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Details for: PREPIDIL GEL

Company: PFIZER CANADA ULC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00860786PREPIDIL GELDINOPROSTONE0.5 MG / 2.5 MLGELINTRACERVICAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

PREPIDIL gel is used to start the “cervical softening” and dilation of the cervix in pregnant women at the end of pregnancy.

What it does

PREPIDIL gel is an oxytocic agent, its effect on uterine smooth muscle leads to the cervix ripening (opening of the uterus) and results in labour induction.

When it should not be used

PREPIDIL gel should not be used if:

  • You cannot be given Oxytocic drugs or unable to have prolonged contractions of the uterus;
  • You have ruptured amniotic membranes or choriamnionitis (inflammation of the fetal membranes)
  • You have unexplained vaginal bleeding during pregnancy;
  • You are unable to have vaginal delivery;
  • When drugs used to stimulate labour are not required or when prolonged contraction of the uterus may be harmful to the baby’s safety or stability of the uterus
  • You are allergic to prostaglandins or any other oxytocic drug or any of the other ingredients in PREPIDIL Gel;
  • You have no engagement of the baby head (baby's head down into the pelvis), or abnormal position of the placenta or umbilical cord; or fetal malpresentation (baby in the difficult position for the birth process);
  • You have or have had untreated pelvic inflammatory disease;
  • You are having heart, lung, kidney, or liver disease; PREPIDIL gel should not be used together with other oxytocics.
What the medicinal ingredient is

Dinoprostone (PGE2)

What the non-medicinal ingredients are

Colloidal silicon, dioxide and triacetin

What dosage form it comes in

PREPIDIL is supplied as a translucent sterile gel preparation in a prefilled syringe with an accompanying catheter.

Each syringe contains:
 0.5 mg dinoprostone (PGE2)/2.5 mL Syringe (3 g)

Warnings and precautions

PREPIDIL should be given to you by doctor experienced in using this drug.

PREPIDIL gel may cause uterine rupture and/or cervical laceration (tearing), and anaphylactoid syndrome of Pregnancy (amniotic fluid embolism).

BEFORE you use PREPIDIL gel talk to your doctor if:

  • You are 35 years of age and over with complications during pregnancy;
  • You have had blood clotting problem after giving birth (post-partum);
  • You have or have had seizure;
  • You have asthma or glaucoma;
  • You have heart, liver, kidney problem;
Interactions with this medication

Before receiving PREPIDIL gel, tell your doctor if you are taking other drugs, including non-prescription and natural health products.

Proper use of this medication

Usual Dose

The recommended dose of PREPIDIL (dinoprostone gel) is 0.5 mg equivalent to the use of one prefilled syringe. Each syringe is intended for single dose administration.

After you doctor has placed the gel, you should remain lying on your back for 10-15 minutes to minimize gel leakage.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

N/A

Side effects and what to do about them

Possible side effects on mother (10%), including uterine contractile abnormalities without fetal heart change (5%), vomiting and diarrhea (5%), fever (>1%), back pain (>1%), warm feeling in vagina (>1%).

Possible side effects on baby (16%), including fetal heart rate change and unclassified fetal distress (13%), uterine contractile abnormalities with fetal heart change (3%), and depressed neonates (13 % at 1 minute):

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
Common
Abnormal labour affecting fetus   ✔  
Fetal distress syndrome   ✔  
Uterine hypertonus   ✔  
Uncommon
Nausea, vomiting, diarrhea   ✔ ✔

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

How to store

Store in a refrigerator at a temperature lower than 4°C

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.pfizer.ca This leaflet was prepared by Pfizer Canada inc.

Last revised: September 05, 2012

Date modified: