Pitocin

Oxytocin


Par Pharmaceutical, Inc.
Human Prescription Drug
NDC 42023-130
Pitocin also known as Oxytocin is a human prescription drug labeled by 'Par Pharmaceutical, Inc.'. National Drug Code (NDC) number for Pitocin is 42023-130. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Pitocin drug includes Oxytocin - 10 [iU]/mL . The currest status of Pitocin drug is Active.

Drug Information:

Drug NDC: 42023-130
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Pitocin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Oxytocin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Par Pharmaceutical, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:OXYTOCIN - 10 [iU]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 May, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA018261
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Par Pharmaceutical, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:207315
238013
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000009705
N0000175828
M0015703
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:1JQS135EYN
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Oxytocic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Uterine Smooth Muscle Contraction or Tone [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Oxytocin [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Increased Uterine Smooth Muscle Contraction or Tone [PE]
Oxytocic [EPC]
Oxytocin [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
42023-130-066 VIAL in 1 CARTON (42023-130-06) / 50 mL in 1 VIAL01 May, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Pitocin oxytocin oxytocin oxytocin chlorobutanol acetic acid

Drug Interactions:

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

Boxed Warning:

Important notice elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. since the available data are inadequate to evaluate the benefits-to-risks considerations, pitocin is not indicated for elective induction of labor.

Indications and Usage:

Indications and usage important notice elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. since the available data are inadequate to evaluate the benefits-to-risks considerations, pitocin is not indicated for elective induction of labor. 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 in
evitable 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.

Warnings:

Warnings 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.

General Precautions:

General all patients receiving intravenous oxytocin must be under continuous observation by trained personnel who have a thorough knowledge of the drug and are qualified to identify complications. a physician qualified to manage any complications should be immediately available. electronic fetal monitoring provides the best means for early detection of overdosage (see overdosage section). however, it must be borne in mind that only intrauterine pressure recording can accurately measure the intrauterine pressure during contractions. a fetal scalp electrode provides a more dependable recording of the fetal heart rate than any external monitoring system. 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 hyp
ersensitive to oxytocin. this fact must be considered by the physician in exercising his judgment regarding patient selection. except in unusual circumstances, 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. because of the variability of the combinations of factors which may be present in the conditions listed above, the definition of "unusual circumstances" must be left to the judgment of the physician. 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.

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. the dosage of oxytocin is determined by the uterine response and must therefore be individualized and initiated at a very low level. 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 parenteral administration of pitocin for the induction or stimulation of labor. accurate control of the rate of infusion is essential and is best accomplished by an infusion pump. it is convenient to piggyback the pitocin infusion on a physiologic electrolyte solution, permitting the pitocin infusion to be stopped abruptly without interrupting the electrolyte infusion. this is done in the following way. preparation the standard solution for infusion of pitocin is prepared by a
dding 1 ml (containing 10 units of oxytocin) to 1000 ml of 0.9% aqueous sodium chloride or ringer's lactate. the combined solution containing 10 milliunits (mu) of oxytocin/ml is rotated in the infusion bottle for thorough mixing. establish the infusion with a separate bottle of physiologic electrolyte solution not containing pitocin. attach (piggyback) the pitocin-containing bottle with the infusion pump to the infusion line as close to the infusion site as possible. administration the initial dose should be 0.5–1 mu/min (equal to 3–6 ml of the dilute oxytocin solution per hour). at 30–60 minute intervals the dose should be gradually increased in increments of 1–2 mu/min until the desired contraction pattern has been established. once the desired frequency of contractions has been reached and labor has progressed to 5–6 cm dilation, the dose may be reduced by similar increments. studies of the concentrations of oxytocin in the maternal plasma during pitocin infusion have shown that infusion rates up to 6 mu/min give the same oxytocin levels that are found in spontaneous labor. at term, higher infusion rates should be given with great care, and rates exceeding 9–10 mu/min are rarely required. before term, when the sensitivity of the uterus is lower because of a lower concentration of oxytocin receptors, a higher infusion rate may be required. monitoring electronically monitor the uterine activity and the fetal heart rate throughout the infusion of pitocin. attention should be given to tonus, amplitude and frequency of contractions, and to the fetal heart rate in relation to uterine contractions. if uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane (see precautions section). discontinue the infusion of pitocin immediately in the event of uterine hyperactivity and/or fetal distress. administer oxygen to the mother, who preferably should be put in a lateral position. the condition of mother and fetus should immediately be evaluated by the responsible physician and appropriate steps taken. b. control of postpartum uterine bleeding intravenous infusion (drip method). if the patient has an intravenous infusion running, 10 to 40 units of oxytocin may be added to the bottle, depending on the amount of electrolyte or dextrose solution remaining (maximum 40 units to 1000 ml). adjust the infusion rate to sustain uterine contraction and control uterine atony. intramuscular administration. 1 ml (10 units) of pitocin can be given after the delivery of the placenta. c. treatment of incomplete, inevitable, or elective abortion intravenous infusion of 10 units of pitocin added to 500 ml of a physiologic saline solution or 5% dextrose-in-water solution may help the uterus contract after a suction or sharp curettage for an incomplete, inevitable, or elective abortion. subsequent to intra-amniotic injection of hypertonic saline, prostaglandins, urea, etc., for midtrimester elective abortion, the injection-to-abortion time may be shortened by infusion of pitocin at the rate of 10 to 20 milliunits (20 to 40 drops) per minute. the total dose should not exceed 30 units in a 12-hour period due to the risk of water intoxication. directions for dispensing pharmacy bulk package – not for direct infusion: the pharmacy bulk package is for use in a pharmacy admixture service only in a suitable work area, such as a laminar flow hood. the closure should be penetrated only once utilizing an appropriate sterile transfer device, which allows measured distribution of the contents. the transfer device should be inserted into the pharmacy bulk package using aseptic technique. contents should be used as soon as possible following initial closure puncture. discard any unused portion within 24 hours of first entry. following closure puncture, container should be maintained under labeled storage conditions between 20° to 25°c (68° to 77°f) under a laminar flow hood until contents are dispensed.

Contraindications:

Contraindications 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.

Adverse Reactions:

Adverse reactions the following adverse reactions have been reported in the mother: anaphylactic reaction premature ventricular contractions postpartum hemorrhage pelvic hematoma cardiac arrhythmia subarachnoid hemorrhage fatal afibrinogenemia hypertensive episodes nausea rupture of the uterus vomiting 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 neonate: due to induced uterine motility: due to use of oxytocin in the mother: bradycardia low apgar scores at five minutes premature ventricular contractions and other
arrhythmias neonatal jaundice permanent cns or brain damage neonatal retinal hemorrhage fetal death neonatal seizures have been reported with the use of pitocin. for medical advice about adverse reactions contact your medical professional. to report suspected adverse reactions, contact par pharmaceutical at 1-800-828-9393 or fda at 1-800-fda-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Adverse Reactions Table:

Anaphylactic reactionPremature ventricular contractions
Postpartum hemorrhage Pelvic hematoma
Cardiac arrhythmia Subarachnoid hemorrhage
Fatal afibrinogenemia Hypertensive episodes
NauseaRupture of the uterus
Vomiting

Due to induced uterine motility: Due to use of oxytocin in the mother:
Bradycardia Low Apgar scores at five minutes
Premature ventricular contractions and other arrhythmias Neonatal jaundice
Permanent CNS or brain damage Neonatal retinal hemorrhage
Fetal death
Neonatal seizures have been reported with the use of Pitocin.

Drug Interactions:

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

Use in Pregnancy:

Pregnancy teratogenic effects animal reproduction studies have not been conducted with oxytocin. there are no known indications for use in the first 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. nonteratogenic effects see adverse reactions in the fetus or neonate.

Overdosage:

Overdosage 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 mmhg or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, uteroplacental hypoperfusion, and variable deceleration of fetal heart, fetal hypoxia, hypercapnia, perinatal hepatic necrosis 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.

Description:

Description pitocin (oxytocin injection, usp) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. pitocin is a nonapeptide found in pituitary extracts from mammals. it is standardized to contain 10 units of oxytocic hormone/ml and contains 0.5% chlorobutanol, a chloroform derivative as a preservative, 1.65 mg acetic acid and 0.16 mg ammonium acetate as buffers, and with the ph adjusted with acetic acid to achieve a targeted ph of 3.5. pitocin may contain up to 16% of total impurities. the hormone is prepared synthetically to avoid possible contamination with vasopressin (adh) and other small polypeptides with biologic activity. pitocin has the empirical formula c 43 h 66 n 12 o 12 s 2 (molecular weight 1007.19). the structural formula is as follows: chemical structure

Clinical Pharmacology:

Clinical pharmacology uterine motility depends on the formation of the contractile protein actomyosin under the influence of the ca 2+- dependent phosphorylating enzyme myosin light-chain kinase. oxytocin promotes contractions by increasing the intracellular ca 2+ . oxytocin has specific receptors in the myometrium and the receptor concentration increases greatly during pregnancy, reaching a maximum in early labor at term. the response to a given dose of oxytocin is very individualized and depends on the sensitivity of the uterus, which is determined by the oxytocin receptor concentration. however, the physician should be aware of the fact that oxytocin even in its pure form has inherent pressor and antidiuretic properties which may become manifest when large doses are administered. these properties are thought to be due to the fact that oxytocin and vasopressin differ in regard to only two of the eight amino acids (see precautions section). oxytocin is distributed throughout the extra
cellular fluid. small amounts of the drug probably reach the fetal circulation. oxytocin has a plasma half-life of about 1 to 6 minutes which is decreased in late pregnancy and during lactation. following intravenous administration of oxytocin, uterine response occurs almost immediately and subsides within 1 hour. following intramuscular injection of the drug, 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 are excreted in urine unchanged.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility 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.

How Supplied:

How supplied pitocin (oxytocin injection, usp) synthetic is available as follows: ndc 42023-130-06 packages of six 50 ml pharmacy bulk packages, each containing 10 units of oxytocin per ml (total = 500 units of oxytocin per vial). storage store between 20° to 25°c (68° to 77°f). see usp controlled room temperature.

Package Label Principal Display Panel:

Principal display panel - 50 ml vial label ndc42023- 130 -06 pitocin ® (oxytocin injection, usp) synthetic 500 units/50 ml (10 units/ml) pharmacy bulk package - not for direct infusion for intravenous infusion or intramuscular injection 50 ml vial image 1 50 ml pharmacy bulk pack vial label


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