Adult Dosing

Induction or stimulation of labor (Drip Method)

• 0.5 to 1 mU/min IV; adjust by no more than 1-2 mU/min IV at 30-60 minutes intervals until contraction pattern similar to normal labor is obtained
• The dose may be reduced by similar increments once the desired frequency of contractions has been reached

Postpartum hemorrhage

• Intravenous infusion (drip method):
• 10-40 U in 1,000 mL diluents to run as infusion at rate necessary to control uterine atony

• Intramuscular administration:
• 10 U (1 mL) IM after delivery of placenta

Incomplete or inevitable abortion

• 10-20 mU/min IV infusion
• Max: 30 U in 12 hrs

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Induction or stimulation of labor
• Postpartum hemorrhage
• Treatment of incomplete or inevitable abortion

• Hypersensitivity to any of the ingredients of the product
• Benefit-to-risk ratio favors surgery
• Vaginal delivery contraindicated
• Cephalopelvic disproportion
• Vasa previa
• Cord presentation or prolapsed
• Significant unfavorable fetal position or presentation
• Active genital HSV infection
• Invasive cervical CA
• Inadequate progress with adequate contractions
• Fetal distress without imminent delivery
• Total placenta previa
• Uterine hyperactivity or hypertonicity

• Therapy is not indicated for elective labor induction because available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction; elective induction defined as labor initiation without medical indications

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• As available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction, therapy should not be given for elective labor induction; elective induction defined as labor initiation without medical indications [US Black Box Warning]
• Oxytocin must be administered only by the intravenous route and with adequate medical supervision in a hospital when given for induction of labor or stimulation of labor
• Administer therapy under continuous observation by trained personnel with a thorough knowledge of the drug and qualified to identify complications. Make sure that a physician qualified to manage any complications is immediately available
• Hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin
• Do not administer therapy in conditions such as prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus including, caesarean section, overdistension of the uterus, grand multiparity or invasive cervical carcinoma
• Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have been reported
• Therapy may cause increased water reabsorption from the glomerular filtrate

Cautions: Use cautiously in

• Major cervical or uterine surgery history
• Grand multiparity
• Overdistended uterus
• Hydramnios
• Borderline cephalopelvic disproportion
• Prematurity
• Uterine rupture risk
• Uterine sepsis history
• Traumatic delivery history

Pregnancy Category:X

Breastfeeding: Probably safe. Administration of oxytocin to mothers having difficulty in breastfeeding has not been clearly shown to have a beneficial effect on lactation success or in the treatment of breast engorgement. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 26 April 2011). Manufacturer advises caution.

• CV: Maternal reactions including cardiac arrhythmias, premature ventricular contractions, hypertensive episodes; fetal or neonatal reactions including bradycardia, premature ventricular contractions, other arrhythmias
• CNS: Fetal or neonatal reactions including permanent CNS or brain damage and seizures
• EENT: Fetal or neonatal reactions including retinal hemorrhage
• GI: Maternal reactions including nausea and vomiting
• GU: Maternal reactions including rupture of uterus, uterine hypertonicity
• HEPA: Fetal or neonatal reactions including jaundice
• METABOLIC: Maternal reactions including severe water intoxication with convulsion, coma, and death
• MISC: Maternal reactions including anaphylactic reaction, fatal absence of fibrinogen in the plasma, pelvic hematoma, postpartum hemorrhage, subarachnoid hemorrhage; fetal and neonatal reactions including death, low Apgar scores at 5 min

• Endogenous hormone; acts on the smooth muscle of the uterus to stimulate contractions, vasopressive and antidiuretic effects
• Metabolized by liver
• Small amounts are excreted unchanged in the urine
• Half-life: 1-6 minutes

US Trade Name(s)

• Pitocin
• Syntocinon (Discontinued)

US Availability

oxytocin (generic)

• SOLN for INJ: 10 U/mL

Pitocin

• SOLN for INJ: 10 U/mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Syntocinon

UK Availability

Syntocinon

• SOLN for INJ: 5 U/mL (1 mL amp)
• SOLN for INJ: 10 U/mL (1 mL amp)

Australian Trade Name(s)

• Syntocinon

Australian Availability

Syntocinon

• SOLN for INJ: 5 U/mL (1 mL amp)
• SOLN for INJ: 10 U/mL (1 mL amp)

[Outline]

Endocrine/Metabolic

Hormones; Miscellaneous

Obstetrics/Gynecology

Oxytocics

Pricing data from www.DrugStore.com in U.S.A.

• Oxytocin 10 UNIT/ML SOLN [Vial] (APP PHARMACEUTICAL)
  1 ml = $14.99
  2 ml = $18.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.