Drug Catalog - Product Detail
OXYTOCIN FOR INJECTION - SYNTHETIC INJECT. 10 UNITS/ML 25X1ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00641-6114-25 | HIKMA | 1 | 10UNIT/ML | SOLUTION |
PACKAGE FILES
Generic Name
OXYTOCIN
Substance Name
OXYTOCIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR
Application Number
NDA018243
Description
DESCRIPTION Each mL of Oxytocin Injection sterile solution contains an oxytocic activity equivalent to 10 USP Posterior Pituitary Units, Chlorobutanol (a chloroform derivative), 0.5%, as a preservative, and acetic acid to adjust pH (3.0 to 5.0). Oxytocin is intended for IM or IV use. Oxytocin is a synthetic polypeptide; it occurs as a white powder and is soluble in water. It may be designated chemically as: Structural formula
How Supplied
HOW SUPPLIED Oxytocin Injection, USP (synthetic), 10 USP units per mL is packaged in single or multiple dose vial and supplied as follows: NDC Vial Size Fill Volume Usage Package size 0641-6114-25 2 mL 1 mL Single Dose Vial 25 0641-6115-25 10 mL 10 mL Multiple Dose Vial 25 Store at 25°C (77°F); excursions permitted to 15–30°C (59-86°F) [See USP Controlled Room Temperature]. Do not freeze. Do not use if solution is discolored or contains a precipitate. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutcial Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.
Indications & Usage
INDICATIONS AND USAGE IMPORTANT NOTICE Oxytocin 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 is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve early vaginal delivery. 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, preeclampsia at or near term, when delivery is in the best interests 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 second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Postpartum Oxytocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
Dosage and Administration
DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dosage of oxytocin is determined by the uterine response. The following dosage information is based upon various regimens and indications in general use. A. 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 nonoxytocin-containing solution should be started. Physiologic electrolyte solution should be used except under unusual circumstances. To prepare the usual solution for infusion, 1-mL Oxytocin Injection, 10 USP Units/mL is combined aseptically with 1,000 mL of nonhydrating diluent (physiologic electrolyte solution). The combined solution, rotated in the infusion bottle to ensure thorough mixing, containing 10 mU/mL. Add the container with dilute oxytocic 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 to 2 mU/min. the dose may be gradually increased in increments of no more than 1 to 2 mU/min. 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 the 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 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent (physiologic electrolyte solution) and run a rate necessary to control uterine atony. Intramuscular Administration: 1 mL (10 units) of oxytocin can be given after the 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 oxytocin have been added should be infused at a rate of 20 to 40 drops per minutes.