NDC 0641-6115 Oxytocin

Oxytocin

NDC Product Code 0641-6115

NDC 0641-6115-25

Package Description: 25 VIAL in 1 CARTON > 10 mL in 1 VIAL (0641-6115-01)

NDC Product Information

Oxytocin with NDC 0641-6115 is a a human prescription drug product labeled by Hikma Pharmaceuticals Usa Inc.. The generic name of Oxytocin is oxytocin. The product's dosage form is injection and is administered via intramuscular; intravenous form.

Labeler Name: Hikma Pharmaceuticals Usa Inc.

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Oxytocin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OXYTOCIN 10 [USP'U]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • ACETIC ACID (UNII: Q40Q9N063P)
  • WATER (UNII: 059QF0KO0R)
  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • ACETIC ACID (UNII: Q40Q9N063P)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Increased Uterine Smooth Muscle Contraction or Tone - [PE] (Physiologic Effect)
  • Oxytocic - [EPC] (Established Pharmacologic Class)
  • Oxytocin - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hikma Pharmaceuticals Usa Inc.
Labeler Code: 0641
FDA Application Number: NDA018243 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 04-29-1980 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Oxytocin Injection

Oxytocin Injection is pronounced as (ox i toe' sin)

Why is oxytocin injection medication prescribed?
Oxytocin injection is used to begin or improve contractions during labor. Oxytocin also is used to reduce bleeding after childbirth. It also may be used along with other ...
[Read More]

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Oxytocin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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:

Clinical Pharmacology

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.

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.

Contraindications

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.

Warnings

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.

General

  • All patients receiving intravenous infusions of oxytocin must be under continuous observation by trained personnel with a thorough knowledge of the drug and are qualified to identify complications. A physician qualified to manage any complications should be immediately available.
  • When properly administered, oxytocin should stimulate uterine contractions similar 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.
  • Except in unusual circumstances, oxytocin should not be administered in the following conditions: prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus, including cesarean section, overdistention of the uterus, grand multiparity, or invasive cervical carcinoma. 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 only be made by carefully weighing the potential benefits which oxytocin can provide in a given case against the rare occurrence of hypertonicity or tetanic spasm with this drug.
  • Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths and permanent CNS or brain damage of the infant due to various causes have been reported to be 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.
  • Oxytocin should be considered for use only in patients who have been carefully selected. Pelvic adequacy must be considered and maternal and fetal conditions thoroughly evaluated before use of the drug.

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.

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.

Pregnancy Category C.

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.

Nonteratogenic Effects

See “ADVERSE REACTIONS” in the fetus or infant.

Labor And Delivery

See “INDICATIONS AND
USAGE”

Nursing Mothers

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.

Adverse Reactions

The following adverse reactions have been reported in the mother:Anaphylactic reaction                                NauseaPostpartum hemorrhage                            VomitingCardiac arrhythmia                                    Premature ventricular contractionsFatal afibrinogenemia                                Pelvic hematomaExcessive 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

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 H2O 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.

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.

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    25Store 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.

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