Description

Flutamide Film-Coated Tablets (250 mg)

Healthy Inc is a specialized global supplier and exporter of advanced uro-oncology, high-containment hormonal, and targeted antineoplastic therapeutics. We provide ultra-high-purity, kinetically precise Flutamide Film-Coated Tablets (250 mg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4) oral solid dosage facilities. This “Non-Steroidal Antiandrogen (NSAA)” is a massive-volume, highly critical export to urology centers, national prostate cancer networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, foundational intervention for Metastatic Prostate Cancer (Stage D2) when utilized in combination with LHRH agonists.

Product Overview

This highly advanced formulation operates as a targeted biochemical shield. Prostate cancer cells are fueled almost entirely by androgens (testosterone and DHT). Flutamide physically starves the tumor by cutting off its ability to “feed” on these hormones, halting malignant growth and inducing tumor regression.

The “Androgen Receptor Antagonist & Flare-Shield” Specialist:

• Mechanism 1 (The Competitive Receptor Blockade): Flutamide and its active metabolite (hydroxyflutamide) are profound, competitive inhibitors of the androgen receptor. They aggressively bind to the receptors located directly on the prostate cancer cells. By physically occupying the lock, they prevent the body’s natural testosterone and highly potent dihydrotestosterone (DHT) from binding, completely paralyzing the tumor’s primary growth signal.
• Mechanism 2 (The LHRH Flare Protection – CRITICAL): The gold-standard treatment for advanced prostate cancer is chemical castration using LHRH agonists. However, these injectable drugs cause an initial, massive surge of testosterone (the “flare”) before shutting production down. This flare can cause explosive tumor growth, severe bone pain, and fatal spinal cord compression. Flutamide is initiated prior to or concurrently with the LHRH agonist to completely block this testosterone surge from reaching the tumor, neutralizing the catastrophic flare effect.
• The “Maximum Androgen Blockade” Paradigm: Even after surgical or chemical castration, the adrenal glands continue to produce a small amount of circulating androgens (about 5-10%). By combining castration with Flutamide, oncologists achieve “Maximum Androgen Blockade” (MAB), starving the tumor of absolutely all androgenic fuel and significantly extending patient survival.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the antiandrogen API.

*Pack Sizes: 10×10 Blisters or Bottles of 100 (Optimized specifically for strict, high-volume chronic oncology dispensing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• OEB 4 High-Containment & Hormonal Segregation (CRITICAL COMPLIANCE): Flutamide is a potent antiandrogen. Manufacturing this compound in standard generic facilities is strictly prohibited due to the severe risk of feminization and endocrine disruption in factory workers and the threat of cross-contaminating other drugs. Our production takes place in dedicated High-Containment Isolator blocks (OEB 4) equipped with terminal HEPA filtration. Furthermore, our formulation undergoes rigorous *in-vitro* dissolution testing to guarantee identical pharmacokinetic bioequivalence to the originator, ensuring precise 8-hour serum levels.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of androgen-dependent malignancies:

• Metastatic Prostate Cancer (Stage D2): Used in combination with Luteinizing Hormone-Releasing Hormone (LHRH) agonists (such as Leuprolide or Goserelin) for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
• Hirsutism & PCOS (Off-Label / Regional): Occasionally utilized in severe, refractory cases of hyperandrogenism in women, though heavily restricted due to hepatotoxicity.

Dosage & Administration

Recommended Dosage (Strictly as per Uro-Oncologist Guidelines):

• Prostate Cancer: The recommended adult dosage is 250 mg taken orally three times a day at 8-hour intervals (total daily dose of 750 mg).
• Administration: Can be taken with or without food. Tablets must be swallowed whole. Strict compliance to the 8-hour schedule is mandatory to prevent gaps in androgen blockade.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Severe Hepatotoxicity): Flutamide has been linked to severe, highly fatal liver injury, including acute hepatic failure requiring liver transplantation. Strict, periodic Liver Function Tests (LFTs) are absolutely mandatory prior to initiation and monthly for the first 4 months. Therapy must be discontinued immediately if jaundice develops or ALT levels exceed twice the upper limit of normal.
• Amber / Yellow-Green Urine: Flutamide metabolites frequently completely change the color of the patient’s urine to a dark amber or yellow-green. Patients must be explicitly warned of this harmless effect so they do not panic and assume their kidneys are failing.
• Gynecomastia & Hot Flashes: Severe breast tenderness, enlargement (gynecomastia), and intense vasomotor hot flashes are extremely common side effects of total androgen blockade.
• Teratogenic Warning: Strictly contraindicated in women who are or may become pregnant due to severe fetal harm (feminization of male fetuses). Handlers who are pregnant must not touch crushed or broken tablets.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Uro-Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antiandrogens, Antineoplastics, and OEB 4 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for national prostate cancer programs in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.