INDICATIONS AND USAGE
|Syntocinon® (oxytocin) injection is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risk 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.|
Syntocinon® (oxytocin) 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) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In the second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.
Syntocinon® (oxytocin) injection is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, wherever solution and container permit.
A. Induction of 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 oxytocin stimulation of the uterine musculature will soon wane.
- An intravenous infusion of non-oxytocin containing solution should be started. Physiologic electrolyte solution should be used except under unusual circumstances.
- To prepare the usual solution for infusion, the contents of one 1-mL ampul are combined aseptically with 1,000 mL of non-hydrating diluent. The combined solution, rotated in the infusion bottle to insure thorough mixing, contains 10 mU/mL. Add the container with dilute oxytocin solution to the system through use of a constant infusion pump or other such device, to control accurately the rate of infusion.
- The initial dose should be no more than 1-2 mU/minute. The dose may be gradually increased in increments of no more than 1-2 mU/minute, until a contraction pattern has been established which is similar to norma1 labor.
- The fetal heart rate, resting uterine tone, and the frequency, duration, and force of contractions should be monitored.
- The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and the fetus must be evaluated by the responsible physician.
B. Control of Postpartum Uterine Bleeding
- Intravenous Infusion (Drip Method): To control postpartum bleeding, 10-40 units of oxytocin may be added to 1,000 mL of a non-hydrating diluent and run at a rate necessary to control uterine atony.
- Intramuscular Administration: 1 mL (10 units) of oxytocin can be given after delivery of the placenta.
C. Treatment of Incomplete or Inevitable Abortion
Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of Syntocinon® (oxytocin) have been added should be infused at a rate of 20-40 drops/minute.
Syntocinon ® (oxytocin) injection, USP
Available as a 1 mL sterile ampul containing 10 USP or International Units of oxytocin. SandoPak® unit dose packages of 50 ampuls (NDC 0078-0060-04).
Store and dispense
Below 77ºF (25ºC); DO NOT FREEZE.
Sandoz Pharmaceuticals Corporation East Hanover, New Jersey 07936
REV: MAY 1996 30288904
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