Oxytocin 10 [USP'U]/mL
Oxytocin · INJECTION · West-Ward Pharmaceuticals Corp
Oxytocin is a injection containing oxytocin at 10 [USP'U]/mL, taken intramuscular. Manufactured by West-Ward Pharmaceuticals Corp.
Key Facts
- Brand Name
- Oxytocin
- Generic Name
- Oxytocin
- NDC Code (Product)
0143-9743- Manufacturer
- West-Ward Pharmaceuticals Corp
- Strength
- 10 [USP'U]/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA200219
- Drug Class
- Oxytocic [EPC]
- Marketing Start
- 02/13/2013
Recall History
Pharmedium Services, LLC
Subpotent Drug
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Central Admixture Pharmacy Services, Inc.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Pharmedium Services, LLC
Subpotent Drug
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
QuVa Pharma, Inc.
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Pharmedium Services, LLC
Subpotent Drug
Advanced Pharma Inc.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications. Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is…
Dosage & Administration
DOSAGE AND ADMINISTRATION Dosage of oxytocin is determined by uterine response. The following dosage information is based upon the various regimens and indications in general use. Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor. Accurate control of the rate of infusion flow is essential. An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane. An intravenous infusion of a non-oxytocin containing solution should be started. Physiologic electrolyte solutions should be used except under unusual circumstances. To prepare the usual solution for intravenous infusion–one mL (10 units) is combined aseptically with 1,000 mL of a non-hydrating diluent. The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytoc…
Warnings
WARNINGS Oxytocin injection (synthetic) when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.
Contraindications
CONTRAINDICATIONS Oxytocin injection (synthetic) is contraindicated in any of the following conditions: • Significant cephalopelvic disproportion; • Unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, i.e., transverse lies; • In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; • In cases of fetal distress where delivery is not imminent; • Prolonged use in uterine inertia or severe toxemia; • Hypertonic uterine patterns; • Patients with hypersensitivity to the drug; • Induction or augmentation of labor in those cases where vaginal delivery is contraindicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions have been reported in the mother: • Anaphylactic reaction • Postpartum hemorrhage • Cardiac arrhythmia • Fatal afibrinogenemia • Nausea • Vomiting • Premature ventricular contractions • Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus. The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred and is associated with a slow oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water intoxication has been reported. The following adverse reactions have been reported in the fetus or infant: Due to induced uterine mobility: • Bradycardia • Premature ventricular contractions and other arrhythmias • Permanent CNS or brain damage • Fetal death Due to use of oxytocin in the mother: • Neonatal retinal hemorrhage • Low Apgar scores at five minutes • Neonatal jaun…
Frequently Asked Questions
What is Oxytocin used for?
Oxytocin contains Oxytocin. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Oxytocin a controlled substance?
Oxytocin is not classified as a controlled substance by the DEA.
What is the generic name for Oxytocin?
The generic name for Oxytocin is Oxytocin. There are 2 other brand versions of Oxytocin.
What is the NDC code for Oxytocin 10 [USP'U]/mL?
The NDC (National Drug Code) for Oxytocin 10 [USP'U]/mL is 0143-9743, listed by West-Ward Pharmaceuticals Corp.