Doxazosin, and even Tamsulosin) also block Alpha-1B receptors located in the blood vessels. When an elderly man stands up, those older drugs cause his blood pressure to dangerously plummet, leading to dizzy spells and falls. Because Silodosin is exponentially more selective for the Alpha-1A (prostate) receptor over the Alpha-1B (blood vessel) receptor, it delivers maximum urinary relief with practically zero risk of orthostatic hypotension.
  • Rapid Onset: Unlike hormonal BPH drugs (like Finasteride) that take 6 months to shrink the prostate, Silodosin provides significant, noticeable relief of urinary hesitation, frequency, and nighttime waking (nocturia) within just a few days of starting the medication.

Product Composition & Strength

We supply this product as a Precision-Blended Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the active pharmaceutical ingredient.

Active IngredientStrengthPrimary Clinical Function
Silodosin INN/Ph.Eur.8 mgGlobal Clinical Standard: Maximum adult daily dose for the rapid relief of lower urinary tract symptoms (LUTS) associated with BPH.
ExcipientsMannitol / Pregelatinized Starch / Sodium Stearyl Fumarate / Hypromellose / Titanium DioxideDiluent / Binder / Lubricant / Film-Coating (Engineered for highly synchronized gastric dissolution and optimal bioavailability)

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for high-compliance 30-day urology dispensing regimens).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Urology Distributors, and Hospital Procurement Boards.

HS Code3004.90.99 (Medicaments containing other active substances – Urologicals)
CAS Number160970-54-7
Dosage FormFilm-Coated Tablet (Immediate Release)
PackagingAlu-Alu Blisters (STRICTLY MANDATORY). Ensures the absolute protection of the highly sensitive formulation from environmental humidity and hydrolytic degradation across Zone IVb tropical climates.
StorageStore strictly below 30°C in a dry place. Protect from Light and Moisture.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Precision Low-Dose Geometric Blending: Distributing an 8 mg active ingredient uniformly throughout a standard tablet matrix requires elite pharmaceutical engineering. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by rigorous HPLC content uniformity testing, to guarantee that every single tablet delivers the exact milligram dose, preventing sub-therapeutic clinical failures or localized toxicity.

Therapeutic Indications (Human Use)

Indicated for the targeted management of lower urinary tract symptoms (LUTS):

  • Benign Prostatic Hyperplasia (BPH): Treatment of the signs and symptoms of BPH in adult men, specifically targeting urinary frequency, urgency, weak stream, and incomplete emptying.
  • CRITICAL LIMITATION: Silodosin is not indicated for the treatment of hypertension.

Dosage & Administration

Recommended Dosage (Strictly as per Urologist Guidelines):

  • Standard Adult Dosing: 8 mg taken orally once daily.
  • Administration (THE MEALTIME RULE): To ensure consistent absorption and drastically reduce the minimal risk of orthostatic hypotension, the tablet MUST be taken with a meal, ideally at the same time every day.
  • Renal Impairment: In patients with moderate renal impairment (Creatinine Clearance 30-50 mL/min), the dose must be strictly reduced to 4 mg once daily. It is contraindicated in patients with severe renal impairment (CCr < 30 mL/min).

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • Retrograde Ejaculation (Signature Side Effect): Because Silodosin powerfully relaxes the bladder neck, seminal fluid can travel backward into the bladder instead of out through the urethra during orgasm. Patients must be warned that they may experience a massive decrease in, or complete absence of, semen (anejaculation). This is harmless, completely reversible upon stopping the drug, and proves the medication is physically working.
  • Intraoperative Floppy Iris Syndrome (IFIS): Alpha-blockers cause the muscle in the iris of the eye to lose its tone. If a patient requires cataract surgery, they must inform their ophthalmologist that they are taking Silodosin, as IFIS can severely complicate the surgical procedure.
  • Hepatic Impairment: Contraindicated in patients with severe hepatic impairment.
  • CYP3A4 Drug Interactions: Silodosin is heavily metabolized by the CYP3A4 liver enzyme. Co-administration with potent CYP3A4 inhibitors (like Ketoconazole, Ritonavir, or Clarithromycin) is strictly contraindicated, as it will cause a massive, toxic accumulation of Silodosin in the blood.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Urological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for urology clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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