May 22, 2017
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Cervidil

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Cervidil




Side Effects
Interactions

SIDE EFFECTS

Cervidil 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 – Treated Drug-Related Advers e Events

  Controlled Studies*
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 101-801†
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
*Controlled Studies (with and without retrieval system)
†Controlled Study (with retrieval system)

Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil.

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. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers evaluation (18).

Post-Marketing Surveillance

Immune System Disorders: Hypersensitivity

Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (see WARNINGS)

Reproductive system: Reports of uterine rupture have been reported in association with use of Cervidil some required a hysterectomy and some resulted in subsequent fetal or neonatal death.

Vascular Disorders: Hypotension

Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism

To report SUSPECTED ADVERSE REACTIONS, contact FERRING PHARMACEUTICALS INC. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the Cervidil (dinoprostone) Side Effects Center for a complete guide to possible side effects

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.

Drug Abuse And Dependence

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

REFERENCES

18. MacKenzie, I.; Information on File: Ferring Controlled Therapeutics Limited (Scotland).

Read the Cervidil Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/1/2017

Side Effects
Interactions

Cervidil - User Reviews

Cervidil User Reviews

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Here is a collection of user reviews for the medication Cervidil sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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