INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
PRANDIN E2™ 1 mg (Vaginal Gel)
PRANDIN E2™2 mg (Vaginal Gel)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form)

PRANDIN E2™ 1 mg (Vaginal Gel)
PRANDIN E2™2 mg (Vaginal Gel)

COMPOSITION:
Each unit dose of 3,0 grams (2,5 mL) contains 1,0 mg or 2,0 mg dinoprostone.

PHARMACOLOGICAL CLASSIFICATION:
A 19 Oxytocics

PHARMACOLOGICAL ACTION:
PGE2 promotes cervical ripening and stimulates uterine smooth muscle contractions.

INDICATIONS:
PRANDIN E2™ Vaginal Gel is indicated for induction of labour in at-term or near-term pregnant patients where there are no foetal or maternal contra-indications.

CONTRA-INDICATIONS:
PRANDIN E2™ Vaginal Gel should not be used in patients known to be hypersensitive to PGE2 or any other constituents of the gel.
Labour should not be induced in patients who have any of the following findings:

1.	Grand multiparity (five or more previous deliveries).
2.	Engagement of the head has not taken place.
3.	The chorioamniotic membranes have been ruptured.
4.	The patient has had previous uterine surgery, e.g. caesarean section, hysterotomy or myomectomy.
5.	Cephalopelvic disproportion.
6.	Foetal heart rate pattern suggests incipient foetal compromise.

DOSAGE AND DIRECTIONS FOR USE:
For labour induction at-/or near-term, the initial dose is 1 mg of PGE2 gel into the posterior fornix of the vaginal canal. After 6 hours, a second dose of either 1 or 2 mg of PRANDIN E2™ Vaginal Gel may be administered depending upon need; i.e. an absence of response to the initial 1 mg dose indicates the 2 mg dose should be given, while a 1 mg dose would be suggested to augment an already present response to the initial dose.
A maximum dose of 3 mg may be used.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The following side-effects have been seen in patients treated with PGE₂ gel for labour induction:

1.	Altered foetal heart rate patterns diagnosed as foetal distress: hyperstimulation
2.	Uterine hypercontractility
3.	Uterine hypertonus
4.	Nausea, vomiting and diarrhoea
5.	Lowered blood pressure

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. Transient elevations of body temperature have been observed with doses used for pregnancy termination. PGE2 is also capable of stimulating the smooth muscle of the gastro-intestinal tract. This property may be responsible for the vomiting and/or diarrhoea that is sometimes associated with the use of PGE2.
SpecialPrecautions:

1.	It is recommended, during labour induction with PGE2 gel, that continuous electronic monitoring of uterine activity and foetal heart rate be employed.
2.	PGE2 gel for labour induction should be used with caution in patients with compromised cardiovascular, hepatic, or renal function and in patients with asthma.
3.	If patients develop uterine hypertonus or hypercontractility or where abnormal foetal heart patterns develop, the clinical situation must be re-evaluated and suitable measures instituted.
4.	As with any oxytocic agent, the possibility of uterine rupture should be considered in the presence of excessive uterine activity or unusual uterine pain.
5.	Oxytocin and prostaglandin therapy should not be used concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The principal expressions of an exaggerated response to PRANDIN E2™ Vaginal Gel are either myometrial, hypercontractility or hypertonus. Management of an exaggerated myometrial response should include evacuation of the medication from the vaginal tract, placing the patient in a lateral semi-recumbent position and administration of oxygen. An adrenergic beta2-stimulant may be given intravenously to alleviate the hypertonus.

IDENTIFICATION:
A colourless, semi-translucent, viscous gel.

PRESENTATION:
PRANDIN E2™ 1 mg or 2 mg Vaginal Gel is supplied as a semi-translucent, thixotropic sterile gel as follows:
1 mg or 2 mg PGE2 per 3 g in syringes for intravaginal application.

STORAGE INSTRUCTIONS:
Store in a refrigerator (2 - 8°C).
Keep out of reach of children.

REGISTRATION NUMBERS:

PRANDIN E2™ 1 mg Vaginal Gel:	W/19/455
PRANDIN E2™ 2 mg Vaginal Gel:	W/19/456

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 September 1990

™= Trademark

METHOD OF ASSEMBLY:
Instructions:

1.	Remove syringe from blister pack.
2.	Remove protective end cap (to serve as plunger extension).
3.	Insert protective end cap into syringe.
4.	Administer syringe contents.

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