Umedica Labs




Full Prescribing Info
Each mL contains: Oxytocin BP (as Oxytocin Concentrated Solution) 10 IU eq. to 16 mcg/mL (It is Obtained from Synthetic Origin), Water For Injections BP q.s.
Pharmacology: Pharmacokinetics: Oxytocin undergoes enzymatic destruction in the gastrointestinal tract but it is rapidly absorbed from the mucous membranes when given intranasally. It is metabolised by the liver and kidneys with a plasma half-life of only a few minutes. Only small amounts are excreted unchanged in the urine.
Oxytocin is used for the induction and augmentation of labour, to control postpartum bleeding and uterine hypotonicity in the third stage of labour, and to promote lactation in cases of faulty milk ejection.
Dosage/Direction for Use
Induction or enhancement of labour: IV drip infusion of a 5% dextrose solution, containing 5 IU Oxytocin per 500 mL 3rd stage labour and puerperium; 5-10 IU IM or 5 IU IV slowly.
Caesarean section: 5 IU after delivery.
Or as prescribed by the physician.
Hypertonic contractions, cephalopelvic disproportion, excessive distention of the uterus as in multiple pregnancy, hydramnios, hypersensitivity to the drug, elderly multiparae, previous caesarean section or other surgery involving the uterus, severe toxaemia, predisposition to amniotic fluid, placenta praevia.
Special Precautions
Only under hospital conditions with qualified medical supervision and careful obstetrical monitoring allowing dosage adjustment to individual responses.
Adverse Reactions
Oxytocin given in high doses, or to women who are hypersensitive to it, may cause uterine hyperstimulation with hypertonic or tetanic contractions, leading to uterine rupture and soft tissue damage. Effects in the fetus include bradycardia, arrhythmias, asphyxiation and perhaps death.
Maternal deaths from severe hypertension and subarachnoid haemorrhage have occurred. Rapid intravenous injection of Oxytocin has produced acute transient hypotension with flushing and reflex tachycardia. Postpartum haemorrhage, fatal afibrinogenaemia and disseminated intravascular coagulation have been reported, but may be due to complications of labour induction rather than Oxytocin itself.
High doses of Oxytocin infused over prolonged periods can also cause water retention leading to hyponatraemia and intoxication, which may progress to convulsions, coma, and even death. Vasopressin-like activity is more likely with Oxytocin of natural origin but may occur even with the synthetic peptide.
Other adverse effects include headache, nausea and vomiting, skin rashes, cardiac arrhythmias, pelvic haematoma and anaphylactic and other hypersensitivity reactions.
There are reports of neonatal jaundice and retinal haemorrhage associated with the use of Oxytocin in the management of labour.
Drug Interactions
Oxytocin may enhance the vasopressor effects of sympathomimetics. Some inhalational anaesthetics, such as cyclopropane or halothane, may enhance the hypotensive effect of Oxytocin and reduce its oxytocic effect, cardiac arrhythmias may occur. Prostaglandins and Oxytocin may potentiate the effects of each other on the uterus; the UK licensed product information for Oxytocin states that it should not be started for 6 hours after use of vaginal prostaglandins.
Store at temperatures not exceeding 30°C.
ATC Classification
H01BB02 - oxytocin ; Belongs to the class of oxytocin and analogues. Used in posterior pituitary lobe hormone preparations.
Soln for inj (amp) 10 IU/mL x 1 mL x 10's.
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