Instruction for use: Prepidil

Dosage Form:Intracervical gel

Active substance: Dinoprostone*

ATX

G02AD02 Dinoprostone

Pharmacotherapeutic group:

The labor-related stimulant is a PGE2 preparation [Prostaglandins, thromboxanes, leukotrienes and their antagonists]

The nosological classification (ICD-10)

O62.2 Other types of weakness in labor: Atony of the uterus; Weakness of labor; Reduced uterine tone; Induction of labor; Induction of labor with full term pregnancy; Induction of labor with full term or almost full pregnancy; Activation of labor

Composition and release form

Gel for endocervical administration 3 g (2.5 ml)

Dinoprostone 0.5 mg

As well as colloidal silicon dioxide; Triacetin

In disposable syringes of 3 g each, complete with sterile catheter; In a pack of cardboard 1 set.

Pharmacology

Mode of action - stimulating generic activity.

Stimulates smooth muscles, modulates the reaction of internal organs to various hormonal effects. Increases the blood supply of the cervix, contributes to its softening and opening.

Pharmacokinetics

After endocervical administration of the gel, Cmax is reached after 30-45 minutes, and then rapidly decreases.

Indications of the drug Prepidil

Preparation of the cervix for childbirth.

Contraindications

Hypersensitivity, the presence of anamnestic information about caesarean section, extensive surgical interventions on the uterus, difficult and / or traumatic births, 6 or more term pregnancies, mismatch of the pelvis of the mother and fetal head, abnormal fetal position, previous fetal distress, opening of the fetal bladder, spotting During pregnancy from the genital tract, unspecified etiology, infection of the lower genital tract.

Side effects

Abnormal uterine contractions, vomiting and / or diarrhea, changes in fetal heart rate, fetal distress, reduced neonatal status (Apgar score below 7).

Interaction

Strengthens the tocotropic activity of oxytocin.

Dosing and Administration

The contents of the syringe (3 g of gel corresponds to 0.5 mg of dinoprostone) are inserted into the cervical canal (below the inner pharynx) with the help of the attached catheter. After the procedure, it takes 10-15 minutes to lie on your back to minimize the leakage of the gel.

If the desired result is achieved from the use of Prepidilum, the recommended interval before the administration of IV oxytocin is 6-12 hours. If the response to the initial dose of Prepidil is not achieved, you can assign it again. The recommended repeated dose is 0.5 mg, and the interval from the previous administration is 6 hours. The need for an additional appointment and interval should be determined by the doctor, based on the clinical situation. The maximum recommended dose for a 24-hour period is 1.5 mg.

Overdose

Treatment: symptomatic, intravenous administration of beta-adrenomimetics or rapid delivery.

Precautionary measures

The use is possible only in a hospital. Before the appointment of Prepidil, it is necessary to assess the conformity of the size of the fetus and pelvis. Mandatory monitoring of uterine activity, the state of the cervix and fetus. In the presence of an anamnesis of hypertensive or tetanic uterine contractions, renal or hepatic pathology (accompanied by metabolic disorders), continuous monitoring of uterine activity and fetal status and careful observation are required. Caution is used in patients with asthma or increased intraocular pressure (glaucoma).

Special instructions

It is necessary to avoid the introduction of the gel in the extraamniosic space (possibly hyperstimulation of the uterus).

Storage conditions of Prepidil

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of Prepidil

2 years.

Do not use beyond the expiration date printed on the package.