OXYTOCIN 10 USP UNITS IN DEXTROSE 5%
Clinical safety rating
cautionComprehensive clinical and safety monograph for OXYTOCIN 10 USP UNITS IN DEXTROSE 5% (OXYTOCIN 10 USP UNITS IN DEXTROSE 5%).
Comprehensive clinical and safety monograph for OXYTOCIN 10 USP UNITS IN DEXTROSE 5% (OXYTOCIN 10 USP UNITS IN DEXTROSE 5%).
Induction of laborAugmentation of laborFacilitation of uterine contractions during the third stage of laborPostpartum hemorrhage (off-label)
Increases intracellular calcium in uterine myofibrils, stimulating contractions. Binds to oxytocin receptors in myometrium and mammary glands.
| Metabolism | Metabolized primarily by oxytocinase in the liver, kidney, and placenta. Also degraded by peptidases in the gastrointestinal tract when given orally (not clinically used). |
| Excretion | Renal: >99% as unchanged drug; <1% hepatic metabolism and biliary excretion. |
| Half-life | Terminal half-life: 1-6 minutes (IV); clinical effect ceases rapidly after infusion stops due to rapid clearance. |
| Protein binding | Low; approximately 30%, primarily bound to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg; reflects distribution primarily in extracellular fluid. |
| Bioavailability | IV: 100%; IM: approximately 80-85%. |
| Onset of Action | IV: 1 minute; IM: 3-5 minutes. |
| Duration of Action | IV: 30-60 minutes (after infusion end); IM: 2-3 hours. |
| Molecular Weight | 1007.2 Da (synthetic oxytocin nonapeptide) |
IV infusion: 0.5-2 mU/min, increased by 1-2 mU/min every 30-60 min until desired uterine activity, then reduce; max 20 mU/min.
| Dosage form | INJECTABLE |
| Renal impairment | No specific GFR-based dose adjustment for oxytocin. Use with caution in severe renal impairment due to fluid overload risk from dextrose 5%. |
| Liver impairment | No specific Child-Pugh-based adjustment. Use with caution in severe hepatic impairment. |
| Pediatric use | Not indicated in pediatric patients. Use in adolescents for labor induction similar to adult dosing. |
| Geriatric use | Not typically used in geriatric population. If used, start at low end of dosing range and monitor for fluid overload and cardiovascular effects. |
| 1st trimester | Oxytocin is a peptide hormone not known to cause fetal harm when used at therapeutic doses for induction or augmentation of labor. However, use in first trimester is rare and not indicated; available data do not suggest increased risk of major birth defects. |
| 2nd trimester | No known teratogenic effects at therapeutic doses. Use only when clearly indicated for labor management. |
| 3rd trimester | Oxytocin is used for induction or augmentation of labor. Continuous monitoring required due to risk of uterine hyperstimulation, fetal distress, and water intoxication. |
Clinical note
Comprehensive clinical and safety monograph for OXYTOCIN 10 USP UNITS IN DEXTROSE 5% (OXYTOCIN 10 USP UNITS IN DEXTROSE 5%).
| Placental transfer | Oxytocin crosses the placenta to a limited extent. Placental transfer is minimal at low infusion rates, but higher doses may lead to detectable fetal levels. Endogenous oxytocin is also produced by the fetus. |
| Breastfeeding | Oxytocin is naturally present in breast milk and is not considered harmful to the nursing infant. Exogenous oxytocin is rapidly degraded in the gastrointestinal tract if ingested. Use during breastfeeding is considered compatible. |
| Lactation Rating | L1 (Safe) |
| Teratogenic Risk | Oxytocin is not associated with structural teratogenicity. In the first trimester, no increased risk of congenital anomalies has been reported. In the second and third trimesters, exogenous oxytocin is used therapeutically for induction/augmentation of labor and may cause uterine hyperstimulation, leading to fetal distress, hypoxia, or preterm birth if not properly monitored. |
| Fetal Monitoring | Continuous fetal heart rate monitoring and maternal uterine activity monitoring are required. Assess maternal vital signs, fluid balance (risk of water intoxication), and signs of uterine hyperstimulation. Monitor for fetal bradycardia, late decelerations, or variable decelerations, and adjust infusion rate accordingly. |
| Fertility Effects | Oxytocin does not affect fertility. It is used therapeutically during labor and has no known impact on ovulation, implantation, or gamete transport. No endogenous hormonal disruption relevant to fertility. |
■ FDA Black Box Warning
Oxytocin should be administered only by intravenous infusion with careful monitoring. Severe adverse effects, including uterine rupture, water intoxication, and fetal distress, can occur. It is not intended for prolonged use.
| Serious Effects |
Hypersensitivity to oxytocin or any component of the formulationSignificant cephalopelvic disproportionFetal distress where delivery is not imminentUnfavorable fetal presentation (e.g., transverse lie)Uterine hyperactivity or hypertonic uterine contractions not due to laborProlapsed umbilical cordInability to achieve vaginal delivery (e.g., placenta previa, vasa previa)Severe toxemia (preeclampsia/eclampsia) where vaginal delivery is contraindicated
| Precautions | May cause uterine hyperstimulation leading to fetal distress, uterine rupture, or maternal death. Risk of water intoxication with high doses or prolonged infusion. Monitor maternal vital signs, uterine activity, and fetal heart rate continuously. |
| Food/Dietary | No known food interactions. Maintain adequate hydration as per clinical status. |
| Clinical Pearls | Administer as a continuous IV infusion with strict monitoring of uterine activity and fetal heart rate. Use an infusion pump to avoid bolus administration. Hypotension and tachycardia may occur with rapid infusion; slow rate if hyperstimulation occurs. Have magnesium sulfate available for tocolysis if needed. Do not use for elective induction before 39 weeks gestation. |
| Patient Advice | This medication is given to start or strengthen labor contractions. · You will be monitored closely for your baby's heart rate and your contractions. · Report any contractions that are too frequent or prolonged, or if you feel severe pain. · Tell your nurse immediately if you have difficulty breathing or signs of allergic reaction. |
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