PREPIDIL- dinoprostone gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DINOPROSTONE (UNII: K7Q1JQR04M) (DINOPROSTONE - UNII:K7Q1JQR04M)

Tilgjengelig fra:

Pharmacia and Upjohn Company LLC

INN (International Name):

DINOPROSTONE

Sammensetning:

DINOPROSTONE 0.5 mg in 3 g

Administreringsrute:

VAGINAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction. Endocervically administered PREPIDIL Gel is not recommended for the following: - cases with a history of cesarean section or major uterine surgery - cases in which cephalopelvic disproportion is present - cases in which there is a history of difficult labor and/or traumatic delivery - grand multiparae with six or more previous term pregnancies cases with non-vertex presentation - cases with hyperactive or hypertonic uterine patterns - cases of fetal distress where delivery is not imminent - in obstetric emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention No drug abuse or drug dependence has been seen with the use of PREPIDIL Gel.

Produkt oppsummering:

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. PREPIDIL Gel needs to be stored under continuous refrigeration (36° to 46°F; 2° to 8°C).

Autorisasjon status:

New Drug Application

Preparatomtale

PREPIDIL- DINOPROSTONE GEL
PHARMACIA AND UPJOHN COMPANY LLC
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PREPIDIL GEL
DINOPROSTONE CERVICAL GEL
For Endocervical Use
DESCRIPTION
PREPIDIL Gel contains dinoprostone as the naturally occurring form of
prostaglandin E (PGE ) 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 C
H O 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:
CLINICAL PHARMACOLOGY
PREPIDIL Gel (dinoprostone) administered endocervically may stimulate
the myometrium of the gravid
uterus to contract in a manner similar to contractions seen in the
term uterus during labor. Whether or not
this action results from a direct effect of dinoprostone on the
myometrium has not been determined.
Dinoprostone is also capable of stimulating smooth muscle of the
gastrointestinal tract in humans. This
activity may be responsible for the vomiting and/or diarrhea that is
occasionally seen when
dinoprostone is used for preinduction cervical ripening.
In laboratory animals, and also in humans, large doses of dinoprostone
can lower blood pressure,
probably as a result of its effect on smooth muscle of the vascular
system. With the doses of
dinoprostone used for cervical ripening this effect has not been seen.
In laboratory animals, and also in
humans, dinoprostone can elevate body temperature; however, with the
dosing used for cervical
ripening this effect has not been seen.
In addition to an oxytocic effect, there is evidence suggesting that
this agent has a local cervical effect
in initiating softening, effacement, and dilation. These changes,
referred to as cer