Dapsone (100mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Dapsone is a synthetic sulfone antibacterial and anti-inflammatory agent, primarily used for the treatment of leprosy (Hansen's disease) and dermatitis herpetiformis. It acts as a competitive antagonist of para-aminobenzoic acid (PABA) and inhibits bacterial folate synthesis. In the Indian context, it is a cornerstone of the National Leprosy Eradication Programme (NLEP) as part of Multi-Drug Therapy (MDT).

OnsetDurationBioavailability
Clinical improvement in dermatitis herpetiformis is typically seen within 24-48 hours. For leprosy, bactericidal effects begin within hours, but clinical response may take several weeks.Approximately 24-30 hours, supporting once-daily dosing.70-80% following oral administration.

2. Mechanism of Action

Dapsone's primary mechanism is bacteriostatic against Mycobacterium leprae. It is a structural analogue of PABA and competitively inhibits dihydropteroate synthase (DHPS), an enzyme in the bacterial folate synthesis pathway. This depletes tetrahydrofolate, essential for DNA synthesis. Its anti-inflammatory effect in dermatological conditions is mediated by inhibition of neutrophil myeloperoxidase and chemotaxis, and scavenging of reactive oxygen species.

3. Indications & Uses

  • Leprosy (all forms, as part of Multi-Drug Therapy - MDT)
  • Dermatitis Herpetiformis (maintenance therapy)

4. Dosage & Administration

Adult Dosage: Leprosy (MDT): 100 mg once daily. Dermatitis Herpetiformis: Start 50 mg daily, titrate to response (usual range 50-300 mg daily). PCP Prophylaxis: 100 mg daily.

Administration: Administer orally with or without food. Taking with food may reduce GI upset. Tablet should be swallowed whole with a full glass of water. For leprosy MDT, dapsone is taken concurrently with rifampicin and clofazimine as per NLEP guidelines.

5. Side Effects

Common side effects may include:

  • Dose-related hemolytic anemia (mild to moderate)
  • Methemoglobinemia (cyanosis, headache, fatigue)
  • Nausea, vomiting, anorexia
  • Headache, dizziness
  • Mild skin rash

6. Drug Interactions

DrugEffectSeverity
RifampicinIncreases metabolism of dapsone, reducing its plasma levels and half-life. Critical in MDT; doses are adjusted accordingly.Major
ProbenecidDecreases renal excretion of dapsone, increasing its plasma levels and risk of toxicity.Major
TrimethoprimSynergistic antifolate effect; dramatically increases risk of hematological toxicity (agranulocytosis, megaloblastic anemia).Contraindicated
Primaquine, ChloroquineIncreased risk of hemolytic anemia and methemoglobinemia.Major
DidanosineReduced absorption of dapsone if taken concurrently. Separate administration by at least 2 hours.Moderate
MethotrexateIncreased risk of pancytopenia due to combined antifolate effect.Major
Folic acid antagonists (e.g., Pyrimethamine)Increased hematological toxicity.Major
Amitriptyline, ClozapineIncreased risk of agranulocytosis.Moderate

7. Patient Counselling

  • DO take the medication exactly as prescribed, even if you feel well.
  • DO report for regular blood tests (CBC, LFT) as advised by your doctor.
  • DO inform all your doctors and your dentist that you are taking dapsone.
  • DO use sun protection (sunscreen, protective clothing) as dapsone may increase sun sensitivity.
  • DONT stop taking the medication suddenly without consulting your doctor, especially for leprosy.
  • DONT take any other medicines, including over-the-counter drugs or herbal supplements, without checking with your doctor or pharmacist.

8. Toxicology & Storage

Overdose: Severe nausea, vomiting, hyperexcitability, seizures, metabolic acidosis. The hallmark is severe methemoglobinemia (cyanosis, chocolate-brown blood, dyspnea, tachycardia, headache, fatigue, coma) and acute hemolytic anemia.

Storage: Store below 30°C, in a cool, dry place, protected from light. Keep the container tightly closed. Keep out of reach of children.