Prepidil intracervical gel 0.5mg / 3g syringe with catheter 1 pc. (Dinoprostone)

Latin name

PREPIDIL

Release form

Gel for endocervical administration

Packaging

In a disposable plastic syringe 3 g of gel. In 1 blister pack 1 syringe complete with a catheter. In a cardboard bundle 1 pack.

Indications

Stimulation of cervical maturation in the presence of medical indications for induction of labor.

Contraindications

Conditions in which prolonged uterine contractions are contraindicated: Multiple pregnancy.

6 or more term pregnancies.

If insertion of the fetal head has not occurred.

Caesarean section or major surgical procedures on the uterus (history).

Difficult and / or traumatic birth (history).

Preexisting fetal distress.

Discrepancy between the dimensions of the pelvis and the fetal head.

Violations of the fetal heart rate.

Obstetric situation in which surgery is preferable.

Genital bleeding of unknown origin during pregnancy.

Infections of the lower genital tract.

Abnormal presentation of the fetus.

Caution is advised to use the drug in: Cardiovascular diseases.

Arterial Hypertension.

Impaired liver and / or kidney function.

Bronchial asthma.

Glaucoma or ophthalmic hypertension.

When opening the fetal bladder.

Use during pregnancy and lactation

Any dose of the drug that causes a prolonged increase in uterine tone poses a certain risk to the embryo or fetus.

In experimental animal studies, prostaglandin E 2 causes an increase in skeletal abnormalities in rats and rabbits, and embryotoxicity of dinoprostone in rats and rabbits has been revealed.

Prostaglandins are excreted in breast milk in very small quantities, regardless of the duration of delivery.

Composition of

In 1 syringe (3 g) of intracervical gel contains:

Active ingredient: dinoprostone 500 μg

Excipients: silicon dioxide colloidal anhydrous, triacetylglycerol (triacetylglycerol).

Dosage and administration

Initial dose: The entire contents of the syringe (500 μg dinoprostone in 3 g of gel) is injected into the cervical canal just below the level of the internal pharynx using the attached catheter. After administration of the drug, the patient should lie on her back for 10-15 minutes to minimize leakage of the gel. If the response to the initial dose of the drug is not reached, then the drug is re-administered. The recommended repeated dose is 500 mcg, and the interval from the previous administration is at least 6 hours. The need for an additional appointment is determined based on the clinical situation. The maximum recommended cumulative dose in 24 hours is 1.5 mg.

Syringe Assembly Instructions:

Remove the sterile syringe and catheter from its packaging.

Remove the protective cap from the tip of the syringe.

Insert the cap into the syringe to use it as a piston.

Place the catheter firmly on the tip of the syringe (until it clicks) and inject the contents of the syringe into the patient.

Side effects

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

Drug Interaction

Dinoprostone enhances the action of oxytocin on the uterus, so it is not recommended to use the drug in conjunction with other generic stimulants. Oxytocin can only be used 6 hours after dinoprostone administration.

Overdose

Symptoms: uterine hypertension, increased and increased uterine contractions, fetal distress. The onset of overdose symptoms is indicative of increased individual sensitivity to the drug, since a true overdose is unlikely because the syringe with the drug contains a single dose.

Treatment: symptomatic. The drug is removed from the vagina, placing the patient in a supine position. If simple drug withdrawal is not sufficient to stop uterine hyperstimulation and / or fetal distress, beta-adrenomimetics are administered. The use of oxygen is shown. At inefficiency - rapid delivery.

Storage conditions

The drug should be stored in the refrigerator at a temperature of 2 ° to 8 ° C.

Expiration

2 years.

Deystvuyuschee substances

Dinoprostone

Pharmacy terms of sale

Prescription

dosage form

dosage form

gel intracervical



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