Sodium stibogluconate


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IM//IV Visceral leishmaniasis 20 mg/kg (as pentavalent antimony) daily for 30 days (28 days for L. infantum). Cutaneous leishmaniasis For lesions requiring systemic therapy: 20 mg/kg (as pentavalent antimony) daily for 10-20 days. Mucocutaneous leishmaniasis 20 mg/kg (as pentavalent antimony) for 30 days. Intralesional Cutaneous leishmaniasis 100-500 mg (as pentavalent antimony), every 3-7 days for 1-5 sessions.
Dosage Details
Intralesional
Cutaneous leishmaniasis
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.
Renal Impairment
Significant impairment: Contraindicated.
Hepatic Impairment
Contraindicated.
Contraindications
Hepatic and significant renal impairment. Concomitant use of amphotericin B and other drugs that prolong QT interval.
Special Precautions
Patient with CV disease, history of ventricular arrhythmias, risk factors for QT prolongation (e.g. congenital QTc prolongation). Children. Pregnancy and lactation.
Adverse Reactions
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.
MonitoringParameters
Monitor ECG before and during therapy; CBC and LFT periodically, serum creatinine, serum amylase.
Overdosage
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.
Drug Interactions
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.
Action
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.
Chemical Structure

Chemical Structure Image
Sodium stibogluconate

Source: National Center for Biotechnology Information. PubChem Database. CID=135393449, https://pubchem.ncbi.nlm.nih.gov/compound/135393449 (accessed on Jan. 23, 2020)

Storage
Store at or below 25°C. Do not freeze. Protect from light.
ATC Classification
P01CB02 - sodium stibogluconate ; Belongs to the class of antimony-containing agents. Used in the treatment of leishmaniasis and trypanosomiasis.
References
Anon. Sodium Stibogluconate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/05/2018.

Buckingham R (ed). Pentavalent Antimony Compounds. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2018.

Joint Formulary Committee. Sodium Stibogluconate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2018.

Preston CL (ed). Interactions of Sodium Stibogluconate. Stockley’s Drug Interactions [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2018.

Disclaimer: This information is independently developed by MIMS based on Sodium stibogluconate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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