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PROSTIN E2 is a brand name for Dinoprostone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
PROSTIN E2 (dinoprostone) should not be used in patients with known hypersensitivity to dinoprostone or any other constituents of the tablet (corn starch, colloidal silicon dioxide, lactose anhydrous, magnesium stearate powder; food grade, microcrystalline cellulose).
Labour should not be induced in patients who have any of the following: 1. Patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate. These include the following situations: a.
Patients with a history of cesarean section or major uterine surgery; b. Patients with cephalopelvic disproportion; c. Patients with a history of difficult labour and/or traumatic delivery; d. Grand multiparae with six or more previous term pregnancies; e.
Patients with suspected or clinically evident pre-existing fetal distress; f. Patients with overdistention of the uterus (multiple pregnancy, polyhydramnios); g. patients with pre-existing uterine hypertonus; h. circumstances that make it impossible for a responsible physician to be present.
2. Engagement of the head has not taken place; 3. Patients with unexplained vaginal bleeding during this pregnancy; 4. Patients with fetal malpresentation; 5. Patients with gynecological, obstetrical or medical conditions that preclude vaginal delivery.
6. Patients whose pregnancy is complicated by an abnormal position of the placenta or umbilical cord. Prostin® E2 (dinoprostone) Product Monograph Page 4 of 23 7. Patients with a past history of, or existing pelvic inflammatory disease, unless adequate prior treatment has been instituted; 8.
Patients with active cardiac, pulmonary, renal or hepatic disease. PROSTIN E2 should not be used simultaneously with other oxytocics (see Warnings). WARNINGS PROSTIN E2 (dinoprostone), like other effective oxytocic agents, should be used with strict adherence to recommended dosages, by medically trained personnel in hospital surroundings that can provide immediate intensive care and facilities for immediate surgical intervention.
The sequential use of oxytocin immediately following PROSTIN E2 has been carried out. It has been found that prostaglandins might potentiate the effect of oxytocin. THEREFORE, INFUSION OF OXYTOCIN SHOULD NOT BE STARTED UNTIL AT LEAST ONE HOUR HAS ELAPSED FOLLOWING THE LAST ORAL DOSE OF PROSTIN E2.
Reports of epileptic seizures with other forms of prostaglandin by routes other than oral have been published. The association of prostaglandin with seizures has not been conclusively proven. One epileptic patient under poor control, when treated with PROSTIN E2 Tablets, did experience a grand mal seizure.
Therefore, it is recommended that PROSTIN E2 Tablets be used in known epileptics only when their epilepsy is under good control and then only with maximum care and observation on the part of the physician in charge. Elective induction of labor should not be employed in these patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dinoprostone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Women aged 35 years or older, those with complications during pregnancy including severe preeclampsia and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation.
In addition, these factors may further increase the risk associated with labor induction (see section ADVERSE REACTIONS). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum period.
Prostin® E2 (dinoprostone) Product Monograph Page 5 of 23 The Health Professional should be alert that the intracervical placement of dinoprostone gel may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).
PRECAUTIONS Prior to and during the use of labour inducing agents including PROSTIN E2 tablets (dinoprostone), uterine activity, fetal status and the character of the cervix (dilation and effacement) should be carefully monitored to detect possible evidence of undesired responses.
These include hypertonus, sustained uterine contractility or fetal distress. As with other effective oxytocic agents, it is recommended, during labour induction with PROSTIN E2 tablets, that continuous electronic monitoring of uterine activity and fetal heart rate be employed; particularly in cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions.
Cephalopelvic relationships should be carefully evaluated before the use of labour inducing agents, including PROSTIN E2 tablets. PROSTIN E2 tablets for labour induction should be used with caution in patients with compromised cardiovascular, hepatic or renal function and in patients with asthma or glaucoma.
Prostaglandins are excreted in human milk. Supportive data on the effect on infants are still inconclusive. Consistent with treatment with any labour inducing agent, patients who develop uterine hypertonus or hypercontractility or in whom nonreassuring fetal heart patterns develop should be managed in a manner that addresses the welfare of the fetus and mother.
Prostin® E2 (dinoprostone) Product Monograph Page 6 of 23 As with any oxytocic agent, the possibility of uterine rupture and/or cervical laceration should be considered in the presence of excessive uterine activity or unusual uterine pain, or where high- tone myometrial contractions are sustained.
Animal studies lasting several weeks at high doses have shown that prostanglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment.
There is no evidence that short term administration of PROSTIN E2 can cause similar bone effect.
Drug Interactions:
PROSTIN E2 tablets, like all prostaglandins, may potentiate the uterine response to oxytocin. Patients […]