Indications: Treatment of infections of the respiratory tract buccal cavity skin and soft tissues due to susceptible organisms. N. gonorrhoeae: as an alternate choice of treatment for gonorrhea in patients allergic to the penicillin. (Before treatment of gonorrhea, the possibility of concomitant infection due to T. pallidum should be excluded.

Cautions: in patients with a predisposition to QT interval prolongation (including electrolyte disturbances and concomitant use of drugs that prolong the QT interval).

Macrolides may aggravate myasthenia gravis.

Contra-indications: Hypersensitivity to spiramycin, other macrolides (eg, erythromycin) or any component of the formulation.

Pregnancy: Implications Crosses placenta. Specific safety information is not available. However, spiramycin has been used to treat Toxoplasma gondii to prevent transmission from mother to fetus. Lactation Enters breast milk/compatible (based on other macrolides).

Breast-feeding: Considerations Excreted in breast milk in bacteriostatic concentrations. Dietary Considerations May be taken without regard to meals. Food may improve gastrointestinal tolerance.

Side Effects: Dermatologic: Angioedema (rare), pruritus, rash, urticaria. Gastrointestinal: Diarrhea, nausea, pseudomembranous colitis (rare), vomiting. Hepatic: Transaminases increased. Neuromuscular & skeletal: Paresthesia (rare). Miscellaneous: Anaphylactic shock (rare).

Dose: Oral, 1 to 2 grams two times a day, or 500 mg to 1 gram three times a day. For severe infections, the dose may be increased to 2 to 2.5 grams two times a day.