Prandin 1 mg and 2 mg Vaginal Gel

PRANDIN E 2 Vaginal Gel is indicated for induction of labour in at-term or near-term pregnant patients where there are no foetal or maternal contraindications.

For labour induction at-/or near-term, the initial dose is 1 mg of PGE 2 gel into the posterior fornix of the vaginal canal. After 6 hours, a second dose of either 1 or 2 mg of PRANDIN E 2 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.

Instructions on the method of assembly:

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

PRANDIN E 2 Vaginal Gel should not be used in patients known to be hypersensitive to PGE 2 or any other constituents of the gel. Labour should not be induced in patients who have any of the following findings:

• Grand multiparity (five or more previous deliveries).
• Engagement of the head has not taken place.
• The patient has had previous uterine surgery, e.g. caesarean section, hysterotomy or myomectomy.
• Cephalopelvic disproportion.
• Foetal heart rate pattern suggests incipient foetal compromise.
• Obstetric conditions where either maternal or foetal benefit/risk ratio favours surgical intervention.
• Unexplained vaginal discharge and/or unexplained uterine or vaginal bleeding during current pregnancy.

1. It is recommended, during labour induction with PGE 2 gel, that continuous electronic monitoring of uterine activity and foetal heart rate be employed.

2. PGE 2 gel for labour induction should be used with caution in patients with compromised cardiovascular, hepatic, or renal function and in patients with asthma.

3. Caution should also be exercised in the administration of oxytocic agents, including PRANDIN E 2 Vaginal Gel, for the induction of labour in patients with multiple gestation.

4. 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.

5. As with any oxytocic agent, the possibility of uterine rupture should be considered in the presence of excessive uterine activity or unusual uterine pain.

6. Oxytocin and prostaglandin therapy should not be used concomitantly.

7. PRANDIN E 2 Vaginal Gel should be used with caution in patients in whom the chorioamniotic membranes have been ruptured.

8. Patients with glaucoma or raised intraocular pressure.

The response to oxytocin may be accentuated in the presence of exogenous prostaglandin therapy. Concurrent use with other agents is not recommended. The sequential use of oxytocin following administration of PRANDIN E 2 Vaginal Gel is recommended, with a dosing interval of at least 6 hours.

Very Common: u2265 1/10 (u2265 10%)

Common: u2265 1/100 and < 1/10 (u2265 1% and < 10%)

Very rare: < 1/10 000 (< 0,01%)

SYSTEM ORGAN CLASS FREQUENCY UNDESIRABLE EFFECTS

Investigations: Very Common Altered foetal heart rate patterns diagnosed as foetal distress: hyperstimulation

Gastrointestinal disorders: Common Nausea, vomiting and diarrhoea

Musculoskeletal and connective tissue disorders: Common Back pain

Pregnancy, puerperium and perinatal conditions: Common Uterine hypercontractility; Uterine hypertonus

Very rare Still birth

Reproductive system and breast disorders: Common Warm feeling in vagina

General disorders and administration site conditions: Common Fever

Immune system disorders: Very rare Hypersensitivity reactions

Vascular disorders: Very rare Lowered blood pressure

In both laboratory animals and man, large doses of PGE 2 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. PGE 2 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 PGE 2.

The principal expressions of an exaggerated response to PRANDIN E 2 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 u03b2 2 - stimulant may be given intravenously to alleviate the hypertonus.