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Details for: PROSTIN E2 TABLETS

Company: PFIZER CANADA ULC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00400688PROSTIN E2 TABLETSDINOPROSTONE0.5 MGTABLETORAL
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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

PROSTIN® E2 Tablets is used to induce labour in pregnant women at the end or near the end of pregnancy.

What it does

PROSTIN® E2 Tablets is an oxytocic agent, it 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

PROSTIN® E2 Tablets should not be used if:

  • You cannot be given Oxytocic drugs or unable to have prolonged contractions of the uterus;
  • 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 of the other ingredients in the PROSTINE E2 tablets;
  • You have no engagement of the baby head (baby’s head down into the pelvic), 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, PROSTIN E2 Tablet should not be used together with other oxytocics
What the medicinal ingredient is

Dinoprostone

What the non-medicinal ingredients are

Corn starch, colloidal silicon dioxide, lactose anhydrous, magnesium stearate powder; food grade, microcrystalline cellulose.

What dosage form it comes in

PROSTIN® E2 Tablets are in glass bottles containing 10 tablets each.

Warnings and precautions

PROSTIN® E2 Tablets should be given to you only by doctor experienced in using the drug.

BEFORE you use PROSTIN® E2 Tablets talk to your doctor if:

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

Before receiving PROSTIN E2 Tablets, tell your doctor if you are taking others drugs including non-prescription and natural health products.

Proper use of this medication

Usual Dose

The recommended dose of PROSTIN® E2 Tablets is 0.5 mg (one tablet) followed in one hour by a second dose of 0.5 mg (one tablet). All subsequent doses should be given hourly. The lowest effective dose should be used. All doses should be taken with a small amount of water.

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

In studies the most commonly reported adverse reactions were vomiting, with or without nausea and diarrhea (21% at dose 0.5 – 3.0 mg).

Other adverse reactions include Fetal heart changes (6.5%), uterine hypertonus (3.1%), and fetal distress syndrome.

This is not a complete list of side effects. For any unexpected effects while taking PROSTIN® E2 Tablets, contact your doctor or pharmacist.

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 talk with your doctor or pharmacist
Common
Abnormal labour affecting fetus   ✔  
Fetal distress syndrome   ✔  
Uerine hypertonus   ✔  
Uncommon
Nausea, vomiting     ✔
diarrhea   ✔  

This is not a complete list of side effects. For any unexpected effects while taking PROSTIN® E2 Tablets, 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 three 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: 05 September 2012

Date modified: