INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
PREPIDIL™ GEL 0,5 mg

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PREPIDIL™ GEL 0,5 mg

COMPOSITION:
Each unit dose of 3 g contains 0,5 mg dinoprostone.

PHARMACOLOGICAL CLASSIFICATION:
A 19 Oxytocics

PHARMACOLOGICAL ACTION:
PREPIDIL Gel 0,5 mg, administered endocervically, facilitates preinduction cervical softening (cervical maturation) in patients with unfavourable induction features. The specific mechanism of action is not fully defined. However, experimental data in humans demonstrates that PGE2 increases the volume of blood flow in the cervix similar to that observed in early stages of spontaneous labour. This data strongly suggests that endocervical administration of PGE2 affects cervical haemodynamics, thus leading to cervical maturation.
In both laboratory animals and man, large doses of PGE2 can lower blood pressure, probably as a consequence of its effect on smooth muscle of the vascular system, and transient elevations of the body temperature have been observed. PGE2 is also capable of stimulating the smooth muscle of the gastro-intestinal tract.

INDICATIONS:
Cervical ripening in term or near term pregnant women who have a single baby (or foetus) with a vertex presentation.

CONTRA-INDICATIONS:
Endocervically administered gel is not recommended for the following:

1.	Patients in whom oxytocic drugs are generally contra-indicated or where prolonged contractions of the uterus are considered inappropriate, such as:
-	Cases with a history of caesarean section or major uterine surgery.
-	Cases in which major degree of cephalopelvic disproportion may be present.
-	Cases in which there is a history of difficult labour and/or traumatic delivery.
-	Grand multiparae with six or more previous term pregnancies.
2.	Patients with ruptured membranes.
3.	Patients with known hypersensitivity to prostaglandin.
4.	Patients with unexplained vaginal bleeding during the pregnancy.
5.	Patients with non-vertex presentations.
6.	Foetal heart rate pattern suggests incipient foetal compromise.

WARNINGS:
Since it has been found that prostaglandins may potentiate the effect of oxytocin, it is recommended that, if these drugs are used in sequence, the patient's uterine activity
be carefully monitored.

DOSAGE AND DIRECTIONS FOR USE:
PREPIDIL Gel 0,5 mg is supplied as a translucent sterile gel preparation of 0,5 mg PGE2 per 3 g, in syringes with an accompanying catheter for endocervical application. See attached diagram for assembly instructions.
Utilizing the catheter provided, the entire contents of the syringe should be administered by gentle expulsion into the cervical canal just below the level of the internal cervical os. After placement of the gel, the patient should be instructed to remain in the dorsal position for 10 - 15 minutes to minimise gel leakage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Special Precautions:

1.	Prior to and during use, uterine activity, foetal status, and the character of the cervix (dilation and effacement) should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus, sustained uterine contractility or foetal distress. In cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine contractions and the state of the foetus be continuously monitored. The possibility of uterine rupture should be born in mind where high-tone myometrial contractions are sustained.
2.	Foeto-pelvic relationships should be carefully evaluated before the use of PREPIDIL Gel 0,5 mg.
3.	Caution should be exercised in the administration of PREPIDIL Gel 0,5 mg in patients with:
a)	Asthma or a history of asthma, as acute bronchospasm can be precipitated.
b)	Glaucoma or raised intraocular pressure.
c)	Compromised cardiovascular, hepatic or renal function.
4.	Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment. There is no evidence that short term administration of prostaglandin E2 can cause similar bone effects.
5.	Caution should be taken so as not to administer the PREPIDIL Gel 0,5 mg above the level of the internal os. Placement of PREPIDIL Gel 0,5 mg into the extra amniotic space has been associated with uterine hyperstimulation.

SIDE-EFFECTS:

1.	Intrapartum foetal heart rate changes and unclassified foetal distress during, or subsequent to, PREPIDIL Gel 0,5 mg treatment.
2.	Uterine contractile abnormalities (increased frequency, tone, or duration) with or without foetal heart rate changes.
3.	Vomiting and/or diarrhoea.
4.	Depressed neonates at birth (Apgar scores below 7).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment of overdosage must be symptomatic, since clinical studies with prostaglandin antagonists have not progressed to the point where recommendations may be made.

IDENTIFICATION:
A translucent gel.

PRESENTATION:
PREPIDIL Gel 0,5 mg is supplied as a translucent sterile gel as follows:
0,5 mg PGE2 per 3 g in syringe with accompanying catheter for endocervical application.

STORAGE INSTRUCTIONS:
Store in a refrigerator at 4°C.
Keep out of reach of children.

REGISTRATION NUMBER:
U/19/259

NAME AND ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Limited
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 May 1991

™ = Trade Mark

METHOD OF ASSEMBLY OF SYRINGE AND CATHETER:
INSTRUCTIONS:
Remove sterile catheter and sterile syringe from package.

{illustrated}

1.	Remove peel-off seal from end of syringe.
2.	Remove protective end cap (to serve as plunger extension).
3.	Insert protective end cap into plunger stopper assembly in barrel of syringe.
4.	Firmly attach catheter hub to syringe tip (catheter has to click into place).
5.	Administer syringe contents endocervically.

New addition to this site: February 2005
Source: Pharmaceutical Industry
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