Prostenongel^® (Gel) Instructions for Use

Marketing Authorization Holder

Pharmsintez PJSC (Russia)

Manufactured By

Kevelt AS (Estonia)

ATC Code

G02AD02 (Dinoprostone)

Active Substance

Dinoprostone (Rec.INN WHO registered)

Dosage Form

Prostenongel®

Intracervical gel 1 mg/dose: syringe 3.5 g (1 dose) in a set with a catheter

Dosage Form, Packaging, and Composition

Intracervical gel viscous, colorless, homogeneous.

Excipients : colloidal silicon dioxide – 0.22 g, glycerol (glycerin) – 1.89 g, propylene glycol – 1.29 g, ethanol 96% – 0.099 g.

3.5 g (1 dose) – sterilized polypropylene syringes (1) in a set with a catheter – cardboard packs.

Clinical-Pharmacological Group

Prostaglandin preparation that increases the tone and contractile activity of the myometrium

Pharmacotherapeutic Group

Labor stimulant – synthetic prostaglandin E2 analogue

Pharmacological Action

An analogue of prostaglandin E₂ (PGE₂). It has a stimulating effect on organs containing smooth muscle cells, including on the contractile activity and tone of the myometrium, and also modulates the response of internal organs to various hormonal influences.

With endocervical application, Dinoprostone promotes pre-induction softening of the cervix (ripening) in patients with unfavorable induction parameters, increasing the overall effectiveness of induction. The specific mechanism of action is not fully understood. It has been shown that Dinoprostone increases the blood supply to the cervix similar to what happens in the initial period of spontaneous labor. Based on this, it is believed that with endocervical administration, Dinoprostone affects the hemodynamics of the cervix, promoting its ripening.

Pharmacokinetics

The results of measuring plasma concentrations of the metabolite 13,14-dihydro-15-keto-PGE₂ showed that PGE₂ is rapidly absorbed, the time to reach C_max in plasma is 50-75 min. The mean C_max values in plasma after endocervical administration of dinoprostone were 433±51 pg/ml, and in the control group – 137±24 pg/ml.

PGE₂ is intensively metabolized in the lungs to form metabolites, which undergo further metabolism in the liver and kidneys. It is excreted mainly by the kidneys in the form of metabolites.

Indications

Stimulation of cervical ripening, induction of labor in women with full-term or near-term pregnancy.

ICD codes

Dosage Regimen

Administer endocervically into the cervical canal just below the level of the internal os.

Use only in a hospital setting under strict medical supervision by an obstetrician-gynecologist.

The dosage regimen is individual and determined by the physician based on cervical status and obstetric indications.

Apply the entire 1 mg dose from a single syringe. Do not administer more than one dose per 24-hour period.

Monitor uterine activity, cervical ripening, and fetal heart rate continuously during and after administration.

Discontinue use immediately upon onset of active labor, occurrence of uterine hypertonus, or signs of fetal distress.

Do not administer if membranes are ruptured or if there is unexplained vaginal bleeding.

Assess the pelvis-to-fetal-head relationship prior to administration.

Exercise extreme caution in patients with a history of uterine surgery, grand multiparity, or previous fetal distress.

Adverse Reactions

From the genitourinary system uterine hypertonus, tetanic uterine contractions (increase in frequency, uterine tone or duration of contractions), uterine rupture.

From the digestive system nausea, vomiting, diarrhea.

Other facial flushing, trembling, increased body temperature, leukocytosis, back pain. Effect on the fetus – fetal distress syndrome/change in fetal heart rate, fetal compression, asphyxia.

Contraindications

Hypersensitivity to dinoprostone; 6 or more full-term pregnancies in history, cesarean section or major surgical interventions on the uterus (in history), difficult and/or traumatic childbirth (in history), previous fetal distress, discrepancy between the size of the mother’s pelvis and the fetal head, bloody discharge from the genital tract of unspecified nature during pregnancy, infections of the lower genital tract, abnormal fetal position, ruptured amniotic sac.

With caution before use for labor induction, it is necessary to carefully assess the correspondence between the size of the pelvis and the fetal head; during labor, it is necessary to carefully monitor uterine activity, the course of the process of cervical ripening and dilation, and the condition of the fetus. If there is a history of hypertonic or tetanic uterine contractions, uterine activity and fetal status are monitored throughout the entire period of induced labor. If the patient continues to have highly toxic contractions, the possibility of uterine rupture should be considered.

Use in Pregnancy and Lactation

Used during pregnancy strictly according to indications. Any dose of dinoprostone that causes a prolonged increase in uterine tone poses a certain risk to the embryo or fetus.

When used for labor stimulation and induction preparation, Dinoprostone can cause changes in fetal heart rate during labor, fetal distress, and a decrease in the status of the newborn (Apgar score less than 7).

Geriatric Use

Not applicable.

Special Precautions

Use only in a specialized hospital setting under strict medical supervision.

In women over 35 years of age with complications that arose during pregnancy, as well as with a gestational age of more than 40 weeks, there is an increased risk of postpartum disseminated intravascular coagulation, therefore Dinoprostone should be used with caution in such patients. Immediately after childbirth (as early as possible) it is necessary to determine whether the patient is at risk of developing fibrinolysis.

Drug Interactions

With simultaneous use with oxytocin, Dinoprostone potentiates its effect on the uterus.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.