A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Prepidil Side Effects, and Drug Interactions - Dinoprostone cervical
Prepidil Side Effects, and Drug Interactions - Dinoprostone cervical
Prepidil® Gel
SIDE EFFECTS
PREPIDIL Gel is generally well-tolerated. In controlled trials,
in which 1731 women were entered, the following events were reported at an occurrence
of ³ 1%:
|
Adverse Reaction
|
PGE2 (N = 884)
|
Control* (N = 847)
|
|
Maternal
|
N (%)
|
N (%)
|
|
Uterine contractile abnormality
|
58 (6.6)
|
34 (4.0)
|
|
Any gastrointestinal effect
|
50 (5.7)
|
22 (2.6)
|
|
Back pain
|
27 (3.1)
|
0 (0)
|
|
Warm feeling in vagina
|
13 (1.5)
|
0 (0)
|
|
Fever
|
12 (1.4)
|
10 (1.2)
|
|
Fetal
|
|
Any fetal heart rate abnormality
|
150 (17.0)
|
123 (14.5)
|
|
Bradycardia
|
36 (4.1)
|
26 (3.1)
|
|
Deceleration
|
|
|
|
Late
|
25 (2.8)
|
18 (2.1)
|
|
Variable
|
38 (4.3)
|
29 (3.4)
|
|
Unspecified
|
19 (2.1)
|
19 (2.2)
|
*placebo gel or no treatment
In addition, in other trials amnionitis and intrauterine fetal
sepsis have been associated with extra-amniotic intrauterine administration
of PGE2. Uterine rupture has been reported in association with the
use of PREPIDIL Gel intracervically. Additional events reported in the literature,
associated by the authors with the use of PREPIDIL Gel, included premature rupture
of membranes, fetal depression (1 min Apgar <
7), and fetal acidosis (umbilical artery pH <
7.15).
DRUG ABUSE AND DEPENDENCE
No drug abuse or drug dependence has been seen with the use
of PREPIDIL Gel.
3.DRUG INTERACTIONS
:
PREPIDIL Gel may augment the activity of other oxytocic agents and their concomitant use is not recommended. For the sequential use of oxytocin following PREPIDIL Gel administration, a dosing interval of 6-12hours is recommended.
4.Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenic bioassay studies have not been conducted in animals with PREPIDIL Gel due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.
5.Pregnancy, Teratogenic Effects: PREGNANCY CATEGORY C
Prostaglandin E2 produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since PREPIDIL Gel is administered after the period of organogenesis. PREPIDIL Gel has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. See statements under General Precautions.
6.Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
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