Sulfonamide Antibiotic | Uncoated tablets | B2B pharmaceutical enquiries
Composition: Each uncoated tablet contains Sulphadiazine IP 500 mg.
Usage: Selected susceptible infections; historical use for urinary tract infections. Current use includes combination treatment of toxoplasmosis when clinically indicated.
Therapeutic category: Sulfonamide Antibiotic.
SKU: Sulphadiazine Tablets IP 500 mg
Categories: Pharmaceutical Exporter India · Pharmaceutical Formulations India · WHO GMP Certified Formulations
Sulphadiazine Tablets IP is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.
Sulphadiazine Tablets IP 500 mg are uncoated oral sulfonamide antibiotic tablets. Sulphadiazine inhibits folate synthesis in susceptible microorganisms. Its role in routine urinary tract infections is now limited by resistance and the availability of other agents; one important clinical use is in combination with pyrimethamine and leucovorin for selected toxoplasmosis infections.
The supplied product description identifies Healthy Life Pharma Pvt. Ltd. as manufacturer and Healthy Inc as exporter. Certifications, facility processes, approvals and export availability should be independently verified before publication.
| Product name | Sulphadiazine Tablets |
|---|---|
| Active ingredient | Sulphadiazine IP 500 mg per tablet |
| Strength | 500 mg |
| Dosage form | Uncoated tablet |
| Pharmacopoeial standard | IP (as stated in supplied composition) |
| CAS number | 68-35-9 |
| Therapeutic class | Sulfonamide antibiotic / antifolate |
| Packaging | To be confirmed against approved pack specification |
| Shelf life | To be confirmed from approved stability data |
Manufacturing of uncoated Sulphadiazine Tablets requires suitable powder flow, blend uniformity, controlled compression, disintegration and dissolution. Formulation development may use appropriate granulation and excipient selection based on validated process studies. Any claims regarding a specific wet-granulation line, machinery, dust control or facility controls require manufacturer confirmation.
Appropriate batch-release testing includes identification, assay, uniformity of dosage units, disintegration/dissolution, related substances and other tests prescribed by the applicable approved IP specification. Numerical assay, dissolution and impurity limits should be verified from the current monograph and registered product dossier, rather than presented as universal limits.
Sulphadiazine competitively inhibits dihydropteroate synthase, reducing microbial folate synthesis. It is a bacteriostatic sulfonamide. Clinicians may use it with pyrimethamine and leucovorin for toxoplasmosis, including selected cases of toxoplasmic encephalitis. Other historical uses include susceptible bacterial infections and selected alternatives for rheumatic fever prophylaxis, depending on local guidelines and susceptibility.
Antibiotic stewardship: Do not describe sulphadiazine as a routine first-line urinary tract infection treatment; use must reflect culture/susceptibility and current local clinical guidance.
B2B partners should request the current Certificate of Analysis, approved product specifications, stability data, pack options and destination-market registration status. CTD/ACTD dossiers, Free Sale Certificates, COPP and WHO-GMP documentation must be confirmed as available and valid for the relevant facility and product. Commercial terms and export logistics are subject to agreement.
Q: What is the confirmed composition?
A: Each uncoated tablet contains Sulphadiazine IP 500 mg.
Q: Why is adequate hydration important?
A: Sulphadiazine can crystallize in urine and injure the kidneys; clinicians may recommend hydration and other measures based on the patient’s condition.
Q: Can patients with sulfonamide antibiotic allergy use it?
A: A history of serious sulfonamide hypersensitivity is an important contraindication; medical assessment is essential.
Prescription medicine: The dose, duration and need for combination therapy depend on the infection, weight, renal function and local treatment guidelines. For toxoplasmosis, sulphadiazine is used with pyrimethamine and leucovorin under specialist supervision; doses should not be extrapolated from a general product page. Swallow tablets with water and follow prescriber instructions. Maintain hydration unless medically restricted.
Possible adverse effects include nausea, vomiting, rash and crystalluria. Serious reactions include Stevens–Johnson syndrome/toxic epidermal necrolysis, blood disorders, severe hypersensitivity and kidney injury. Urgent assessment is needed for rash with blistering, fever, mouth sores, unusual bruising or reduced urination. Patients with sulfonamide allergy, significant kidney/liver disease, G6PD deficiency, or pregnancy-related concerns require careful clinical assessment. Periodic blood counts and renal monitoring may be indicated.
Store in the original container or blister according to the approved product label, protected from excessive moisture and light. Confirm the temperature limit and expiry date from the registered product specifications. Keep out of reach of children.
For professional and B2B reference. Prescribing information, manufacturing claims, certification and market-specific approvals require verification.