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Cervidil (Dinoprostone Vaginal) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

2. Drug Interactions: Cervidil may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert. No other drug interactions have been identified.

OVERDOSAGE

Cervidil is used as a single dosage in a single application. Overdosage is usually manifested by uterine hyperstimulation which may be accompanied by fetal distress and is responsive to removal of the insert. Other treatment must be symptomatic since, to date, clinical experience with prostaglandin antagonists is insufficient.

The use of beta-adrenergic agents should be considered in the event of undesirable increased uterine activity.

CONTRAINDICATIONS

Cervidil is contraindicated in:

  • * Patients with known hypersensitivity to prostaglandins.
  • * Patients in whom there is clinical suspicion or definite evidence of fetal distress where delivery is not imminent.
  • * Patients with unexplained vaginal bleeding during this pregnancy.
  • * Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion.
  • *

    Patients in whom oxytocic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery (see PRECAUTIONS and ADVERSE REACTIONS ).

  • * Patients already receiving intravenous oxytocic drugs.
  • * Multipara with 6 or more previous term pregnancies.

DRUG ABUSE AND DEPENDENCE

No drug abuse or dependence has been seen with the use of Cervidil.

References

  1. Physiology of Labor In: Williams Obstetrics. Eds. Pritchard, J. A., MacDonald, P. C., and Gant, N.F. Appleton-Century-Crofts, Conn, Pp 295-321, (1985).
  2. Rall, T. W. and Schliefer, L. S. Oxytocin, prostaglandin, ergot alkaloids, and other drugs; tocolytics agents, In: The Pharmacological Basis of Therapeutics. Eds. Gilman, A.G., Goodman, L.S., Rall, T.W., and Murad, F. MacMillan, Publ. Co., New York, Pp. 926-945, (1985).
  3. Casey, M.L. and MacDonald, P.C. The initiation of labor in women: Regulation of phospholipid and arachidonic acid metabolism and of prostaglandin production. Semin. Perinat. 10:270-275, (1986).
  4. Casey, M.L., MacDonald, P.C. and Mitchell, M.D. Stimulation of Prostaglandin E2 production in amnion cells in culture by a substance(s) in human fetal urine. Biochem. Biophys. Res. Comm. 114:1056, (1983).
  5. Olson, C.M., Lye, S.J., Skinner, K. and Challis, J.R.G. Prostanoid concentrations in maternal/fetal plasma and amniotic fluid and intrauterine tissue prostanoid output in relation to myometrial contractility during the onset of Endocrinology, 116: 389-397, (1985).
  6. Ledger, W.L., Ellwood, D.A., and Taylor, M.J. Cervical softening in late pregnant sheep by infusion of Prostaglandin E2 into cervical artery. J. Reprod. Fert. 69, 511-515, (1983).
  7. Olson, D.M., Lye, S.J., Skinner, K. and Challis, J.R.G. Early changes in prostaglandin concentrations in ovine maternal and fetal plasma, amniotic fluid and from dispersed cells of intrauterine tissues before the onset of ACTH-induced pre-term labor. J. Reprod. Fert., 71: 45-55, (1984).
  8. Caldero-Garcia, R. and Posiero, J. Oxytocin and the contractility of the human uterus, Ann, N. Y. Acad. Sci. 75:813, (1959).
  9. Posiero, J. and Noriega-Guerra, L. Dose-response relationships in uterine effects of oxytocin infusion. Oxytocin. Eds., Caldero-Garcia, R. and Heller, J. Pergamon Press, New York, (1961).
  10. Cibils, L. Enhancement of induction of labor. In: Risks in the Practice of Modern Obstetrics. Aldjem, S. Ed. Mosby Publishing, St. Louis, (1972).
  11. Bryman, I., Lindblom, B., and Norstrom, A. Extreme sensitivity of cervical musculature to prostaglandin E2 in early pregnancy. Lancet, 2:1471, (1982).
  12. Thiery, M. Induction of labor with prostaglandins. In: Human Parturition. Eds. Keirse, M.J.N.C., Anderson, A.B.M., and Gravenhorst, J.B. Martinus Nijhoff Publ., Boston, 155-164, (1979).
  13. Thiery, M. and Amy, J.J. Induction of labor with prostaglandins. In:Advances in Prostaglandin Research. Prostaglandin and Reproduction, Karim, S.M.M., Ed., MTP, Lancaster, Pp. 149-228, (1975).
  14. MacLennan, A.H., Katz, M., and Creasey, R. The morphologic characteristics of cervical ripening induced by the hormones relaxin and prostaglandin F2 in a rabbit model. Am. J. Obstet. Gynecol, 152:910696, (1985).
  15. Bishop, E. Elective induction of labor. Obstet & Gynecol, 5: 519-527, (1955).
  16. Bishop, E. Pelvic scoring for elective induction. Obstet & Gynecol. 24: 266-268, (1969).
  17. Thiery, M. Preinduction cervical ripening. In: Obstetrics and Gynecology Annual, Vol. 12, Ed. Wynn, R. M. Appleton-Century-Crofts, New York, Pp. 103-146, (1983).
  18. MacKenzie, I.; Information on File: Controlled Therapeutics (Scotland).

Mfg by:
Controlled Therapeutics
East Kilbride, Scotland, G74 5PB

Made in the U.K.

Distributed by:
FOREST PHARMACEUTICALS, INC.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045 USA

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