Active Ingredient: Dinoprostone
Dinoprostone is indicated for the induction of labour, especially in patients with favourable induction features, when there are no foetal or maternal contra-indications.
For this indication, competent medicine agencies globally authorize below treatments:
Endocervical
3 - 6 mg
From 3 To 6 mg once every day
3 mg
3 mg to be inserted high into the posterior fornix. 3 mg may be inserted after six to eight hours if labour is not established. Maximum dose 6 mg.
The tablets should be inserted high into the posterior fornix.
Intravenous
0.25 - 1.5 ug
From 0.25 To 1.5 ug once every day
0.25 ug
Directions for the Preparation of a Dilute Solution:
For use by IV drip (a drip set delivering 60 drops/per ml must be used) or constant rate infusion pump. Withdraw 0.75 ml from the ampoule using an aseptic technique and add to 500 ml sterile normal saline or 5% dextrose. Shake to ensure uniformity.
After dilution attach label provided. Use dilute solution within 24 hours of preparation and store in a refrigerator at 2-8°C.
The dose of dinoprostone used normally depends not only upon the indication but also on patient response.
The following is a guide to dosage:
Dilute with normal saline or 5% dextrose to produce a 1.5 micrograms/ml solution. The 1.5 micrograms/ml solution is infused at 0.25 micrograms/minute for 30 minutes and then maintained or increased. Cases of foetal death in utero may require higher doses. An initial rate of 0.5 micrograms/minute may be used with stepwise increases, at intervals of not less than one hour.
The appearance of foetal distress or uterine hypertonus requires cessation of therapy until the state returns to normal. The situation should be re-assessed and, if necessary, the infusion can be recommenced but at lower dosage rates, 50% of the last dose level used.
If no response is seen within the first 12-24 hours of treatment, the medication should be discontinued.
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