Expiration date: 02/2025

The composition and form of issue:

Gel for endocervical introduction 3 g (2.5 ml)

dinoprostone 0.5 mg

as well as colloid dvuoksid silicon triacetin 

in disposable plastic syringes 3 grams, complete with a sterile catheter into the cardboard pack 1 set.

Pharmacological action:

Stimulates smooth muscle, modulates the response of internal organs to various hormonal influences. Increases blood flow to the cervix, promotes its softening and dilatation.

Pharmacokinetics:

After the introduction of the endocervical gel Cmax achieved after 30-45 min, and then decreases rapidly.

Indications:

Preparation of the cervix for childbirth.

Contraindications:

Hypersensitivity, presence of anamnestic information about caesarean section, extensive surgical interventions on the uterus, difficult and/or traumatic childbirth, 6 or more full-term pregnancies, the discrepancy between the size of mother's pelvis and the fetal head, aberrant fetal position, preceding distress of the fetus, an autopsy of membranes, bleeding during pregnancy from the genital tract unknown etiology, infection of the lower genital tract.

Side effects:

Abnormal uterine contractions, vomiting and/or diarrhea, a change in fetal heart rate, fetal distress, reduced the status of the newborn (assessment of Apgar score below 7).

Drug interactions:

Tocotrienol increases the activity of oxytocin.

Method of application and dose:

The contents of the syringe (3 g of gel equivalent to 0.5 mg of dinoprostone) with the supplied catheter is inserted into the cervical canal (below the level of the internal OS). After the procedure, you need 10-15 min to lie on the back, to minimize leakage of the gel.

If the desired result from the use of Prepidil is achieved, the recommended interval before the appointment/oxytocin is 6-12 hours If response to initial dose of Prepidil not achieved, you can assign it again. Recommended repeat dose — 0.5 mg, and the interval from last injection to 6 h. the Need for additional purpose and interval should be determined by the doctor based on the clinical situation. The maximum recommended dose per 24-hour period is 1.5 mg.

Overdose:

Treatment: symptomatic, in/with the introduction of beta-agonists, or quick delivery.

Precautions:

The application is only possible in a hospital. Until the appointment of Prepidila it is necessary to assess the conformity of the size of the fetus and pelvis. Be sure to monitoring of uterine activity, cervical status and fetal well-being. When there is a history of hypertonic or tetanic uterine contractions, kidney or liver disease (accompanied by metabolic disorders) requires continuous monitoring of uterine activity and fetal condition and closely monitored. Be used with caution in patients with asthma or increased intraocular pressure (glaucoma).

Special instructions:

Avoid injection of the gel in ekstraamnioticescoe space (the possible hyperstimulation of the uterus).