Finished product reference

Meglumine Antimonate

Injection, Solution · Parenteral · 300 mg/1mL · 5 mL

List code
797
Pharmacologic class
Pentavalent antimonial; antileishmanial

What it is and how it works

Meglumine antimoniate is a pentavalent antimony compound that is reduced to the trivalent form within macrophages and parasites. It inhibits Leishmania glycolytic and fatty-acid oxidation enzymes and trypanothione reductase, disrupting parasite energy metabolism and redox defence.

Indications

Treatment of cutaneous leishmaniasis (intralesional or systemic), mucocutaneous leishmaniasis and visceral leishmaniasis (kala-azar).

Dosage and administration (summary)

Systemic: 20 mg/kg/day of pentavalent antimony by deep intramuscular or slow intravenous injection for 20 days (cutaneous) or 28–30 days (visceral or mucocutaneous). Intralesional: injected into the lesion, usually once weekly, according to national protocols.

Contraindications

Significant cardiac, hepatic or renal impairment; hypersensitivity to antimony compounds.

Warnings and precautions

Cardiotoxicity with QT prolongation and arrhythmias may occur; ECG monitoring is required, especially with systemic therapy. Pancreatitis, hepatotoxicity, nephrotoxicity, musculoskeletal pain and cytopenias may occur; monitor amylase or lipase, liver and renal function and blood counts.

Pregnancy

Avoid in pregnancy; consider alternative treatment or defer treatment of cutaneous disease.

Storage and supply

Store below 30 °C, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

Tell us the quantity, the market and the timing.

Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.

Telephone+98 21 8888 3325 · office hours 09:00–17:00, Tehran
OfficeHaniya Parsan Darou, 3rd floor, No. 326, Zafar Street, Africa Boulevard, Tehran 1968734974, Iran
Emailcontact@hanpars.com