PRANDIN E2 Vaginal Gel Ref.[50238] Active ingredients: Dinoprostone

Source: Marketing Authorisation Holder  Revision Year: 2018  Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196, South Africa

4.3. Contraindications

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 patient has had previous uterine surgery, e.g. caesarean section, hysterotomy or myomectomy.
  4. Cephalopelvic disproportion.
  5. Foetal heart rate pattern suggests incipient foetal compromise.
  6. Obstetric conditions where either maternal or foetal benefit/risk ratio favours surgical intervention.
  7. Unexplained vaginal discharge and/or unexplained uterine or vaginal bleeding during current pregnancy.

4.4. Special warnings and precautions for use

  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. Caution should also be exercised in the administration of oxytocic agents, including PRANDIN E2 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 E2 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.

4.5. Interaction with other medicinal products and other forms of interaction

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 E2 Vaginal Gel is recommended, with a dosing interval of at least 6 hours.

4.8. Undesirable effects

Very Common: ≥1/10 (≥10%)
Common: ≥1/100 and <1/10 (≥1% and <10%)
Very rare: <1/10 000 (<0,01%)

SYSTEM ORGAN CLASSFREQUENCYUNDESIRABLE EFFECTS
InvestigationsVery CommonAltered foetal heart rate patterns
Gastrointestinal disordersCommonNausea, vomiting and diarrhoea
Musculoskeletal and connective tissue disordersCommonBack pain
Pregnancy, puerperium and perinatal conditionsCommonUterine hypercontractility; Uterine hypertonus
Very rareStill birth
Reproductive system and breast disordersCommonWarm feeling in vagina
General disorders and administration site conditionsCommonFever
Immune system disordersVery rareHypersensitivity reactions
Vascular disordersVery rareLowered 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.

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