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PROSTIN E2 VAGINAL is a brand name for Dinoprostone, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE PROSTIN E2 vaginal gel (dinoprostone) is indicated for the induction of labour in term or near term pregnant women who have favourable induction features, a singleton pregnancy and a vertex presentation. CONTRAINDICATIONS PROSTIN E2 vaginal gel (dinoprostone) should not be used in patients with known…
Verbatim from this product's HC label. Tap a section to expand.
For intravaginal use only. Not to be used intracervically. For the induction of labour in term or near term pregnant women who have favourable induction features, a singleton pregnancy and a vertex presentation: An initial dose of 1mg PROSTIN E2 vaginal gel (dinoprostone) placed into the posterior fornix of the vaginal canal is recommended.
A dose of 1 mg or 2 mg of PROSTIN E2 vaginal gel may be repeated, once, 6 hours later depending upon the patient’s response to the initial dose. Patients should remain in a lateral or supine position for 30 minutes after administration to prevent leakage of the gel.
PROSTIN E2 vaginal gel prefilled syringes contain overfill and are designed to deliver a dose of 1 mg or 2 mg dinoprostone. The syringe should be assembled by following the sequence in the diagram. 1. Remove protective end cap (to serve as plunger rod).
2. Insert protective end cap into the syringe. 3. Administer syringe content. 5 Description: Dinoprostone is a white crystalline powder. It has a melting point range of 64ºC to 71ºC. 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/100 mL.
Stability and Storage Recommendations:
PROSTIN E2 vaginal gel has a shelf life of 24 months when stored at 2 - 8ºC, under continuous refrigeration. AVAILABILITY OF DOSAGE FORMS PROSTIN E2 vaginal gel (dinoprostone) is supplied as a semi-translucent viscous gel in a single dose container/closure system.
5 mL). Non medicinal ingredients: colloidal silicon dioxide and triacetin The contents of one syringe to be used for one patient. Discard after use. Prostin E2 Vaginal Gel (dinoprostone vaginal gel) Product Monograph Page 9 of 21 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 nontoxic to the nonpregnant mice. It caused fetal death in the pregnant mice. Dinoprostone was injected subcutaneously into rats (2 mg/rat/day) on days 4, 5 and 6 of pregnancy. Only 1 out of 6 animals was pregnant on day 10.
d. on days 4 through 7 of pseudo-pregnancy. Dose levels in excess of 2 mg/day were found to be toxic and/or fatal to rats. Dinoprostone infused into rats through an indwelling subcutaneous catheter at a rate of l0 mg/kg/day for 48 hours starting on day 5 of pregnancy, reduced pregnancy rate from 87% (control) to 17% (treated) by day 10 or 11.
5 mg/day) on days 9, 10, and 11 of gestation. 5 mg groups, maternal weight decreased, litter weight and size also decreased and an increase in the number of resorption sites was observed. In some cases, the skeletal abnormalities were due to a teratogenic effect.
, stimulated maximal uterine contractions in pregnant Rhesus (Macaca Mulatta) monkeys. d. starting on day 34 (3 injections) terminated pregnancy, but injections initiated on day 42 did not. 0 mg of dinoprostone stimulated uterine contractility for 3 to 4 hours in Rhesus monkeys treated at day 120 - 125 of pregnancy.
0 mg of dinoprostone stimulated uterine contractility for 5 hours. 5 mg of dinoprostone stimulated uterine contractility for 5 hours. 0 mg/animal. Relaxin increased the wet weight, volume and glycogen content of the uterus and uterine cervix.
Dinoprostone did not affect any of these parameters, nor did it modify the action of relaxin on them. In addition, dinoprostone did not alter the inner circumference of the uterine cervix as did relaxin. Prostin E2 Vaginal Gel (dinoprostone vaginal gel) Product Monograph Page 10 of 21 Studies of Effect on the Central Nervous System: Prostaglandins are natural constituents of nervous tissue and are released from the brain following stimulation of afferent pathways.
The literature is not extensive but does suggest that they may play a role of modulators. Studies have shown that the phosphodiesterase activity in mouse brain synaptic vesicles was inhibited by 58% at dinoprostone concentration of 1 x 10-3M.
The significance of these findings is not known. In rats, dinoprostone has been shown not to alter the utilization or […]