OXYTOCIN INJECTION 10IU 1ML

OXYTOCIN INJECTION 10IU 1ML

  • Documents: GMP,COPP,CTD

OXYTOCIN INJECTION 10IU 1ML

Indications:

Induction of labour for medical reasons; stimulation of labour in hypotonic uterine inertia; during caesarean section, following delivery of the child; prevention and treatment of postpartum uterine atony and haemorrhage.

Early stages of pregnancy as a adjunctive therapy for the management of incomplete, inevitable, or missed abortion.

Dosage and Administration:

Caesarean section: 5 IU by slow iv injection immediately after delivery.

Prevention of postpartum uterine haemorrhage: The usual dose is 5 IU slowly iv after delivery of the placenta. In women given oxytocin for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage: 5 IU slowly iv, followed in severe cases by iv infusion of a solution containing 5 to 20 IU of oxytocin in 500ml of a non-hydrating diluent, run at the rate necessary to control uterine atony.

Incomplete, inevitable, or missed abortion: 5 IU slowly iv, if necessary followed by iv infusion at a rate of 20 to 40mU/min or higher.

Children: Not applicable.

Elderly: Not applicable.

Route of administration: Intravenous infusion or intravenous injection.

Warnings:

Administration of oxytocin at excessive doses results in uterine overstimulation with hypertonicity of the uterus and may cause reversible foetal distress.

Precautions for use:

For the induction of labour, administration of oxytocin by direct IM or IV injection is formally avoided. Administration by IV infusion should only be under qualified medical supervision.

Contra-indications:

Hypersensitivity to the active substance or to any of the excipients;

Dystocia;

Fragility or overdistension of the uterus;

Hypertonic uterine contractions or foetal distress, when delivery is not imminent; Pre-eclamptic toxaemia and severe cardiovascular disorders;

Predisposition to amniotic fluid embolism (foetal death in utero, retroplacentar hematoma);

Placenta praevia.

Drug interactions:

Some inhalation anaesthetics, e.g., cyclopropane or halothane, may enhance the hypotensive effect of oxytocin and reduce its oxytocic action.

When given during or after epidural anaesthesia, oxytocin may potentiate the pressor effect of sympathomimetic vasoconstrictor agents.

Prostaglandins :

Since it has been found that prostaglandins potentiate the effect of oxytocin and are risk factors of uterine rupture, it is not recommended that these drugs are used together. If used in sequence, the patient's uterine activity should be carefully monitored.

Pregnancy:

Animal reproduction studies have not been conducted with oxytocin. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it is not expected to present a risk of foetal abnormalities when used as indicated.

Lactation:

Oxytocin may be found in small quantities in mother's breast milk. However, oxytocin is not expected to cause harmful effects in the newborn because it passes into the alimentary tract where it undergoes rapid inactivation.

Storage instructions:

Stored in a cool dark place (protected from light and not exceeding 20℃).