INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
PROSTIN E2™ 0,5 mg (Tablets)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PROSTIN E2™ 0,5 mg (Tablets)

COMPOSITION:
Each tablet contains 0,5 mg dinoprostone.

PHARMACOLOGICAL CLASSIFICATION:
A 19 Oxytocics

PHARMACOLOGICAL ACTION:
The exact mode of action of the prostaglandins is not yet completely understood. PROSTIN E2™ tablets have been shown to have a local action on isolated uterine musculature and clinically its main action is oxytocic. However, unlike other oxytocics, PROSTIN E2™ tablets exhibit the capacity of the prostaglandins to influence uterine activity at any stage of gestation. PROSTIN E2™ tablets do not exhibit an antidiuretic effect.

INDICATIONS:
PROSTIN E2™ tablets are indicated for the induction of labour when there are no foetal or maternal contra-indications.

CONTRA-INDICATIONS:
There are no absolute contra-indications to the use of PROSTIN E2™tablets. However, its use is not recommended in the following circumstances:

1.	Where the patient is sensitive to prostaglandin.
2.	For 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 degrees of cephalopelvic disproportion may be present;
	Cases in which there is clinical suspicion or definite evidence of pre-existing foetal distress;
	Cases in which there is a history of difficult labour and/or traumatic delivery;
	Grand multiparae with six or more previous pregnancies.
3.	Cases with a recent history of pelvic inflammatory disease.

DOSAGE AND DIRECTIONS FOR USE:
PROSTIN E2™tablets are not for vaginal use. Continuous administration of the drug for more than two days is not recommended. The dosage of PROSTIN E2™ tablets must be adapted to the patient's response and should always be maintained at the lowest level which will produce satisfactory uterine response. All doses should be taken with a small amount of water.
An initial dose of 0,5 mg (one tablet) should be given. Thereafter, doses should be given hourly. The usual dose will be 0,5 mg (one tablet), but if uterine activity is inadequate, 1 mg (2 tablets) may be given hourly until such time as adequate uterine activity is established. It is recommended that a total SINGLE dose of 1,5 mg (three tablets) not be exceeded. Thereafter it may be possible to reduce the dosage to 0,5 mg (one tablet) hourly.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Clinical studies have not revealed any life-threatening adverse reactions. However, occasional uterine hypertonus has followed initial dosage. The incidence of side-effects is directly dose-related. Nausea, vomiting and diarrhoea have been noted following oral administration of PROSTIN E2™tablets, but have seldom been severe enough to necessitate discontinuation of medication.
Caution should be exercised in the administration of PROSTIN E2™ tablets for the induction of labour in patients with:

1.	Glaucoma or raised intra-ocular pressure.
2.	Asthma or a history of asthma.

In addition, in labour induction cephalopelvic relationship should be carefully evaluated before use of PROSTIN E2™tablets. During use, uterine activity, foetal status, and the progression of cervical dilation should be carefully monitored to detect possible evidence of unphysiological responses, e.g. hypertonus, sustained uterine contractions, or foetal distress. In cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the foetus should be continuously monitored throughout labour. The possibility of uterine rupture should be borne in mind where high-tone myometrial contractions are sustained. Since it has been found that prostaglandins may potentiate the effect of oxytocin, it is recommended that these drugs not be used together, and if used in sequence, that the patient's uterine activity be carefully monitored.
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 PROSTIN E2™ tablets can cause similar bone effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Uterine hypertonus of unduly severe uterine contractions have rarely been encountered, but might be anticipated to result from overdosage. In the rare instance where temporary discontinuation of therapy is not effective in reversing foetal distress or uterine hypertonus then prompt delivery is indicated.
Treatment of overdosage must be, at this time, symptomatic, since clinical studies with prostaglandin antagonists have not progressed to the point where recommendations may be made. It is currently believed that vomiting produced by overdosage may act as a self limiting factor in protecting the patient.

IDENTIFICATION:
PROSTIN E2™ Tablets are presented as white, roughly rectangular tablets, embossed on one side to resemble the letter "U" with the number 76 on the reverse side.

PRESENTATION:
PROSTIN E2™ 0,5 mg tablets are available in glass bottles with 10 tablets.

STORAGE INSTRUCTIONS:
PROSTIN E2™ Tablets have a shelf-life of 2 years when stored at 2 - 8°C, and three months after opening at 2 - 8°C.
Store in refrigerator (2 - 8°C).
Keep out of reach of children.

REGISTRATION NUMBER:
J/19/8

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:
10 March 1983

™ = Trademark

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