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Oxytocin Injection, USP (synthetic) | Oxytocin [West-Ward Pharmaceutical Corp.] | BioPortfolio

13:22 EST 27th January 2019 | BioPortfolio
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FOR INTRAVENOUS INFUSION OR INTRAMUSCULAR USE

Rx only

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:

The pharmacologic and clinical properties of oxytocin are identical with those of naturally occurring oxytocin principle of the posterior lobe of pituitary. Oxytocin exerts a selective action on the smooth musculature of the uterus, particularly toward the end of pregnancy, during labor, and immediately following delivery. Oxytocin stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature.

When given in appropriate doses during pregnancy, oxytocin is capable of eliciting graded increases in uterine motility from a moderate increase in the rate and force of spontaneous motor activity to sustained titanic contraction. The sensitivity of the uterus to oxytocic activity increases progressively throughout pregnancy until term when it is maximal.

Oxytocin is distributed throughout the extracellular fluid. Small amounts of this drug probably reach the fetal circulation. Oxytocin has a plasma half-life of about 3 to 5 minutes. Following parenteral administration, uterine response occurs within 3 to 5 minutes and persists for 2 to 3 hours. Its rapid removal from plasma is accomplished largely by the kidney and the liver. Only small amounts oxytocin are excreted in the urine unchanged.

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.

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.

Oxytocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

Oxytocin is contraindicated in any of the following conditions:

significant cephalopelvic disproportion;

unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, e.g., 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;

hypertonic uterine patterns;

hypersensitivity to the drug.

Prolonged use in uterine inertia or severe toxemia is contraindicated.

Oxytocin should not be used in cases where vaginal delivery is not indicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.

Oxytocin, when given for induction or stimulation of labor, must be administered only by intravenous infusion (drip method) and with adequate medical supervision in a hospital.

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 abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia.

There are no animal or human studies on the carcinogenicity and mutagenicity of this drug, nor is there any information on its effect on fertility.

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. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated.

See “ ADVERSE REACTIONS ” in the fetus or infant.

See “ INDICATIONS AND USAGE ”

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxytocin is administered to a nursing woman.

The following adverse reactions have been reported in the mother:

Anaphylactic reaction                                Nausea

Postpartum hemorrhage                            Vomiting

Cardiac arrhythmia                                    Premature ventricular contractions

Fatal afibrinogenemia                                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, 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 motility)

    Bradycardia

    Premature ventricular contractions and other arrhythmias

    Permanent CNS or brain damage

    Fetal death

(Due to use of oxytocin in the mother)

    Low Apgar scores at five minutes

    Neonatal jaundice

    Neonatal retinal hemorrhage

Overdosage with oxytocin depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm HO or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, utero-placental hypoperfusion, and variable deceleration of fetal heart, fetal hypoxia, hypercapnia, or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of oxytocin, is a serious complication that may occur if large doses (40 to 50 milliunits/minute) are infused for long periods. Management consists of immediate discontinuation of oxytocin and symptomatic and supportive therapy.

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.

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.

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.

Oxytocin Injection, USP (synthetic), 10 USP units per mL is packaged in single or multiple dose vial and supplied as follows:

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.

 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

Manufactured by:by Gland Pharma LimitedHyderabad-India

Distributed by:

WEST-WARDPHARMACEUTCIALS Eatontown, NJ 07724 USA

Revised June 2011

462-604-00

NDC 0641-6114-01Oxytocin Injection, USP (synthetic)10 USP Units/mLFor IV Infusion or IM Use1 mL Single Dose Vial

NDC 0641-6115-01Oxytocin Injection, USP (synthetic)10 USP Units/mLFor IV Infusion or IM Use10 mL Multiple Dose Vial

Manufacturer

West-Ward Pharmaceutical Corp.

Active Ingredients

Source

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