Description

Dexamethasone Tablets (0.5mg / 4mg / 8mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Dexamethasone Tablets in India. Dexamethasone is a potent, long-acting Synthetic Glucocorticoid (Corticosteroid). It is roughly 25 to 30 times more potent than Hydrocortisone and virtually devoid of mineralocorticoid activity (sodium retaining effects), making it the drug of choice for treating severe inflammation and cerebral edema where water retention must be avoided.

We offer Contract Manufacturing (Third Party) services for this essential medicine. Dexamethasone gained global prominence recently as a life-saving intervention for severe respiratory distress (including COVID-19 protocols). Our WHO-GMP certified facility in Mumbai has high-capacity manufacturing lines capable of producing millions of tablets daily to meet emergency procurement demands. Healthy Inc manages the export logistics, supplying hospitals, government stockpiles, and pharmacy chains across Latin America, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

High potency, low dose stability.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronized Homogeneity: Since Dexamethasone is effective at very low doses (0.5mg), proper distribution within the tablet is critical. We use Micronized API and Geometric Dilution blending to ensuring that every tablet has the exact same potency, preventing sub-therapeutic or toxic dosing.

  • Direct Compression: Dexamethasone is heat-sensitive. We often utilize Direct Compression technology to avoid the heat and moisture of wet granulation, preserving the chemical stability of the steroid molecule over its 3-year shelf life.

  • High-Speed Output: Designed for pandemic preparedness, our lines are optimized for rapid changeover and high-volume throughput.

• The Exporter: Healthy Inc

  • Emergency Kits: We are experienced in supplying “Dexa” in hospital bulk packs (1000s) for ICU usage and blister packs for outpatient tapering regimens.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Content Uniformity: We perform rigorous statistical testing (AV value) to ensure strict dose consistency across the batch.

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

5. Why Use Dexamethasone?

Stops inflammation at the source.

• Mechanism: Dexamethasone diffuses into the cell and binds to the Glucocorticoid Receptor in the cytoplasm. The complex moves to the nucleus and modulates DNA transcription.

  It inhibits the production of pro-inflammatory cytokines (like IL-1, IL-6, TNF-alpha) and prostaglandins. Unlike other steroids, it has minimal effect on salt and water retention.

• Key Indications:

  • Severe Inflammation: Arthritis, severe allergic reactions, and asthma flares.

  • Cerebral Edema: Reducing brain swelling associated with tumors or trauma.

  • Respiratory Distress: Standard of care for hypoxemic patients (e.g., severe COVID-19 or pneumonia).

  • Oncology: Used to prevent chemotherapy-induced nausea and vomiting (CINV) and to treat certain blood cancers (Myeloma).

  • Fetal Lung Maturation: Given to mothers at risk of preterm delivery.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Dexamethasone Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Decadron?

  A: Decadron is the brand name (Merck). We manufacture the Generic Equivalent (Dexamethasone).

• Q: Does it cause weight gain?

  A: Yes. Long-term use often causes increased appetite and fat redistribution (Moon Face / Buffalo Hump). This is less common with short courses (less than 2 weeks).

• Q: Can I stop it suddenly?

  A: NO. If taken for more than a few days, it suppresses your natural adrenal glands. Sudden stopping can cause an “Adrenal Crisis” (shock). Dosage must be tapered down slowly.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Anti-inflammatory: 0.75mg to 9mg daily in divided doses.

• Cerebral Edema: Initial high dose (IV), followed by 4mg tablet every 6 hours.

• Respiratory (COVID-19 protocol): 6mg once daily for up to 10 days.

• Administration: Take with food or milk to minimize gastric irritation.

9. Side Effects and Precautions

• Endocrine: Hyperglycemia (high blood sugar – caution in Diabetics), Cushing’s Syndrome, Adrenal Suppression.

• Immune: Increases susceptibility to infection (Immunosuppression).

• Musculoskeletal: Osteoporosis (long-term use) and muscle wasting.

• Psychiatric: Mood swings, insomnia, or euphoria (“Steroid Psychosis”).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.