Препидил®

General characteristics. Structure:

Active agent: contains in one syringe (3 g of gel): Dinoprostonum of 0,5 mg; excipients: silicon dioxide colloid anhydrous, triacetin.

Pharmacological properties:

Pharmacodynamics. Dinoprostonum or E2 (PGE2) prostaglandin belongs to the class of the unsaturated fatty acids synthesized in physiological conditions in an organism. Dinoprostonum strengthens blood supply of a neck of uterus, accelerating its maturing (a softening, smoothing and disclosure) that corresponds to changes, characteristic of normally proceeding childbirth. Maturing of a neck of uterus leads to reduction of resistance of a neck of uterus with simultaneous increase in sokratitelny activity of a myometrium and to delivery. The specific mechanism of action of PGE2 at intracervical use still is up to the end not studied. Dinoprostonum is capable to make also stimulating impact on smooth muscles of digestive tract that can sometimes make sick and/or vomiting at purpose of drug for maturing of a neck of uterus. In high doses Dinoprostonum can cause a lowering of arterial pressure (perhaps because of its action on smooth muscles of blood vessels), and also fervescence; however, these effects are not observed when using Dinoprostonum in the doses recommended for maturing of a neck of uterus.

Pharmacokinetics.

Absorption. After intracervical introduction of 0,5 mg the maximum concentration of Dinoprostonum in a blood plasma is reached in 30 - 45 minutes then quickly decreases to norm, irrespective of the level of a sokratitelny uterine activity. Linkng of Dinoprostonum with albumine of a blood plasma makes 73%. Distribution and metabolism. Dinoprostonum is well distributed in mother's organism. PGE2 is quickly metabolized with education 13, 14-digidro-15-keto-PGE2 which then turns in 13,14-digidro-15-keto-PGA2. Dinoprostonum is completely metabolized in an organism: substantially in lungs, and then a liver and kidneys. In blood and urine not less than 9 metabolites of PGE2 are found.

Removal. Dinoprostonum and its metabolites are removed generally by kidneys, small amounts - through intestines.

Indications to use:

Stimulation of maturing of a neck of uterus in the presence of medical and obstetric indications to induction of patrimonial activity at full-term and it is close to the full-term pregnancy.

Route of administration and doses:

Initial dose: all contents of the syringe (0,5 mg of Dinoprostonum in 3 g of gel) by means of the applied catheter enter slightly lower than the level of an internal pharynx into the cervical canal. After administration of drug the patient has to lie 10-15 minutes on spin to minimize a gel effluence. If the answer to an initial dose of drug is not reached, then the drug is administered repeatedly. The recommended repeated dose - 0,5 mg, and an interval from the previous introduction – not less than 6 hours. Need of additional appointment will be defined by a clinical situation. The maximum recommended dose for the 24-hour period makes 1,5 mg. Instructions for assembly of the syringe Take the sterile syringe and a catheter from packaging. 1.   Remove a protective cap from a syringe tip. 2. Insert a cap into the syringe to use it as the piston. 3. Densely put on a catheter a syringe tip (before click) and enter to the patient syringe contents.

Features of use:

Only for use in the conditions of a hospital! Before purpose of drug it is necessary to estimate compliance of the sizes of a head of a fruit and the woman's basin. At use of drug it is necessary to show care not to allow administration of gel higher than the level of an internal pharynx in ekstraamniotichesky space ( the uterus hyper tone is possible). During use of drug it is necessary to monitor process of maturing and disclosure of a neck of uterus, to carry out continuous monitoring of a sokratitelny uterine activity and condition of a fruit. In the presence in the anamnesis of hypertensive or tetanic uterine reductions observation of a sokratitelny uterine activity and a condition of a fruit during the entire period of the induced childbirth is necessary. At development of a hyper tone of a uterus or strengthening and increase of reductions of a uterus, and also at change of a cardiac rhythm of a fruit it is necessary to carry out the actions aimed at safety of a fruit and mother. It is necessary to remember a possibility of a hysterorrhesis. 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 women in labor with care. It is necessary to define as soon as possible right after childbirth whether there is no risk of development of a fibrinolysis at patients. Intra cervical introduction of Dinoprostonum of gel can lead to an iatrogenic rupture of a bag of waters, with the subsequent embolism amniotic waters.

Side effects:

Tetanic reductions of a uterus (increase in frequency or duration of reductions, uterus hyper tone), a hysterorrhesis, premature opening of a bag of waters, nausea, vomiting, diarrhea, fervescence, a dorsodynia, a caumesthesia in a vagina, hypersensitivity reaction, local irritation a fabrics/erythema, rash, tranzitorny vazovagalny symptoms (inflows, a shiver, a headache, dizziness), placental detachment, an embolism amniotic waters, rash, bronchial asthma, a bronchospasm, feeling of constraint in a breast. Disturbances from the blood circulatory system and lymphatic system: the increased risk of the puerperal disseminated intravascular coagulation at women in labor, stimulated use of Dinoprostonum; leukocytosis. Influence on a fruit: the fruit distress syndrome (change of a cardiac rhythm of a fruit), decrease in assessment of a condition of the newborn on a scale Apgar is lower than 7 points, a fruit prelum, fruit acidosis, antenatal/intranatal death of a fruit.

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 introduction of Dinoprostonum.

Contraindications:

Hypersensitivity to prostaglandins or any other component of drug; 
- polycarpous pregnancy;  
- 6 and more full-term pregnancies in the anamnesis;      
- tetanus or hyper tone of a uterus;    
- placental presentation or vessels;      
- if there was no insertion of a head of a fruit;    
- surgical interventions on a uterus in the anamnesis (for example, Cesarean section or a hysterotomy);       difficult and/or traumatic childbirth (in the anamnesis);
- the previous fruit distress;    
- clinical or anatomic narrow basin;      
- any presentations, except occipital;      
- disturbances of a rhythm of cordial reductions of a fruit;      
- an obstetric situation, at which preferably surgical intervention;     
- allocations from patrimonial ways (including bloody) not clear etiology;
- cervicitis and vulvovaginitis;
- pelviperitonitis;      
- heart diseases, lungs, kidneys or a liver in an aggravation stage at mother;        
- opening of a bag of waters (dribble of waters) of any genesis.

Overdose:

Symptoms: the uterus hyper tone, strengthening and increase of reductions of a uterus, a fruit distress, decrease in assessment of a condition of the newborn on a scale Apgar is lower than 7 points, a fruit prelum, fruit acidosis, antenatal/intranatal death of a fruit. Treatment: symptomatic, if necessary appoint oxygen. For the termination of hyper stimulation of a uterus and/or a distress of a fruit enter intravenously beta2-adrenomimetik. At inefficiency - bystry delivery.

Storage conditions:

List B. At a temperature from +2 to +8 °C, in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Gel of intracervical 0,5 mg: on 3 g of gel in one-time syringes from polyethylene of low density; 1 sterile plastic catheter in a plastic blister strip packaging and 1 syringe, placed in a plastic blister strip packaging, together with the application instruction in a cardboard pack.