Finished product reference
Spiramycin
Tablet · Oral · 500 mg
- List code
- 1168
- Pharmacologic class
- Macrolide antibacterial
What it is and how it works
Spiramycin binds to the 50S ribosomal subunit and inhibits bacterial protein synthesis. It achieves high tissue and placental concentrations and is also active against Toxoplasma gondii.
Indications
Prevention of congenital toxoplasmosis (fetal transmission) in pregnant women with acute toxoplasmosis; respiratory, oropharyngeal and skin infections caused by susceptible organisms, and as an alternative in macrolide-indicated infections.
Dosage and administration (summary)
Taken orally; usually 6–9 million IU (about 2–3 g) daily in 2–3 divided doses.
Contraindications
Hypersensitivity to spiramycin or other macrolides; breast-feeding (relative).
Warnings and precautions
Gastrointestinal disturbance is common; QT prolongation, cholestatic hepatitis and severe skin reactions have been reported rarely. Use with caution in hepatic impairment and G6PD deficiency (risk of haemolysis), and in neonates.
Pregnancy
Used in pregnancy specifically to reduce the risk of mother-to-fetus transmission of toxoplasmosis.
Storage and supply
Store below 25 °C.
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.
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