Spiramycin is indicated for the treatment of infections of the respiratory tract, oral cavity (buccal cavity), skin, and soft tissues caused by susceptible microorganisms. It is also used as an alternative treatment for gonorrhea caused by Neisseria gonorrhoeae in patients who are allergic to penicillins. Before treating gonorrhea, concomitant infection with Treponema pallidum should be ruled out.

Spiramycin is a macrolide antibiotic produced by Streptomyces ambofaciens. It is active against several Gram-positive organisms, including Staphylococcus aureus (including penicillin-resistant strains), β-hemolytic streptococci, Streptococcus viridans, Streptococcus faecalis, Streptococcus pneumoniae, Corynebacterium diphtheriae, and clostridia. Except for Bordetella pertussis, Haemophilus influenzae (approximately 50% of strains), and Neisseria, most Gram-negative organisms are generally resistant to spiramycin. Bacterial resistance to spiramycin has been reported, including cross-resistance with erythromycin. However, many erythromycin-resistant strains of S. aureus remain sensitive to spiramycin.

The mechanism of action of macrolide antibiotics has long been debated. Spiramycin is a 16-membered macrolide that inhibits translocation by binding to the bacterial 50S ribosomal subunit in a 1:1 ratio. It acts as a potent inhibitor of ribosomal binding of both donor and acceptor substrates. Its primary mechanism involves promoting the dissociation of peptidyl-tRNA from the ribosome during the translocation process, thereby inhibiting bacterial protein synthesis.

Adult: 6 to 9 Million International Units per 24 hours, in 2 divided doses. In severe infections, the daily dosage may be increased to 12 to 15 Million International Units per day. Gonorrhea: 12 to 13.5 Million International Units in a single dose.

Children: The usual daily dosage is based on 150,000 I.U./kg body weight in 2 or 3 divided doses.

Spiramycin is stable in gastric juices and absorption is not affected by food. In severe infections, the daily dosage may be increased by one half. In the treatment of beta hemolytic streptococcal infections, adequate Spiramycin dosage should be administered for 10 days.

Rovamycine has been reported to inhibit the absorption of carbidopa and reduce plasma levels of levodopa. If concomitant use is necessary, patients should be closely monitored and the dosage of levodopa should be adjusted accordingly.

Spiramycin is contraindicated in patients with known hypersensitivity to the drug. Cerebrospinal fluid levels of spiramycin are significantly lower than blood levels and are not clinically effective; therefore, it should not be used in patients with meningitis.

Possible side effects include nausea, vomiting, diarrhea, bowel inflammation, pruritus (itching of the skin), and tingling or numbness sensations in the skin.

The safety of Spiramycin during pregnancy has not been established.

Antibiotics, including Spiramycin, should be used with caution in patients with a history of allergy, especially drug allergies. The risk of superinfection due to overgrowth of non-susceptible organisms should be considered during prolonged or repeated therapy. If superinfection occurs, the drug should be discontinued and appropriate treatment initiated.

No cases of accidental overdose have been reported. At oral doses above 4 g per day, abdominal discomfort, nausea, or diarrhea may occur. No specific antidote is available; management should be symptomatic and supportive.

Macrolides

Store in a dry place at 15°C to 30°C.