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  • Prostin E2 – Vaginal Gel
    / Pfizer


    Active Ingredient
    Dinoprostone 1 mg / 3 g

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Gel

    1 mg / 3 g

    partial basket chart 35540 16671

    Gel

    2 mg / 3 g

    partial basket chart 35605 16672

    Related information


    Dosage

    For labor induction at or near term, the initial dose of 1 mg of Prostin E2 Vaginal Gel should be administered by gentle expulsion of the entire content of the syringe into the posterior fornix of the vaginal canal. The patient should remain in supine position for at least 30 minutes. After 6 hours, a second dose of either 1 or 2 mg of Prostin E2 Vaginal Gel may be administered if necessary:
    – 2 mg in case of absence of response to initial dose;
    – 1 mg to augment an already present response to the initial dose.
    SYRINGE ASSEMBLY INSTRUCTIONS:
    1. Remove peel-off seal.
    2. Remove protective end cap (to serve as plunger rod).
    3. Insert protective end cap into the syringe.
    4. Administer syringe content.


    Indications

    Prostin E2 Vaginal Gel is indicated for labor induction in term and near term pregnant women who have favorable induction features and who have singleton pregnancy with a vertex presentation.


    Contra-Indications

    Prostin E2 Vaginal Gel should not be used where the patient is sensitive to prostaglandins or other constituents of the gel.
    Prostin E2 Vaginal Gel is not recommended in the following circumstances:
    For patients in whom oxytocic drugs are generally contra-indicated or where prolonged contractions of the uterus are considered inappropriate such as: Cases with a history of Caesarean section or major uterine surgery; Cases where there is cephalopelvic disproportion; Cases in which fetal malpresentation is present; Cases where there is clinical suspicion or definite evidence of pre-existing fetal distress; Cases in which there is a history of difficult labour and/or traumatic delivery; Grand multiparae with over five previous term pregnancies.
    2. Patients with ruptured membranes.
    3. In patients with a past history of, or existing, pelvic inflammatory disease, unless adequate prior treatment has been instituted.
    4. In patients where there is clinical suspicion or definite evidence of placenta praevia or unexplained vaginal bleeding during this pregnancy.
    5. Patients with active cardiac, pulmonary, renal or hepatic disease.


    Special Precautions

    This product is only available to hospitals and clinics with specialised obstetric units and should only be used where 24-hour resident medical cover is provided.
    Use the total contents of the syringe for one patient only. Discard after use. Use caution in handling the product to prevent contact with skin. Wash hands thoroughly with soap and water after administration.
    Prostin E2 Vaginal Gel and Prostin E2 Vaginal Tablets are not bioequivalent.
    Caution should be exercised in the administration of Prostin E2 Vaginal Gel for the induction of labour in patients with:
    (i) asthma or a history of asthma; (ii) epilepsy or a history of epilepsy; (iii) glaucoma or raised intra-ocular pressure; (iv) compromised cardiovascular, hepatic, or renal function; (v) hypertension.
    As with any oxytocic agent, Prostin E2 Vaginal Gel should be used with caution in patients with compromised (scarred) uteri.
    For full details see prescribing information.


    Side Effects

    Cardiac disorders: Cardiac arrest.
    Vascular disorders: Hypertension.
    Gastrointestinal disorders: Diarrhoea, nausea, vomiting.
    General disorders and administration site conditions: Fever.
    Immune system disorders: Hypersensitivity reactions such as anaphylactoid reactions and anaphylactic reactions including anaphylactic shock.
    Musculoskeletal and connective tissue disorders: Back pain.
    Pregnancy, Puerperium and Perinatal conditions: Maternal-related conditions: Uterine hypertonus, uterine rupture, abruptio placenta, pulmonary amniotic fluid embolism, rapid cervical dilatation. Foetus-related conditions: Uterine hypercontractility with/without fetal bradycardia fetal distress/altered fetal heart rate (FHR). Neonatal conditions: Neonatal distress, neonatal death, stillbirths, low Apgar score.
    Reproductive system and breast disorders: Warm feeling in vagina, irritation, pain.
    Respiratory, thoracic and mediastinal disorders: Asthma, bronchospasm.
    Skin and subcutaneous tissue disorders: Rash.
    Blood and lymphatic system disorders: An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labour was induced by pharmacological means, either with dinoprostone or oxytocin. The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labours).


    Drug interactions

    Since it has been found that prostaglandins potentiate the effect of oxytocin, it is not recommended that these drugs are used together. If used in sequence, the patient’s uterine activity should be carefully monitored.


    Pregnancy and Lactation

    Pregnancy: Prostin E2 Vaginal Gel is only used during pregnancy, to induce labour.
    Lactation: Prostaglandins are excreted in breast milk. This is not expected to be a hazard given the circumstances in which the product is used.


    Overdose

    Overdosage may be expressed by uterine hypercontractility and uterine hypertonus. During use, uterine activity, fetal status and the progression of cervical dilation should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus, sustained uterine contractions, or fetal distress. Because of the transient nature of PGE2-induced myometrial hyperstimulation, non-specific, conservative management was found to be effective in the vast majority of cases: i.e. maternal position change and administration of oxygen to the mother. If conservative management is not effective, ß-adrenergic drugs may be used as a treatment of hyperstimulation following administration of PGE2 for cervical ripening, in appropriate patients.


    Important notes

    Storage: Store in a refrigerator at 2-8°C.


    Manufacturer
    PFIZER Manufacturing Belgium NV, Belgium
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