CERVIDIL 10 MG — DIN 02231047

What is CERVIDIL?

CERVIDIL 10 MG contains DINOPROSTONE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02231047, held by FERRING INC, supplied as INSERT for VAGINAL administration. Health Canada currently lists it as marketed, status dated 17-Jun-1997. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is CERVIDIL used for?

CERVIDIL® (dinoprostone vaginal insert) is indicated for: 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 labour.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

CERVIDIL is used as a single dosage in a single application. 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 labour, 12 hours after insertion, or in the event of an adverse reaction, e.g., uterine hyperstimulation. If subsequent administration of uterotonic drugs is needed, a dosing interval of at least 30 minutes is recommended following the removal of the vaginal delivery system. CERVIDIL requires no reconstitution prior to use. It should be removed from the freezer just prior to insertion; no thawing is required. The insert is placed transversely high in the posterior fornix of the vagina immediately after removal from its foil package. A minimal amount of water-miscible lubricant may be used to assist in insertion. Patients should remain in the supine position for 2 hours following insertion, but thereafter may be ambulatory. Uterine contractions and fetal condition must be monitored at frequent regular intervals. The vaginal delivery system must be removed when cervical ripening is complete, upon onset of labour (defined as regular painful uterine contractions every 3 minutes), 12 hours after insertion, or in the event of uterine hyperstimulation, fetal distress, or maternal systemic adverse effects.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

CERVIDIL is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • Patients when labour has started. • Patients in whom there is clinical suspicion or definite evidence of fetal distress where delivery is not imminent. • Patients with placenta previa or unexplained vaginal bleeding during this pregnancy. • Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion. • Patients in whom uterotonic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity (previous caesarean section or major uterine surgery). • Patients who have had previous major uterine cervix surgery (e.g. other than biopsies and cervical abrasion) or rupture of the uterine cervix. • Multipara with 6 or more previous term pregnancies. • Patients with a history of difficult labour and/or traumatic delivery. • Patients with overdistension of uterus (multiple pregnancy, polyhydramnios). • Patients with fetal malpresentation. • Patients with a history of epilepsy whose seizures are poorly controlled. • Simultaneous use with other uterotonic drugs and/or other labour induction agents. • History of, or current pelvic inflammatory disease, unless adequate prior treatment has been instituted.

Warnings and precautions

CERVIDIL should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities. The condition of the cervix should be assessed carefully before CERVIDIL is used. After insertion, uterine activity and fetal condition must be monitored carefully and regularly. If there is any suggestion of maternal or fetal complications or if adverse effects occur, the vaginal delivery system should be removed. Since prostaglandins potentiate the effect of uterotonic drugs, CERVIDIL must be removed before uterotonics administration is initiated and the patient's uterine activity carefully monitored for uterine hyperstimulation. If uterine hyperstimulation is encountered or if labour commences, the vaginal insert should be removed. CERVIDIL should also be removed prior to amniotomy. The vaginal insert should be removed if there is evidence of maternal systemic adverse PGE2 effects such as nausea, vomiting, hypotension or tachycardia. The experience of CERVIDIL in patients with ruptured membranes is limited; use with caution. Special attention should be given to uterine activity and fetal condition. Caution should be exercised in patients with a history of previous uterine hypertonicity, glaucoma, or a history of childhood asthma, even if no asthma attacks in adulthood or unexplained genital bleeding during the current pregnancy. Use with caution in multiple pregnancy (no studies performed). Use with caution when the woman has had more than three full term deliveries (no studies performed). A second dose of CERVIDIL is not recommended. Use in patients with diseases affecting dinoprostone metabolism/excretion (lung, liver, renal disease) is not recommended. Women aged 35 and over, with complications during pregnancy (gestational diabetes, arterial hypertension, hypothyroidism), and gestational age above 40 weeks have a higher postpartum risk for developing disseminated intravascular coagulation (DIC); use with caution. The physician should look carefully for early signs of developing DIC in the immediate postpartum phase. The possibility of uterine rupture and/or cervical laceration should be born in mind where hypertonic myometrial contractions are sustained. Uterine rupture has been reported, mainly in patients with contraindicated conditions. Cephalopelvic relationships should be carefully evaluated. Prolonged treatment of newborn infants with prostaglandin E1 can induce proliferation of bone; no evidence of similar effects with short term administration of prostaglandin E2. The qualified healthcare professional should be alert that, as with other labour induction methods, use of dinoprostone may result in inadvertent abruption of placenta and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism). Monitoring and Laboratory Tests: After insertion, the patient should remain supine and monitored for 2 hours for any evidence of uterine hyperstimulation, change in fetal heart rate or maternal blood pressure or heart rate. If any of these changes occur, removal of CERVIDIL should be considered.