What Cervidil 10mg is used for and how to use it
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Cervidil - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: Canada
Condition: Labor Induction
Class: Uterotonic agents
Form: Vaginal (e.g., douche, pessary, etc.)
Ingredients: dinoprostone, hydrogel polymer, macrogol 8000, dicyclohexylmethane-4,4’diisocyanate, 1,2,6-hexanetriol, polyester retrieval system

Cervidildinoprostone, 10 mg vaginal insert

About This Medication

What the Medication is Used For

Cervidil is used to start or continue “cervical ripening” in patients at the end of pregnancy when there is a medical or obstetrical reason to induce labour.

What it Does

Cervidil ripens the cervix (opening of the uterus) in patients at the end of pregnancy where there is a medical or obstetrical reason for the induction of labour. Cervical ripening describes the changes in the cervix during the final weeks of normal pregnancy when the cervix gradually becomes softer, more flexible, stretchy, and shorter.

When it Should not be Used

Cervidil should not be used or left in place;

  • When labour has started
  • When there is a known sensitivity to prostaglandins (Cervidil is a prostaglandin which is like a hormone in the body)
  • When there is a suspicion or evidence of a problem with the baby and delivery will not be soon
  • When the placenta is attached close to or covering the cervix (opening into the uterus) or there is unexplained vaginal bleeding during this pregnancy
  • When there is evidence or strong suspicion that the baby’s head is too large to fit through the mother’s pelvis
  • When drugs used to stimulate labour are not indicated or when prolonged contraction of the uterus may be harmful to the baby’s safety or stability of the uterus (previous cesarean section or major uterine surgery)
  • When there have been many pregnancies (6 or more previous term pregnancies)
  • When there is a history of difficult labour and/or delivery
  • When the uterus is very large (multiple pregnancy, too much amniotic fluid around the baby)
  • When the baby is not in the correct position to deliver properly head first
  • When there is a history of epilepsy and seizures are poorly controlled
  • When other drugs are being given to stimulate labour (See Warnings)
  • When there is a history of, or current pelvic inflammatory disease (infection or inflammation of the uterus, fallopian tubes, and ovaries) unless adequate prior treatment has been given

What the Medicinal Ingredient Is

Dinoprostone

What the Important Nonmedicinal Ingredients Are

Hydrogel Polymer

Prepared with:

Macrogol 8000

Dicyclohexylmethane-4,4’diisocyanate

1,2,6-Hexanetriol

Polyester Retrieval system

What Dosage Forms it Comes In

Vaginal Insert, 10 mg

Warnings and Precautions

Serious Warnings and Precautions

For Hospital Use Only

Cervidil should be administered only by trained obstetrical staff in a hospital setting with appropriate obstetrical care facilities.

BEFORE you use Cervidil please talk to your doctor:

  • Since prostaglandins increase the effect of other drugs used to stimulate labour, Cervidil must be removed before another drug to stimulate labour is started and your uterine activity should be carefully monitored for uterine overstimulation.
  • If excessive stimulation of the uterus occurs or if labour starts, Cervidil should be removed. Cervidil should also be removed before artificial tearing of the membranes to induce or speed up labour. Cervidil should be removed if you experience any adverse effects such as nausea, vomiting, lowered blood pressure or an abnormal rapid heart rate.
  • The experience of Cervidil in patients with ruptured membranes is limited. Therefore, Cervidil should be used with caution in those patients. Since the release of dinoprostone from Cervidil can be affected in the presence of amniotic fluid, special attention should be given to uterine activity and the baby’s condition.
  • Your doctor should use caution using Cervidil for cervical ripening if you have a history of previous uterine overactivity, glaucoma (increased pressure in the eyes), or a history of childhood asthma, even though there have been no asthma attacks in adulthood.
  • Women aged 35 and over (occasionally also younger women), women with complications during pregnancy and women with a pregnancy of more than 40 weeks, have a higher risk for developing a generalized blood clotting disorder. The risk of this blood clotting disorder may be higher in women with induced labour. Therefore, dinoprostone other drugs used to stimulate labour should be used with caution in these women. Immediately after the delivery the physician should look carefully for early signs of developing this clotting disorder.
  • Uterine activity, status of the baby and the progression of cervical dilatation and shortening should be carefully monitored whenever Cervidil is in place. If there is any evidence of uterine overstimulation, sustained uterine contractions, problems with the baby, or other adverse reactions concerning the mother or baby removal of the insert should be considered. The possibility of uterine rupture and/or cervical tearing should be considered when very strong contractions are sustained.
  • The size of the baby’s head compared to your pelvis should be carefully evaluated before the use of Cervidil.
  • There are different types of prostaglandins. Prolonged treatment of newborn infants with a prostaglandin E1 may affect bone growth. There is no evidence that short term administration of prostaglandin E2 (Cervidil) can cause similar bone effects.
  • Patients with severe kidney disease and/or severe liver disease accompanied by metabolic abnormalities should be treated with caution. Make sure your doctor knows if you have any health problems.

Interactions With This Medication

Cervidil may increase the activity of other drugs used to stimulate labour and their use at the same time is not recommended. A waiting period of at least 30 minutes is recommended before the use of other drugs used to stimulate labour following the removal of Cervidil. No other drug interactions have been identified.

Proper Use of This Medication

To remove Cervidil from the packaging, first tear the foil along the top of the sachet. Do not use scissors or sharp implements to cut the foil as this may damage the product. Use the retrieval system to gently pull the product out of the sachet.

After removal from the patient, ensure that the entire product (vaginal delivery system and retrieval system) has been removed from the vagina.

Usual dose

The dosage of dinoprostone in Cervidil 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 or 12 hours after insertion.

One Cervidil is placed in the space behind the cervix immediately after removal from its foil package. The insertion of Cervidil does not require sterile conditions. Cervidil must not be used without its retrieval system. There is no need for previous warming of the product. A minimal amount of K-Y jelly (or other water-based lubricant) may be used to assist in insertion of Cervidill. Care should be taken to prevent excess contact or coating with the lubricant and thus prevent optimal swelling and release of dinoprostone from Cervidil. You should remain lying on your back for 2 hours following insertion, but you can then be up and about.

Overdose

Cervidil is used once only. An overdose is usually shown by strong uterine contractions. If an overdose is suspected, Cervidil can be removed easily by pulling on the retrieval string.

If any prolonged increased uterine activity occurs, the use of medication to treat these undesirable effects should be considered.

Missed Dose

N/A

Side Effects and What to do About Them

Cervidil is well tolerated. In studies in which 658 women were treated and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported: Out of 102 patients five (4.9%) had uterine overstimulation. Of these, three (2.9%) of the cases were associated with fetal distress. Of the five cases, four resolved after the removal of Cervidil.

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

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom/effect Talk with your doctor or pharmacist Stop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
Common Abnormal
labour
affecting fetus
Fetal heart rate
disorder
Fetal distress
syndrome
Uterine
hypertonus
Uncommon Nausea,
vomiting,
diarrhea

This is not a complete list of side effects. For any unexpected effects while taking Cervidil contact your doctor or pharmacist.

How to Store It

Store in a freezer between -20oC and -10oC

Reporting Suspected Side Effects

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

 

toll-free telephone: 866-234-2345

toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

 

By regular mail: National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

 

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

More Information

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Ferring Inc., at: 1-800-263-4057