Details for: PROSTIN E2 VAGINAL GEL
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01919679 | PROSTIN E2 VAGINAL GEL | DINOPROSTONE | 1 MG / 3 G | GEL | VAGINAL |
| 01919687 | PROSTIN E2 VAGINAL GEL | DINOPROSTONE | 2 MG / 3 G | GEL | VAGINAL |
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 Vaginal Gel is used to induce labour in pregnant women at the end or near the end of pregnancy.
What it does
PROSTIN E2 Vaginal Gel is an oxytocic agent, its effect on uterine smooth muscle leads to cervix ripening (opening of the uterus) and results in labour induction.
When it should not be used
PROSTIN E2 Vaginal Gel should not be used if:
- You cannot be given Oxytocic drugs or unable to have prolonged contractions of the uterus;
- You have a ruptured amniotic membranes or choriamnionitis (inflammation of the fetal membranes);
- You have unexplained vaginal bleeding during pregnancy
- You are unable to have vaginal delivery;
- You are allergic to prostaglandins or any oxytocic drug or any of the ingredients in PROSTIN E2 Vaginal Gel;
- You have no engagement of the baby’s 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 Vaginal Gel should not be used together with other oxytocics.
What the medicinal ingredient is
Dinoprostone
What the non-medicinal ingredients are
Colloidal silicon dioxide and triacetin
What dosage form it comes in
PROSTIN E2 Vaginal Gel is semi-translucent viscous gel in
a single dose pre-filled-syringe. Each syringe contains 1.0 mg
dinoprostone / 2.0 mL or 2.0 mg dinoprostone/2.5 mL.
Each syringe contains:
1.0 mg dinoprostone (PGE2)/2.5 mL Syringe (3 gm)
2.0 mg dinoprostone (PGE2)/2.5 mL Syringe (3 gm)
Warnings and precautions
PROSTIN E2 Vaginal Gel should be given to you by a
doctor experienced in using the drug.
PROSTIN E2 Vaginal Gel may cause uterine rupture
and/or cervical laceration (tearing), and anaphylactoid
syndrome of pregnancy (amniotic fluid embolism)
BEFORE you use PROSTIN E2 Vaginal 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 PROSTIN E2 Vaginal Gel, tell your doctor if you are taking other drugs, including non-prescription and natural health products.
Proper use of this medication
Usual Dose
An initial dose of 1 mg is to be given to you intra vaginally. A
dose of 1 mg or 2 mg PROSTIN E2 Vaginal Gel may be
repeated, once, 6 hours later depending upon the response to
the initial dose.
You should remain lying down (a lateral or supine position)
for 30 minutes after the drug was given to prevent leakage of
the gel.
Overdose
Missed Dose
N/A
Side effects and what to do about them
- Possible side effects on mother: strong uterine contractions, failed induction, failure to progress, diarrhea, nausea, vomiting, fever, severe allergic reaction (anaphylactic reaction, analyphylactic shock, anaphylactoid reaction), back pain, uterine rupture, abnormal uterine contraction, warm feeling in vagina, cardiac arrest.
- Possible side effects on baby: abnormal heart rate, distress (unwell), still birth.
- Serious side effect reported with the use of PROSTIN E2 Vaginal Gel: blood clots inside the blood vessels throughout the body (disseminated intravascular coagulation).
| 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 | ✔ | ||
| Increased uterine contractions | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking PROSTIN E2 Vaginal Gel, contact your doctor or pharmacist.
How to store
Store in a refrigerator at 2-8°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: September 13, 2012