Prepidil
Prepidil: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. In case of impaired renal function
- 11. For violations of liver function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Prepidil
ATX code: G02AD02
Active ingredient: dinoprostone (dinoprostone)
Manufacturer: Pfizer MFG. Belgium NV (Belgium)
Description and photo update: 2018-04-07
Prices in pharmacies: from 659 rubles.
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Prepidil is a drug for increasing the tone and contractile activity of the myometrium.
Release form and composition
Prepidil is produced in the form of an intracervical gel: a translucent mass with a viscous structure (3 g each in a disposable polyethylene syringe, in a plastic blister strip packaging 1 syringe complete with a catheter, 1 package in a cardboard box).
1 syringe contains:
- active substance: dinoprostone - 0.5 mg;
- auxiliary components: triacetylglycerol (triacetylglycerol), colloidal anhydrous silicon dioxide.
Pharmacological properties
Pharmacodynamics
Prepidil is a labor stimulant. Its active substance, dinoprostone (prostaglandin E 2), belongs to unsaturated fatty acids synthesized under physiological conditions. It is believed that when used intracervically, dinoprostone potentiates the blood supply to the cervix, accelerating the process of its maturation. It is manifested by a decrease in the resistance of the cervix, a simultaneous increase in the contractile activity of the myometrium and delivery, characteristic of a normally proceeding labor.
The stimulatory effect of dinoprostone on smooth muscle to ripen the cervix may cause undesirable gastrointestinal effects such as nausea and / or vomiting.
Doses of dinoprostone in excess of therapeutic ones can potentiate a decrease in blood pressure, an increase in body temperature.
Pharmacokinetics
Absorption of Prepidil occurs quickly. The maximum concentration of dinoprostone in blood plasma after intracervical administration of 0.5 mg occurs in 30–45 minutes, then, regardless of the degree of uterine contractile activity, it rapidly decreases to the initial level.
Plasma protein binding (albumin) - 73%.
Penetrates into various biological fluids and tissues and is distributed in them.
Dinoprostone is rapidly and completely metabolized to form 13,14-dihydro-15-keto-prostaglandin E 2 with its subsequent conversion to 13,14-dihydro-15-keto-prostaglandin A 2. A significant part of the drug is metabolized in the lungs, a smaller part in the liver and kidneys. 9 or more prostaglandin E 2 metabolites are found in blood and urine.
Excretion of Prepidil mainly occurs through the kidneys, to a lesser extent through the intestines.
Indications for use
According to the instructions, Prepidil is indicated for use in women with medical indications for induction of labor to stimulate the maturation of the cervix.
Contraindications
- conditions in which prolonged contractions of the uterus are contraindicated, including the presence of bloody discharge of unknown genesis from the genital tract during gestation, multiple pregnancies, fetal heart rhythm disturbances, previous fetal distress, inconsistency in the size of the pelvis and fetal head, abnormal presentation of the fetus, infections of the lower genitalia pathways, an indication of a history of 6 or more term pregnancies, extensive surgical interventions on the uterus, the use of a cesarean section in a previous delivery or previous difficult and / or traumatic childbirth, and also if the fetal head has not been inserted;
- obstetric situation in which surgery is most preferable;
- hypersensitivity to the components of the drug.
Caution should be exercised when using Prepidil in patients with impaired renal and / or liver function, cardiovascular diseases, arterial hypertension, glaucoma, ophthalmic hypertension, bronchial asthma, and an open fetal bladder.
Instructions for use of Prepidil: method and dosage
Gel Prepidil is intended to be inserted into the cervical canal just below the level of the internal os using the catheter included in the kit.
The sterile syringe and catheter must be removed from the packaging before direct insertion. After removing the protective cap from the tip of the syringe, it is inserted into the syringe as a plunger. Then a catheter is put on the tip of the syringe, the tightness of its fit is determined by a click, and the contents of the syringe are injected to the woman in labor. After intracervical administration of the drug, it is necessary to maintain a supine position for 1/4 hour, this will maximize the prevention of gel leakage.
The need for prescribing a gel or its additional administration is determined by the doctor based on individual clinical indications.
Recommended dosage of Prepidil: initial dose - 0.5 mg (contents of one syringe). In the absence of the desired response to the initial dose within the next six hours, it is possible to re-administer the drug at the same dose. The maximum cumulative dose should not exceed 1.5 mg in 24 hours.
Side effects
- on the part of the mother's body: nausea, vomiting, diarrhea, tetanic (prolonged) contractions of the uterus, characterized by an increase in frequency, uterine tone or duration of contractions, uterine rupture, back pain, increased body temperature, a feeling of warmth in the vagina, hypersensitivity reactions;
- from the fetus: distress syndrome or changes in heart rate, stillbirth, against the background of the use of oral and injection forms of dinoprostone - a decrease in the assessment of the condition of the newborn below 7 points on the Apgar scale.
In addition, from the side of the blood coagulation system in post-marketing observations, an increase in the risk of developing postpartum disseminated intravascular coagulation was noted in patients whose labor was stimulated by the use of dinoprostone or oxytocin.
Overdose
Symptoms: increased frequency and increase in the degree of contractions and hypertonicity of the uterus, fetal distress.
Treatment: symptomatic therapy. Prepidil should be removed from the vagina immediately.
If uterine hyperstimulation and / or fetal distress continues, intravenous beta-adrenomimetics and oxygen are indicated. In the absence of effect, measures of rapid delivery are taken.
Since the syringe contains a single dose of the drug, overdose symptoms are evidence of increased individual sensitivity to dinoprostone.
special instructions
Gel Prepidil is intended for hospital use only.
The appointment of the drug should be made after a preliminary assessment of the correspondence between the sizes of the fetal head and the woman's pelvis.
With the introduction of Prepidil, the gel should not be allowed to enter the extra-amniotic space, this can contribute to hyperstimulation of the uterus.
The introduction of the drug should be accompanied by continuous monitoring of the contractile activity of the uterus and the condition of the fetus.
Particularly careful monitoring of the process of maturation, dilatation of the cervix and the condition of the fetus during the entire period of induced labor should be provided for women with a history of hypertensive or tetanic uterine contractions. The high risk of uterine rupture should be considered. In the event of an increase and increase in the frequency of contractions or the development of hypertonicity of the uterus, as well as in violation of the fetal heart rate, emergency measures are required to ensure the safety of the mother and the fetus.
Due to the increased risk of postpartum disseminated intravascular coagulation in women over the age of 35 with complications during gestation, as well as with a gestational age of more than 40 weeks, dinoprostone should be prescribed to such women in labor with extreme caution. After delivery, it is necessary to immediately determine the degree of risk of developing fibrinolysis in them.
Application during pregnancy and lactation
Experimental studies on animals confirm an increase in skeletal anomalies against the background of the use of prostaglandin E 2 and the embryotoxicity of dinoprostone, therefore, Prepidil in a dose that contributes to a long-term increase in uterine tone poses a certain threat to the embryo or fetus.
Regardless of the time of delivery in breast milk, prostaglandins are excreted in very small quantities.
With impaired renal function
Prepidil should be used with caution in patients with impaired renal function.
For violations of liver function
The gel should be prescribed with caution in case of liver dysfunction.
Drug interactions
It is not recommended to use Prepidil simultaneously with other drugs that stimulate labor activity, since it enhances their effect on the uterus. If it is necessary to use oxytocin, it can be administered only 6 hours after dinoprostone.
Analogs
Prostenongel and Prostin E 2 are analogues of Prepidil.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 2-8 ° C in the refrigerator.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Prepidil
Reviews of Prepidil are in most cases negative. Patients report a lack of therapeutic effect after the introduction of the gel into the cervical canal. The body's response to drug administration is not the same. In some women, immediately after the introduction, some activation of labor activity was observed, which then completely subsided. In others, the introduction of the gel was not accompanied by any changes, except for the flow of the gel and tingling inside. After the introduction of the gel, labor began on the fourth day by natural means or by caesarean section. Women are unanimous in the opinion that the drug is useless. Everyone justifies consent to its use by a delicate situation in which one can hardly disobey the doctor's recommendations. Fear for the baby's life and the desire for a quick, safe delivery prevail over doubt and common sense.
In some cases, it is indicated that the injection procedure is painful. The disadvantages of Prepidil include the risk of side effects, the high price of the gel, and difficulties in purchasing.
Price for Prepidil in pharmacies
The price of Prepidil for one syringe with a catheter can start from 721 rubles.
Prepidil: prices in online pharmacies
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Drug name Price Pharmacy |
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Prepidil 0.5 mg / 3 g intracervical gel 3 g 1 pc. 659 r Buy |
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Prepidil gel for intracervic. entered 0.5mg syringe 3g 718 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
