Source: FDA, National Drug Code (US) Revision Year: 2019
PREPIDIL Gel contains dinoprostone as the naturally occurring form of prostaglandin E2 (PGE2) and is designated chemically as (5Z, 11a, 13E, 15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid. The molecular formula is C20H32O5 and the molecular weight is 352.5. Dinoprostone occurs as a white to off-white crystalline powder with a melting point within the range of 65° to 69°C. It is soluble in ethanol, in 25% ethanol in water, and in water to the extent of 130 mg/100 mL. The active constituent of PREPIDIL Gel is dinoprostone 0.5 mg/3 g (2.5 mL gel); other constituents are colloidal silicon dioxide NF (240 mg/3 g) and triacetin USP (2760 mg/3 g).
The structural formula is represented below:
| How Supplied | ||||
|---|---|---|---|---|
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PREPIDIL Gel is available as a sterile semitranslucent viscous preparation for endocervical application: 0.5 mg PGE2 per 3.0 g (2.5 mL) in syringe. In addition, each package contains two shielded catheters (10 mm and 20 mm tip) enclosed in sterile envelopes. The contents are not guaranteed sterile if envelopes are not intact. Each 3 gram syringe applicator contains: dinoprostone, 0.5 mg; colloidal silicon dioxide, 240 mg; triacetin, 2760 mg.
Distributed by: Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017 |
| Drug | Countries | |
|---|---|---|
| PREPIDIL | Austria, Canada, France, Croatia, Netherlands, Poland, Tunisia, United States |
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