IPRADOL® INFUSION 25µg/10 mL

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

IPRADOL® INFUSION 25µg/10 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

IPRADOL^® INFUSION 25µg/10 mL

COMPOSITION:
Each 10 mL contains 25 µg Hexoprenaline sulphate.

PHARMACOLOGICAL CLASSIFICATION:
A 18.9 Uterine antispasmodics

PHARMACOLOGICAL ACTION:
Ipradol (Hexoprenaline sulphate) is a Beta₂ -Selective Sympathomimetic agent which exhibits minimal cardiovascular side-effects, causes uterine muscle relaxation by synthesis of CYCLIC AMP.

INDICATIONS:
To prevent the onset of premature labour in high risk cases e.g.

a)	As a loading-dose to achieve a rapid blood level of the drug prior to an intravenous infusion, in the treatment of premature labour.
b)	To remove rapidly hypertonic uterine action which may occur with oxytocic drugs in the induction of labour.
c)	As a temporising measure in the treatment of foetal distress, before vaginal delivery (when imminent) or Caesarean section.
d)	To rapidly stop contractions as a temporising measure before Caesarean section, where there is a prolapsed cord, especially if the patient needs to be transported to hospital.
e)	As an aid when performing an external cephalic version in an irritable uterus.
f)	When oxytocic agents have inadvertently been given after birth of the first twin.
g)	To stop contractions when an impending rupture of the uterus threatens.
h)	When manual removal of the placenta is complicated by a constriction ring.

CONTRA-INDICATIONS:
Caution should be exercised in patients suffering from hyperthyroidism, manifest cardiac disease, congestive cardiac failure and diabetes.
Ipradol should not be used in the presence of:

a)	Severe accidental haemorrage.
b)	Ruptured membranes where "bubbles" are found in the liquid following speculum examination.
c)	Evidence of intra-uterine infection of the foetus as shown by foetal heart-rate greater than 160 beats per minute for longer than four hours.
d)	Dismaturity (small-for-date babies) associated with placental inefficiency.

WARNING:
NOT TO BE USED IF CLOUDY OR IF A PRECIPITATE IS PRESENT.

DOSAGE AND DIRECTIONS FOR USE:

a)	Loading Dose Slow administration of intravenous hexoprenaline sulphate (Ipradol) 10 µg, (i.e. 4 mL).
b)	Maintenance Dose Infusion of hexoprenaline 100 µg (4 x 10 mL ampoules) per 1 000 mL in 5% dextrose solution and infuse at a rate of 15 drops per minute, that is to administer between 0,30 µg and 0,45 µg per minute to maintain a maternal pulse rate at approximately 120-140 beats per minute.

TABLETS
Oral Administration: (0,5 mg Hexoprenaline sulphate per tablet)
After successfully stopping labour contractions for the first 24 hours, Ipradol tablets are then indicated for as long as suppression is considered justified.
Prior to stopping the intravenous drip and maintaining the patient on a prophylactic dosage of Ipradol tablets, it is recommended that an Ipradol tablet should be given three hours prior to the stopping of the intravenous drip and that a further tablet be given when the intravenous drip is stopped, and thereafter the suggested maintenance dosage of Ipradol tablets is 1-2 tablets q.i.d., on discharge if deemed necessary by the physician.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Tremor and palpitations with tachycardia may occur but owing to the greater Beta₂-affinity of Ipradol the above side-effects are unlikely to occur with the recommended dosage.

Special Precautions
Should not be taken where maternal heart disease complicates pregnancy.
The concomitant use of other sympathomimetic agents should be carefully controlled. It is of no benefit to the patient to exceed doses as recommended and prescribed.
Beta₂-adrenergic sympathomimetics used in obstetrics affect carbohydrate metabolism, viz glycogenolysis and lipolysis. The glucose tolerance test is elevated and there is an increased secretion of insulin. These effects are found with both the intravenous and oral forms of Ipradol, but are, however, corrected by the body within 48 hours.
The diabetic patient should be closely observed for 48 hours as regards her insulin or oral antidiabetic requirements, as during this period she may require additional anti-diabetic treatment.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage immediately stop Ipradol treatment and administer a Beta-blocker e.g. Propranolol in an adequate dosage.

IDENTIFICATION:
A clear, colourless solution packed in clear glass ampoules.

PRESENTATION:
10 mL Clear glass ampoules containing 25 µg Hexoprenaline Sulphate (that is, 2,5 µg per mL).

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
K/18.9/61

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
Port Elizabeth
6001

DATE OF PUBLICATIONS OF THIS PACKAGE INSERT:

May 1977.	12-196/11-95
	KOHLER C&P P.E.