Oxytocin

Indications

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, USP (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 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; stimulation or reinforcement of labor, as in selected cases of uterine inertia.

Dosage and administration (summary)

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.

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.

Warnings and precautions

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.

Pregnancy

Pregnancy Category C There are no known indications for use of oxytocin in the first and second trimester of pregnancy other than in relation to spontaneous or induced abortion.

Storage and supply

HOW SUPPLIED Oxytocin Injection, USP (synthetic) is supplied as follows: NDC 0143-9743-25 Package of 25. 1 mL fill in a 2 mL vial, 10 USP Units per mL. NDC 0143-9742-25 Package of 25. 10 mL fill in a 10 mL vial, 10 USP Units per mL. Discard unused portion. Use only if solution is clear and seal is intact. Store at 20º to 25ºC (68º to 77ºF) .

Source: Oxytocin (Oxytocin) — US FDA prescribing information, 2018-12-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.