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PREPIDIL is a brand name for Dinoprostone, supplied as a gel. 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.
In clinical trials of PREPIDIL (dinoprostone gel), the most commonly seen reactions were intrapartum fetal heart rate changes and unclassified fetal distress during or subsequent to PREPIDIL administration. 5 mg administered endocervically) in which oxytocin was used as the control.
The control group had comparable incidences of adverse events. Fetal Effects (l6%): Intrapartum fetal heart rate changes including bradycardia and unclassified fetal distress during or subsequent to Prepidil Gel treatment (l3%); Uterine contractile abnormalities with fetal heart rate changes (3%); Depressed neonates at birth (Apgar Scores below 7): l minute (l3%) 5 minutes (l%) Maternal Effects (l0%): Uterine contractile abnormalities without fetal heart rate changes (5%); Gastrointestinal effects (vomiting and/or diarrhea - 5%) Miscellaneous (≥1%) Fever Back pain Warm feeling in vagina PREPIDIL Gel (dinoprostone) Product Monograph Page 7 of 28 Post-Marketing Adverse Drug Reactions Blood and lymphatic system disorders: An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by pharmacological means, either with dinoprostone or oxytocin (see section WARNINGS).
The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labors). Adverse event reports not listed above that have been received from spontaneous post-marketing reports for PREPIDIL since market introduction are shown below.
g. Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction) Gastrointestinal disorders: Nausea Pregnancy, puerperium and perinatal conditions: Uterine rupture OVERDOSE\ Overdosage with PREPIDIL may be expressed by uterine hypercontractility and uterine hypertonus.
, maternal position change and administration of oxygen to the mother. β-adrenergic drugs may be used as a treatment of hyperstimulation following the administration of PGE2 for cervical ripening. 5 mg. 5 mg dinoprostone. This product is intended for single dose administration.
Utilizing the catheter provided, administer the entire contents of the syringe by gentle expulsion into the cervical canal just below the level of the internal cervical os. No attempt should be PREPIDIL Gel (dinoprostone) Product Monograph Page 8 of 28 made to administer the small amount of gel remaining in the catheter.
Care should be taken not to administer PREPIDIL above the level of the internal os. Placement of the gel into the amniotic space has been associated with uterine hyperstimulation. (See PRECAUTIONS) After placement of the gel, the patient should be instructed to remain in the dorsal position for l0 - l5 minutes to minimize gel leakage.
DOSAGE FORMS Availability PREPIDIL (dinoprostone gel) is supplied as a translucent sterile gel preparation in a prefilled syringe with an accompanying catheter. 5 mL) Non medicinal ingredients: colloidal silicon dioxide and triacetin SEE DIAGRAM FOR ASSEMBLY INSTRUCTIONS (APPENDIX A) APPENDIX A Syringe Assembly Instructions PREPIDIL Gel (dinoprostone) Product Monograph Page 9 of 28 1.
Endocervically administered PREPIDIL (dinoprostone gel) is not recommended for use in the following: l. 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 a major degree of 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, polyhydromnias).
2. Patients with ruptured amniotic membranes or suspected chorioamnionitis; 3. Patients with known hypersensitivity to the prostaglandins or any ingredient in the formulation; 4. Patients with unexplained vaginal bleeding during this pregnancy; 5.
Patients with fetal malpresentation; 6. Patients with gynecological, obstetrical or medical conditions that preclude vaginal delivery. 7. Patients whose pregnancy is complicated by an abnormal position of the placenta or umbilical cord.
PREPIDIL should not be used simultaneously with other oxytocics (see WARNINGS). PREPIDIL should not be used in patients with a history of epilepsy. PREPIDIL Gel (dinoprostone) Product Monograph Page 4 of 28 WARNINGS PREPIDIL (dinoprostone gel), like other effective oxytocic agents, should be used with strict adherence to recommended dosages, by medically trained personnel in hospital surroundings with appropriate obstetrical care facilities.
The use of oxytocin following pre-induction cervical ripening with PREPIDIL has been studied. Prostaglandins may potentiate the effect of oxytocin on the uterus. Therefore, to preclude inappropriate augmentation of one oxytocic agent with another, it is recommended that induction with an oxytocic agent not be implemented until six (6) to twelve (12) hours after application of PREPIDIL for cervical ripening.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Remove protective end cap (to serve as plunger rod). 2. Insert protective end cap into the syringe. 3. Firmly attach catheter hub to syringe tip (catheter has to click into place) and administer syringe content. PREPIDIL has a shelf life of 24 months when stored at 4°C, under continuous refrigeration.
5 Chemical Name: (5z,ll-alpha,l3E,l5S)-ll,l5-Dihydroxy-9-oxo-prosta-5,l3-dien-l-oic acid. 5 mL). Dinoprostone is a white crystalline powder. It has a melting point range of 64°C to 7l°C. Dinoprostone is readily soluble in the triacetin component of the gel formulation.
It is also soluble in ethanol and in 25% ethanol in water. Solubility in water is limited to 130 mg/l00 mL. PREPIDIL Gel (dinoprostone) Product Monograph Page 11 of 28 PHARMACOLOGY Pregnancy has been interrupted in hamsters, mice, rats and Rhesus monkeys by administering dinoprostone.
Some skeletal abnormalities were also observed in rats when dinoprostone was administered to the mother on days 9, l0 and 11 of gestation. In a similar study, in rabbits, this effect was not observed. Also, pseudo-pregnancy was shortened in rats, and uterine motility stimulated in Rhesus monkeys.
Cervical diameter, weight or glycogen content were not altered in rats treated with dinoprostone. Dinoprostone was injected subcutaneously into two groups of 5 hamsters (Mesocricetus auratus) each, (plus a control group of 8 hamsters), as a single injection on day 4 of pregnancy.
25 mg dinoprostone or saline respectively. Some depression of normal activity was noted following prostaglandin injection. Dinoprostone was injected intravenously into 2 groups of mice; pregnant and nonpregnant, at a dose of 30 mg/kg.
This dosage was non-toxic to the nonpregnant mice. It caused fetal death in the pregnant mice. Dinoprostone was injected subcutaneously into rats (2mg/rat/day) on days 4, 5 and 6 of pregnancy. Only 1 out of 6 animals was […]
Patients requiring oxytocin induction after PREPIDIL administration should be carefully monitored. 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.
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 PREPIDIL (dinoprostone gel), uterine activity, fetal status and the character of the cervix (dilatation and effacement) should be carefully monitored to detect possible evidence of undesired responses.
These include hypertonus, sustained uterine contractility or fetal distress. In cases where there is a known history of hypertonic uterine PREPIDIL Gel (dinoprostone) Product Monograph Page 5 of 28 contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the fetus should be continuously monitored.
The possibility of uterine rupture and/or cervical laceration should be born in mind where high-tone myometrial contractions are sustained. Cephalopelvic relationships should be carefully evaluated before the use of PREPIDIL. Caution should be exercised in the administration of PREPIDIL in patients with the following medical conditions: Asthma or a history of asthma; Glaucoma or raised intraocular pressure.
Prostaglandins are excreted in breast milk at very low concentrations. No measurable differences were observed in the milk of mothers delivering prematurely and at term. Prolonged treatment of newborn infants with prostaglandin E1 can induce proliferation of bone.
There is no evidence that short term administration of prostaglandin E2 can cause similar bone effects. Caution should be taken not to administer PREPIDIL above the level of the internal os. Placement of PREPIDIL into the extra-amniotic space has been associated with uterine hyperstimulation.
Patients with severe renal disease and/or severe hepatic disease accompanied by metabolic aberrations should be dosed with caution. Drug Interactions PREPIDIL, like all prostaglandins, may potentiate the uterine response to oxytocin.
Patients requiring oxytocin induction, after pre-induction cervical ripening with PREPIDIL, should be carefully monitored. (See WARNINGS) PREPIDIL Gel (dinoprostone) Product Monograph Page 6 of 28 ADVERSE REACTIONS In clinical trials of PREPIDIL (dinoprostone gel), the most commonly seen reactions were intrapartum fetal heart rate changes and unclassified fetal distress during or subsequent to PREPIDIL administration.
5 mg administered endocervically) in which oxytocin was used as the control. The control group had comparable incidences of adverse events. Fetal Effects (l6%): Intrapartum fetal heart rate changes including bradycardia and unclassified fetal distress during or subsequent to Prepidil Gel treatment (l3%); Uterine contractile abnormalities with fetal heart rate changes (3%); Depressed neonates at birth (Apgar Scores below 7): l minute (l3%) 5 minutes (l%) Maternal Effects (l0%): Uterine contractile abnormalities without fetal heart rate changes (5%); Gastrointestinal effects (vomiting and/or diarrhea - 5%) Miscellaneous (≥1%) Fever Back pain Warm feeling in vagina […]