اکسیتوسین
Oxytocin Injection (Pitocin)
اکسیتوسین

نام ژنریک

Oxytocin

شکل دارویی

اشكال دارويي:


Injection: 5 U/ml, 1ml, 10 U/ml

موارد مصرف

موارد و مقدار مصرف


الف)‌ القاي زايمان.


بزرگسالان: ابتدا mU/min1-5/0 انفوزيون وريدي مي‌ شود. سرعت انفوزيون را مي‌ توان به آهستگي افزايش داد (mU/min 2-1 هر 60-30 دقيقه تا پاسخ مناسب) با برقراري روند زايمان بايد سرعت انفوزيون كاهش يابد.


ب)‌ تسريع زايمان.


بزرگسالان: ابتدا mU/min 2 انفوزيون وريدي مي شود. سرعت انفوزيون را مي‌ توان به آهستگي تا حداكثر mU/min 20 افزايش داد.


پ) كاهش خونريزي بعد از زايمان پس از خروج جفت.


بزرگسالان: mU/min 40-20 بعد از خروج جفت انفوزيون وريدي مي‌ شود (مقدار كلي 10 ميليون واحد است). مي‌ توان دارو را به‌صورت عضلاني تزريق كرد .


ت) القاي سقط جنين.


بزرگسالان: 10 واحد در ml 500 دكستروز 5% و يا نرمال سالين مخلوط شود و با سرعت mU/min 100-10 تزريق وريدي گردد (بيش از 30 واحد در 12 ساعت مصرف نشود).


ث) آزمون اثر اكسي توسين (Oxytocin Challenge test) براي بررسي زجر جنيني بعد از هفته سي و يكم بارداري.


بزرگسالان: با افزودن 10-5 واحد اكسي توسين به يك ليتر دكستروز پنج درصد تزريقي محلول آماده مي‌ شود (كه حاوي mU/min 10-5 اكسي توسين است). مقدار mU/min 5/0 انفوزيون مي‌ شود و سپس، به تدريج هر 15 دقيقه بر اين مقدار افزوده مي‌ شود تا حداكثر به mU/min 20 برسد. بعد از سه انقباض متوسط رحمي در هر 10 دقيقه، بايد انفوزيون قطع شود. پاسخ ضربان قلب جنين مي‌ تواند پروگنوز وضعيت را مشخص نمايد.


مكانيسم اثر


اثر اكسي توسيك: اكسي توسين نفوذ پذيري سديم در رشته‌هاي عضلاني رحم را افزايش داده و به طور مستقيم انقباض عضلات صاف رحم را تحريك مي‌ كند. در صورت وجود غلظت زياد استروژن، آستانه تحريك كاهش مي‌ يابد. پاسخ رحم به اين دارو با افزايش طول مدت بارداري زياد مي‌ شود ‌و طي يك زايمان فعال باز هم بيشتر افزايش مي‌ يابد. پاسخ رحم به اين دارو شبيه به انقباضات رحم در زايمان است.

موارد منع مصرف

عوارض جانبي


براي مادر


اعصاب مركزي: خونريزي زير عنكبوتيه ناشي از زيادي فشار خون، ‌تشنجات يا اغما ناشي از مسموميت با آب.


قلبي ـ ‌عروقي: افزايش فشار خون، افزايش ضربان قلب، افزايش بازگشت سيستميك وريدي و برون ده قلبي، ‌آريتمي.


دستگاه گوارش: تهوع، استفراغ.


خون: فقدان فيبرينوژن خون كه ممكن است مربوط به افزايش خونريزي بعد از زايمان باشد.


ادراري- تناسلي : پارگي جفت، جريان مختل خون در رحم، ‌افزايش حركات رحمي، هماتوم لگن، ‌خونريزي پس از زايمان، انقباضات تتاني رحمي، ‌پارگي رحم.


ساير عوارض: حساسيت مفرط (آنافيلاكسي)، احتباس آب.


براي جنين


اعصاب مركزي:‌ صدمه مغزي جنين.


قلبي ـ ‌عروقي: براديكاردي، انقباضات نارس بطني، آريتمي.


چشم، گوش ،‌ حلق، بيني : خونريزي چشمي.


کبد: زردي.


تنفسي: آنوکسيا، آزفکسيا.


ساير عوارض: رتبه Apgar پايين.


مسموميت و درمان


تظاهرات باليني: تحريك بيش از حد رحم كه موجب انقباضات شبه كزاز، پارگي احتمالي رحم، پارگي دهانه گردن رحم، جدا شدن زودرس جفت، ‌ايجاد اشكال در جريان خون رحم، آمبولي مايع آمنيوتيك و آسيب جنين مي‌ شود.


درمان: اين دارو داراي نيمه عمر بسيار كوتاهي است . بنابراين، درمان با اين دارو بايد قطع شود و اقدامات حمايتي به عمل آيد.

موارد قابل توجه

-

مکانیزم اثر

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت مفرط به دارو، مواردي كه به دليل مضرات دارو براي مادر يا جنين ، ‌عمل جراحي ترجيح داده مي‌ شود، بروز الگوهاي همراه با زيادي فشار خون در زايمان، ‌در مواردي كه زايمان مهبلي منع شده است. توكسمي شديد، ‌رحم هيپرتونيك، وضعيت چرخيده جنين در رحم، نارس بودن جنين، ‌اورژانس‌هاي زنان زايمان خاص، ‌اختلالات سري ـ‌ لگني، ‌جفت سر راهي.


موارد احتياط: زماني كه مراحل اول و دوم زايمان بطور طبيعي طي گرديده؛ سابقه جراحي رحمي و سرويكس (از جمله سزارين)، سپسيس رحمي، زايمان تروماتيك، رحم بيش از حد منبسط، سرطان تهاجمي سرويكس، ‌چند زايي.


تداخل دارويي‌


مصرف همزمان با سمپاتومي متيك‌ها باعث افزايش اثر تنگ كنندگي عروقي اكسي توسين مي‌ شود، ‌ممكن است باعث افزايش فشار خون مادر پس از زايمان گردد.


مصرف اكسي توسين به هنگام بيهوشي با تيوپنتال ممكن است باعث تأخير در القاء بيهوشي شود . با احتياط مصرف شوند.


اثر بر آزمايشهاي تشخيصي : گزارش موجود نيست .

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: هورمون بيرون زاد.


طبقه‌بندي درماني: اكسي توسيك، محرك شيردهي.


طبقه‌بندي مصرف در بارداري: رده X


ملاحظات اختصاصي


اين دارو بايد انفوزيون وريدي شود. از تزريق وريدي آن به صورت حمله اي خودداري شود.


اكسي توسين بايد فقط از يك راه مصرف، تجويز شود.


هر 15 دقيقه يك بار انقباضات رحم، سرعت ضربان قلب، فشار خون، فشار داخل رحم، ‌تعداد ضربان قلب جنين و چگونگي از دست رفتن خون پيگيري و گزارش شوند.


در موارد استفاده از آزمون اثر اكسي توسين، ‌تعداد ضربان قلب جنين و انقباضات رحم بلافاصله قبل از انفوزيون و در طول آن پيگيري شود. اگر تعداد ضربان قلب جنين در طول آزمون تغيير نكند، آزمون يك هفته ديگر تكرار مي‌ شود. در صورت مشاهده كاهش ديررس تعداد ضربان قلب جنين، ‌مسئله پايان دادن به بارداري نيز بايد در نظر گرفته شود .


اين دارو ممكن است موجب بروز اثر آنتي ديورتيك شود، مقدار مصرف مايعات و دفع آنها پيگيري شود.


طي انفوزيون طولاني مدت اكسي توسين، بيمار بايد از نظر بروز علائم مسموميت با آب پيگيري شود.


براي شل كردن عضلات رحم، در صورت لزوم، بايد محلول 20 درصد سولفات منيزيم در دسترس باشد.


به طور معمول از راه تزريق عضلاني اين دارو توصيه نمي‌ شود، ‌ولي بعد از خروج جفت، براي كنترل خونريزي رحم بعد از زايمان، مي‌ توان مقدار 10 واحد از دارو را تزريق كرد.


محلول حاوي mU/ml 10 را مي‌ توان با اضافه كردن 10 واحد اكسي توسين به يك ليتر محلول كلرور سديم 9/0 درصد يا دكستروز پنج درصد تزريقي تهيه نمود. محلول حاوي mU/ml 20 را نيز مي‌ توان با اضافه كردن 10 واحد اكسي توسين به 500 ميلي ليتر محلول كلرور سديم 9/0 درصد يا دكستروز پنج درصد تزريقي تهيه كرد.


توصيه مي شود دارو براي موارد پزشكي و درماني و نه براي القاء سقط اختياري، استفاده گردد.


مصرف در شيردهي: مقادير كمي از اين دارو در شير ترشح مي‌ شود. خطرات اين داور براي شيرخوار بايد ارزيابي شود.

Oxytocin Injection (Pitocin)

Pitocin®
(oxytocin) Injection, USP, Synthetic

DRUG DESCRIPTION

Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin (oxytocin injection) 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. Pitocin (oxytocin injection) 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 (oxytocin injection) has the empirical formula C46H66N12O12S2, (molecular weight 1007.19). The structural formula is as follows:

Pitocin (oxytocin) structural formula illustration

What are the possible side effects of oxytocin (Pitocin, Syntocinon)?

Side effects with oxytocin are not common. Serious side effects include:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
  • difficulty urinating;
  • chest pain or irregular heart beat;
  • difficulty breathing;
  • confusion;
  • sudden weight gain or excessive swelling;
  • severe headache;
  • rash;
  • excessive vaginal bleeding; or
  • seizures.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you...

Read All Potential Side Effects and See Pictures of Pitocin »

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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 (oxytocin injection) is not indicated for elective induction of labor.

Antepartum: Pitocin (oxytocin injection) 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 (oxytocin injection) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

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.

Induction or Stimulation of Labor

Intravenous infusion (drip method) is the only acceptable method of parenteral administration of Pitocin (oxytocin injection) 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 (oxytocin injection) infusion on a physiologic electrolyte solution, permitting the Pitocin (oxytocin injection) infusion to be stopped abruptly without interrupting the electrolyte infusion. This is done in the following way.

Preparation

a. The standard solution for infusion of Pitocin (oxytocin injection) 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.

b. Establish the infusion with a separate bottle of physiologic electrolyte solution not containing Pitocin (oxytocin injection) .

c. Attach (piggyback) the Pitocin (oxytocin injection) 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 (oxytocin injection) 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

a. Electronically monitor the uterine activity and the fetal heart rate throughout the infusion of Pitocin (oxytocin injection) . 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).

b. Discontinue the infusion of Pitocin (oxytocin injection) 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.

Control of Postpartum Uterine Bleeding

  1. 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.
  2. Intramuscular administration, (One mL) Ten (10) units of Pitocin (oxytocin injection) can be given after the delivery of the placenta.

Treatment of Incomplete, Inevitable, or Elective Abortion

Intravenous infusion of 10 units of Pitocin (oxytocin injection) 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 (oxytocin injection) 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

Pitocin (Oxytocin Injection, USP) Synthetic is available as follows: NDC 60793-265-25 Packages of twentyfive oversized 1-mL Steri-Vials®, each containing 10 units of oxytocin. NDC 60793-267-01 A 10 mL multiple-dose Steri-ViaP containing 10 units of oxytocin per mL (total = 100 units of oxytocin).

Storage

Store at 15°-25°C (59°-77°F).

Prescribing Information as of March 2007. Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN 37620. FDA Rev date:7/27/2007

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following adverse reactions have been reported in the mother:

Anaphylactic reaction
Postpartum hemorrhage
Cardiac arrhythmia
Fatal afibrinogenemia
Hypertensive episodes
Nausea
Vomiting
Premature ventricular contractions
Pelvic hematoma
Subarachnoid hemorrhage
Hypertensive episodes
Rupture of the uterus

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:

Bradycardia
Premature ventricular contractions and other arrhythmias
Permanent CNS or brain damage
Fetal death
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
Neonatal retinal hemorrhage

Read the Pitocin (oxytocin injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction selected. Pevic adequacy must be considered and maternal and fetal conditions evaluated before use of the drug.

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.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Pitocin (oxytocin injection) , 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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

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.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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 H20 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.

CONTRAINDICATIONS

Antepartum use of Pitocin (oxytocin injection) is contraindicated in any of the following circumstances:

  1. Where there is significant cephalopelvic disproportion;
  2. In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery;
  3. In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention;
  4. In fetal distress where delivery is not imminent;
  5. Where adequate uterine activity fails to achieve satisfactory progress;
  6. Where the uterus is already hyperactive or hypertonic;
  7. 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;
  8. In patients with hypersensitivity to the drug.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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 (see PRECAUTIONS section).

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 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.

REFERENCES

1. Seitchik J, Castillo M: Oxytocin augmentation of dysfunctional labor. I. Clinical data. Am J Obstet Gynecol 1982; 144:899-905.

2. Seitchik J, Castillo M: Oxytocin augmentation of dysfunctional labor. II. Muciparous patients. Am J Obstet Gynecol 1983; 145:777-780.

3. Fuchs A, Goeschen K, Husslein R 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 oxytocininduced labor at term. Am J Obstet Gynecol 1983; 145:497-502.

4. Seitchik J, Amico J, et al: Oxytocin augmentation of dysfunctional labor. IV. Oxytocin pharmacokinetics. Am J Obstet Gynecol 1984; 150:225-228.

5. American College of Obstetricians and Gynecologists: ACOG Technical Bulletin Number 110-November 1987: Induction and augmentation of labor.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Pitocin®
(oxytocin) Injection, USP, Synthetic

DRUG DESCRIPTION

Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin (oxytocin injection) 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. Pitocin (oxytocin injection) 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 (oxytocin injection) has the empirical formula C46H66N12O12S2, (molecular weight 1007.19). The structural formula is as follows:

Pitocin (oxytocin) structural formula illustration

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Pitocin®
(oxytocin) Injection, USP, Synthetic

DRUG DESCRIPTION

Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin (oxytocin injection) 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. Pitocin (oxytocin injection) 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 (oxytocin injection) has the empirical formula C46H66N12O12S2, (molecular weight 1007.19). The structural formula is as follows:

Pitocin (oxytocin) structural formula illustration

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Pitocin®
(oxytocin) Injection, USP, Synthetic

DRUG DESCRIPTION

Pitocin (oxytocin injection, USP) is a sterile, clear, colorless aqueous solution of synthetic oxytocin, for intravenous infusion or intramuscular injection. Pitocin (oxytocin injection) 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. Pitocin (oxytocin injection) 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 (oxytocin injection) has the empirical formula C46H66N12O12S2, (molecular weight 1007.19). The structural formula is as follows:

Pitocin (oxytocin) structural formula illustration

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Pitocin Patient Information Including Side Effects

Brand Names: Pitocin, Syntocinon

Generic Name: oxytocin (Pronunciation: ox e TOW sin)

What is oxytocin (Pitocin)?

Oxytocin is a natural hormone that causes the uterus to contract.

Oxytocin is used to induce labor, strengthen labor contractions during childbirth, control bleeding after childbirth, or to induce an abortion.

Oxytocin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of oxytocin (Pitocin)?

Side effects with oxytocin are not common. Serious side effects include:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
  • difficulty urinating;
  • chest pain or irregular heart beat;
  • difficulty breathing;
  • confusion;
  • sudden weight gain or excessive swelling;
  • severe headache;
  • rash;
  • excessive vaginal bleeding; or
  • seizures.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

  • redness or irritation at the injection site;
  • loss of appetite; or
  • nausea or vomiting.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Pitocin (oxytocin injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about oxytocin (Pitocin)?

Oxytocin should be administered as an injection into a muscle or intravenously by a healthcare provider. It should be administered in a clinical setting where a healthcare provider can monitor uterine contractions and other vital signs (blood pressure, heart rates) and where an emergency situation can be handled properly.

Side Effects Centers

Pitocin Patient Information including How Should I Take

What should I discuss with my healthcare provider before using oxytocin (Pitocin)?

Do not take oxytocin without first talking to your doctor if you

  • have or have had cervical cancer;
  • have an allergy to oxytocin, other medications, dyes, foods, or preservatives;
  • have eclampsia;
  • have herpes;
  • have had more than 7 pregnancies;
  • are experiencing premature labor;
  • have had a caesarean section (C-section);
  • have had any surgery on the cervix or uterus;
  • have a prolapsed uterus; or
  • have a breech, placenta previa or any other issues with the fetus or umbilical cord.

You may not be able to use oxytocin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Tell your doctor about all prescription or over-the-counter medicines including vitamins, minerals, and herbal products that your are taking.

Tell your doctor if you drink alcohol or caffeine drinks regularly, if you are a smoker or if you use illegal drugs. These factors can affect the way oxytocin works in your body.

There are no known indications for the use of oxytocin in the first or second trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its properties, it would not be expected to present a risk of harm to the baby when used as indicated under the supervision of a trained healthcare professional. Ask your doctor to answer any questions you have about the use of oxytocin and your pregnancy.

How should I use oxytocin (Pitocin)?

Oxytocin should be administered as an injection into a muscle or intravenously by a healthcare provider. It should be administered in a clinical setting where a healthcare provider can monitor uterine contractions and other vital signs (blood pressure, heart rates) and where an emergency situation can be handled properly.

Your healthcare provider will store oxytocin as directed by the manufacturer.

Side Effects Centers

Pitocin Patient Information including If I Miss a Dose

What happens if I miss a dose (Pitocin)?

Since the medication will be administered by a healthcare provider, missing a dose should not occur.

What happens if I overdose (Pitocin)?

If an overdose of oxytocin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Oxytocin should be administered in a clinical setting where a healthcare provider can monitor uterine contractions and other vital signs (blood pressure, heart rates) and where an emergency situation can be handled immediately.

What should I avoid while using oxytocin (Pitocin)?

Tell your doctor if you drink alcohol or caffeine drinks regularly, if you are a smoker or if you use illegal drugs. These factors can affect the way oxytocin works in your body.

What other drugs will affect oxytocin (Pitocin)?

Other drugs can interact with oxytocin resulting in dangerous side effects and/or decreased effectiveness. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, without first talking to your doctor during treatment with oxytocin.

Where can I get more information?

Your pharmacist has additional information about oxytocin written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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