PROSTIN

What it is

PROSTIN E2 Vaginal Gel contains dinoprostone 1 mg or 2 mg as the active ingredient in each unit dose of 3 grams (2.5 mL). It is a vaginal gel presented as a translucent triacetin-based, thixotropic gel formulation.

Approved indications

— Induction of labour in term or near-term pregnant women who have favourable induction features and who have singleton pregnancy with a vertex presentation.

Dosing overview

For labour induction at or near term, in women with favourable induction features with singleton pregnancy and vertex presentation, the initial dose is 1 mg of PROSTIN E2 Vaginal Gel. The gel should be inserted high into the posterior fornix of the vagina, avoiding administration into the cervical canal. The patient should be instructed to remain recumbent for at least 30 minutes. A further dose of either 1 or 2 mg of PROSTIN E2 Vaginal Gel may be given after 6 hours on the basis of clinical assessment of response on the proviso that the maximum dose of PROSTIN E2 Vaginal Gel does not exceed 3 mg (or 60 µg/kg for a 50 kg woman) over a 6 hour period.

Key safety warnings

PROSTIN E2 Vaginal Gel is not to be used intra-cervically. The intracervical placement of dinoprostone gel may result in inadvertent disruption and subsequent embolization of antigenic tissue, which may cause, in rare circumstances, the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism). Women aged 35 years or older, those with complications during pregnancy 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 labour induction. Therefore, in these women, use of PROSTIN E2 Vaginal Gel should be undertaken with caution. PROSTIN E2 Vaginal Gel for labour induction should be used with caution in patients with compromised cardiovascular, hepatic or renal function and in patients with asthma, epilepsy, glaucoma or raised intraocular pressure, or ruptured chorioamniotic membranes. PROSTIN E2 Vaginal Gel should only be used under the supervision of qualified medical personnel in obstetric units with facilities for fetal and maternal monitoring and operative delivery. It is recommended that during induction of labour with PROSTIN E2 Vaginal Gel that continuous monitoring of uterine activity and fetal heart rate be employed. PROSTIN E2 Vaginal Gel should not be used simultaneously with other oxytocics, and when used sequentially, uterine activity should be carefully monitored.

Contraindications

PROSTIN E2 Vaginal Gel should not be used in patients known to be hypersensitive to dinoprostone or any other constituent of the gel (triacetin or colloidal anhydrous silica). PROSTIN E2 Vaginal Gel should not be used in patients with the following conditions: grand multiparity (five or more previous deliveries) ; cases in which the presenting part is above the pelvic inlet ; history of previous uterine surgery ; cephalopelvic disproportion ; abnormal cardiotocography or suspected fetal compromise ; malpresentation ; unexplained vaginal discharge and/or abnormal uterine bleeding during the current pregnancy ; cases where vaginal delivery is not indicated such as vasa praevia or active herpes genitalis ; and multiple gestation.

Regulatory history

PROSTIN E2 Vaginal Gel 1 mg and 2 mg (dinoprostone) were first listed on the ARTG on 27 August 1991.