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Oxytocin: Drug information

Oxytocin: Drug information
(For additional information see "Oxytocin: Patient drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
ALERT: US Boxed Warning
Appropriate use:

Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, oxytocin is not indicated for elective induction of labor.

Brand Names: US
  • Pitocin
Pharmacologic Category
  • Oxytocic Agent
Dosing: Adult

Note: Dosage is determined by uterine response and must be individualized and initiated at a very low level for each patient.

Induction or stimulation of labor: IV: Administration requires the use of an infusion pump. The ideal dosing regimen has not been determined (Leduc 2013) and various protocols are available (ACOG 2009; Leduc 2013; Wei 2010); refer to institution-specific protocol. To prevent medication errors, the dose should be administered using a ready-to-use standardized infusion (Drummond 2018). Discontinue the oxytocin infusion immediately in the event of uterine hyperactivity and/or fetal distress. If uterine contractions become too powerful, the infusion can be stopped abruptly.

Initial: 0.5 to 1 milliunits/minute; gradually increase dose in increments of 1 to 2 milliunits/minute every 30 to 60 minutes until desired contraction pattern is established; dose may be decreased by similar increments after desired frequency of contractions is reached and labor has progressed to 5 to 6 cm dilation. Higher infusion rates may be needed prior to term due to a lower sensitivity of the uterus. Infusion rates up to 6 milliunits/minute provide oxytocin levels similar to those with spontaneous labor; rates >9 to 10 milliunits/minute are rarely required.

Low-dose regimen (off-label dose): Initial 0.5 to 2 milliunits/minute, incrementally increase by 1 to 2 milliunits/minute every 15 to 40 minutes (ACOG 2009).

High-dose regimen (off-label dose): Initial 6 milliunits/minute, incrementally increase by 3 to 6 milliunits/minute every 15 to 40 minutes. Reduce the incremental increase to 3 milliunits/minute if hyperstimulation occurs; reduce the incremental increase to 1 milliunit/minute for recurrent hyperstimulation (ACOG 2009).

Postpartum uterine bleeding: Note: Oxytocin is used for both prevention and treatment of postpartum hemorrhage associated with uterine atony and vaginal or surgical delivery (Vallera 2017; WHO 2012). Due to desensitization of oxytocin receptors and changes in receptor density in the myometrium, larger doses may be needed in women undergoing a nonelective cesarean delivery if oxytocin was previously administered during labor; repeated doses may become ineffective (Dyer 2011; Vallera 2017). Oxytocin may be administered by slow IV bolus, IV infusion, or IM injection. Rapid IV bolus administration is associated with cardiovascular collapse (ACOG 183 2017; Vallera 2017); rapid IV boluses are not recommended for women with cardiovascular risk factors (Sentilhes 2016). In women not requiring treatment by IV infusion, administration via slow IV bolus may be preferred over IM injection for the prevention of postpartum hemorrhage based on a study evaluating oxytocin use following vaginal delivery (Adnan 2018).

IM: 10 units after delivery of the placenta.

IV: Note: The optimal regimen has not been established (AWHONN 2015; Dyer 2011; Vallera 2017); refer to institution-specific protocol. To prevent medication errors, the dose should be administered using a ready-to-use standardized infusion (Drummond 2018).

5 units (Sentilhes 2016) or 10 units (AWHONN 2015; Sentilhes 2016; WHO 2012) may be given initially and can be followed by a maintenance infusion of up to 10 units/hour (AWHONN 2015; Sentilhes 2016). Maximum cumulative dose: 40 units (Sentilhes 2016). Adjust infusion rate to sustain uterine contraction and control uterine atony.

Lower bolus doses (0.5 to 3 units) for the prevention of postpartum bleeding have also been evaluated in women undergoing elective cesarean delivery (Butwick 2010; Carvalho 2004).

Adjunctive treatment of abortion: IV:

Incomplete, inevitable, or elective abortion: 10 units as an IV infusion after suction or a sharp curettage (used to help contract the uterus)

Midtrimester elective abortion: 10 to 20 milliunits/minute; maximum total dose: 30 units/12 hours (may decrease injection to abortion time)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Pitocin: 10 units/mL (1 mL, 10 mL, 50 mL) [contains chlorobutanol (chlorobutol)]

Generic: 10 units/mL (1 mL, 10 mL, 30 mL)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Generic: 10 units/mL (1 mL, 5 mL, 10 mL)

Administration: Adult

Induction or stimulation of labor: Administer as an IV infusion (drip method) by use of an infusion pump; accurate control of the rate of infusion flow is essential.

Incomplete or inevitable abortion: Administer by IV infusion

Postpartum uterine bleeding: Administer by IV or IM. IM administration may be used when IV access is not available (AWHONN 2015). IV push is not recommended; rapid IV bolus administration is associated with cardiovascular collapse (ACOG 183 2017; Vallera 2017). Slow IV injections (5 or 10 units over 1 minute) are preferred for women without cardiovascular risk factors; very slow injections (≥5 minutes) are preferred for women with cardiovascular risk factors (Sentilhes 2016).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.

NIOSH recommends double gloving, a protective gown, ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) when compounding. Double gloving and a gown are required during administration (NIOSH 2016). Premixed solutions may be excluded from some hazardous drug handling requirements. Assess risk to determine appropriate containment strategy (USP-NF 2017).

Use: Labeled Indications

Antepartum: Induction of labor in patients with a medical indication (eg, Rh problems, maternal diabetes, preeclampsia, at or near term); stimulation or reinforcement of labor (as in selected cases of uterine inertia); adjunctive therapy in management of incomplete or inevitable abortion

Postpartum: To produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication (IV formulation) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Sound-alike/look-alike issues:

Pitocin may be confused with PIT or Pitressin (names to describe vasopressin)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined:

Cardiovascular: Cardiac arrhythmia, hypertensive crisis, hypotension (Dyer 2011), subarachnoid hemorrhage, tachycardia (Dyer 2011), ventricular premature contractions

Endocrine & metabolic: Water intoxication (severe water intoxication with seizure and coma is associated with a slow oxytocin infusion over 24 hours)

Gastrointestinal: Nausea, vomiting

Genitourinary: Postpartum hemorrhage, uterine rupture

Hematologic & oncologic: Pelvic hematoma

Hypersensitivity: Anaphylaxis

Contraindications

Hypersensitivity to oxytocin or any component of the formulation; significant cephalopelvic disproportion; unfavorable fetal positions or presentations (such as transverse lies); fetal distress when delivery is not imminent; hypertonic or hyperactive uterus; contraindicated vaginal delivery (invasive cervical cancer, active genital herpes, prolapse of the cord, cord presentation, total placenta previa, or vasa previa); obstetrical emergencies where surgical intervention is favored; where adequate uterine activity fails to achieve satisfactory progress

Canadian labeling: Additional contraindications (not in US labeling): Severe toxemia; prematurity or unripe cervix; predisposition to uterine rupture (eg, grand multiparity, overdistention of the uterus, previous caesarian delivery, other surgery involving the uterus); prolonged use in uterine inertia; factors predisposing to thromboplastin or amniotic fluid embolism (eg, prolonged retention of dead fetus, placental abruption); serious medical or obstetric conditions and any condition in which fetal distress already occurs; inability of physician to be in attendance

Warnings/Precautions

Concerns related to adverse effects:

• Antidiuretic effect: May produce intrinsic antidiuretic effect (ie, water intoxication). Severe water intoxication with convulsions, coma, and death may occur, particularly with large doses (40 to 50 milliunits/minute) or when given as a slow infusion over 24 hours and if the patient is receiving fluids by mouth.

• Cardiovascular effects: Arrhythmias, hypotension, myocardial ischemia, peripheral vasodilation, and tachycardia have been reported following administration. The risk of adverse events is influenced by dose and route of administration and is increased in women with cardiovascular disease. Use with extreme caution in hemodynamically unstable patients (Dyer 2011).

• Maternal deaths: Maternal deaths caused by hypertensive episodes, subarachnoid hemorrhage, or rupture of the uterus and fetal deaths have occurred with oxytocic medications when used for induction of labor or for augmentation in the first and second stages of labor.

• Uterine effects: High doses or hypersensitivity to oxytocin may cause uterine hypertonicity, spasm, tetanic contraction, or rupture of the uterus.

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: To be used for medical rather than elective induction of labor. Oxytocin is used to initiate or improve uterine contractions in order to achieve a vaginal delivery; it should only be used when medically needed for fetal or maternal reasons. Medical indications for labor induction may include Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interest of mother or fetus, or premature rupture of membranes when delivery is indicated. Use is generally not recommended in the following conditions: Fetal distress, hydramnios, partial placenta previa, prematurity, borderline cephalopelvic disproportion, or conditions where there is a predisposition for uterine rupture (eg, previous major surgery on cervix or uterus, cesarean section, overdistention of the uterus, grand multiparity, past history of uterine sepsis or traumatic delivery).

• Appropriate use: Abortion: For the adjunctive management of abortion in the first trimester, curettage is generally considered primary therapy. Oxytocin infusion in second trimester abortion will often be effective; however, other therapy may be required.

• Trained personnel: IV preparations should be administered by adequately trained individuals familiar with its use and able to identify complications; continuous observation is necessary for all patients.

Metabolism/Transport Effects

None known.

Drug Interactions

Carboprost Tromethamine: May enhance the adverse/toxic effect of Oxytocic Agents. Specifically, oxytocic effects may be enhanced. Risk X: Avoid combination

Dinoprostone: May enhance the adverse/toxic effect of Oxytocin. Specifically, oxytocic effects may be enhanced. Management: Concomitant use of dinoprostone and oxytocin is not recommended. If used sequentially, monitor uterine activity closely. Administer oxytocin 30 minutes after removing dinoprostone vaginal insert and 6 to 12 hours after the application of dinoprostone gel. Risk D: Consider therapy modification

EPHEDrine (Nasal): Oxytocin may enhance the hypertensive effect of EPHEDrine (Nasal). Risk C: Monitor therapy

EPHEDrine (Systemic): Oxytocin may enhance the hypertensive effect of EPHEDrine (Systemic). Risk C: Monitor therapy

Gemeprost: May enhance the adverse/toxic effect of Oxytocin. Risk X: Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

MiSOPROStol: May enhance the adverse/toxic effect of Oxytocin. Specifically, oxytocic effects may be enhanced. Management: The manufacturer of misoprostol recommends avoiding concomitant use with oxytocin. Misoprostol may augment effects of oxytocin, particularly when given within 4 hours of oxytocin initiation. Risk D: Consider therapy modification

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Pregnancy Considerations

[US Boxed Warning]: To be used for medical rather than elective induction of labor.

Small amounts of exogenous oxytocin are expected to reach the fetal circulation. When used as indicated, teratogenic effects would not be expected. Nonteratogenic adverse reactions are reported in the neonate as well as the mother.

Breast-Feeding Considerations

Endogenous oxytocin mediates milk ejection. Administration of exogenous oxytocin may disrupt the initiation of breastfeeding (Buckley 2015).

Monitoring Parameters

Fluid intake and output during administration, uterine activity (tonus, amplitude, and frequency of contractions), maternal blood pressure; fetal heart rate in relation to uterine contractions.

Mechanism of Action

Oxytocin stimulates uterine contraction by activating G-protein-coupled receptors that trigger increases in intracellular calcium levels in uterine myofibrils. Oxytocin also increases local prostaglandin production, further stimulating uterine contraction.

Pharmacodynamics and Pharmacokinetics

Onset of action: Uterine contractions: IM: 3 to 5 minutes; IV: ~1 minute

Duration: IM: 2 to 3 hours; IV: 1 hour

Half-life elimination: 1 to 6 minutes; decreased in late pregnancy and during lactation

Excretion: Urine (small amount unchanged)

Pricing: US

Solution (Oxytocin Injection)

10 units/mL (per mL): $0.91 - $3.60

Solution (Pitocin Injection)

10 units/mL (per mL): $1.68

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Ao Sai Juo Xing (CN);
  • Cetocin (PH);
  • Decatocin (ID);
  • Evatocin (LK, PH);
  • Litocin (TW);
  • Matosin (ID);
  • NeOxyn (PH);
  • Ocin (BD);
  • Octocin (TH);
  • Ofost (CZ, RO);
  • Oksitocins (EE);
  • Oxitol (PY);
  • Oxitone (AE, CY, IL, IQ, IR, LB, LY, OM, PH, QA, SA, SY, YE);
  • Oxitopisa (CR, DO, GT, HN, NI, PA, SV);
  • Oxocin (TW);
  • Oxycinon (EG);
  • Oxyla (ID, MY);
  • Partocon INJ (FI);
  • Pitocin (BD, EC);
  • Pitocin INJ (IN);
  • Pitogin (ID);
  • Piton S INJ (AE, CY, IQ, IR, LB, LY, NL, OM, QA, SA, SY, YE);
  • Protocin (ID);
  • Santocyn (ID);
  • Solvoxine (PH);
  • Synthetic Oxytocin INJ (IN);
  • Syntocinon (BH, CL, CR, DK, DO, EG, GT, HN, HR, IS, JO, KW, LU, MT, NI, PA, PT, QA, SI, SV, TH, TR, VN);
  • Syntocinon INJ (AR, AT, AU, BE, BF, BJ, BR, CH, CI, ES, ET, FI, FR, GB, GH, GM, GN, HK, ID, IE, IT, KE, LR, MA, ML, MR, MU, MW, MX, MY, NE, NG, NL, NZ, PH, PK, PL, PY, SC, SD, SE, SG, SL, SN, TN, TZ, UG, UY, VE, ZA, ZM, ZW);
  • Syntocinon Spray (AT, CH, NO, PL, SE);
  • Tiacinon (ID);
  • Udoxan (MY);
  • Vitocin (LK);
  • Xitocin (CR, DO, GT, HN, MX, NI, PA, SV);
  • Xytocin (BD)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 40-NF 35). Rockville, MD: United States Pharmacopeia Convention; 2017:83-102.
  2. Adnan N, Conlan-Trant R, McCormick C, Boland F, Murphy DJ. Intramuscular versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery: randomised controlled trial. BMJ. 2018;362:k3546. doi: 10.1136/bmj.k3546. [PubMed 30181338]
  3. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins - Obstetrics. ACOG practice bulletin No.107: induction of labor. Obstet Gynecol. 2009;114(2, pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. [PubMed 19623003]
  4. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Obstetrics. Practice bulletin No. 183: postpartum hemorrhage. Obstet Gynecol. 2017;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. [PubMed 28937571]
  5. Buckley SJ. Executive summary of hormonal physiology of childbearing: evidence and implications for women, babies, and maternity care. J Perinat Educ. 2015;24(3):145-153. doi: 10.1891/1058-1243.24.3.145. [PubMed 26834435]
  6. Butwick AJ, Coleman L, Cohen SE, Riley ET, Carvalho B. Minimum effective bolus dose of oxytocin during elective Caesarean delivery. Br J Anaesth. 2010;104(3):338-343. doi: 10.1093/bja/aeq004. [PubMed 20150347]
  7. Carvalho JC, Balki M, Kingdom J, Windrim R. Oxytocin requirements at elective cesarean delivery: a dose-finding study. Obstet Gynecol. 2004;104(5, pt 1):1005-1010. doi: 10.1097/01.AOG.0000142709.04450.bd. [PubMed 15516392]
  8. Drummond S. Oxytocin use in labor: legal implications. J Perinat Neonatal Nurs. 2018;32(1):34-42. doi:10.1097/JPN.0000000000000300 [PubMed 29240650]
  9. Dyer RA, Butwick AJ, Carvalho B. Oxytocin for labour and caesarean delivery: implications for the anaesthesiologist. Curr Opin Anaesthesiol. 2011;24(3):255-261. doi: 10.1097/ACO.0b013e328345331c. [PubMed 21415725]
  10. Guidelines for oxytocin administration after birth: AWHONN practice brief number 2. J Obstet Gynecol Neonatal Nurs. 2015;44(1):161-163. doi: 10.1111/1552-6909.12528. [PubMed 25421530]
  11. Leduc D, Biringer A, Lee L, Dy J; Clinical Practice Obstetrics Committee; Special Contributors. Induction of labour. J Obstet Gynaecol Can. 2013;35(9):840-857. doi: 10.1016/S1701-2163(15)30842-2. [PubMed 24099451]
  12. Oxytocin injection [prescribing information]. Eatontown, NJ: West-Ward Pharmaceuticals; June 2011.
  13. Oxytocin injection [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada Inc; December 2018.
  14. Pitocin (oxytocin) [prescribing information]. Chestnut Ridge, NY: Par Pharmaceutical; November 2020.
  15. Rajan PV, Wing DA. Postpartum hemorrhage: evidence-based medical interventions for prevention and treatment. Clin Obstet Gynecol. 2010;53(1):165-181. doi: 10.1097/GRF.0b013e3181ce0965. [PubMed 20142654]
  16. Sentilhes L, Vayssière C, Deneux-Tharaux C, et al. Postpartum hemorrhage: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care (SFAR). Eur J Obstet Gynecol Reprod Biol. 2016;198:12-21. doi: 10.1016/j.ejogrb.2015.12.012. [PubMed 26773243]
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  19. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 5, 2016.
  20. Vallera C, Choi LO, Cha CM, Hong RW. Uterotonic medications: oxytocin, methylergonovine, carboprost, misoprostol. Anesthesiol Clin. 2017;35(2):207-219. doi: 10.1016/j.anclin.2017.01.007. [PubMed 28526143]
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  22. WHO recommendations for the prevention and treatment of postpartum haemorrhage. 2012. http://apps.who.int/iris/bitstream/handle/10665/75411/9789241548502_eng.pdf;jsessionid=04705030FD90293BA82A345466056577?sequence=1
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