Clinical Overview
Dinoprostone Gel 0.5 mg (Pre-filled syringe) is a sterile endocervical gel containing synthetic Prostaglandin E2 (PGE2) on the WHO Model List of Essential Medicines. It stimulates local collagenase breakdown, cervical ripening, dilatation, and myometrial contractility mimicking natural onset of labor. Indicated for cervical ripening and induction of labor in pregnant women at or near term with a medical or obstetric indication for induction and an unfavorable Bishop's score (<=6).
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
For endocervical administration ONLY by a qualified obstetrician in a hospital labor and delivery unit: Warm syringe to room temperature. Position patient in dorsal lithotomy, visualize cervix with speculum, insert the pre-filled catheter into cervical canal just below internal os, and slowly instill 0.5 mg (full syringe). The patient must remain recumbent in supine position for at least 30 minutes to minimize leakage. Continuous electronic fetal monitoring (CTG) and uterine activity monitoring required.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Mild uterine contractions, cervical soreness, nausea, vomiting, diarrhea, flushing, low-grade temperature elevation. Rare/Severe: Uterine hyperstimulation/tetanic contraction, uterine rupture, fetal distress/bradycardia, amniotic fluid embolism, and placental abruption.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Contraindicated in patients with cephalopelvic disproportion, non-vertex presentation, fetal distress, unexplained vaginal bleeding during current pregnancy, placenta previa, multiparity (>=6 previous term pregnancies), previous cesarean section or major uterine surgery, and acute pelvic inflammatory disease. Wait at least 6 hours before initiating intravenous oxytocin.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Gynecological, Obstetric & Endocrinological Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice or reproductive healthcare guidance. Hormonal medications, uterotonics, corticosteroids, fertility therapies, and emergency contraceptives have profound systemic actions and must be administered strictly under the supervision of a registered gynecologist, obstetrician, or endocrinologist.