How often does pitocin lead to c section: The Truth About Pitocin (and When It’s Worth the Risk)
Posted onThe Truth About Pitocin (and When It’s Worth the Risk)
Pitocin can help some women avoid more serious medical interventions. But Pitocin has several troubling side effects that you need to be aware of.
By the time 40 weeks rolls around, there’s nothing most pregnant mamas want more than to meet their babies. Who can blame them, either? Pregnancy is tough on the body, and those headaches, swollen feet, and sleepless nights can really get the best of you. And when you’re feeling so vulnerable, it can be confusing if your birth plan doesn’t go quite as, well, planned.
So what do you do if your healthcare provider recommends Pitocin to medically induce?
While Pitocin can be a helpful labor tool, many healthcare providers don’t adequately explain the risks—and even the benefits!—of induction or augmentation of labor with Pitocin.
This post is not about judging or shaming any mamas who were administered Pitocin. In some cases—both before and after birth—it can be a true necessity. When I was in labor with my first baby, I needed “a hit of Pit” to continue laboring, and that intervention may have saved me from a surgical birth.
Instead, this post is about educating moms about Pitocin. Many mamas don’t even know that side effects exist. This needs to change.
What is Pitocin?
The body produces a hormone called oxytocin, also known as the love hormone ?, that helps the uterus contract during labor (its also released while nursing and during sex). Pitocin is a synthetic form of oxytocin.
But what does Pitocin do?
When labor stalls or when inducing labor with Pitocin is medically necessary (more on that below), Pitocin is used to jump start or speed up labor. When administered, Pitocin binds to oxytocin receptors in the body, causing the uterus to contract. (source) Researchers are unsure if Pitocin crosses the blood-brain barrier.
When is Pitocin Medically Necessary?
Induction is considered medically necessary when the risk of baby remaining in the womb outweighs any risks associated with induction.
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Here are some times when Pitocin should be considered:
1. When certain health conditions affect mama or baby
There are a number of rare, but serious health conditions and infections—gestational diabetes, preeclampsia, intrauterine growth restriction, and more—that may make it too risky for mama to carry baby to 40 weeks or beyond.
2. Water broke, but contractions haven’t started in 24-48 hours
If mama’s water breaks and contractions don’t start within 24 hours, many practitioners will want to induce. This is based on research performed in the 1950s and ’60s suggesting the chances of infection go up dramatically if babies are born any later than 24 hours after the membranes rupture. However, new research shows that women who meet certain criteria can safely wait 48 hours for contractions to begin (expectant management). To do so, mama needs meet the following criteria:
- Term, uncomplicated, singleton pregnancy
- Fetus in vertex position (head down)
- Clear amniotic fluid
- No infections (including GBS)
- No fever
- Normal fetal heart rate
- No vaginal exam at baseline
- Keep vaginal exams to a minimum (vaginal exams increase infection risk)
3.
Labor stalls
If mom is more than 6 cm or if baby is in distress, Pitocin may be needed. If labor slows or stalls, but both mom and baby are doing well (and labor was not induced and mom is less than 6 cm dilated), evidence suggests that it’s best to let birth unfold on its own.
4. After labor, if bleeding cannot be stopped
Even after birth, Pitocin causes contractions in the uterus. These contractions squeeze down on the raw blood vessels that are exposed as the placenta is released, reducing bleeding and hemorrhaging. These contractions also help the uterus contract back to it’s normal size. Therefore, Pitocin can be a great tool for managing excessive blood loss or even to push out a stubborn placenta that doesn’t want to come out.
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When Pitocin Isn’t Necessary
In a perfect world, Pitocin would only be used when medically necessary to improve outcomes for both mom and baby. In reality, Pitocin is often used without a medical reason. Some of the non-medically necessary reasons are:
1. Convenience
Some doctors schedule inductions to avoid scheduling conflicts. There are obvious problems with this!
2. Mama goes past 40 weeks
Evidence shows there’s no reason to induce before 42 weeks when the mom and baby are healthy. The American College of Obstetrics and Gynecology (ACOG) recommends that induction should take place between 42 weeks 0 days and 42 weeks 6 days.
3. Mama is ready
Those last few weeks can be tough, and some women begin to think induction seems like a good idea (I get it!). But induction can be risky as the baby and your body may need those last few days to prepare for birth.
4. Baby is getting big
Many women are told they should induce before baby gets too big. When a baby is too big to fit through the pelvis, this is called cephalopelvic disproportion (CPD). This condition is actually very rare unless mama had a pelvic injury or was malnourished as a child. (source) Additionally, in studies, ultrasound predictions of baby’s size are historically inaccurate (by several pounds in some cases!).
That said, certain conditions like gestational diabetes can cause higher birth weight. In those cases induction is usually recommended.
Is Pitocin Being Overused?
Before Pitocin was created in 1955, if labor stalled for too long in a hospital, the next step would often be to perform a C-section. With Pitocin, women who would otherwise be resigned to surgery could birth their babies vaginally.
But today, about 40 percent of laboring women report being induced.
Most midwives and birth workers agree that statistics like that are far too high, and that Pitocin is used much too frequently today.
Another problem with Pitocin is that many moms who receive it don’t fully understand:
- why they’re being induced
- and what potential complications are associated with Pitocin
Side Effects of Pitocin
It’s important that each mom, in partnership with her healthcare provider, has the information—both the benefits and the risks—she needs to make an informed decision about whether or not Pitocin is the right intervention for her. Since we’ve already touched on all of the great things Pitocin can do during labor, let’s unpack some of the potential side effects:
1. Pitocin can lead to other interventions
As with other interventions, like epidurals, saying yes to Pitocin means you’re also saying yes to a number of other interventions including continuous fetal monitoring and IV fluids (that’s how the Pitocin gets into your body). You may also end up needing an epidural, since Pitocin contractions are more intense and more painful—especially if used for several hours.
A survey of first-time moms with term births found that 61 percent of women, who went into labor spontaneously, asked for an epidural.
In contrast, 78 percent of women who were induced asked for an epidural.
Those who had induction and epidural were 6 times more likely (a 31 percent chance) to have a c-section than those who had neither.
This survey didn’t distinguish between methods of induction so we don’t know if all of these inductions required Pitocin or not, but the large difference in epidural use in the induction group vs. the spontaneous labor group is interesting and worth considering.
2. It can increase your risk of postpartum depression and anxiety
Oxytocin is often touted as the bonding hormone between mama and baby, so in theory, researchers thought that a synthetic version of oxytocin would provide the same positive effects on mama’s mental health, right? Wrong! Although researchers hypothesized that receiving synthetic oxytocin (Pitocin) during labor would reduce postpartum depression and anxiety, it actually had the opposite effect.
Mamas with a history of depression and/or anxiety who received Pitocin during labor had a 36% increased risk of developing postpartum depression and anxiety. Even mamas without a previous history of depression and anxiety still had a 32% increased risk!
3. You’re on the hospital “clock”
Additionally, when you’re on Pitocin, you’re on the clock, meaning the hospital or doctor usually expects a certain amount of progress per hour. Many hospitals use 1 cm per hour, after reaching 4 cm, as their guide (known as the Freedman’s Curve). But a recent study found that the slowest rate of dilation that is considered normal is 1/2 cm per hour—half the rate that many hospitals and doctors use.
It’s easy to believe that certain interventions, especially ones like fetal monitoring or IV fluid don’t interfere with birth and are a good “insurance plan” in case something goes wrong, but having interventions “just in case” may cause unnecessary fear and stress that can interfere with the natural labor process. As Judith A. Lothian RN, writes in an article published in the Journal of Perinatal Education:
“Catecholamines, the stress hormones, are released if the mother is fearful or if she does not feel safe and protected. Early in labor, high levels of catecholamines can slow or even stop labor… Having a deep understanding and confidence in the normal physiologic process of labor and birth and confidence in her own ability to give birth makes it easier for a woman to let go of the belief that technology and routine interventions make birth safer for mothers and babies.
”
4. Longer labor
While augmentation is more likely to shorten labor (even if that means it ends in a C-section), induction with Pitocin can have the opposite effect and actually lengthen labor. One study found that women who were induced spent a considerable amount of additional time in labor, compared to women who went into labor spontaneously. The reason could be that your body or baby simply isn’t ready yet. There are some criteria that can help determine if induction will work well for you or not. Calculate your Bishop Score to see if you’re a good candidate.
If you begin labor at home, you have the freedom to go through early labor in as much or little time as you need (not to mention in the comfort of your own home). When you’re induced, you may have to go through all of early labor at the hospital—and early labor can take a long time!
5. Higher risk of C-section
Sometimes Pitocin doesn’t help the body dilate. If nothing is happening at all, you may be sent home. But in many cases, especially if mama’s water has broken, there is no turning back. In 25 percent of cases, induction isn’t successful and C-section is necessary. One study found that induction actually doubled the risk of C-section.
6. Higher risk of hemorrhage
One of the biggest benefits of Pitocin is its ability to reduce postpartum hemorrhage (PPH) by helping the uterus contract back to its normal size after delivery of the placenta. The American Academy of Family Physicians (AAFP) considers Pitocin the first and best choice for treating postpartum hemorrhage, because it has fewer side effects than other medications.
But studies indicate postpartum hemorrhage is also a side effect, because it can cause uterine rupture. The intense contractions can cause the uterus to tear in a VBAC situation or even in a uterus without scarring. Uterine rupture is a rare, but catastrophic condition that can lead to fetal and maternal death. One healthcare center found that 77 percent of their patients with uterine rupture were given Pitocin during labor.
Research suggests that another cause of postpartum hemorrhage is the continuous flow of oxytocin (Pitocin) instead of the body’s typical pulsed flow. This can make the uterus less sensitive to oxytocin, making it harder for natural oxytocin (or even Pitocin) to help stimulate the contraction of the uterus after delivery of the placenta.
6. Stronger contractions
Pitocin labor is different than natural labor. Experts agree that contractions are much longer, stronger, and closer together than natural contractions. Also, the uterus doesn’t get to completely relax in between contractions.
When the uterus is contracting so strongly for such long periods and with little break in between, babies can suffer from lack of blood flow and oxygen deprivation, causing abnormal fetal heart rate patterns and fetal distress.
7. Straining for baby
Pitocin can also cause some issues for baby. The U.S. package insert explicitly states the serious risks to baby, including:
- fetal heart abnormalities (slow heart beat, PVCs, and arrhythmias)
- low APGAR scores
- neonatal jaundice
- neonatal retinal hemorrhage
- permanent central nervous system or brain damage
- fetal death
Additionally, one study found that babies born after augmentation with Pitocin had almost three times greater risk of oxygen deprivation, which can lead to Cerebral Palsy or brain damage.
Labor induced with Pitocin was also linked to higher chances of baby being admitted to the NICU for longer than 24 hours.
The Truth About Pitocin
Pitocin can be a huge help to many mamas before, during, and after birth.
When mom is educated about both the risks and benefits of Pitocin, she can make an informed and empowered choice during her labor. If Pitocin is necessary, by all means, use it! And let go of any guilt, as it truly can help in many labors.
- When Pitocin is used well, it can help moms avoid cesarean section.
- When Pitocin is used unnecessarily, it can trigger a “cascade of interventions” that actually leads moms to cesarean section.
Most midwives and birth workers consider Pitocin to be grossly overused.
Pitocin does have a number of side effects that many moms don’t know about before they receive it.
Pitocin Dosage
If you do need Pitocin during labor you may consider asking the nurses what dosage you’re at (or having a support person do it for you). Ask your healthcare provider to keep your dosage as low as possible. (It’s a good idea to put this in your birth plan—just in case.)
Studies of the concentrations of oxytocin in the maternal plasma during Pitocin infusion show that infusion rates up to 6 mU/min give the same oxytocin levels that are found in spontaneous labor.
At term, higher infusion rates should be given with great care, and rates exceeding 9–10 mU/min are rarely required. Before term, when the sensitivity of the uterus is lower because of a lower concentration of oxytocin receptors, a higher infusion rate may be required. (source)
But remember every patient and every situation is different. Talk to your healthcare provider and be sure everyone is on the same page before you go into your birth.
How About You?
What did your doctor tell you about Pitocin? Did you receive Pitocin before or after labor?
Induction of labor with oxytocin increases cesarean section rate as compared with oxytocin for augmentation of spontaneous labor in nulliparous parturients controlled for lumbar epidural analgesia
Comparative Study
. 2004 Sep;16(6):411-4.
doi: 10.1016/j.jclinane.2003.11.004.
Bupesh Kaul
1
, Manuel C Vallejo, Sivam Ramanathan, Gordon Mandell, Amy L Phelps, Ashi R Daftary
Affiliations
Affiliation
- 1 Department of Anesthesiology, Magee-Womens Hospital and the University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
[email protected]
-
PMID:
15567643
-
DOI:
10.1016/j.jclinane.2003.11.004
Comparative Study
Bupesh Kaul et al.
J Clin Anesth.
2004 Sep.
. 2004 Sep;16(6):411-4.
doi: 10.1016/j.jclinane.2003.11.004.
Authors
Bupesh Kaul
1
, Manuel C Vallejo, Sivam Ramanathan, Gordon Mandell, Amy L Phelps, Ashi R Daftary
Affiliation
- 1 Department of Anesthesiology, Magee-Womens Hospital and the University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
[email protected]
-
PMID:
15567643
-
DOI:
10.1016/j.jclinane.2003.11.004
Abstract
Study objectives:
To study labor outcomes in parturients receiving oxytocin for augmentation or induction of labor, in the presence of labor epidural analgesia.
Design:
Retrospective study of data from a continuous quality improvement database.
Setting:
Tertiary-care hospital with more than 8000 deliveries per annum.
Measurements and main results:
Of the 1671 healthy nulliparous women with singleton pregnancies and who requested labor epidural analgesia at our institution, 675 patients received oxytocin during elective induction of labor, whereas 996 patients received oxytocin for augmentation of spontaneous labor. Measured variables were cervical dilatation at time of epidural analgesia request, epidural insertion to 10-cm time, duration of stage 2 of labor, normal spontaneous vaginal delivery rate, cesarean section rate, operative vaginal delivery rate, and baby weight. Women admitted for induction of labor requested epidural analgesia sooner than those who had their labor augmented (p < 0.001). The incidence of cesarean section was higher in the induced group (p = 0.008).
Conclusion:
Patients who have their labor induced request analgesia sooner and are at a higher risk of cesarean section than are patients who go into labor spontaneously. Any study that purports to assess the effects of epidural analgesia in labor should distinguish between induced and augmented/spontaneous labor.
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Caesarean section should only be performed if medically indicated
Caesarean section should only be performed if medically indicated.
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- Caesarean section should only be performed if medically indicated
\n
\nA caesarean section may be necessary in situations where vaginal delivery could pose a risk to the mother or baby, such as prolonged labour, distress, or fetal presentation. At the same time, caesarean section can lead to serious complications, disability or death, especially in the absence of opportunities to safely perform surgical interventions or treat possible complications.
\n
Impact on reducing maternal and child mortality
\n
\nSince 1985, it has been accepted in the international health community that the ideal caesarean section rate is 10-15%. Findings from new studies show that if caesarean section rates increase to 10% at the population level, maternal and neonatal mortality rates decrease. However, if the frequency of its implementation exceeds 10%, the available data do not indicate an improvement in mortality rates.
\n
\n“These findings highlight the importance of caesarean section in saving maternal and newborn lives,” says Dr Marleen Temmerman, Director of the WHO Department of Reproductive Health and Research. “They also show how important it is to ensure that caesarean sections are available to women who need it, and not just strive to achieve any specific targets. ”
\n
\nAt the population level, the effect of caesarean section on maternal and neonatal outcomes, such as stillbirth or complications such as birth asphyxia, remains unknown. Further research is needed regarding the effects of caesarean section on women’s psychological and social well-being.
\n
\nDue to additional costs, high rates of unnecessary caesarean sections can result in a drain on resources to the detriment of other services in overburdened and weak health systems.
\n
Robson system
\n
\nThe lack of a standardized internationally recognized classification system for consistent monitoring and comparative analysis of data on the frequency of caesarean section, which is of practical importance, is one of the factors hindering a better understanding of trends in this area . The WHO proposes to adopt the Robeson classification as the internationally recognized caesarean section classification system.
\n
\nAccording to the Robeson system, each woman entering the maternity ward can be assigned to one of 10 groups based on easily identifiable characteristics such as the number of previous pregnancies, whether the baby is head-first, gestational age, caesarean section history, number of children and signs of onset of labor. The use of this system will allow for a comparative analysis of the frequency of caesarean sections both within individual institutions and between different health care institutions, as well as between countries and regions.
\n
\n“Obtaining information in a standardized, unified and reproducible manner is essential for healthcare providers who want to optimize caesarean delivery and evaluate and improve the quality of care,” explains Dr. Temmerman. “We call on the entire medical community and decision-makers to take these findings into account and put them into practice as soon as possible.”
\n
Notes to editors
\n
\nThe WHO caesarean section statement is based on two studies performed under the UNDP/UNFPA/WHO/World Bank Special Program for Research, Development and Research Training in Human Reproduction. This program, carried out with the participation of the WHO Department of Reproductive Health and Research, is the main instrument for conducting research in the field of human reproduction in the United Nations system.
\n
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Caesarean section is one of the most common surgical procedures in the world, and its frequency continues to increase, especially in high- and middle-income countries. While caesarean sections can save lives, they are often performed when there is no medical indication, putting women and their children at risk of developing health problems in the short or long term. The new WHO statement highlights the importance of taking into account the needs of the patient in each case and abandoning the practice of achieving targets.
A caesarean section may be necessary when vaginal delivery could pose a risk to the mother or baby, such as prolonged labor, distress, or fetal presentation. At the same time, caesarean section can lead to serious complications, disability or death, especially in the absence of opportunities to safely perform surgical interventions or treat possible complications.
Impact on reduction of maternal and child mortality
Since 1985, it has been accepted in the international health community that the ideal caesarean section rate is 10-15%. Findings from new studies show that if caesarean section rates increase to 10% at the population level, maternal and neonatal mortality rates decrease. However, if the frequency of its implementation exceeds 10%, the available data do not indicate an improvement in mortality rates.
“These findings highlight the importance of caesarean section in saving maternal and newborn lives,” says Dr Marleen Temmerman, Director of the WHO Department of Reproductive Health and Research. “They also show how important it is to ensure that caesarean sections are available to women who need it, and not just strive to achieve any specific targets.”
At the population level, the impact of caesarean section rate on maternal and neonatal outcomes, such as stillbirth or complications such as birth asphyxia, remains unknown. Further research is needed regarding the effects of caesarean section on women’s psychological and social well-being.
Because of the added cost, high rates of unnecessary caesarean sections can result in a drain on resources to the detriment of other services in overburdened and weak health systems.
Robeson system
The lack of a standardized, internationally recognized classification system for consistent monitoring and comparative analysis of data on caesarean section rates of practical relevance is one of the factors hindering a better understanding of trends in this area. The WHO proposes to adopt the Robeson classification as the internationally recognized caesarean section classification system.
According to the Robeson system, each woman entering the maternity ward can be assigned to one of 10 groups based on easily identifiable characteristics such as number of previous pregnancies, whether the baby is head-first, gestational age, history of caesarean section, number of children, and signs start of childbirth. The use of this system will allow for a comparative analysis of the frequency of caesarean sections both within individual institutions and between different health care institutions, as well as between countries and regions.
“Getting information in a standardized, unified, and reproducible manner is essential for healthcare providers who want to optimize caesarean delivery and evaluate and improve the quality of care,” explains Dr. Temmerman. “We call on the entire medical community and decision-makers to take these findings into account and put them into practice as soon as possible. ”
Notes to editors
The WHO statement on the caesarean section rate is based on the results of two studies carried out under the UNDP/UNFPA/WHO/World Bank Special Program for Research, Development and Research in Human Reproduction. This program, carried out with the participation of the WHO Department of Reproductive Health and Research, is the main instrument for conducting research in the field of human reproduction in the United Nations system.
Pitocin (oxytocin injection): Uses, Dosage, Side Effects, Interactions, Prevention
- Generic Name: Oxytocin Injection
- Brand Name: Pitocin
- Product Description
- Indications 9000 5
- Dose
- Side effects and drug interactions
- Warnings and Precautions
- Overdose and Contraindications
- Clinical pharmacology
- Medication guide
Product description
What is pitocin and how is it used?
Pitocin (oxytocin injection) is a natural uterine contracting hormone used to induce labor, increase contractions during labor, control bleeding after childbirth, or to terminate a pregnancy.
What are the side effects of Pitocin?
Common Pitocin side effects include:
- redness or irritation at the injection site,
- loss of appetite,
- nausea,
- vomiting,
- cramps,
- abdominal pain,
- more intense more or more frequent contractions (this is an expected effect of oxytocin),
- runny nose,
- sinus pain or irritation, or
- memory problems.
Tell your doctor if you experience any serious side effects of Pitocin, including:
- fast, slow or irregular heartbeat;
- excessive bleeding long after delivery;
- Headache,
- confusion,
- slurred speech,
- hallucinations,
- severe vomiting,
- loss of coordination,
- unsteadiness,
- seizure (convulsions) ,
- fainting,
- shallow breathing or breathing that stops; or
- dangerously high blood pressure (severe headache, blurred vision, tinnitus, restlessness, confusion, chest pain, shortness of breath, irregular heartbeat, convulsions).
Wholesale package from pharmacies — not for direct infusion
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DESCRIPTION
Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin for intravenous infusion or intramuscular injection. Pitocin is a nonapeptide found in mammalian pituitary extracts. It is standardized to contain 10 units of oxytocin hormone/ml and contains 0.5% chlorobutanol, a derivative of chloroform, as a preservative, pH adjusted with acetic acid. Pitocin can contain up to 16% of the total amount of impurities. The hormone is produced synthetically to avoid possible contamination by vasopressin (ADH) and other small polypeptides with biological activity. Pitocin has the empirical formula C 43 H 66 N 12 OR 12 S two (molecular weight 1007.19). The structural formula is as follows:
Indications
INDICATIONS
Important note
Planned induction of labor defined as the onset of labor in a pregnant woman who does not have a medical indication for labor induction. Because the available data are insufficient to assess the benefit/risk ratio, Pitocin is not indicated for elective induction of labor.
Antenatal
Pitocin is indicated for initiating or ameliorating uterine contractions, if desired and deemed appropriate for reasons of concern to the fetus or mother, to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with medical indications for initiation of labor such as Rh factor, maternal diabetes, near or near term preeclampsia when labor is in the best interest of the mother and fetus or terminated prematurely and delivery is indicated; (2) stimulation or intensification of labor, as in isolated cases of uterine inertia; (3) as adjunctive therapy in the treatment of incomplete or unavoidable abortion. In the first trimester, curettage is usually considered the primary therapy. In second trimester abortions, an infusion of oxytocin often helps empty the uterus. However, in such cases, other treatments may be required.
Postpartum
Pitocin is indicated for uterine contractions during the third stage of labor and for the control of postpartum haemorrhage or hemorrhage.
DOSAGE
DOSAGE AND ADMINISTRATION
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration if solution and container permit.
The dosage of oxytocin is determined by the response of the uterus and therefore must be individualized and started at a very low level. The following dosage information is based on various regimens and general indications.
Induction or induction of labor
Intravenous infusion (drip method) is the only acceptable method of parenteral administration of Pitocin for induction or induction of labor. Precise control of the infusion rate is essential and is best achieved with an infusion pump. Pitocin infusion is convenient to use under physiological conditions. electrolyte solution, which allows you to abruptly stop the infusion of pitocin without interrupting the electrolyte infusion. This is done in the following way.
Preparation
- Pitocin infusion standard solution is prepared by adding 1 ml (containing 10 units of oxytocin) to 1000 ml of 0.9% aqueous sodium chloride or Ringer’s lactate solution. A combination solution containing 10 milliunits (mU) of oxytocin/mL is swirled in the infusion bottle for thorough mixing.
- Start the infusion from a separate bottle of pitocin-free physiological electrolyte solution.
- Attach the pitocin bottle with infusion pump to the infusion line as close to the infusion site as possible.
Administration
The initial dose should be 0.5–1 IU/min (equivalent to 3–6 ml of a diluted oxytocin solution per hour). At 30-60 minute intervals, the dose should be gradually increased in increments of 1-2 mU/min until the desired reduction pattern is achieved. After reaching the desired contraction rate and progression of labor to 5-6 cm, the dose can be reduced in a similar way.
Studies of maternal plasma oxytocin concentrations during Pitocin infusion have shown that infusion rates up to 6 mU/min produce the same levels of oxytocin found in spontaneous labor. In term, higher infusion rates should be administered with great caution, and rates exceeding 9-10 mU/min, rarely required. Prior to delivery, when uterine sensitivity is lower due to lower concentrations of oxytocin receptors, a higher infusion rate may be required.
Monitoring
- Electronically monitor uterine activity and fetal heart rate during Pitocin infusion. Attention should be paid to the tone, amplitude and frequency of contractions, as well as the fetal heart rate compared to uterine contractions. If uterine contractions become too strong, the infusion can be stopped abruptly and the oxytocin stimulation of the uterine muscles will soon subside (see PRECAUTIONS section).
- Stop Pitocin infusion immediately if uterine hyperactivity and/or fetal distress occurs.
Give the mother oxygen, which should preferably be placed in a lateral position. The condition of the mother and fetus should be immediately assessed by the responsible physician and appropriate measures taken.
Control of postpartum uterine bleeding
- Intravenous infusion (drip method). If the patient is receiving an intravenous infusion, 10 to 40 units of oxytocin may be added to the vial, depending on the amount of electrolyte or dextrose solution remaining (40 units to 1000 ml maximum). Adjust infusion rate to maintain uterine contraction and control uterine atony.
- Intramuscular administration. After delivery of the placenta, 1 ml (10 units) of Pitocin can be administered.
Treatment of incomplete, inevitable, or planned abortion
Intravenous infusion of 10 units of pitocin added to 500 ml of saline or 5% dextrose in water may help the uterus contract after suction or abrupt curettage in incomplete, inevitable, or planned abortion.
After intra-amniotic injection of hypertonic saline, prostaglandins, urea, etc. For planned mid-trimester abortion, the time from injection to abortion can be shortened by Pitocin infusion at a rate of 10 to 20 milliunits (20 to 40 drops). in a minute. The total dose should not exceed 30 units in a 12-hour period due to the risk of water poisoning.
Dosing Directions
Pharmacy Bulk Pack — Not for Direct Infusion
Pharmacy Bulk Pack is intended for pharmacy use only in a suitable work area, such as a laminar flow hood. The closure should only be pierced once, using an appropriate sterile transfer device that allows the distribution of the contents to be dispensed. The transfer device should be inserted into the bulk pack at the pharmacy under aseptic conditions.
The content should be used as soon as possible after the initial closure puncture. Cancel any unused portion within 24 hours of first entry. Once the closure has been punctured, the container must be stored under designated storage conditions at 20° to 25°C (68° to 77°F) under a laminar flow fume hood until contents are dispensed.
HOW SUPPLIED
Pitocin (oxytocin injection, USP) synthetic is available as follows:
NDC 42023-130-06 Six 50 ml pharmacy bulk packs, each containing 10 units of oxytocin per ml (total = 500 units of oxytocin per vial).
Storage Location
Store between 20 and 25°C (68 and 77°F). See Room Temperature Controlled USP .
RECOMMENDATIONS
1. Seichik J., Castillo M: Oxytocin that increases dysfunctional labor. I. Clinical data. Am J Obstet Gynecol 1982; 144:899-905.
2. Seichik J., Castillo M: Oxytocin increasing dysfunctional labor. II. Multiparous patients. Am J Obstet Gynecol 1983; 145:777-780.
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3. Fuchs A, Goeschen K, Husslein P, et al: Oxytocin and the onset of human childbearing. III. Plasma concentrations of oxytocin and 13,14-dihydro-15-keto-prostaglandin F2a in spontaneous and oxytocin-induced term deliveries. Am J Obstet Gynecol 1983; 145:497-502.
4. Seichik J, Amiko J, et al.: Oxytocin enhancing dysfunctional labor. IV. Pharmacokinetics of oxytocin. Am J Obstet Gynecol 1984; 150:225-228.
5. American College of Obstetricians and Gynecologists: ACOG Technical Bulletin No. 110 — Nov. 1987: Induction and augmentation of labor.
Manufactured and distributed by: JHP Pharmaceuticals, LLC, Rochester, MI 48307. Revised: March 2013
Side effects and drug interactions
SIDE EFFECTS
The following maternal adverse reactions have been reported:
Anaphylactic reaction | Premature ventricular contractions |
Postpartum haemorrhage | |
Cardiac arrhythmia | Subarachnoid hemorrhage |
Fatal afibrinogenemia | Hypertensive episodes |
Nausea | Uterine rupture |
Vomiting |
Excessive dosage or hypersensitivity to the drug may lead to uterine hypertonicity, spasm, tetanus contractions or uterine rupture.
When taking the drug should take into account the possibility of increased blood loss and afibrinogenemia.
Severe water intoxication with convulsions and coma has occurred associated with slow administration of oxytocin over a 24 hour period. Maternal deaths have been reported due to oxytocin-induced water poisoning.
The following adverse reactions have been reported in the fetus and newborn:
Due to induced uterine motility: | Due to the use of oxytocin in the mother: |
Bra dicardia | Low Apgar scores after five minutes |
Premature ventricular contractions and other arrhythmias | Neonatal jaundice |
Permanent CNS or brain damage | Neonatal retinal hemorrhage |
Fetal death | |
Neonatal convulsions have been reported with the use of Pitocin. |
Consult your physician for medical advice on adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
DRUG INTERACTIONS
Severe hypertension has been reported when oxytocin was administered three to four hours after prophylactic administration of a vasoconstrictor in combination with caudal block anesthesia. Cyclopropane anesthesia can alter the cardiovascular effects of oxytocin, leading to unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia.
Warnings and Precautions
WARNINGS
Pitocin used to induce labor or increase uterine activity should only be given intravenously and under proper medical supervision in a hospital.
PRECAUTIONS
General
- All patients receiving intravenous oxytocin should be closely monitored by trained personnel who are knowledgeable about the drug and able to detect complications.
A physician qualified to treat any complications must be available immediately. Electronic fetal monitoring is the best way to detect overdose early (see OVERDOSE section). However, it must be taken into account that only intrauterine pressure recording can accurately measure intrauterine pressure during contractions. The fetal scalp electrode provides a more reliable recording of the fetal heart rate than any external monitoring system.
- When used correctly, oxytocin should stimulate uterine contractions comparable to those seen in conventional labor. Excessive stimulation of the uterus by improper insertion can be dangerous for both the mother and the fetus. Even with proper use and proper monitoring, patients whose uteruses are hypersensitive to oxytocin may experience hypertonic contractions. This fact should be taken into account by the doctor when making a conclusion on the selection of patients.
- Except in unusual circumstances, oxytocin should not be given in the following conditions: fetal distress, hydramnios, partial placenta previa, prematurity, borderline cephalopastic disproportion, and any condition in which there is a predisposition to uterine rupture, such as previous major surgery on the cervix or uterus including caesarean section, excessive distension of the uterus, a large number of children in the uterus, or a history of uterine sepsis or traumatic birth.
Because of the variability in the combinations of factors that may be present in the conditions listed above, the definition of «unusual circumstances» should be left to the discretion of the clinician. The decision can only be made by carefully weighing the potential benefits that oxytocin can provide in this case, against the rare but certain ability of the drug to cause hypertonicity or tetanic spasm.
- Maternal deaths have been reported due to episodes of hypertension, subarachnoid hemorrhage, uterine rupture and fetal death from various causes associated with the use of parenteral oxytocin drugs to induce labor or increase in the first and second stages of labor.
- Oxytocin has been shown to have an intrinsic antidiuretic effect by increasing water reabsorption from the glomerular filtrate. Therefore, the possibility of water intoxication should be considered, especially when oxytocin is given continuously as an infusion and the patient receives fluids by mouth.
- When oxytocin is used to induce or enhance an existing labor, patients must be carefully selected.
Before using the drug, it is necessary to consider the adequacy of the pelvic organs and assess the condition of the mother and fetus.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no studies of carcinogenicity and mutagenicity of this drug in animals or humans, as well as information on its effect on fertility.
Pregnancy
Teratogenic effects
Animal reproduction studies have not been conducted with oxytocin. There are no known indications for use in the first trimester of pregnancy, except in cases of spontaneous or induced abortion. Based on the extensive experience with this drug, its chemical structure and pharmacological properties, it cannot be expected to present a risk of fetal abnormalities when used as directed.
Non-teratogenic effects
See ADVERSE REACTIONS in the fetus or newborn.
Work and delivery
See INDICATIONS section.
Overdose and contraindications
OVERDOSAGE
Oxytocin overdose is highly dependent on uterine hyperactivity, whether or not associated with hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions or resting tone of 15 to 20 mm Hg. fetal heart, fetal hypoxia, hypercapnia, perinatal hepatic necrosis or death. Water intoxication with convulsions, caused by the innate antidiuretic action of oxytocin, is a serious complication that can occur with long-term administration of high doses (40 to 50 milliunits per minute). Treatment consists of immediate discontinuation of oxytocin and symptomatic and supportive therapy.
CONTRAINDICATIONS
Prenatal use of Pitocin is contraindicated in any of the following circumstances:
- Where there is significant cephalopiasis disproportion;
- In unfavorable positions or presentations of the fetus, such as transverse lie, which cannot be delivered without transformation before delivery;
- In obstetric emergencies where the balance of benefit and risk to the fetus or mother favors surgery;
- In fetal distress where delivery is not inevitable;
- When adequate uterine activity does not lead to satisfactory progress;
- When the uterus is already hyperactive or hypertonic;
- In cases where vaginal delivery is contraindicated, eg, invasive cervical carcinoma, active genital herpes, common placenta previa, vase previa, umbilical cord presentation, or cord prolapse;
- In patients with hypersensitivity to the drug.
Clinical pharmacology
CLINICAL PHARMACOLOGY
Motility of the uterus depends on the formation of the contractile protein actomyosin under the influence of Ca 2+ -dependent phosphorylating enzyme myosin light chain kinase. Oxytocin promotes contraction by increasing intracellular Ca 2+ . Oxytocin has specific receptors in the myometrium, and the concentration of receptors increases significantly during pregnancy, reaching a maximum during early term delivery. The response to a given dose of oxytocin is very individual and depends on the sensitivity of the uterus, which is determined by the concentration of oxytocin receptors. However, the clinician should be aware that oxytocin, even in its purest form, has inherent pressor and antidiuretic properties that can occur when high doses are taken. These properties are thought to be related to the fact that oxytocin and vasopressin differ in only two of the eight amino acids (see PRECAUTIONS section).