Sulfadoxine and Pyrimethamine Tablets (SP)

1. Product Introduction

Sulfadoxine and pyrimethamine (SP) is a fixed-dose antifolate antimalarial combination. The supplied compositions specify uncoated USP tablets containing 500 mg sulfadoxine with 25 mg pyrimethamine, and lower-strength IP tablets containing 125 mg sulphadoxine with 6.25 mg pyrimethamine. Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter.

SP is used in selected malaria prevention and treatment programmes, including intermittent preventive treatment of malaria in pregnancy (IPTp) where recommended. Its suitability depends on local resistance patterns, national guidelines, and patient-specific contraindications. Certification and export authorization claims require documentary verification.

2. Product Specifications

3. Manufacturing Technology

For this fixed-dose combination, manufacturing controls should support uniform distribution of the lower-dose pyrimethamine component alongside sulfadoxine. Appropriate blending, granulation or direct compression methods are selected through validated formulation development. Tablet hardness, friability, disintegration, and dissolution must meet the applicable approved specifications.

Protective packaging should be qualified for the target climate and stability profile. Claims about specific processing equipment, 3-tablet packs or production sites should be checked against manufacturing records.

4. Quality Assurance

Quality assurance should include identification and assay of both active ingredients, uniformity of dosage units, dissolution, related substances, and stability studies under relevant conditions. Acceptance limits must follow the applicable USP/IP monograph and approved dossier rather than generic numerical assumptions. Batch-specific certificates of analysis should support release decisions.

5. Therapeutic Uses

Mechanism: Sulfadoxine inhibits parasite dihydropteroate synthase, while pyrimethamine inhibits dihydrofolate reductase. Their combined action disrupts folate metabolism in susceptible malaria parasites.

Clinical context: WHO recommends SP for intermittent preventive treatment in pregnancy in eligible malaria-endemic settings, typically beginning in the second trimester. It is also used in certain seasonal malaria chemoprevention regimens with other agents. SP alone is not an appropriate universal first-line treatment for malaria; treatment selection depends on current national guidance and local resistance.

6. Export and Regulatory Support

Potential B2B documentation may include an applicable CTD/ACTD dossier, certificate of analysis, product registration documents, stability data and relevant manufacturing certifications, subject to availability and destination-country requirements. Healthy Inc is identified as the exporter. Verify current WHO-GMP status, certificates, registration and commercial shipping terms before publication or tender submission.

7. Frequently Asked Questions

8. Dosage and Administration

Dosing depends on the indication, patient age/weight, strength, local malaria programme and clinical guidance. In eligible IPTp programmes, the usual adult SP dose is 1,500 mg sulfadoxine plus 75 mg pyrimethamine per administration (equivalent to three 500 mg/25 mg tablets), with doses spaced at least one month apart from the second trimester onward. This is not a universal malaria-treatment schedule. The 125 mg/6.25 mg tablets require separate strength-specific dose calculations.

Administration should be supervised by a qualified clinician or programme provider. Do not use these examples as a prescription.

9. Side Effects and Precautions

Important risks: Serious sulfonamide hypersensitivity reactions, including Stevens–Johnson syndrome/toxic epidermal necrolysis; blood dyscrasias; hepatic or renal adverse effects; and gastrointestinal symptoms. Stop treatment and seek urgent medical attention for rash with blistering, mucosal sores, fever or other severe reactions.

Precautions: Avoid in patients with relevant sulfonamide allergy and other label-specific contraindications. IPTp-SP is generally not given in the first trimester or concurrently with cotrimoxazole prophylaxis. High-dose folic acid may interfere with SP antimalarial efficacy; antenatal folate use should follow local guidance. Evaluate other antifolate drugs, renal/hepatic impairment and age-specific restrictions before use.

10. Storage Instructions

Store in the original, properly closed packaging under the temperature and humidity conditions stated on the approved product label. Protect from moisture and light as required by the validated stability specification. Keep out of reach of children. Do not publish a fixed 36-month shelf life or specific storage temperature without approved supporting data.