DRUGS & SUPPLEMENTS

Oxytocin

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Oxytocin uses


DESCRIPTION

Oxytocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic Oxytocin, for intravenous infusion or intramuscular injection. Oxytocin 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, with the pH adjusted with acetic acid. Oxytocin 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. Oxytocin has the empirical formula C43H66N12O12S2 (molecular weight 1007.19). The structural formula is as follows:

Chemical Structure

CLINICAL PHARMACOLOGY

Uterine motility depends on the formation of the contractile protein actomyosin under the influence of the Ca2+-dependent phosphorylating enzyme myosin light-chain kinase. Oxytocin promotes contractions by increasing the intracellular Ca2+. 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.

Oxytocin is distributed throughout the extracellular 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.

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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, Oxytocin is not indicated for elective induction of labor.

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 vaginal delivery. It is indicated for 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

Antepartum use of Oxytocin 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.
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WARNINGS

Oxytocin, 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.

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. 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 hypersensitive 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.

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

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.

Labor and Delivery

See INDICATIONS AND USAGE section.

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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 Oxytocin.


For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical, Inc. at 1-800-828-9393 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

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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.

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 is the only acceptable method of parenteral administration of Oxytocin 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 Oxytocin infusion on a physiologic electrolyte solution, permitting the Oxytocin infusion to be stopped abruptly without interrupting the electrolyte infusion. This is done in the following way.

  • Preparation
    • The standard solution for infusion of Oxytocin is prepared by adding the contents of one 1-mL vial 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 Oxytocin.
    • 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 Oxytocin 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 Oxytocin. 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 Oxytocin 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. (One mL) Ten (10) units of Oxytocin can be given after the delivery of the placenta.

C. Treatment of Incomplete, Inevitable, or Elective Abortion

Intravenous infusion of 10 units of Oxytocin 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 Oxytocin 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.

HOW SUPPLIED

Oxytocin Synthetic is available as follows:

NDC 42023-116-25 Packages of twenty-five oversized 1-mL vials, each containing 10 units of Oxytocin.

NDC 42023-116-01 A 10 mL multiple-dose vial containing 10 units of Oxytocin per mL (total = 100 units of Oxytocin).

NDC 42023-116-02 Packages of twenty-five 10 mL multiple-dose vial, each containing 10 units of Oxytocin per mL (total = 100 units of Oxytocin per vial).

STORAGE

Store between 20° to 25°C (68° to 77°F).

REFERENCES

  • Seitchik J, Castillo M: Oxytocin augmentation of dysfunctional labor. I. Clinical data. Am J Obstet Gynecol 1982; 144:899–905.
  • Seitchik J, Castillo M: Oxytocin augmentation of dysfunctional labor. II. Multiparous patients. Am J Obstet Gynecol 1983; 145:777–780.
  • Fuchs A, Goeschen K, Husslein P, et al: Oxytocin and the initiation of human parturition. III. Plasma concentrations of Oxytocin and 13, 14-dihydro-15-keto-prostaglandin F2a in spontaneous and oxytocin-induced labor at term. Am J Obstet Gynecol 1983; 145:497–502.
  • Seitchik J, Amico J, et al: Oxytocin augmentation of dysfunctional labor. IV. Oxytocin pharmacokinetics. Am J Obstet Gynecol 1984; 150:225–228.
  • American College of Obstetricians and Gynecologists: ACOG Technical Bulletin Number 110-November 1987: Induction and augmentation of labor.

Rx only.

Manufactured by:

Par Pharmaceutical Companies, Inc.

Spring Valley, NY 10977

I01/15

OS116J-01-90-01

3000791F

NDC 42023-116-25

Oxytocin®

(Oxytocin Injection, USP)

Synthetic

10 Units/mL

IV Infusion or IM

1mL Single Dose Vial

NDC 42023-116-02

Oxytocin ®

(Oxytocin Injection, USP)

Synthetic

100 units/10 mL

(10 units/mL)

For Intravenous Infusion

or Intramuscular Injection

10 mL Multiple Dose Vial

Oxytocin pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Oxytocin available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Oxytocin destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Oxytocin Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Oxytocin pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."PITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "OXYTOCIN". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Oxytocin - DrugBank". http://www.drugbank.ca/drugs/DB0010... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Oxytocin?

Depending on the reaction of the Oxytocin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Oxytocin not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Oxytocin addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Oxytocin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Oxytocin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sDrugs.com website users shows the following figures about several people who felt the medicine Oxytocin is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Not expensive1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Oxytocin drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Oxytocin is mentioned below.
Visitors%
Once in a day1
100.0%

One visitor reported doses

What is the dose of Oxytocin drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 101-200mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
101-200mg1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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