CERVIDIL 10 mg/241mg

DINOPROSTONE · INSERT · Ferring Pharmaceuticals Inc.

No Recall History

Plain English

Cervidil is a vaginal insert containing dinoprostone, a prostaglandin analog used to prepare the cervix for labor induction in pregnant patients at term. It releases medication gradually to help soften and dilate the cervix over a 12-24 hour period.

Key Facts

Brand Name: CERVIDIL
Generic Name: DINOPROSTONE
NDC Code (Product): 55566-2800
Manufacturer: Ferring Pharmaceuticals Inc.
Strength: 10 mg/241mg
Dosage Form: INSERT
Route: VAGINAL
Marketing Status
Application #: NDA020411
Drug Class: Prostaglandin Analog [EPC]
Marketing Start: 03/30/1995

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

foetal exposure during pregnancy115 reports

drug exposure during pregnancy70 reports

caesarean section60 reports

maternal exposure during pregnancy58 reports

exposure during pregnancy53 reports

off label use45 reports

premature separation of placenta43 reports

uterine hyperstimulation37 reports

drug ineffective36 reports

premature baby35 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. CERVIDIL is a prostaglandin analog indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer a single vaginal insert (10 mg) for up to 12 hours of use (approximately 0.3 mg of dinoprostone is released per hour) ( 2.1 ) Remove upon onset of active labor or 12 hours after insertion. ( 2.1 ) Carefully monitor for uterine activity, fetal status and the progression of cervical dilatation and effacement. ( 2.1 ) CERVIDIL should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities ( 2.2 ). See full prescribing information for complete preparation, administration, and removal instructions. ( 2.2 , 2.3 ) 2.1 Dosage Instructions Administer one CERVIDIL insert (10 mg) intravaginally for use up to 12 hours (approximately 0.3 mg of dinoprostone is released per hour) [see Dosage and Administration (2.2) ]. Monitor uterine activity, fetal status, and the progression of cervical dilatation and effacement with the use of CERVIDIL. Remove CERVIDIL 12 hours after insertion with the onset of active labor, prior to an amniotomy, occurrence of uterine tachysystole, uterine hypersystole/hypertonicity, or fetal distress [see Warnings and Precautions (5.4) ] . Remove CERVIDIL at least 30 minu…

Contraindications

4 CONTRAINDICATIONS CERVIDIL is contraindicated in patients with: Known hypersensitivity to prostaglandins [see Adverse Reactions (6.2) ] Evidence or clinical suspicion of fetal distress where delivery is not imminent Unexplained vaginal bleeding in the current pregnancy Evidence or clinical suspicion of marked cephalopelvic disproportion Conditions for which induction of labor is contraindicated Conditions for which oxytocic drugs are contraindicated Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety Concurrent use with intravenous oxytocic agents [see Warnings and Precautions (5.4) and Drug Interactions (7) ] Six or more previous term pregnancies CERVIDIL is contraindicated for: Known hypersensitivity to prostaglandins ( 4 ) Evidence or clinical suspicion of fetal distress, where delivery is not imminent ( 4 ) Unexplained vaginal bleeding in the current pregnancy ( 4 ) Evidence or clinical suspicion of marked cephalopelvic disproportion ( 4 ) Contraindication to induction of labor ( 4 ) Concurrent use with intravenous oxytocic age…

Drug Interactions

7 DRUG INTERACTIONS Oxytocic Agents : May augment the activity of oxytocic agents; concomitant use of intravenous oxytocic agents is contraindicated ( 4 , 7.1 ). Remove vaginal insert at least 30 minutes before administering an oxytocic agent. ( 7.1 ) 7.1 Oxytocic Agents CERVIDIL is contraindicated in patients receiving intravenous oxytocic agents because CERVIDIL may augment the activity of oxytocic agents. A dosing interval of at least 30 minutes is recommended for the sequential use of an oxytocic agent following the removal of CERVIDIL.

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: Disseminated Intravascular Coagulation [see Warnings and Precautions (5.2) ] Amniotic Fluid Embolism [see Warnings and Precautions (5.3) ] Uterine Tachysytole and Uterine Hypersystole/Hypertonicity [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 2 %) are uterine tachysystole without fetal distress, uterine tachysystole with fetal distress, and fetal distress without uterine tachysystole. ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In placebo-controlled trials of 658 pregnant women (320 CERVIDIL-treated women and 338 placebo-treated women), the following treatment related adverse reactions (see Table 1 ) occurred at an incidence…