Indications
Infectious conditions in respiratory, cutaneous and genital tracts caused by sensitive organisms.
Prophylaxis of meningitis caused by Meningococci in patients with contraindication to rifampicin.
Prevention of congenital toxoplasmosis during pregnancy.
Chemoprophylaxis of recurrent acute rheumatic arthritis in patients allergic to penicillins.
Contraindications
Patients with known hypersensitivity to spiramycin, erythromycin or to any ingredient in the formulation.
Compositon/Ingredients
Spiramycin 3.000.000 IU
Dosage and administration
Treatment of infectious conditions in respiratory, cutaneous and genital tracts; Chemoprophylaxis of recurrent acute rheumatic arthritis in patients allergic to penicillins:
- Adults: 5 million – 3 million IU daily, in 2 or 3 divided doses. Doses up to 15 million units have been given daily in divided doses for severe infections.
- Children ≥ 30 kg: 150 thousand IU/kg daily, in 3 divided doses. Use other preparation for children < 30 kg.
Prophylaxis of meningitis due to Meningococci:
- Adults: 3 million IU every 12 hours for 5 days.
- Children ≥ 20 kg: 75 thousand IU/kg every 12 hours for 5 days. Use other preparation for children < 20 kg.
Prevention of congenital toxoplasmosis during pregnancy: 9 million IU daily in divided doses for 3 weeks, repeated 2-weekly intervals
Precaution
Spirastad 3 M.I.U must be discontinued if at the start of treatment, patients experience generalized erythema and pustules accompanied by fever. Any further administration of spiramycin alone or in combination is contraindicated.
Spirastad 3 M.I.U should be used cautiously in patients with hepatic dysfunction, heart disease, arrhythmia (including people tend to prolong the QT interval); pregnant women.
Mothers should discontinue breast feeding during spiramycin administration.
Patients should be aware of how they react to drug before driving or operating machinery.
Storage
Store at temperature below 30°C, protect from light.
