OXYTOCIN GRINDEKS SOLUTION FOR INJECTION AND INFUSION 10 IU/ML [SIN17068P]

Product Info

OXYTOCIN GRINDEKS SOLUTION FOR INJECTION AND INFUSION 10 IU/ML

[SIN17068P]

INDICATIONS

Antepartum

• Induction of labor for medical reasons, e.g., in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension associated with significant protein in the urine (pre-eclampsia).

• Enhancement of labor in selected cases of uterine inertia.

• Oxytocin Grindeks may also be indicated in early stage of pregnancy, as adjunctive therapy for management of incomplete, inevitable, or missed abortion.

Postpartum

• During cesarean section, but after the delivery of the child.

• Prevention and treatment of postpartum hemorrhage associated with uterine atony.

RECOMMENDED DOSAGE

General target population

Induction or enhancement of labor
Oxytocin Grindeks 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 Oxytocin Grindeks 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 labor 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 Oxytocin Grindeks 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 Oxytocin Grindeks 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).

CONTRAINDICATIONS

• Known hypersensitivity to oxytocin or to any of the excipients of Oxytocin Grindeks.

• Hypertonic uterine contractions, fetal distress when delivery is not imminent.

Any condition in which, for fetal or maternal reasons, spontaneous labor is unadvisable and/or vaginal delivery is contraindicated, e.g.:

• Significant cephalopelvic disproportion.

• Fetal malpresentation.

• Placenta previa and vasa previa.

• Placental abruption.

• Cord presentation or prolapse.

• Overdistension or impaired resistance of the uterus to rupture as in multiple pregnancy.

• Polyhydramnios.

• Grand multiparity.

• Presence of a uterine scar resulting from major surgery, including classical cesarean section.

Oxytocin Grindeks must not be administered within 6 hours after vaginal prostaglandins have been given (see section INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Oxytocin Grindeks should not be used for prolonged periods in patients with oxytocin-resistant uterine inertia, severe preeclamptic toxaemia, or severe cardiovascular disorders.