Dinoprostone brand name. Dinoprostone: Comprehensive Guide to Uses, Dosing, Side Effects, and More
What are the key indications for dinoprostone. How is dinoprostone administered for labor induction. What are the main side effects and precautions for using dinoprostone. How does dinoprostone work to ripen the cervix and induce labor.
Overview of Dinoprostone and Its Clinical Applications
Dinoprostone, also known by the brand names Cervidil and Prepidil, is a prostaglandin E2 analog used primarily in obstetrics for cervical ripening and labor induction. As a naturally occurring compound involved in promoting labor, dinoprostone plays a crucial role in obstetric care when there is a medical need to initiate the labor process.
The key indications for dinoprostone include:
- Cervical ripening for labor induction in patients at or near term
- Evacuation of uterine contents in cases of missed abortion or intrauterine fetal death up to 28 weeks gestation
- Management of gestational trophoblastic disease
- Use as an abortifacient between 12-20 weeks gestation
It’s important to note that while dinoprostone is effective for initiating labor, it is not a feticidal agent. Administration should only be done by experienced clinicians using proper dosages due to its potent oxytocic properties.
Mechanism of Action: How Dinoprostone Works
Dinoprostone exerts its effects through several key mechanisms:
- Softening and ripening of the cervix by altering collagen structure
- Increasing the elasticity of cervical tissue
- Stimulating uterine contractions
- Enhancing the sensitivity of the uterus to oxytocin
By targeting prostaglandin E2 receptors, dinoprostone promotes the remodeling of cervical tissue, making it more favorable for dilation and effacement. This process, known as cervical ripening, is crucial for successful labor induction.
Prostaglandin E2 Receptors and Their Role
Dinoprostone acts on four subtypes of prostaglandin E2 receptors (EP1, EP2, EP3, and EP4). These receptors are distributed throughout the reproductive tissues and play different roles in the labor process:
- EP1 and EP3 receptors: Primarily responsible for uterine contractions
- EP2 and EP4 receptors: Involved in cervical ripening and relaxation of smooth muscle
The balanced action on these receptors allows dinoprostone to effectively prepare the cervix for labor while also promoting uterine activity.
Dosage Forms and Administration of Dinoprostone
Dinoprostone is available in several formulations, each designed for specific clinical scenarios:
- Vaginal insert (Cervidil): A controlled-release formulation that delivers 10 mg of dinoprostone over 12-24 hours
- Vaginal gel (Prepidil): Contains 0.5 mg of dinoprostone per 3 g of gel
- Vaginal suppository: Used for higher doses in abortion or missed pregnancy management
The choice of formulation depends on the clinical indication and patient factors. For labor induction, the vaginal insert or gel is typically preferred.
Administration Guidelines
How is dinoprostone administered for labor induction? The process typically involves the following steps:
- Patient assessment: Confirm the indication for induction and absence of contraindications
- Preparation: Ensure proper positioning of the patient and availability of monitoring equipment
- Insertion: Place the dinoprostone formulation high in the posterior fornix of the vagina
- Monitoring: Observe the patient for at least 30 minutes post-insertion for signs of hyperstimulation or adverse effects
- Evaluation: Assess cervical changes and uterine activity regularly
Patients should remain recumbent for 1-2 hours after administration to ensure proper absorption and reduce the risk of expulsion.
Efficacy of Dinoprostone in Labor Induction
Numerous studies have demonstrated the effectiveness of dinoprostone for cervical ripening and labor induction. A meta-analysis of randomized controlled trials showed that prostaglandin E2 significantly increased the likelihood of vaginal delivery within 24 hours compared to placebo or no treatment.
Key findings on dinoprostone efficacy include:
- Improved Bishop score: Dinoprostone consistently improves cervical favorability
- Reduced time to delivery: Average reduction of 4-6 hours compared to expectant management
- Decreased need for oxytocin augmentation: About 30% reduction in oxytocin use
- Similar cesarean section rates: No significant increase in operative deliveries
The success rate of dinoprostone for labor induction varies depending on factors such as parity, gestational age, and initial cervical status. Generally, multiparous women and those with more favorable cervices at baseline tend to have better outcomes.
Safety Profile and Adverse Effects of Dinoprostone
While generally considered safe when used appropriately, dinoprostone can cause side effects. What are the main side effects and precautions for using dinoprostone?
Common side effects include:
- Gastrointestinal disturbances: Nausea, vomiting, diarrhea
- Fever and chills
- Back pain
- Uterine hyperstimulation
More serious but rare complications can occur:
- Uterine rupture, particularly in patients with previous uterine surgery
- Amniotic fluid embolism
- Severe vaginal bleeding
- Fetal distress
Healthcare providers must carefully monitor patients receiving dinoprostone for signs of these complications. Immediate removal of the vaginal insert and appropriate interventions should be initiated if concerns arise.
Contraindications and Precautions
Dinoprostone is contraindicated in several situations:
- Known hypersensitivity to prostaglandins
- Active genital herpes infection
- Placenta previa or unexplained vaginal bleeding
- Cephalopelvic disproportion
- Previous cesarean section with classical incision or other major uterine surgery
- Fetal malpresentation
Caution is advised in patients with asthma, glaucoma, or cardiovascular disease due to the potential systemic effects of prostaglandins.
Pharmacokinetics and Drug Interactions
Understanding the pharmacokinetics of dinoprostone is crucial for its safe and effective use:
- Absorption: Rapidly absorbed through vaginal mucosa
- Distribution: Widely distributed throughout the body
- Metabolism: Quickly metabolized in the lungs, liver, and kidneys
- Elimination: Primarily excreted in urine as metabolites
The half-life of dinoprostone is very short, typically less than 1 minute, which contributes to its safety profile as systemic levels quickly decrease upon removal of the vaginal insert.
Potential Drug Interactions
While drug interactions with dinoprostone are relatively uncommon due to its local administration and rapid metabolism, healthcare providers should be aware of potential interactions:
- Oxytocin: May enhance uterine activity; concurrent use requires careful monitoring
- NSAIDs: May decrease the efficacy of dinoprostone
- Antihypertensive medications: Potential for additive hypotensive effects
Clinicians should review all medications a patient is taking before administering dinoprostone to minimize the risk of adverse interactions.
Comparison with Other Labor Induction Methods
How does dinoprostone compare to other methods of labor induction? Several alternatives exist, each with its own pros and cons:
- Mechanical methods (e.g., Foley catheter):
- Similar efficacy to dinoprostone
- Lower risk of uterine hyperstimulation
- May be preferred in patients with previous cesarean section
- Misoprostol (prostaglandin E1 analog):
- More cost-effective than dinoprostone
- Higher risk of uterine hyperstimulation
- Not FDA-approved for labor induction
- Oxytocin:
- More effective when used after cervical ripening
- Requires continuous intravenous administration
- May be less effective in patients with unfavorable cervix
The choice of induction method depends on various factors, including cervical status, obstetric history, and institutional protocols. Many clinicians use a combination approach, starting with cervical ripening using dinoprostone or mechanical methods, followed by oxytocin if needed.
Future Directions and Research in Prostaglandin Use for Labor Induction
As our understanding of the labor process continues to evolve, research in prostaglandin use for labor induction is focusing on several key areas:
- Optimizing dosing regimens:
- Investigating lower doses to maintain efficacy while reducing side effects
- Exploring individualized dosing based on patient characteristics
- Novel delivery systems:
- Development of controlled-release formulations for more consistent drug delivery
- Investigating transdermal or buccal administration routes
- Combination therapies:
- Studying the synergistic effects of prostaglandins with other induction methods
- Evaluating sequential or concurrent use of different prostaglandin analogs
- Predictive models:
- Developing algorithms to predict induction success and guide management
- Incorporating biomarkers and cervical imaging to refine patient selection
These research directions aim to enhance the efficacy, safety, and personalization of labor induction strategies, potentially leading to improved maternal and neonatal outcomes.
Emerging Technologies in Cervical Ripening
Beyond traditional pharmacological approaches, innovative technologies are being explored for cervical ripening:
- Double-balloon catheters: Combining mechanical dilation with local prostaglandin delivery
- Controlled-release hydrogels: Allowing for sustained, localized prostaglandin release
- Ultrasound-guided cervical ripening: Using focused ultrasound to enhance drug delivery and tissue remodeling
These emerging technologies may offer new options for clinicians, potentially improving the efficiency and patient experience of labor induction.
In conclusion, dinoprostone remains a cornerstone in obstetric care for cervical ripening and labor induction. Its well-established efficacy and safety profile, coupled with ongoing research and development, ensure its continued importance in managing labor and delivery. As we advance our understanding of the physiological processes involved in labor initiation, we can anticipate further refinements in the use of prostaglandins like dinoprostone, leading to more personalized and effective approaches to labor induction.
Dinoprostone: MedlinePlus Drug Information
pronounced as (dye noe prost’ one)
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Dinoprostone is used to prepare the cervix for the induction of labor in pregnant women who are at or near term. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Dinoprostone comes as a vaginal insert and as a gel that is inserted high into the vagina. It is administered using a syringe, by a health professional in a hospital or clinic setting. After the dose has been administered you should remain lying down for up to 2 hours as directed by your physician. A second dose of the gel may be administered in 6 hours if the first dose does not produce the desired response.
Before taking dinoprostone,
- tell your doctor and pharmacist if you are allergic to dinoprostone or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins.
- tell your doctor if you have or have ever had asthma; anemia; a cesarean section or any other uterine surgery; diabetes; high or low blood pressure; placenta previa; a seizure disorder; six or more previous term pregnancies; glaucoma or increased pressure in the eye; cephalopelvic disproportion; previous difficult or traumatic deliveries; unexplained vaginal bleeding; or heart, liver, or kidney disease.
Side effects from dinoprostone are not common, but they can occur. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- vomiting
- diarrhea
- dizziness
- flushing of the skin
- headache
- fever
If you experience any of the following symptoms, call your doctor immediately:
- unpleasant vaginal discharge
- continued fever
- chills and shivering
- increase in vaginal bleeding several days after treatment
- chest pain or tightness
- skin rash
- hives
- difficulty breathing
- unusual swelling of the face
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www. fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
Dinoprostone gel should be stored in a refrigerator. The inserts should be stored in a freezer. Keep this medication in the container it came in, tightly closed, and out of reach of children.
- Cervidil®
- Prepidil®
- Prostin E2®
Last Reviewed – 09/01/2010
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Prostaglandin E2 (Dinoprostone) – StatPearls
Michael Xi; Valerie Gerriets.
Author Information and Affiliations
Last Update: June 11, 2022.
Continuing Education Activity
Prostaglandin E2 is an FDA-approved medication used both for the evacuation of uterine contents and labor induction. It is in the prostaglandin class of drugs. This activity outlines the indications, action, and contraindications for prostaglandin E2 as it is used as an abortifacient or a labor inducer. This activity will highlight the mechanism of action, adverse event profile, and other key factors (e. g., off-label uses, dosing, pharmacodynamics, pharmacokinetics, monitoring, relevant interactions) pertinent to the interprofessional team members of patients in need of uterine evacuation or labor induction.
Objectives:
Outline the mechanism of action of prostaglandin E2.
Describe the adverse effects of prostaglandin E2.
Identify the indications for the different forms of prostaglandin E2.
Explain the importance of interprofessional team communication in the administration and monitoring of prostaglandin E2.
Access free multiple choice questions on this topic.
Indications
Prostaglandin E2 (PGE2), also known by the name dinoprostone, is a naturally occurring compound involved in promoting labor, though it is also present in the inflammatory pathway.[1] Prostaglandin E2 is FDA approved for cervical ripening for the induction of labor in patients for which there is a medical indication for induction. When used as a vaginal suppository, it is indicated as an abortifacient from gestational week 12 to 20 or for the evacuation of uterine contents for the management of missed abortion and intrauterine fetal death up to 28 weeks. Prostaglandin E2 is also useful for the management of gestational trophoblastic disease. Importantly, it is not a feticidal agent. Given its oxytocic properties, the administration of dinoprostone should only be at the proper dosages by experienced clinicians.[2]
Mechanism of Action
While the exact mechanism of action is unknown, prostaglandin E2 causes contractions in the myometrium via direct stimulation. It binds to G protein-coupled receptors (GPCRs) EP1-4 that lead to a variety of downstream events depending on the EP subtype and cell-type-specific expression patterns.[3] For example, EP receptors in the myometrium act via cell membrane calcium channels and intracellular cyclic 3’5’-adenosine monophosphate (cAMP). As some of the known receptors for prostaglandin E2 antagonize each other, researchers have hypothesized that the expression of these receptors determines the specific effects. The efficacy of prostaglandin E2 during pregnancy may link to the expression of these receptors. Prostaglandin E2 also promotes cervical dilation, effacement, and softening, similar to the natural progression of pregnancy, possibly due to increased collagenase secretion.[4]
The role of prostaglandin E2 in inflammation is complex; it has demonstrated pro-inflammatory activity in specific settings and plays an anti-inflammatory role in others.[5] These diverse functions appear to depend on the cell type and expression patterns of various receptors. It can promote the activation of inflammatory Th27 cells but suppress IL-2 and IL-12 production in other T cell subsets. Importantly, though in vitro experiments have demonstrated that prostaglandin E2 can inhibit T-cell production, in vivo studies have not yet shown similar results.[6]
Administration
PGE2 is administered vaginally as a suppository, gel, or insert.
The vaginal suppository is for the evacuation of uterine contents. One 20 mg suppository is inserted into the posterior fornix of the vagina every three hours until abortion occurs. If the abortion does not occur within twenty-four hours, or if there are severe side effects, the clinician should stop the drug.[7]
The endocervical gel and vaginal inserts are agents for cervical ripening induction. The cervical gel has a more rapid release than the vaginal insert but might be less convenient, as the procedure requires more vaginal examinations.[4] PGE2 is inserted into the posterior fornix and replaced every six hours until labor induction, as determined by regular, painful contractions.[8] However, drug administration should cease if there are no contractions within twenty-four hours or if there are severe adverse effects, including membrane rupture or uterine hyperstimulation.[9]
Adverse Effects
The most common side effects of prostaglandin E2 concern its impact on gastrointestinal smooth muscle. The suppository correlates with the most severe side effects, with two-thirds of patients experiencing vomiting, two-fifths experiencing diarrhea, and one-third experiencing nausea. Other adverse effects include temperature elevation in half of the patients, headache in one-tenth, and shivering and chills in one-tenth. Anti-emetics and anti-diarrheal medications may be necessary before and during the drug administration to counteract these side effects.[9]
The insert and gel have a less than one percent incidence of gastrointestinal symptoms. However, studies have shown that they have links to a higher chance of uterine hyperstimulation with and without fetal distress (greater than 2%) versus placebo (under1%). Additionally, they also have an increased chance of fetal distress without uterine hyperstimulation (over 2%) versus placebo (1%). There were also associated fetal heart rate changes, with and without distress. In all of these cases, removal of the product resulted in a return to normal, though one case did require treatment with tocolytics.[10]
Contraindications
Prostaglandin E2 is contraindicated in patients with a known hypersensitivity to prostaglandins. As an oxytocic agent, prostaglandin E2 should be avoided in scenarios in which vaginal delivery or the induction of labor is contraindicated and should be stopped before administering oxytocin.
Suppository
Clinicians should avoid the suppository should in patients with acute inflammatory pelvic disease, as well as patients with active cardiac, renal, pulmonary, or hepatic disease. Additionally, it requires caution in patients with a history of these diseases and patients with a history of cervical malignancy, asthma, hypo- or hypertension, anemia, jaundice, pulmonary disease, or epilepsy. The prostaglandin E2 suppository is not indicated for uterine evacuation for fetuses at the stage of viability.[11]
Gel/Insert
The gel or insert versions used for cervical ripening are contraindicated in patients with fetal distress where delivery is not imminent or who have vaginal bleeding during pregnancy, marked cephalopelvic disproportion, and/or multipara with six or more previous term pregnancies. Prostaglandin E2 should also be avoided when prolonged uterine contraction may pose a risk to uterine integrity or fetal safety, such as with prior cesarean section or major uterine surgery. Prostaglandin E2 for labor induction should also be avoided in patients with a history of asthma, glaucoma, or heart disease.[12]
Monitoring
Prostaglandin E2 administration should only take place in a specialized care setting under clinician supervision.
Suppository
Patients should be monitored for adverse effects, especially pyrexia, and the drug should be stopped if any severe adverse reactions occur. Abortion via prostaglandin E2 suppository may be incomplete, which may require further measures such as dilation and curettage.[11]
Gel/Insert
Uterine activity, fetal status, and progression of cervical dilation all require monitoring. In particular, the healthcare team should look for any signs of uterine hyperstimulation, sustained uterine contractions, and fetal distress. If these or any other adverse effects present, the insert should be removed and drug administration stopped. Prostaglandin E2 should also be discontinued before amniotomy and before the administration of oxytocin.[13]
Toxicity
Prostaglandin E2 overdose typically manifests as uterine hyperstimulation, and stopping the drug is the most effective treatment. Also, beta-adrenergic drugs, such as terbutaline, may be used in case of continued symptoms.[13]
Enhancing Healthcare Team Outcomes
Given prostaglandin E2’s oxytocic properties and potential side effects, its administration and possible adverse effects require careful monitoring. The most effective way to do this requires an interprofessional team of clinicians, nurses, and pharmacists to keep track of the patient’s progress. The team should be especially careful to remove prostaglandin E2 before administering other oxytocic drugs, especially when inducing labor.
The pharmacist should make sure that the clinicians are aware of the potential adverse effects of the drug and how to manage them, assist in preventing the above drug interactions, and verify all dosing. If side effects develop, both the nursing staff and pharmacy staff should report back to the clinical team. Neonatal nursing staff will be an invaluable asset during the entire labor and delivery process, regardless of what manner it occurs, assisting during the procedure and taking care of the neonate and mother subsequently.
Followup to prostaglandin E2 administration is typically by either the evacuation of uterine contents or labor. Because of this, patients require constant close observation and will often need further procedures soon after the drug’s desired effect.
Communication among members of the healthcare team will help with understanding the progression of the drug’s effects and the expected outcome, and the next steps to be taken.[14] [Level 3] Given the potential for adverse events with prostaglandin E2, its use requires an interprofessional team approach, including physicians, specialists, specialty-trained nurses, and pharmacists, all collaborating across disciplines to achieve optimal patient results. [Level 5]
Review Questions
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References
- 1.
Konopka CK, Glanzner WG, Rigo ML, Rovani MT, Comim FV, Gonçalves PB, Morais EN, Antoniazzi AQ, Mello CF, Cruz IB. Responsivity to PGE2 labor induction involves concomitant differential prostaglandin E receptor gene expression in cervix and myometrium. Genet Mol Res. 2015 Sep 10;14(3):10877-87. [PubMed: 26400315]
- 2.
Arshat H. Extra-amniotic prostaglandin E2 and intravenous oxytocin in termination of mid-trimester pregnancy and the management of missed abortion and hydatiform mole. Med J Malaysia. 1977 Mar;31(3):220-5. [PubMed: 904515]
- 3.
Sugimoto Y, Narumiya S. Prostaglandin E receptors. J Biol Chem. 2007 Apr 20;282(16):11613-7. [PubMed: 17329241]
- 4.
Bakker R, Pierce S, Myers D. The role of prostaglandins E1 and E2, dinoprostone, and misoprostol in cervical ripening and the induction of labor: a mechanistic approach. Arch Gynecol Obstet. 2017 Aug;296(2):167-179. [PubMed: 28585102]
- 5.
Nakanishi M, Rosenberg DW. Multifaceted roles of PGE2 in inflammation and cancer. Semin Immunopathol. 2013 Mar;35(2):123-37. [PMC free article: PMC3568185] [PubMed: 22996682]
- 6.
Sakata D, Yao C, Narumiya S. Prostaglandin E2, an immunoactivator. J Pharmacol Sci. 2010;112(1):1-5. [PubMed: 20051652]
- 7.
Jain JK, Mishell DR. A comparison of intravaginal misoprostol with prostaglandin E2 for termination of second-trimester pregnancy. N Engl J Med. 1994 Aug 04;331(5):290-3. [PubMed: 8022438]
- 8.
Kho EM, Sadler L, McCowan L. Induction of labour: a comparison between controlled-release dinoprostone vaginal pessary (Cervidil) and dinoprostone intravaginal gel (Prostin E2). Aust N Z J Obstet Gynaecol. 2008 Oct;48(5):473-7. [PubMed: 19032662]
- 9.
Abdelaziz A, Mahmoud AA, Ellaithy MI, Abees SH. Pre-induction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018 Aug;57(4):560-566. [PubMed: 30122579]
- 10.
A Calder And I Z Mackenzie A. Review of Propess- a controlled release dinoprostone (prostaglandin E2 ) pessary. J Obstet Gynaecol. 1997;17 Suppl 2:S53-67. [PubMed: 20521973]
- 11.
Atlas RO, Lemus J, Reed J, Atkins D, Alger LS. Second trimester abortion using prostaglandin E2 suppositories with or without intracervical Laminaria japonica: a randomized study. Obstet Gynecol. 1998 Sep;92(3):398-402. [PubMed: 9721778]
- 12.
Blanchette HA, Nayak S, Erasmus S. Comparison of the safety and efficacy of intravaginal misoprostol (prostaglandin E1) with those of dinoprostone (prostaglandin E2) for cervical ripening and induction of labor in a community hospital. Am J Obstet Gynecol. 1999 Jun;180(6 Pt 1):1551-9. [PubMed: 10368503]
- 13.
ACOG committee opinion. Monitoring during induction of labor with dinoprostone. Number 209, October 1998. Committee on Obstetric Practice. American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1999 Feb;64(2):200. [PubMed: 10189036]
- 14.
O’Dwyer S, Raniolo C, Roper J, Gupta M. Improving induction of labour – a quality improvement project addressing Caesarean section rates and length of process in women undergoing induction of labour. BMJ Qual Improv Rep. 2015;4(1) [PMC free article: PMC4693078] [PubMed: 26734422]
Disclosure: Michael Xi declares no relevant financial relationships with ineligible companies.
Disclosure: Valerie Gerriets declares no relevant financial relationships with ineligible companies.
Dinoprostone – description of the substance, pharmacology, use, contraindications, formula
Contents
Structural formula
Russian name
English title
Latin name
chemical name
Gross formula
Pharmacological group of the substance Dinoprostone
Nosological classification
CAS code
pharmachologic effect
Characteristic
Pharmacology
Application of the substance Dinoprostone
Contraindications
Application restrictions
Use during pregnancy and lactation
Side effects of the substance Dinoprostone
Interaction
Overdose
Dosage and administration
Precautionary measures
Trade names with the active substance Dinoprostone
Structural formula
Russian name
Dinoprostone
English name
Dinoprostone
Latin name
Dinoprostonum ( born Dinoprostoni)
Chemical name
(5Z,11alpha,13E,15S)-11,15-Dihydroxy-9-oxoprosta-5,13-diene-1-oic acid
Gross formula
C 20 H 32 O 5
Pharmacological group of the substance Dinoprostone
Uterotonics
Prostaglandins, thromboxanes, leukotrienes, their analogues and antagonists
Nosological classification
ICD-10 code list
CAS code
363-24-6
Pharmacological action
Pharmacological action 90 099-
uterotonic .
Characteristics
White or almost white crystalline powder. Let’s dissolve in alcohol, in spirit solutions, we will hardly dissolve in water. Molecular weight 352.5.
Pharmacology
Refers to prostaglandins – PGE 2 . It has a stimulating effect on the contractile activity and tone of the myometrium, modulates the response of internal organs to various hormonal influences, causes rhythmic contractions of the pregnant uterus at any stage of pregnancy (sensitivity is higher in the last trimester of pregnancy). When applied topically, it contracts the smooth muscles of the uterus and increases its blood supply, helps soften, smooth and open the cervix and stimulates smooth muscle contractions.
Rapidly metabolized in various tissues, especially in the lungs, but also in the liver and kidneys. It is excreted mainly by the kidneys in the form of metabolites.
Application of the substance Dinoprostone
Stimulation of maturation of the cervix, induction of labor in women with full-term or near-term pregnancy.
Contraindications
Hypersensitivity, history of 6 or more term pregnancies, history of caesarean section or major uterine surgery (history), difficult and/or traumatic delivery (history), prior fetal distress, mismatch between maternal pelvis and fetal head , spotting from the genital tract of an unspecified nature during pregnancy, infection of the lower genital tract, abnormal position of the fetus, opened fetal bladder.
Restrictions for use
Bronchial asthma, glaucoma or ophthalmohypertension, arterial hypertension, cardiovascular disease, epilepsy, impaired liver and/or kidney function.
Use in pregnancy and lactation
In experimental animal studies, prostaglandin E 2 causes an increase in skeletal abnormalities in the offspring of rats and rabbits. Embryotoxicity of dinoprostone was shown in rats and rabbits. Any dose of the drug that causes a prolonged increase in uterine tone poses a certain risk to the embryo or fetus.
FDA fetal category C.
Prostaglandins are excreted in breast milk in very small amounts.
Side effects of the substance Dinoprostone
From the genitourinary system: uterine hypertonicity, tetanic uterine contractions (increased frequency, uterine tone or duration of contractions), uterine rupture.
From the digestive tract: nausea, vomiting, diarrhea.
Others: flushing, trembling, fever, leukocytosis, back pain. Impact on the fetus – fetal distress syndrome / change in fetal heart rate, fetal compression, asphyxia.
Interaction
Enhances the effect of oxytocin.
Overdose
Symptoms: significant increase and increase in uterine contractions, fetal distress.
Treatment: intravenous administration of beta-agonists; in case of inefficiency – rapid delivery.
In case of an overdose of the gel: the drug must be removed from the vagina, placing the patient in a reclining position on her side; shows the use of oxygen.
Dosage and administration
Intravaginally, endocervically. Individual dosage regimen.
Precautions
Dinoprostone is for hospital use only. Before use for the induction of labor, it is necessary to carefully evaluate the conformity of the size of the pelvis and the head of the fetus; during childbirth, it is necessary to carefully monitor uterine activity, the course of the process of maturation and opening of the cervix, and the condition of the fetus. If there is a history of hypertensive or tetanic uterine contractions, the activity of the uterus and the status of the fetus are monitored throughout the entire period of induced labor. If the patient retains high-tonic contractions, the possibility of uterine rupture should be considered.
In women over 35 years of age with complications during pregnancy, as well as at 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 delivery (as early as possible) it is necessary to determine whether the patient is at risk of developing fibrinolysis.
When used in gel form, care must be taken not to inject the gel above the level of the internal os into the extra-amniotic space (possible uterine hyperstimulation).
Trade names with active substance Dinoprostone
Reset filters
Lek. form
All lek. forms gel intracervical system vaginal therapeutic
Dosage
All dosages 0.5 mg 1 mg/dose 10 mg
Manufacturer
All manufacturers Kevelt JSC Pfizer MFG. Belgium N.V. Ferring Controlled Therapeutics Ltd
Information for healthcare professionals only.
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Description DINOPROSTONE indications, dosages, contraindications of the active substance DINOPROSTONE
Rec. INN drug interaction Included in preparations: Pharmacological actionProstaglandin E analog 2 (PGE 2 ). It has a stimulating effect on organs containing smooth muscle cells, incl. on the contractile activity and tone of the myometrium, and also modulates the response of internal organs to various hormonal influences. When used endocervically, dinoprostone promotes pre-induction softening of the cervix (ripening) in patients with unfavorable induction parameters, increases the overall effectiveness of induction. The specific mechanism of action has not been fully elucidated. It has been shown that dinoprostone increases the blood supply to the cervix, similar to how it occurs in the initial period of spontaneous labor. Based on this, it is believed that when administered endocervically, dinoprostone affects the hemodynamics of the cervix, contributing to its maturation. PharmacokineticsMeasurement of plasma concentrations of the metabolite 13,14-dihydro-15-keto-PGE 2 showed that PGE 2 is rapidly absorbed, the time to reach C max in plasma is 50 -75 min. The average values of C max in plasma after endocervical administration of dinoprostone were 433±51 pg/ml, and in the control group – 137±24 pg/ml. PGE 2 is extensively metabolized in the lungs to form metabolites that are further metabolized in the liver and kidneys. It is excreted mainly by the kidneys in the form of metabolites. Indications of the active substance |
O62 | Disorders of labor activity [birth forces] |
Dosing regimen
Endocervical. The dosage regimen is individual, set by an obstetrician-gynecologist. Enter into the cervical canal immediately below the level of the internal pharynx.
Side effects
From the genitourinary system: uterine hypertonicity, tetanic uterine contractions (increased frequency, uterine tone or duration of contractions), uterine rupture.
From the digestive system: nausea, vomiting, diarrhea.
Other: flushing of the face, trembling, fever, leukocytosis, back pain. Impact on the fetus – fetal distress syndrome / change in fetal heart rate, fetal compression, asphyxia.
Contraindications for use
Hypersensitivity to dinoprostone; History of 6 or more full-term pregnancies, history of caesarean section or major uterine surgery, history of difficult and/or traumatic delivery, previous fetal distress, mismatch between maternal pelvis and fetal head, spotting from genital tract, unspecified character during pregnancy, infection of the lower genital tract, abnormal position of the fetus, opened fetal bladder.
Precautions: should be carefully assessed for fetal head and pelvis size before use for induction of labor; during childbirth, it is necessary to carefully monitor uterine activity, the course of the process of maturation and opening of the cervix, and the condition of the fetus. If there is a history of hypertensive or tetanic uterine contractions, the activity of the uterus and the status of the fetus are monitored throughout the entire period of induced labor. If the patient retains highly toxic contractions, the possibility of uterine rupture should be considered.
Use during pregnancy and lactation
Use 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 induction and induction preparation, dinoprostone may cause changes in fetal heart rate during labor, fetal distress, decreased neonatal status (Apgar score less than 7).