Syntocinon

Syntocinon is part of the drug class:

• Oxytocin and analogues

Syntocinon®

(oxytocin) injection, USP

Caution: Federal law prohibits dispensing without prescription.

The following adverse reactions have been reported in the mother: Anaphylactic reaction, Postpartum hemorrhage, Cardiac arrhythmia, Fatal afibrinogenemia, Nausea, Vomiting, Premature ventricular contractions, and Pelvic hematoma.

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 infant:

Due to induced uterine motility: Bradycardia, Premature ventricular contractions and other arrhythmias, Permanent CNS or brain damage, and Fetal death.

Due to use of oxytocin in the mother: Low Apgar scores at 5 minutes. Neonatal jaundice, and Neonatal retinal hemorrhage.

Syntocinon® (oxytocin) injection, USP

Available as a 1 mL sterile ampul containing 10 USP or International Units of oxytocin. SandoPak® unit dose packages of 50 ampuls (NDC 0078-0060-04).

Store and dispense

Below 77ºF (25ºC); DO NOT FREEZE.

Sandoz Pharmaceuticals Corporation East Hanover, New Jersey 07936

REV: MAY 1996                                30288904

Applies to oxytocin: compounding powder, injectable solution, intravenous solution

Cardiovascular

Cardiovascular side effects have included hypertension, premature ventricular contractions, sinus tachycardia, and other cardiac arrhythmias. Neonatal bradycardia, premature ventricular contractions and other arrhythmias have been reported.[Ref]

Nervous system

Nervous system side effects have included mania-like disturbances and seizures. The seizures may have been related to water intoxication. Neonatal seizures and permanent CNS or brain damage has been reported.[Ref]

Metabolic

Metabolic side effects have included water intoxication resulting in coma and seizures.[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reactions.[Ref]

Genitourinary

Genitourinary side effects have included pelvic hematoma. Excessive doses have produced pelvic fracture, uterine hypertonicity, spasm, tetanic contraction and rupture.[Ref]

Hematologic

Hematologic side effects have included postpartum hemorrhage and fatal afibrinogenemia.[Ref]

Hepatic

Hepatic side effects have included neonatal jaundice.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Respiratory

Respiratory side effects have included pulmonary edema.[Ref]

Renal

Renal side effects have included decreases in glomerular filtration rate and renal plasma flow. Doses of 40 milliunits per minute may produce significant decreases in urine output.[Ref]

Local

Local side effects have included nasal irritation and rhinorrhea.[Ref]

Ocular

Ocular side effects have included neonatal retinal hemorrhages.[Ref]

Psychiatric

Psychiatric side effects have included memory impairment and mania in patients on high doses.[Ref]

General

General side effects have include low Apgar scores at 5 minutes. Fetal death has been reported.[Ref]

Some side effects of Syntocinon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.