Patient Medication Information: uses, side effects, how to take - Prostin F2 Alpha
ABOUT THIS MEDICATION
What the medication is used for:
PROSTIN F2α is used to induce labour in pregnant women in the second trimester.
What it does:
PROSTIN F2α 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 F2α should not be used if:
- You are allergic to prostaglandins or any oxytocic drug or any of the other ingredients in PROSTIN F2α;
- You have or have had untreated pelvic inflammatory disease;
- You are having heart, lung, kidney or liver disease.
What the medicinal ingredient is:
PROSTIN F2α (dinoprost tromethamine) is available as 1 mL (5 mg) ampoules
What the nonmedicinal ingredients are:
Benzyl alcohol (preservative), hydrochloric acid, sodium hydroxide and water for injection
What dosage forms it comes in:
PROSTIN F2α is a white or slightly off-white crystalline powder.
Each syringe contains:
5 mg dinoprost /1.0 mL ampoule (closed glass container)
WARNINGS AND PRECAUTIONS
PROSTIN F2α should be given to you by doctor experienced in using the drug.
BEFORE you use PROSTIN F2α 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 heart, liver, kidney problem.
Pregnancy: PROSTIN F2α may cause birth defects. Therefore, a pregnancy diagnosed as a missed abortion should be ended by some other means. Benzyl alcohol (preservative) can cross the placenta and may be harmful to the unborn child.
INTERACTIONS WITH THIS MEDICATION
Before receiving PROSTIN F2α tell your doctor if you are taking other drugs, including non-prescription and natural health products.
PROPER USE OF THIS MEDICATION
Usual dose:
A trained obstetrical staff will perform a transabdominal tap of the amniotic sac. PROSTIN F2α will then be injected intra-amniotically.
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. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
In most commonly events observed with the use of PROSTIN F2α were vomiting (57.1%), nausea (24.8%), and diarrhea (16.1%).
| 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 | |||
Un- Common | Rupture of upper intervaginal cervix Ruptured uterus Convulsions Severe reaction affecting the body Intra-uterine infection | |||
This is not a complete list of side effects. For any unexpected effects while taking PROSTIN F2α, contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature (15-30 °C)
REPORTING SUSPECTED 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: --------------------------------------------------------------------------
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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.