Prostenongel

General characteristics. Structure:

Active component: Dinoprostonum - 1,0 mg.

Excipients: silicon dioxide kollidny - 0,22 g, glycerin (глицерол) - 1,89 g, propylene glycol - 1,29 g, ethanol of 96% - 0,099 g.

Pharmacological properties:

Pharmacodynamics. Prostenongel contains Dinoprostonum - a synthetic analog of E2 prostaglandin. Dinoprostonum causes changes of a neck of a pregnant uterus similar with occurring before childbirth at the full-term pregnancy: softening, smoothing and disclosure (maturing of a neck of uterus). Dinoprostonum also stimulates smooth muscles of digestive tract that can be the cause of a voznikonoveniye of gastrointestinal frustration.

Pharmacokinetics. At intracervical introduction Dinoprostonum is quickly soaked up in blood. Drug is metabolized in lungs. Dinoprostonum metabolites pharmacological are active and undergo further transformations in a liver and kidneys. Drug is removed, mainly, through kidneys. The effect of drug is caused by both measured, and systemic action.

Indications to use:

Induction of childbirth at women with full-term or with almost full-term pregnancy. Preparation of a neck of uterus for childbirth.

Route of administration and doses:

Intratservikalno. Each sterile syringe for single application contains a single dose of drug (1 mg of Dinoprostonum) and lower than the level of an internal pharynx is supplied with a sterile catheter for intracervical introduction. Gel is entered at strict observance of sterility. After administration of drug it is necessary to be in lying situation within 15 minutes. 

To avoid accidental administration of gel it is higher than the level of internal pharynx of a uterus!

In case of insufficient effect administration of drug can be repeated. The repeated dose is entered not earlier than in 6 hours, and makes usually 0,5 mg. It is not recommended to exceed a daily dose of Dinoprostonum of 1,5 mg.

Features of use:

Drug is intended for use only in the conditions of a hospital. At use for induction of childbirth it is necessary to estimate carefully compliance of the sizes of a basin and a head of a fruit. After introduction it is necessary to watch uterine activity, a condition of a fruit, the course of process of maturing and disclosure of a neck of uterus carefully. In the presence in the anamnesis of hypertensive or tetanic uterine reductions monitorirut an uterine activity and the status of a fruit during the entire period of the induced childbirth. If at the patient vysokotonichny reductions of a uterus remain, it is necessary to remember a possibility of a hysterorrhesis. To be careful not to enter gel higher than the level of an internal pharynx into ekstraamniotichesky space (hyper stimulation of a uterus is possible).

At women 35 years with the complications which arose during pregnancy are more senior and also at duration of gestation more than 40 weeks there is an increased risk of the puerperal disseminated intravascular coagulation therefore it is necessary to apply Dinoprostonum at such patients with care. Right after childbirth (as soon as possible) it is necessary to define whether there is no risk of development of a fibrinolysis at the patient.

Side effects:

From reproductive system: tetanic reductions of a uterus; uterus hyper tone; early/premature opening of a bag of waters; placental detachment; feeling of heat in a vagina.

From the alimentary system: nausea; vomiting; diarrhea.

From a nervous system: tranzitorny vazovagalny symptoms (shiver, headache, dizziness).

From respiratory system: bronchospasm; bronchial asthma.

From hemopoietic and lymphatic system: the increased risk of the puerperal disseminated intravascular coagulation at women in labor; embolism amniotic waters; leukocytosis.

From integuments: rash.

Others: pains in a back; feeling of constraint in a breast; fervescence.

From a fruit: fruit prelum; fruit acidosis; pre-natal death of a fruit; change of heart rate of a fruit; fruit distress; the reduced status of the newborn (assessment on a scale Apgar lower than 7).

In isolated cases are possible: an itch in a vagina, tachycardia.

Interaction with other medicines:

Dinoprostonum strengthens action of oxytocin on a uterus therefore it is not recommended to use drug along with oxytocin. Oxytocin can be applied only 6-12 hours later after administration of drug Prostenongel.

Contraindications:

- hypersensitivity to prostaglandins

- placental presentation

- vaginal bleedings of not clear etiology during this pregnancy

- opening of a bag of waters

- polycarpous pregnancy

- cervicitis and vulvovaginitis

- heart diseases, lungs, kidneys or a liver in an aggravation stage

- an obstetric situation (preservation of "immaturity" of a neck of uterus) at which surgical intervention is shown.

Drug Prostenongel is contraindicated in cases when childbirth in patrimonial ways is impossible or undesirable:

- at discrepancy of the sizes of a fruit and a basin

- at abnormal presentations

- after earlier undergone operation of Cesarean section or other extensive uterus operations in the anamnesis

- at difficult and traumatic delivery in the anamnesis

- at the multigiving birth women

- at a hyperactive and gipertonichny uterus

- at a fruit distress in the anamnesis

- at infections of lower parts of a genital tract.

Overdose:

The overdose can be a consequence of both use of an excess dose of drug, and hypersensitivity of the patient to uterotonichesky effect of drug. Symptoms: considerable strengthening and increase of reductions of a uterus.

Treatment: if simple cancellation is not enough for the termination of a uterine hyperactivity and/or a distress of a fruit, intravenously enter beta адреностимуляторы. At inefficiency - bystry delivery.

Storage conditions:

At a temperature from 2 ° to 8 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Gel for intracervical introduction of 1 mg / 3,5 a dose; the syringe of polypropylene 3,5 g with a catheter sterile - on one, a bag (sack) paper, laminated by polypropylene - 1, the instruction, a pack from a cardboard.