Pitocin

Pregnancy Category: X

Lactation: May be distributed milk; commencement of nursing should be delayed for at least 1 day when discontinued; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Before you receive oxytocin, tell your doctor about all your medical conditions or allergies, and all the medicines you are using.

You should not receive this medicine if you have ever had an allergic reaction to oxytocin.

To make sure oxytocin is safe for you, tell your doctor if you have:

• genital herpes;

• diabetes;

• high blood pressure;

• a heart rhythm disorder;

• a history of cervical cancer;

• a history of severe infection in your uterus;

• a history of difficult labor because you have a small pelvis;

• if you have ever had surgery on your cervix or uterus (including a prior C-section);

• if your pregnancy is less than 37 weeks; or

• if you have had 5 or more pregnancies.

Also tell your doctor if you are breast-feeding a baby.

Oxytocin is injected into a vein through an IV. You will receive this injection in a hospital setting.

Your contractions and other vital signs will be watched closely while you are receiving oxytocin. This will help your doctor determine how long to treat you with this medication.

During labor, your baby's heart rate will also be watched with a fetal heart monitor to evaluate any effects of oxytocin on the baby.

General

• Discontinue if prolonged uterine contractions (>90 seconds) or rising intrauterine pressure occur or if uterine motility interferes with fetal heart rate.

• Administer oxygen to the mother.a

• Lateral position preferred for the mother; take other appropriate measures as necessary.a

Administration

Administer by continuous or pulsatile IV infusion using a controlled-infusion device.a c

IM administration to augment or induce labor not recommended because effects it produces are unpredictable and difficult to control.a

Administered IM to reduce postpartum uterine bleeding.

Do not give simultaneously by more than one route of administration.a

IV Administration

Limit administration to trained personnel familiar with oxytocin’s effects.b

For IV infusion, must be diluted preferably in physiologic electrolyte solution (0.9% sodium chloride, lactated Ringer’s, or 5% dextrose injection, except under unusual circumstances).a

For induction or augmentation of labor: Add 10 units (1 mL) to 1 L of appropriate infusion solution for 10 milliunits/mL.a c

For production of intense uterine contractions; to reduce postpartum bleeding; or as an adjunct to prostaglandin or hypertonic abortifacients: add 10 units (1 mL) to 500 mL of appropriate IV solution for 20 milliunits/mL.a

For evaluation of fetal respiratory capability (oxytocin challenge test)†, add 5–10 units (0.5–1 mL) to 1 L of 5% dextrose injection for 5–10 milliunits/mL.a

Determined by uterine response.a

Continuous IV infusion, labor induction: Usually, initiate at 0.5–1 milliunit/minute for low-dose regimens or 6 milliunits/minute for high-dose regimens.a c

Pulsatile IV infusion, labor induction: Controlled-device pulse doses infused over 5–10-seconds at 5- to 8-minute intervals but no sooner than 30 seconds after contraction reaches baseline.d e

Continuous infusion, more intense uterine contractions: 10–100 millunits/minute, depending on use.a

Dosage

Adults

Dosage is determined by uterine response.a b c

Low-dose or high-dose regimens employed, depending on clinician preference.a c

Maximum dosage not established; titrate according to response and tolerance.c

Monitor fetal heart rate and uterine contractions.c

Low-dose regimens and less frequent dose increases associated with decreased uterine hyperstimulation.c

High-dose regimens and more frequent dose increases associated with shorter labor, and less frequent cases of chorioamnionitis and cesarean delivery for dystocia but increased uterine hyperstimulation.c

Low-dose: Usually, initiate at 0.5–1 milliunit/minute.a c

Generally, increase in low-dose regimen by 1- to 2-milliunits/minute at 30- to 60-minute intervals until a response is observed.a c

Low-dose: Alternatively, initiate at 1–2 milliunits/minute.b

Generally, increase in alternative low-dose regimen by 2 millunits/minute at 15-minute intervals.c

High-dose: Usually, initiate at about 6 milliunits/minute.c

Generally, increase in high-dose regimen by about 6 milliunits at 15-minute intervals.c

High-dose: Alternatively, initiate at 6 milliunits/minute.c

Generally, increase in alternative high-dose regimen by 6, 3, or 1 millunits/minute at 20- to 40-minute intervals.c If uterine hyperstimulation develops, do not exceed 3-milliunit/minute increases.c If hyperstimulation recurs, do not exceed 1-millunit/minute increases.c

May reduce infusion rate by similar amounts when the desired frequency of contractions is established (a uterine pattern comparable to spontaneous labor), without evidence of fetal distress, and labor has progressed to 5–6 cm dilation.a

At term, employ higher rates of infusion with caution; rates >9–10 milliunits/minute rarely are required.

Before term, higher infusion rates may be necessary since uterine sensitivity to oxytocin is reduced secondary to decreased oxytocin receptors.a

Infused via controlled-infusion device as periodic rapid pulse doses.c d

Pulsatile dosing may better simulate spontaneous labor.b c d

Pulsatile dosing may reduce the total dose needed.b c d

Initiate at 1 milliunit/pulse (over 10 seconds) every 8 minutes for 3 doses per cycle, doubling the cycle dose as needed at 24-minute intervals (i.e., after each 3-dose cycle) until 32-milliunit pulse is achieved; thereafter, increase in 8-milliunit increments per cycle until adequate uterine activity is achieved.e

Alternatively, a computer-controlled, feedback-loop dosing is used where doses range from 0.67–20 milliunits/pulse (over 5 seconds), repeated no more frequently than every 5 minutes and no sooner than 30 seconds aftera contraction reached baseline.e

Initiate the alternative regimen at 0.67 millunits/pulse (over 5 seconds) every 5 minutes for 40 minutes; if inadequate labor, increase to 2 millunits/pulse every 5 minutes for 40 minutes.e Subsequent increase by 1-milliunit/pulse no more frequently than after each 40-minute cycle.e This regimen includes a computerized feedback loop measuring intrauterine waveform pressures to determine the timing of repeated doses.e

Generally initiated after placental delivery and absence of additional fetuses is established.a

Infuse total of 10 units at 20–40 milliunits/minute; adjust rate to maintain uterine contraction and control uterine atony.a

10 units.

Infuse at 10–100 milliunits/minute.a

Maximum 30-unit cumulative dose within 12-hours because of water intoxication risk.a

Initially, infuse at 0.5 milliunits/minute.a

May gradually increase at 15- to 30-minute intervals to a maximum of 20 milliunits/minute.a

Monitor fetal heart rate and uterine contractions immediately before and during oxytocin infusion.a

Discontinue infusion and compare baseline and oxytocin-induced fetal heart rates when 3 moderate uterine contractions occur within a 10-minute interval.a

Repeat in 1 week if no change in fetal heart rate occurs (negative response).a

Termination of pregnancy may be indicated if late deceleration of fetal heart rate occurs.a

Prescribing Limits

Adults

No maximum dosage established.b

Total of 10 units.a

Usually, a total of 10 units.

Maximum 30 units cumulative dose in 12-hours.a

Maximum of 20 milliunits/minute.a

Oxytocin is a hormone used to help start or continue labor and to control bleeding after delivery. It is also sometimes used to help milk secretion in breast-feeding.

Oxytocin may also be used for other conditions as determined by your doctor.

In general, oxytocin should not be used to start labor unless there are specific medical reasons. Be sure you have discussed this with your doctor before receiving this medicine.

This medicine is available only with your doctor's prescription.

Novartis Pharmaceuticals removed Syntocinon® nasal spray from the market in March 1995.

• It is used to start labor.
• It is used to stop or treat bleeding that happens after a birth or an abortion.
• It is used to end a pregnancy.
• It may be given to you for other reasons. Talk with the doctor.

Use Pitocin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• It is given as an infusion into a vein over a period of time.

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.

NDC 42023-116-25

Pitocin®
(Oxytocin Injection, USP)
Synthetic
10 Units/mL

IV Infusion or IM
1mL Single Dose Vial