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Cervidil

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Cervidil

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.

DOSAGE AND ADMINISTRATION

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 (dinoprostone) should be removed upon onset of active labor or 12 hours after insertion.

Cervidil (dinoprostone) is supplied in an individually wrapped aluminium/polyethylene package with a “tear mark” on one side of the package. The package should only be opened by tearing the aluminium package along the tear mark. The package should never be opened with scissors or other sharp objects which may compromise or cut the knitted polyester pouch that serves as the retrieval system for the polymeric slab.

Cervidil (dinoprostone) must be kept frozen until use, and is administered by placing one unit 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 water-miscible lubricant may be used to assist insertion of Cervidil (dinoprostone) . Care should be taken not to permit excess contact or coating with the lubricant which could prevent optimal swelling and release of dinoprostone from the vaginal insert. Patients should remain in the recumbent position for 2 hours following insertion, but thereafter may be ambulatory. If the patient is ambulatory, care should be taken to ensure the vaginal insert remains in place. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Cervidil (dinoprostone) should also be removed prior to amniotomy.

Upon removal of Cervidil (dinoprostone) , it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient. This is accomplished by visualizing the knitted polyester retrieval system and confirming that it contains the slab. In the rare instance that the slab is not contained within the polyester retrieval system, a vaginal exam should be performed to remove the slab.

HOW SUPPLIED

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

Store in a freezer: between -20°C and -10°C (-4°F and 14°F). Cervidil (dinoprostone) 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.

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. Rev. 04/10.

Last reviewed on RxList: 6/17/2010
This monograph has been modified to include the generic and brand name in many instances.

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