BRICANYL

Posology The dosage should be individualised. v. bolus. The preferred routes will usually be subcutaneous or intramuscular. v. bolus the injection must be made slowly noting patient response. 5 mg) up to four times a day. 3 mg total. 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. 3). 4). 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. 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. 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. 1 mg/ml (10 ml Bricanyl Injection should be added to 40 ml of 5% dextrose). 01 mg/ml (10 ml Bricanyl Injection should be added to 490 ml of 5% dextrose). 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.

The intensity of the adverse reactions depends on dosage and route of administration. An initial dose titration will often reduce the adverse reactions. Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment.

The frequency of side effects is low at the recommended doses. Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Bronchial asthma. Chronic bronchitis, emphysema and other lung diseases where bronchospasm is a complicating factor. g. 4) Vascular Disorders Not Known ^ Peripheral vasodilation Respiratory, Thoracic and Mediastinal Disorders Not Known ^ Paradoxical bronchospasm * Gastrointestinal Disorders Not Known ^ Nausea Mouth and throat irritation Skin and Subcutaneous Tissue Disorders Not Known ^ Urticaria Rash Musculoskeletal and Connective Tissue Disorders # Common Muscle spasms ^ Reported spontaneously in post-marketing data and therefore frequency regarded as unknown * In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation.

This should be immediately treated with a rapid-onset bronchodilator. Bricanyl therapy should be discontinued and after assessment, an alternative therapy initiated. # A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.

Preterm labour The most common undesirable effects of Bricanyl are correlated with the betamimetic pharmacological activity and may be limited or avoided by a close monitoring of haemodynamic parameters, such as blood pressure and heart rate, and an appropriate adjustment of the dose.

They normally recede upon therapy discontinuation. g. 4). * In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation. This should be immediately treated with a rapid-onset bronchodilator.

Bricanyl therapy should be discontinued and after assessment, an alternative therapy initiated. # A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

As for all beta2-agonists caution should be observed in patients with thyrotoxicosis. Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists.

Due to the positive inotropic effect of the beta2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy. g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bricanyl should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.

Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin. Due to the hyperglycaemic effects of beta2-agonists, additional blood glucose controls are recommended initially in diabetic patients.

Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. 5). It is recommended that serum potassium levels are monitored in such situations.

If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication).

Severe exacerbations of asthma should be treated as an emergency in the usual manner. 8). In patients not adequately responding to acute Bricanyl therapy, consideration should be given to the presence of lactic acidosis as a possible contributing factor to ongoing respiratory symptoms.

Tocolysis Any decision to initiate therapy with Bricanyl should be undertaken after careful consideration of the risks and benefits of treatment. Treatment should only be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetal health status.

Tocolysis with beta-agonists is not recommended when membranes have ruptured or the cervix dilation is beyond 4 cm. Bricanyl should be used with caution in tocolysis and supervision of cardiorespiratory function and ECG monitoring, should be performed throughout treatment.

The following monitoring measures must be constantly applied to the mother and, when feasible/appropriate, to the foetus: • Blood pressure and heart rate. • ECG. • Electrolyte and fluid balance–to monitor for pulmonary oedema. • Glucose and lactate levels–with particular regard to diabetic patients- during treatment of preterm labour, when high doses of Bricanyl are used, diabetic mothers may develop hyperglycaemia and lactacidosis.

In these patients glucose and acid-base balance should be carefully monitored. 5). Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop. g. 3). In premature labour in a patient with known or suspected cardiac disease, a physician experienced in cardiology should assess the suitability of treatment before intravenous infusion with Bricanyl.

) in patients treated with Bricanyl solution for injection for preterm labour. Pulmonary oedema As maternal pulmonary oedema and myocardial ischaemia have been reported during or following treatment of premature labour with beta- agonists, careful attention should be given to fluid balance and cardio- respiratory function.

Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema. v. infusion will limit risk of fluid overload. 8). Blood pressure and heart rate Increases in maternal heart rate of the order of 20 to 50 beats per minute usually accompany infusion of beta-agonists.

The maternal pulse rate should be monitored and the need to control such increases by dose reduction or drug withdrawal should be evaluated on a case by case basis. Generally maternal pulse rate should not be allowed to exceed a steady rate of 120 beats per minute.

Maternal blood pressure may fall slightly during the infusion; the effect being greater on diastolic than on systolic pressure. Falls in diastolic pressure are usually within the range of 10 to 20 mmHg. The effect of infusion on foetal heart rate is less marked, but increases of up to 20 beats per minute may occur.

In order to minimise the risk of hypotension associated with tocolytic therapy, special care should be taken to avoid caval compression by keeping the patient in the left or right lateral positions throughout the infusion. Diabetes Administration of beta agonists is associated with a rise of blood glucose.

5). […]

1. In the treatment of premature labour Bricanyl is contraindicated in the following conditions: • A gestational age of < 22 weeks. • As a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.

• Threatened abortion during the 1st and 2nd trimester. g. severe toxaemia, intrauterine infection, vaginal bleeding resulting from placenta praevia, eclampsia or severe preeclampsia, placental abruption, or cord compression. • Intrauterine foetal death, known lethal congenital or lethal chromosomal malformation.

g. g. aortic stenosis.