dinoprostone

Action and Spectrum

Drug Interaction

Adverse Reaction

Frequency defined:  

1-10% 

Gel 

Abnormal uterine contractions 

Back pain 

Fever 

Warm feeling in the vagina 

GI upset 

Insert 

Hypertonic uterine dysfunction with/without fetal distress 

<1% 

Gel 

Uterine rupture 

Amnionitis 

Premature rupture of membranes 

Intravascular coagulation 

Insert 

Uterine rupture 

Hypotension 

Frequency not defined: 

Hot flash 

Dehydration 

Vulvitis 

Eye pain 

Chest pain 

Syncope 

Diaphoresis 

Post-marketing reports 

Headache 

Anaphylactic shock 

Black Box Warning

Contraindication / Caution

Pregnancy / Lactation

Pregnancy consideration: Insufficient data available 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester. 
• Category B: There is no evidence of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. These category drugs should be prohibited for pregnant women. 
• Category N: No data is available for the drug under this category. 

Pharmacology

Adminstartion

Patient Information Leaflet

Patient information leaflet 

Generic Name: dinoprostone 

Pronounced: dino-pro-s-tone  

Why do we use dinoprostone? 

In pregnant women who are at or close to term, it is used to prepare the cervix for the induction of labor