Azotus-50 Tablet
Azathioprine 50 mg Tablets — Steroid-Sparing Immunosuppressant
| Composition | Azathioprine 50 mg |
|---|---|
| Dosage Form | Tablet |
| Pack Type | Blister |
| Pack Size | 10 x 10 Tablets |
| MRP | ₹ 1210 |
| Therapy | G.P. + Orthopaedics + Gynaecology — Purine Antagonist / Immunosuppressant |
| Storage | Store below 30 °C in a dry place, protected from light and moisture. |
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About Azotus-50 Tablet
Azotus-50 Tablet contains Azathioprine 50 mg, a classical thiopurine immunosuppressant used in autoimmune disease, solid organ transplant rejection prophylaxis, and inflammatory bowel disease (IBD). Despite the availability of newer biologics, Azathioprine remains a cornerstone steroid-sparing agent in rheumatology, gastroenterology and transplant medicine due to its proven long-term efficacy and oral convenience.
Azathioprine is a prodrug metabolised in vivo to 6-mercaptopurine and ultimately to 6-thioguanine nucleotides, which incorporate into DNA and RNA and inhibit purine synthesis. This selectively suppresses rapidly proliferating lymphocytes — the basis of its immunosuppressant action. Therapeutic monitoring (TPMT genotype, regular CBC and LFTs) is essential.
Azotus-50 is manufactured by Trumac Healthcare under WHO-GMP conditions. Available for monopoly-based PCD pharma franchise and third-party manufacturing — a specialty SKU for rheumatology, gastroenterology and transplant centres.
Indications
- Renal and other solid-organ transplant rejection prophylaxis
- Severe rheumatoid arthritis (DMARD)
- Systemic lupus erythematosus with major organ involvement
- Crohn's disease and ulcerative colitis (steroid-sparing maintenance)
- Autoimmune hepatitis maintenance
- Myasthenia gravis (specialist use)
- Pemphigus and severe atopic dermatitis (refractory cases)
Mechanism of Action
Azathioprine is non-enzymatically converted to 6-mercaptopurine, then metabolised by HGPRT to thioinosine monophosphate and ultimately to 6-thioguanine nucleotides, which are incorporated into DNA. This produces strand breakage and inhibits T-cell and B-cell proliferation. The drug also inhibits Rac1 GTPase in activated T cells, promoting apoptosis.
Dosage & Administration
Adults: 1–3 mg/kg/day orally, adjusted by clinical response and serum 6-thioguanine levels. TPMT genotype/phenotype testing recommended before initiation to identify poor metabolisers at risk of severe myelosuppression. Monitor CBC and LFTs weekly initially, then monthly.
Side Effects
Bone marrow suppression (leucopenia most common), nausea, vomiting, hepatotoxicity, increased infection risk, hypersensitivity reactions, pancreatitis. Long-term: increased risk of skin cancers and lymphoma. Rare: hepatosplenic T-cell lymphoma (with IBD).
Contraindications & Precautions
Hypersensitivity to azathioprine or 6-mercaptopurine. TPMT deficiency. Severe bone marrow suppression. Pregnancy (Category D). Concomitant allopurinol or febuxostat without significant dose reduction (xanthine oxidase inhibition raises toxicity). Active serious infection.
Storage
Store below 30 °C in a dry place, protected from light and moisture.
Azotus-50 Tablet is available for monopoly-based PCD pharma franchise across India and for third-party manufacturing under your brand. WHO-GMP certified, with full visual-aid and promotional support. Become a Trumac franchise partner →
Frequently Asked Questions
What is Azotus-50 Tablet used for?
Azotus-50 Tablet contains Azathioprine 50 mg, an immunosuppressant used for organ transplant rejection prophylaxis, rheumatoid arthritis, SLE, Crohn's disease, ulcerative colitis and autoimmune hepatitis.
What monitoring is needed with Azathioprine?
TPMT testing before starting, then regular CBC and LFTs (weekly initially, then monthly), plus monitoring for signs of infection, easy bruising or persistent fatigue.
Is Azotus-50 available for PCD pharma franchise?
Yes, Trumac Healthcare offers Azotus-50 Tablet on monopoly-based PCD pharma franchise and for third-party manufacturing — a specialty SKU.
How should Azotus-50 Tablet be stored?
Store below 30 °C in a dry place, away from direct sunlight and moisture.
Is Azotus-50 WHO-GMP certified?
Yes, Azotus-50 Tablet is manufactured in WHO-GMP and DCGI-compliant facilities.
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