Last reviewed · How we verify
Prostin
At a glance
| Generic name | Prostin |
|---|---|
| Also known as | Prostin E2 vaginal tablets |
| Sponsor | KK Women's and Children's Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with PROSTIN VR PEDIATRIC Sterile Solution. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and PROSTIN VR PEDIATRIC should be used where ventilatory assistance is immediately available.
Common side effects
- Apnea
- Fever
- Flushing
- Bradycardia
- Seizures
- Hypotension
- Tachycardia
- Sepsis
- Diarrhea
- Hypokalemia
- Cardiac arrest
- Edema
Serious adverse events
- Apnea
- Fever
- Seizures
- Cardiac arrest
- Cerebral bleeding
- Congestive heart failure
- Ventricular fibrillation
- Respiratory depression
- Peritonitis
- Shock
Key clinical trials
- Mechanical Dilation of the Cervix in a Scarred Uterus (NA)
- Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess (PHASE3)
- Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study
- What After the First Propess (PHASE2)
- Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy (NA)
- Propess Versus Prostin for Induction of Labour in Women With Term PROM (PHASE4)
- Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients (PHASE4)
- Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prostin CI brief — competitive landscape report
- Prostin updates RSS · CI watch RSS
- KK Women's and Children's Hospital portfolio CI