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Drug Description

Presentation

Indications

Adult Dosage

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

An initial dose of 250 micrograms (1.0 ml) of Hemabate should be administered as a deep intramuscular injection.

If necessary, further doses of 250 micrograms may be administered at intervals of approximately 1.5 hours. In severe cases the interval between doses may be reduced at the discretion of the attending physician, but it should not be less than 15 minutes. The total dose of Hemabate should not exceed 2 mg (8 doses).

Contra Indications

1. Hemabate should not be used where the patient is sensitive to carboprost tromethamine or any of the excipients.

2. Acute pelvic inflammatory disease.

3. Patients with known active cardiac, pulmonary, renal, or hepatic disease.

Special Precautions

Hemabate should be used by medically trained personnel and is available only to hospitals and clinics with specialised obstetric units where 24 hour resident medical cover is provided. Hemabate, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages.

This preparation should not be used for induction of labour.

Hemabate must not be given intravenously.

Special caution is necessary in patients with history of asthma, hypo- or hypertension, cardiovascular, renal, or hepatic disease, glaucoma or raised intra-ocular pressure, anaemia, jaundice, diabetes, or epilepsy.

Benefit/risk ratio should be assessed in patients with cardiovascular disease (risk of decreased blood pressure up to cardiovascular collapse, bradycardia), and in patients (possibility of decreased pulmonary blood flow and increased arterial pulmonary pressure).

Very rare cases of cardiovascular collapse have been reported following the use of prostaglandins. This should always be considered when using Hemabate.

Decreases in maternal arterial oxygen content have been observed in patients treated with carboprost tromethamine. A causal relationship to carboprost tromethamine has not been established, however, it is recommended that patients with pre-existing cardio-pulmonary problems receiving Hemabate are monitored during treatment and given additional oxygen if necessary.

As with any oxytocic agent, Hemabate should be used with caution in patients with previously compromised (scarred) uteri.

Prior treatment with, or concomitant administration of anti-emetics and antidiarrhoeal drugs significantly reduces the very high incidence of the gastrointestinal side effects common to all prostaglandins. Their use should be considered an integral part of the management of patients.

Transient pyrexia that may be due to hypothalamic thermoregulation has been observed after intramuscular Hemabate. Temperature elevations exceeding 1.1 °C were observed in approximately one-eighth of patients who received the recommended dosage regimen but if not complicated by endometritis, the temperature elevation will usually return to normal within several hours of the last injection.

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 Hemabate can cause similar bone effects.

Interactions

As Hemabate can potentiate the effect of other oxytocics, concomitant use is not recommended.

Adverse Reactions

The table below lists the adverse effects identified through clinical trials and post-marketing surveillance by System Organ Class (SOC) and frequency. Within each frequency grouping, adverse events are presented in order of decreasing seriousness. Frequencies are defined as: very common ( 1/10), common ( 1/100 to < 1/10), uncommon (1/1000 to < 1/100), or not known (cannot be estimated from the available data).

The adverse effects of Hemabate are generally transient and reversible on discontinuation of therapy. The most frequent adverse reactions observed are related to its contractile effect on smooth muscles.

* Events reported for both intramuscular and intra-amniotic routes of administration are marked with an asterisk. All other events were reported only for the intramuscular route.

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