Description
Hydrocortisone Tablets (5 mg / 10 mg / 20 mg)
Healthy Inc is a specialized global supplier and exporter of advanced endocrinology, immunology, and segregated corticosteroid therapeutics. We provide ultra-high-purity, kinetically precise Hydrocortisone Uncoated / Scored Tablets (5 mg / 10 mg / 20 mg), manufactured in WHO–GMP certified, strictly isolated hormonal oral solid dosage facilities. This “Short-Acting Glucocorticoid & Cortisol Replacement” is a highly critical, life-saving export to endocrinology centers, rare disease NGO networks, pediatric hospitals, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, foundational intervention for Primary Adrenal Insufficiency (Addison’s Disease) and Congenital Adrenal Hyperplasia (CAH).
Product Overview
This highly advanced formulation operates not just as a drug, but as a direct physiological replacement. It is biologically identical to endogenous human cortisol, acting as the master regulator of the body’s metabolism, blood pressure, and immune response to acute stress.
The “Physiological Biomimicry & Diurnal Regulator” Specialist:
- Mechanism 1 (The Genomic Anti-Inflammatory Engine): Hydrocortisone passively crosses the cell membrane and binds to the intracellular glucocorticoid receptor. This complex then moves directly into the cell’s nucleus, where it forcefully rewrites gene transcription. It violently suppresses the production of inflammatory cytokines and prostaglandins, halting severe allergic reactions and autoimmune tissue destruction.
- Mechanism 2 (The Lifesaving Adrenal Replacement): In patients with Addison’s disease, the adrenal glands have been destroyed. During physical stress (like an infection or surgery), normal humans pump out massive amounts of cortisol to keep their blood pressure from crashing. Addison’s patients cannot. Oral Hydrocortisone replaces this vital hormone, regulating sodium/water balance and maintaining vascular tone, literally keeping the patient alive.
- The “Diurnal Rhythm” Dosing Paradigm: Unlike standard medications, Hydrocortisone for adrenal insufficiency must mimic the sun. The human body naturally surges with cortisol in the morning and tapers off at night. Our precisely scored 5mg and 10mg tablets allow endocrinologists to prescribe a “split-dose” regimen (e.g., 15mg upon waking, 5mg in the afternoon) to perfectly replicate the body’s natural circadian rhythm, preventing severe fatigue and metabolic collapse.
Product Composition & Strength
We supply this product as a Precision-Blended, Scored Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the micronized steroid payload.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Hydrocortisone USP/Ph.Eur. | 5 mg / 10 mg (Scored) | Titration & Afternoon Standard: Highly precise, low-dose units engineered for pediatric CAH dosing and the critical “afternoon taper” in adult replacement therapy. |
| Hydrocortisone USP/Ph.Eur. | 20 mg (Scored) | Morning Surge & Acute Flare Standard: High-efficacy dosing to replicate the natural morning cortisol spike, or for short-term suppression of acute severe allergic or inflammatory conditions. |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Sodium Starch Glycolate / Magnesium Stearate | Diluent / Binder / Superdisintegrant / Lubricant (Engineered utilizing Micronized API—the steroid particles are milled to a microscopic size before blending to guarantee immediate, consistent gastric absorption, which is critical to avoid unpredictable hormone spikes) |
*Pack Sizes: Bottles of 100 or 10×10 Blisters (Optimized specifically for strict chronic, lifelong endocrinology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Endocrinology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.32.00 (Medicaments containing corticosteroid hormones, their derivatives or structural analogues) |
| CAS Number | 50-23-7 (Hydrocortisone) |
| Dosage Form | Uncoated / Scored Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates, ensuring absolute API integrity. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Hormonal Segregation & Micronized Dispension (CRITICAL COMPLIANCE): Manufacturing systemic corticosteroids is a high-risk operation. To prevent catastrophic cross-contamination of non-steroidal drugs, our Hydrocortisone lines are housed in completely isolated, dedicated hormonal blocks with independent HVAC systems. Furthermore, standard raw hydrocortisone is highly insoluble. We utilize advanced air-jet milling to micronize the API, ensuring flawless content uniformity across even the smallest 5mg tablets. This proves to major hospital boards that our dosing is clinically exact.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of endocrine failure and severe inflammation:
- Adrenocortical Insufficiency: The primary, foundational replacement therapy for Addison’s disease (primary) or pituitary failure (secondary).
- Congenital Adrenal Hyperplasia (CAH): Lifelong management to suppress excess androgen production in pediatric and adult patients.
- Acute Inflammatory/Allergic States: Short-term management of severe asthma exacerbations, extreme contact dermatitis, and severe autoimmune flare-ups.
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist Guidelines):
- Adrenal Replacement Therapy: Typically 20 mg to 30 mg daily, divided to mimic the diurnal rhythm (e.g., 15-20 mg upon waking, and 5-10 mg in the late afternoon).
- The “Sick Day” Rule (CRITICAL SURVIVAL PROTOCOL): During periods of physical stress (fever, infection, surgery), the patient’s body requires massively increased cortisol. The oral dose must be doubled or tripled immediately. Failure to do so will result in a fatal adrenal crisis.
- Administration: MUST be taken with food or milk to drastically reduce the risk of severe gastric ulceration.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- HPA Axis Suppression (The Tapering Mandate): In patients taking high doses for inflammation, the drug forces the body’s own adrenal glands to go to sleep. Abruptly stopping the medication will cause fatal acute adrenal insufficiency. The dose must be tapered off slowly over weeks or months.
- Severe Immunosuppression: Corticosteroids massively suppress the immune system. Patients are at a highly elevated risk of severe, opportunistic infections. Exposure to chickenpox or measles can be fatal in non-immune patients taking high doses.
- Osteoporosis & Bone Fractures: Chronic use violently accelerates bone density loss, leading to severe osteoporosis and spontaneous vertebral fractures.
- Psychiatric Disturbances: Can trigger profound steroid-induced psychosis, extreme mood swings, severe insomnia, and depression.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Endocrinology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Corticosteroids, Hormonal Therapies, and Segregated Tableting Formulations. Whether you are looking for a reliable Government Tender Supplier for rare disease 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











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