SYNTOCINON INJECTION 10 iu/ml

MYLAN PHARMACEUTICALS PTE. LTD.

MYLAN PHARMACEUTICALS PTE. LTD.

Therapeutic

Prescription Only

INJECTION

**DOSAGE AND ADMINISTRATION** **Dosage** **General target population** **Induction or enhancement of labor** Syntocinon should be administered as an intravenous (i.v.) drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 10 international units of Syntocinon be added to 1000 mL of a physiological electrolyte solution (such as sodium chloride 0.9%). For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent (see section WARNINGS AND PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 2 milliunits/minute (2 to 4 drops/minute). It may be increased gradually at intervals not shorter than 20 minutes and increments of not more than 1 to 2 milliunits/minute 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 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the unusual event of higher rates being required, as may occur in the management of fetal death in utero or for induction of labor at an earlier stage of pregnancy when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated Syntocinon solution, e.g. 10 international units in 500 mL. 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 and also the fetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, 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 international units, it is recommended that the attempt to induce labor should be terminated; it may be repeated on the following day, starting again from a rate of 1 to 2 milliunits/minute. **Cesarean section** 5 international units by i.v. infusion (5 international units diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery. **Prevention of postpartum uterine hemorrhage** The usual dose is 5 international units by i.v. infusion (5 international units diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), or 5 to 10 international units i.m. after delivery of the placenta. In women given Syntocinon for induction or enhancement of labor, the infusion should be continued at an increased rate during the third stage of labor and for the next few hours thereafter. **Treatment of postpartum uterine hemorrhage** 5 international units by i.v. infusion (5 international units diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), or 5 to 10 international units i.m., followed in severe cases by i.v. infusion of a solution containing 5 to 10 international units of oxytocin in 500 mL of an electrolyte-containing diluent, run at the rate necessary to control uterine atony. **Incomplete, inevitable, or missed abortion** 5 international units by i.v. infusion (5 international units diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) or 5 to 10 international units i.m., if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/min. **Special populations** **Renal impairment** No studies have been performed in renally impaired patients. **Hepatic impairment** No studies have been performed in hepatically impaired patients. **Pediatric patients** No studies have been performed in pediatric patients. **Geriatric patients** No studies have been performed in elderly patients (65 years old and over).