BRICANYL Solution for injection or infusion Ref.[7931] Active ingredients: Terbutaline

Posology

The dosage should be individualised.

For bronchodilation

When a rapid therapeutic response is required, Bricanyl can be administered by any of the three standard parenteral routes: subcutaneous, intramuscular, or i.v. bolus. The preferred routes will usually be subcutaneous or intramuscular. When given as an i.v. bolus the injection must be made slowly noting patient response.

Adults

0.5-1 ml (0.25 – 0.5 mg) up to four times a day.

Paediatric population

Children 2-15 years: 0.01 mg/kg body weight to a maximum of 0.3 mg total.

By infusion: 3-5 ml (1.5-2.5 mg) in 500 ml 5% dextrose, saline or dextrose/saline given by continuous intravenous infusion at a rate of 10-20 drops (0.5-1 ml) per minute for 8 to 10 hours. A corresponding reduction in dosage should be made for children.

Elderly

Dosage as for adults.

In the short term management of uncomplicated premature labour

Treatment with Bricanyl should only be initiated by obstetricians/physicians experienced in the use of tocolytic agents. It should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetus health status.

Duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours; no statistically significant effect on perinatal mortality or morbidity has been observed in randomised, controlled trials. This short term delay may be used to implement other measures known to improve perinatal health.

Bricanyl should be administered as early as possible after the diagnosis of premature labour, and after evaluation of the patient to eliminate any contraindications to the use of terbutaline (see section 4.3). This should include an adequate assessment of the patient’s cardiovascular status with supervision of cardiorespiratory function and ECG monitoring throughout treatment (see section 4.4).

Initially, 5 mcg/min should be infused during the first 20 minutes increasing by 2.5 mcg/min at 20 minute intervals until the contractions stop. More than 10 mcg/min should seldom be given, 20 mcg/min should not be exceeded.

The infusion should be stopped if labour progresses despite treatment at the maximum dose.

If successful, the infusion should continue for 1 hour at the chosen rate and then be decreased by 2.5 mcg/min every 20 minutes to the lowest dose that produces suppression of contractions.

Special cautions for infusion: The dose must be individually titrated with reference to suppression of contractions, increase in pulse rate and changes in blood pressure, which are limiting factors. These parameters should be carefully monitored during treatment. A maximum maternal heart rate of 120 beats per min should not be exceeded.

Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema (see section 4.4). The volume of fluid in which the drug is administered should thus be kept to a minimum. A controlled infusion device should be used, preferably a syringe pump.

Dilution:

The recommended infusion fluid is 5% dextrose. If a syringe pump is available, the concentration of the drug infused should be 0.1 mg/ml (10 ml Bricanyl Injection should be added to 40 ml of 5% dextrose).

At this dilution:

5 mcg/min ≡ 0.05 ml/min and

10 mcg/min ≡ 0.1 ml/min

If no syringe pump is available, the concentration of the drug should be 0.01 mg/ml (10 ml Bricanyl Injection should be added to 490 ml of 5% dextrose).

At this dilution:

5 mcg/min ≡ 0.5 ml/min and

10 mcg/min ≡ 1 ml/min.

Saline should be avoided during pregnancy since the use of this diluent may increase the risk of producing pulmonary oedema. If saline has to be used, the patients should be carefully monitored.

Method of administration

Parenteral – subcutaneous, intramuscular, intravenous.

i) Symptoms

Headache, anxiety, tremor, nausea, tonic cramps, palpitations, tachycardia and arrhythmia. A fall in blood pressure sometimes occurs. Laboratory findings: hypokalaemia, hyperglycaemia and lactic acidosis sometimes occur (see section 4.4).

ii) Management

Mild and moderate cases: Reduce the dose.

Severe cases: Determination of acid-base balance, blood sugar and electrolytes, particularly serum potassium levels. Monitoring of heart rate and rhythm and blood pressure. Metabolic changes should be corrected. A cardioselective beta-blocker (e.g. metoprolol) is recommended for the treatment of arrhythmias causing haemodynamic deterioration. The beta-blocker should be used with care because of the possibility of inducing bronchoconstriction: use with caution in patients with a history of bronchospasm. If the beta2-mediated reduction in peripheral vascular resistance significantly contributes to the fall in blood pressure, a volume expander should be given.

In preterm labour:

Pulmonary oedema: discontinue administration of Bricanyl. A normal dose of loop diuretic (e.g. frusemide) should be given intravenously.

Increased bleeding in connection with Cesarean section: propranolol, 1-2 mg intravenously.

2 years.

Do not store above 25°C. Keep in the outer carton.

Packs of 5 × 1ml glass ampoules.

Packs of 10 × 5ml glass ampoules.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Bronchodilation: the recommended diluent is 5% dextrose, saline or dextrose/saline.

In the management of premature labour, the recommended infusion fluid is 5% dextrose. Saline should be avoided due to the risk of pulmonary oedema. If saline is used, the patient should be carefully monitored.