Adult: 100-500 mg (as pentavalent antimony), every 3-7 days for 1-5 sessions.
Parenteral Visceral leishmaniasis
Adult: 20 mg/kg (as pentavalent antimony) daily for 30 days (28 days for L. infantum) via IM or slow IV injection over at least 5 minutes. Evaluate for evidence of relapse after 2 and 6 months (and after 12 months in Africa). Child: <10 kg: ≥200 mg daily.
Parenteral Cutaneous leishmaniasis
Adult: For lesions requiring systemic therapy: 20 mg/kg (as pentavalent antimony) daily for 10-20 days via IM or slow IV injection over at least 5 minutes. Child: Same as adult dose.
Parenteral Mucocutaneous infection caused by Leishmania
Adult: 20 mg/kg (as pentavalent antimony) for 30 days via IM or slow IV injection over at least 5 minutes. Child: Same as adult dose.
Significant impairment: Contraindicated.
Hepatic and significant renal impairment. Concomitant use of amphotericin B and other drugs that prolong QT interval.
Patient with CV disease, history of ventricular arrhythmias, risk factors for QT prolongation (e.g. congenital QTc prolongation). Children. Pregnancy and lactation.
Significant: Prolonged QT interval, anaemia, leucopenia, thrombocytopenia, cough, vomiting, substernal pain, arthralgia, myalgia, pancreatitis, elevated hepatic and pancreatic enzymes. Blood and lymphatic system disorders: Jaundice. Cardiac disorders: ECG changes (e.g. reduced T-wave amplitude, t-wave inversion). Gastrointestinal disorders: Abdominal pain, diarrhoea, nausea. General disorders and administration site conditions: Malaise, lethargy, fever; transient pain on injection site, venous thrombosis (IV). Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Rigor. Nervous system disorders: Headache, vertigo. Respiratory, thoracic and mediastinal disorders: Nasal or gum bleeding. Skin and subcutaneous tissue disorders: Rash, worsening of lesions on the cheek. Vascular disorders: Facial flushing. Potentially Fatal: Severe inflammation with pharyngeal or tracheal involvement, cardiac arrhythmia. Rarely, pneumonia, anaphylactic shock.
Monitor ECG before and during therapy; CBC and LFT periodically, serum creatinine, serum amylase.
Symptoms: Nausea, vomiting, diarrhoea, hepatitis, haemorrhagic nephritis. Management: Administer IM dimercaprol 200 mg 6 hourly until complete recovery. 2,3-dimercaptosuccinic acid (DMSA) may also be used.
Potentially Fatal: Increased risk of cardiac arrhythmia with amphotericin B; allow a 14-day resting period between sodium stibogluconate treatment and amphotericin B therapy initiation. Concurrent use with drugs that prolong QT interval (e.g. cisapride, astemizole, terfenadine) may increase the risk of torsade de pointes which may lead to ventricular arrhythmia.
Description: Sodium stibogluconate is a pentavalent antimony compound. Its mechanism of action is unknown. However, it has been suggested that the reduction in ATP and GTP (guanosine triphosphate) synthesis contributes to decreased macromolecular synthesis.
Synonym: sodium antimony gluconate. Pharmacokinetics: Absorption: Rapidly absorbed via IV and IM route. Excretion: Via urine (80%, as unchanged drug). Elimination half-life: Initial phase: Approx 2 hours. Terminal phase: Approx 33-76 hours.
Store at or below 25°C. Do not freeze. Protect from light.