Drug: Cervidil

Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr. The chemical name for dinoprostone (commonly known as prostaglandin E2 or PGE2) is 11α, 15S-dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural formula is represented below: The molecular formula is C20H32O5 and its molecular weight is 352.5. Dinoprostone occurs as a white to off-white crystalline powder. It has a melting point within the range of 65° to 69°C. Dinoprostone is soluble in ethanol and in 25% ethanol in water. Each insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer which is a semi-opaque, beige colored, flat rectangular slab measuring 29 mm by 9.5 mm and 0.8 mm in thickness. The insert and its retrieval system, made of polyester yarn, are non-toxic and when placed in a moist environment, absorb water, swell, and release dinoprostone.

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Cervidil (dinoprostone) is well tolerated. In placebo-controlled trials in which 658 women were entered and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported. Table 1 : Total Cervidil (dinoprostone) - Treated Drug Related Adverse Events
  Controlled Studies1 Active Placebo Uterine hyperstimulation with fetal distress 2.8% 0.3% Uterine hyperstimulation without fetal distress 4.7% 0% Fetal Distress without uterine hyperstimulation 3.8% 1.2% N 320 338   STUDY 101-8012   Active Placebo Uterine hyperstimulation with fetal distress 2.9% 0% Uterine hyperstimulation without fetal distress 2.0% 0% Fetal Distress without uterine hyperstimulation 2.9% 1.0% N 102 104 1Controlled Studies (with and without retrieval system)
2Controlled Study (with retrieval system) Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil (dinoprostone) . In study 101-801 (with the retrieval system) cases of hyperstimulation reversed within 2 to 13 minutes of removal of the product. Tocolytics were required in one of the five cases. In cases of fetal distress, when product removal was thought advisable there was a return to normal rhythm and no neonatal sequelae. Five minute Apgar scores were 7 or above in 98.2% (646/658) of studied neonates whose mothers received Cervidil (dinoprostone) . In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil (dinoprostone) , there were no deleterious effects on physical examination or psychomotor evaluation (18). Post-marketing surveillance Immune System Disorders: Hypersensitivity Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See WARNINGS Section) Reproductive system: Reports of uterine rupture have been reported in association with use of Cervidil (dinoprostone) some required a hysterectomy and some resulted in subsequent fetal or neonatal death. Vascular Disorders: Hypotension Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism Drug Abuse And Dependence No drug abuse or dependence has been seen with the use of Cervidil (dinoprostone) . Read the Cervidil (dinoprostone) Side Effects Center for a complete guide to possible side effectsLearn More »

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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.

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Cervidil (dinoprostone) 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.Read the Cervidil Drug Interactions Center for a complete guide to possible interactions Learn More »

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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.

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Cervidil (dinoprostone) 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.
REFERENCES 18. MacKenzie, I.; Information on File: Controlled Therapeutics (Scotland). 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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Cervidil (dinoprostone) 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 usually 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.

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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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General Precautions Since prostaglandins potentiate the effect of oxytocin, Cervidil (dinoprostone) must be removed before oxytocin administration is initiated and the patient's uterine activity carefully monitored for uterine hyperstimulation. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Cervidil (dinoprostone) should also be removed prior to amniotomy. Cervidil (dinoprostone) is contraindicated when prolonged contraction of the uterus may be detrimental to fetal safety and uterine integrity. Therefore, Cervidil (dinoprostone) should not be administered to patients with a history of previous cesarean section or uterine surgery given the potential risk for uterine rupture and associated obstetrical complications, including the need for hysterectomy and the occurrence of fetal or neonatal death. Caution should be exercised in the administration of Cervidil (dinoprostone) for cervical ripening in patients with ruptured membranes, in cases of non-vertex or non-singleton presentation, and in patients with a history of previous uterine hypertony, glaucoma, or a history of childhood asthma, even though there have been no asthma attacks in adulthood. Uterine activity, fetal status and the progression of cervical dilatation and effacement should be carefully monitored whenever the dinoprostone vaginal insert is in place. With any evidence of uterine hyperstimulation, sustained uterine contractions, fetal distress, or other fetal or maternal adverse reactions, the vaginal insert should be removed. An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by physiologic means, either with dinoprostone or oxytocin. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity and fertility studies have not been conducted with Cervidil (dinoprostone) Vaginal Insert. No evidence of mutagenicity has been observed with prostaglandin E2 in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or Ames Assay. Pregnancy Teratogenic Effects - Pregnancy Category C Prostaglandin E2 has produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since Cervidil (dinoprostone) Vaginal Insert is administered after the period of organogenesis. Prostaglandin E2 has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. Pediatric Use The safety and efficacy of Cervidil (dinoprostone) has been established in women of a reproductive age and women who are pregnant. Although safety and efficacy has not been established in pediatric patients, safety and efficacy are expected to be the same for adolescents.Last reviewed on RxList: 6/17/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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