Cervidil Indications, Dosage, Storage, Stability - Dinoprostone

Cervidil Indications, Dosage, Storage, Stability - Dinoprostone

INDICATIONS

Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor.

The dosage of dinoprostone in the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour over a 12 hour period. Cervidil should be removed upon onset of active labor or 12 hours after insertion.

One Cervidil is placed transversely in the posterior fornix of the vagina immediately after removal from its foil package. The insertion of the vaginal insert does not require sterile conditions. The vaginal insert must not be used without its retrieval system. There is no need for previous warming of the product. A minimal amount of K-Y® jelly (or other water-miscible lubricant) may be used to assist in insertion of Cervidil. Care should be taken not to permit excess contact or coating with the lubricant and thus prevent optimal swelling and release of dinoprostone from the vaginal insert. Patients should remain in the supine position for 2 hours following insertion, but thereafter may be ambulatory.

Cervidil (NDC 0456-4123-63) contains 10 mg dinoprostone. The product is wound and enclosed in an aluminum sleeve which is contained in an aluminum/polyethylene pack.

Store in a freezer: between -20°C and -10°C (-4°F and 14°F). Cervidil is packed in foil and is stable when stored in a freezer for a period of three years. Vaginal inserts exposed to high humidity will absorb moisture from the air and thereby alter the release characteristics of dinoprostone. Once used, the vaginal insert should be discarded.

Rx only

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 E ₂ 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 E-2 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 E ₂ 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 F ₂ 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