| Application: | Internal Medicine |
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| Usage Mode: | I.V./I.M. |
| Suitable for: | Elderly, Children, Adult |
| State: | Liquid |
| Shape: | Injection |
| Type: | Organic Chemicals |
| Samples: |
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| Customization: |
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Audited Supplier | Product name | Oxytocin injection |
| Specification | 1ml:10I.U. |
| Packing | Customizable |
| Standard | Bp. USP. |
| Shelf life | 3 Years |
| Sample | Available |
Oxytocin 10 IU/ml Solution for Injection
Each ml of solution contains 10 IU oxytocin, equivalent to 17 micrograms of oxytocin EP in solution.
Each 1ml ampoule also contains 2.9 mg (0.13 mmol) of sodium.
For full list of excipients, see section 6.1.
Solution for injection.
A clear, colourless solution.
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.
Induction or enhancement of labour: Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins. Oxytocin should be administered as an iv drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 5 IU of oxytocin be added to 500ml of a physiological electrolyte solution. For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent (see Section 4.4 "Special warnings and precautions for use"). To ensure even mixing, the bottle or bag must be turned upside down several times before use.
The initial infusion rate should be set at 1 to 4mU/min (2 to 8 drops/min). It may be gradually increased at intervals not shorter than 20 min, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10mU/min (20 drops/min), and the recommended maximum rate is 20mU/min (40 drops/min). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated oxytocin solution, e.g., 10 IU in 500ml.
When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump. The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.
If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4mU/min (see Section 4.3 "Contra-indications").
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.
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