Oxytocin Injection 10U/mL SDV 1 mL 25/Pack (RX)

Oxytocin is a synthetic form of the naturally occurring hormone oxytocin, manufactured for use in medicine, particularly in obstetrics (childbirth and postpartum care). It is on the WHO’s List of Essential Medicines.

Uses

Primary Medical Uses

1. Induction of Labor: To initiate or augment (increase the strength/frequency of) uterine contractions during childbirth.

2. Stimulation of Labor: To strengthen weak or irregular contractions, facilitating vaginal delivery.

3. Control of Postpartum Hemorrhage: To prevent or treat excessive bleeding after childbirth by contracting the uterus.

4. Management of Incomplete or Inevitable Abortion: To facilitate uterine evacuation by inducing contractions.

Features

• Concentration: 10 Units (U) per mL
• Formulation: Injectable solution
• Packaging: 1 mL per Single-Dose Vial (SDV); 25 vials per pack
• Presentation: Clear, sterile, ready-to-use injection
• Manufacturer: Fresenius Kabi, a reputable global pharmaceutical company

Benefits

• Highly effective for inducing and augmenting labor.
• Essential for preventing and managing postpartum hemorrhage (PPH), a leading cause of maternal mortality.
• Predictable onset and dose control via intravenous (IV) or intramuscular (IM) administration.
• Single-dose vials reduce contamination risk.
• Easy storage and handling for hospitals and clinics.

Directions for Use

Must be used by a trained healthcare professional.

Administration

• Route: Intravenous infusion or intramuscular injection.
• Dilution: For IV, oxytocin is diluted in an IV solution (e.g., saline or dextrose).
• Dosage: Varies depending on indication, maternal response, and institutional protocol.
• Common Regimens:
  • Labor induction/augmentation: Usually begins with 0.5 to 1 milliunit/min IV infusion, gradually increased.
  • Postpartum hemorrhage: 10 units IM immediately after delivery or 10-40 units diluted in IV fluid, infused at a controlled rate.

Note:

Never self-administer. Only to be used under direct medical supervision.

Possible Side Effects

Common Side Effects

• Nausea, vomiting
• Increased uterine contractions/cramps

Serious Side Effects / Risks

• Uterine hyperstimulation (overly frequent/intense contractions; can distress the fetus)
• Uterine rupture (especially in women with prior uterine surgery)
• Water intoxication/hyponatremia (with prolonged high dose due to antidiuretic effect)
• Hypotension (low blood pressure)
• Cardiac arrhythmia
• Allergic reactions (rare)

Neonatal Risks

• Fetal distress, asphyxia, or trauma due to intense contractions or reduced uterine blood flow.

Warnings and Precautions

• Monitor closely: Continuous monitoring of fetal heart rate and uterine contractions is required during administration.
• Contraindicated:
  • Significant cephalopelvic disproportion
  • Unfavorable fetal positions preventing vaginal delivery
  • Hyperactive/hypertonic uterus
  • Previous uterine surgery (relative)
• Avoid rapid IV bolus: Can cause hypotension and cardiovascular collapse.
• Avoid excessive doses: Risk of uterine rupture and water intoxication.
• Known hypersensitivity: Contraindicated in patients allergic to oxytocin or any component.

Storage Instructions

• Store at controlled room temperature (usually 15°C to 30°C/59°F to 86°F).
• Protect from light.
• Do not use if solution is discolored or contains particulate matter.
• Single-use only. Discard any unused solution after opening.

Oxytocin Injection 10U/mL SDV 1 mL by Fresenius Kabi is a sterile, single-dose injectable medication primarily used for the induction and augmentation of labor, as well as the prevention and management of postpartum hemorrhage. Packaged in single-dose vials to minimize contamination risk, this pharmaceutical is an essential tool in modern obstetrics, ensuring safe and controlled uterine contractions.