SPIRAMYCIN

Drugs in Pregnancy and Lactation.

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Name: SPIRAMYCIN
Class: Antibiotic
Risk Factor:    C

Fetal Risk Summary

Spiramycin, a macrolide antibiotic available in the United States only as an orphan drug but widely used in Europe for more than 30 years, is used primarily in the treatment of the protozoal infections cryptosporidiosis and toxoplasmosis.

Infection of the mother with Toxoplasmosis gondii early in gestation may result in the birth of infants with a clinical syndrome whose characteristics may include hydrocephalus or microcephalus, hepatosplenomegaly, icterus, maculopapular rash, chorioretinitis, and cerebral calcifications (1,2). No evidence has been found that maternal infection before conception results in infection of the fetus or delivery of an infant with congenital toxoplasmosis (1).

Spiramycin crosses the placenta to the fetus (2). Concentrations of the antibiotic in maternal serum, cord blood, and the placenta after a dosage regimen of 2 g/day were 1.19, 0.63, and 2.75 ΅g/mL, respectively. When the maternal dose was increased to 3 g/day, the levels were 1.69, 0.78, and 6.2 ΅g/mL, respectively. Based on these results, the cord:maternal serum ratio is approximately 0.5. Moreover, at these doses, spiramycin is concentrated in the placenta with levels approximately 2–4 times those in the maternal serum.

No reports of adverse fetal outcome attributable to spiramycin have been located. According to two French investigators in 1974, the antibiotic had been used for more than 15 years in Europe without any evidence of fetal harm (3). Spiramycin, 2–3 g/day in divided dosage throughout the remainder of gestation, is the treatment of choice when primary infection with toxoplasmosis occurs in the pregnant woman (3,4,5,6,7,8,9 and 10). If fetal infection is subsequently diagnosed, pyrimethamine, sulfadoxine or sulfadiazine, and folic acid are added to the spiramycin therapy (11,12,13 and 14). However, the belief that the addition of pyrimethamine and a sulfonamide to the treatment regimen has proven to reduce significantly the incidence of severe congenital toxoplasmosis is still controversial because of the potential added risk to the fetus from the combination drug therapy (15,16).

Breast Feeding Summary

Spiramycin is excreted into breast milk. Nursing infants of mothers receiving 1.5 g/day for 3 days had spiramycin serum concentrations of 20 ΅g/mL (17). This concentration was bacteriostatic (17).

References

  1. Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD: Johns Hopkins University Press, 1989:627.
  2. Remington JS, Desmonts G. Toxoplasmosis. In Remington JS, Klein JO, eds. Infectious Diseases of the Fetus and Newborn Infant. 2nd ed. Philadelphia, PA: WB Saunders, 1983:143–263.
  3. Desmonts G, Couvreur J. Congenital toxoplasmosis: a prospective study of 378 pregnancies. N Engl J Med 1974;290:1110–6.
  4. Desmonts G, Couvreur J. Toxoplasmosis in pregnancy and its transmission to the fetus. Bull NY Acad Med 1974;50:146–59.
  5. Russo M, Galanti B, Nardiello S. Treatment of toxoplasmosis: present knowledge and problems. Ann Sclavo 1980;22:877–88.
  6. Fleck DG. Toxoplasmosis. Arch Dis Child 1981;56:494–5.
  7. Desmonts G, Daffos F, Forestier F, Capella-Pavlovsky M, Thulliez PH, Chartier M. Prenatal diagnosis of congenital toxoplasmosis. Lancet 1985;1:500–4.
  8. Ellis CJ. Antiparasitic agents in pregnancy. Clin Obstet Gynaecol 1986;13:269–75.
  9. Carter AO, Frank JW. Congenital toxoplasmosis: epidemiologic features and control. Can Med Assoc J 1986;135:618–23.
  10. Ghidini A, Sirtori M, Spelta A, Vergani P. Results of a preventive program for congenital toxoplasmosis. J Reprod Med 1991;36:270–3.
  11. Daffos F, Forestier F, Capella-Pavlovsky M, Thulliez P, Aufrant C, Valenti D, Cox WL. Prenatal management of 746 pregnancies at risk for congenital toxoplasmosis. N Engl J Med 1988;318:271–5.
  12. Couvreur J, Desmonts G, Thulliez PH. Prophylaxis of congenital toxoplasmosis: effects of spiramycin on placental infection. J Antimicrob Chemother 1988;22(Suppl B):193–200.
  13. Garin JP, Mojon M, Piens MA, Chevalier-Nuttall I. Monitoring and treatment of toxoplasmosis in the pregnant woman, fetus and newborn. Pediatrie 1989;44:705–12.
  14. Hohlfeld P, Daffos F, Thulliez P, Aufrant C, Courvreur J, MacAleese J, Descombey D, Forestier F. Fetal toxoplasmosis: outcome of pregnancy and infant follow-up after in utero treatment. J Pediatr 1989;115:765–9.
  15. Wilson CB. Treatment of congenital toxoplasmosis during pregnancy. J Pediatr 1990;116:1003–4.
  16. Hohlfeld P, Daffos F. Treatment of congenital toxoplasmosis during pregnancy (reply). J Pediatr 1990;116:1004–5.
  17. Goisis M, Cavalli P. Variations of the organoleptic properties of human milk under treatment with antibiotics. Minerva Ginac 1959;11:794–804. As cited in Onnis A, Grella P. The Biochemical Effects of Drugs in Pregnancy. Vol 2. Chichester: Ellis Horwood Limited, 1984:340–1.

Index

Q&A about Spiramycin

LOLI
What is the pharmacological properties of the spiramycin?
jayarama...
The Pharmacological Properties of Sipramycin is as under -

Spiramycin

CAS Number:8025-81-8

Appearance: white or slightly yellow powder

Assay: 4657iu/mg

Loss on Drying: 1.3%

Sulphated Ash: 0.06%

Heavy Metals: 20ppm

Related substances:1.4%

PH:9.7

Specific Rotation:-81‘¯C

Composition:

spiramycin I : 92.60%

spiramycin II : 0.4%

spiramycin III :1.1%

total Spiramycin I,II,III, :94.1%

Package: 25kg CTN

Conclusion:EP2002

Spiramycin

Spiramycin Adipate