spiramycin
+ metronidazole
Tablets, film coated
1.5 MIU / 250mg
Manufacturer usually replies in 9 days
Dossier type
CTD
Dossier status
Ready to file
Country of origin
Morocco
GMP approvals
WHO
Manufacturer #17079
Manufacturer usually replies in 9 days
Spiramycin
Spiramycin is an antiparasitic and a macrolide antibiotic. it is prescribed to treat toxoplasmosis and
various other infections of soft tissues. Most commonly, it treats toxoplasmosis in pregnant women
since as it decreases the probability of infection in the unborn baby.
Spiramycin was approved in the EU, Canada in 2000. However, it is still an experimental drug in the
The United States, prescribed under special permission from the FDA for toxoplasmosis in the first
trimester of pregnancy.
PINNER- SINDICO isolated a 16-membered ring macrolide in 1954 as a product of Streptomyces
ambofaciens. Oral use has been allowed since 1955 and the parenteral form was introduced into
practice in 1987.
Dosage and administration
Spiramycin is best taken on an empty stomach and should be maintained at a constant level for best
results. That is why the users should not miss any doses and take them evenly spaced times. For
those using suppositories, the directions are to start by removing the foil wrapper and moisten the
suppository with cold water and then insert is lying down as directed. The dose varies by the patient
depending on their condition. The amount of medicine also is decided the strength and the number
of doses taken each day. If taking the oral capsules or tablets to treat infections in adults and
teenagers is 1 to 2 grams, two times a day, or 500 mg to 1 gram three times a day and increased to is
2 to 2.5 grams two times a day for severe infection. If taking injection treatment of infections, the
dose is 500 mg injected slowly into a vein, every eight hours and 1 gram and severe infections.
Consult the doctor for a pediatric dose.
The price of Spiramycin
In the USA, the cost of 10, 1 mL injections costs USD 79, for a supply of 100mg cost USD72. In India,
Spiramycin Tablets cost around USD 17 for a box of 100 tablets each containing 3MIU.
How does Spiramycin work?
Spiramycin as an antibiotic inhibits protein synthesis in the bacterial cell during translocation. Those
who use it frequently develop resistance by several mechanisms and its considerably prevalent.
Spiramycin has an effective antibacterial spectrum against Gram-positive Gram-negative cocci and
rods, and Legionellae, mycoplasmas, chlamydiae, types of spirochetes, Toxoplasma gondii, and
Cryptosporidium species. Its main properties are bacteriostatic. It can exert a bactericide action on
highly sensitive strains. Compared to erythromycin, the difference in effectiveness due to great
affinity to tissues. It is because this is where it achieves the highest concentrations, higher than
serum levels. its slow release of the antibiotic from the tissue compartment, the marked action on
microbes in sub-inhibition concentrations, and the relatively long persisting post-antibiotic effect is
due to its slow release.
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