Endo and Premier, Inc. Collaborate to Address Pitocin® (oxytocin injection, USP) Shortage
Strategic effort aims to bring stable, quality supply to providers and enhanced pricing predictability for critical labor and delivery drug
Pitocin® is used to induce labor in pregnant women. The product is on the
"We're pleased to offer Pitocin® injection through the robust and highly reliable ProvideGx® and PremierProRx® supply channels," said
"This initiative with Endo is yet another step forward to help eliminate drug shortages for our healthcare provider members, create increased market competition and promote more predictable, long-term prices," said
Guided by health systems with more than 1,600 hospitals across the nation,
With a stable supply of Pitocin®,
IMPORTANT SAFETY INFORMATION
Antepartum use of Pitocin is contraindicated in any of the following circumstances:
- Where there is significant cephalopelvic disproportion;
- In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery;
- In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;
- In fetal distress where delivery is not imminent;
- Where adequate uterine activity fails to achieve satisfactory progress;
- Where the uterus is already hyperactive or hypertonic;
- In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord;
- In patients with hypersensitivity to the drug.
Pitocin, when given for induction of labor or augmentation of uterine activity, should be administered only by the intravenous route and with adequate medical supervision in a hospital.
- All patients receiving intravenous oxytocin must be under continuous observation by trained personnel
whohave a thorough knowledge of the drug and are qualified to identify complications. Electronic fetal monitoring provides the best means for early detection of overdosage.
- When properly administered, oxytocin should stimulate uterine contractions comparable to those seen in normal labor. Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. This fact must be considered by the physician in exercising his judgment regarding patient selection.
- Oxytocin should not be administered in the following conditions: fetal distress, hydramnios, partial placenta previa, prematurity, borderline cephalopelvic disproportion, and any condition in which there is a predisposition for uterine rupture, such as previous major surgery on the cervix or uterus including cesarean section, overdistention of the uterus, grand multiparity, or past history of uterine sepsis or of traumatic delivery. The decision can be made only by carefully weighing the potential benefits which oxytocin can provide in a given case against rare but definite potential for the drug to produce hypertonicity or tetanic spasm.
- Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have been reported associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor.
- Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth.
- When oxytocin is used for induction or reinforcement of already existent labor, patients should be carefully selected. Pelvic adequacy must be considered and maternal and fetal conditions evaluated before use of the drug.
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, subarachnoid hemorrhage, hypertensive episodes, and rupture of the uterus.
The following adverse reactions have been reported in the fetus or neonate:
Due to induced uterine motility: Bradycardia, premature ventricular contractions and other arrhythmias, permanent CNS or brain damage, fetal death, and neonatal seizures have been reported with the use of Pitocin.
Due to use of oxytocin in the mother: Low Apgar scores at five minutes, neonatal jaundice, and neonatal retinal hemorrhage.
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.
INDICATIONS AND USAGE
Antepartum: Pitocin 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 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: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
Please click for full Prescribing Information.
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Endo International plc, Linda Huss, Huss.Linda@endo.com; Premier, Inc., Amanda Forster, Public_Relations@premierinc.com