Oxytocin Injection 10I.U./1ML I.M./I.V. COMPOSITON: Each 1mL ampoule contains: Oxytocin................................................…10 I.U. INDICATIONS: 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 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, the first trimester, curettage is generally primary therapy. In second trimester abortion, Oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Oxytocin injection (synthetic) is indicated to produce uterine contractions during the third stage of labor and control postpartum bleeding hemorrhage. CONTRAINDICATIONS: Oxytocin is contraindicated in those patients with history of hypersensitivity to any of the components of the preparation. DOSAGE AND ADMINISTRATIONS: Dosage of Oxytocin us 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 only acceptable method of administration for the induction or stimulation of labor. Accurate control of the rate of infusion water. Flow is essential. A infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate-ae 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. And intravenous 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 non-hydrating diluent. The combined solution, rotated in the infusion bottle to ensure thorough mixing, contains 10 milliunits/mL. Add the container with dilute oxytocin solution to the system through the use of a constant infusion pump of other such device to control accurately the rate of infusion. The initial dose should be no more than 1 to 2 milliunits per mm. The dose may be gradually increased in increments of not more than 1 to 2 milliunits per mm, until a contraction pattern has been established which is similar to normal 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 fetus must be evaluated by responsible physician. CONTROL OF POSTPARTUM UTERINE BLEEDING: Intravenous infusion (Drip Method) to control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 ml of a non-hydrating diluents 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, or as prescribed by the physician. 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 oxytocin have been added should be infused at a rate of 20 to 40 drops/minute. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and contained permit. ADVERSE EFFECTS: 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 results 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 associated with an oxytocin infusion over a 24-hour period. Maternal death due to oxytocin induced water intoxication has been reported. DRUG INTERACTIONS: Severe hypertension has been reported when Oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify Oxytocin's cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with atrioventricular rhythms has also been noted when Oxytocin was used concomitantly with cyclopropane anesthesia. CAUTION: Foods, Drugs, Devices & Cosmetics Act prohibits dispensing without prescription.
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