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Spirastad 3 M.I.U
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Spirastad 3 M.I.U contains spiramycin is considered as a second-line drug for treatment of infectious conditions in respiratory, cutaneous and genital tracts caused by sensitive organisms.

Pack size Box of 10 tablets, 50 tablets
Shelf-life 36 months
Composition Spiramycin
Dosage forms and strengths Film-coated tablet: 3,000,000 IU (3 million IU)
Product code :

PRESCRIBING INFORMATION

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.

Dosage

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

Usage

  • Spirastad 3 M.I.U is administered orally. Because food in the stomach reduces the bioavailability of spiramycin, the dose should be administered at least 2 hours before or 3 hours after a meal.

Patients with known hypersensitivity to spiramycin, erythromycin or to any of the ingredients.

Common

  • Nausea, vomiting, diarrhea, indigestion;
  • Vertigo, headache.

Uncommon

  • Fatigue, epistaxis, sweating, heaviness in the chest;
  • Acute colitis;
  • Exanthema, urticarial.
  • 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.