Berotec Special Precautions

Paradoxical bronchospasm: If paradoxical bronchospasm occurs, should be discontinued immediately and substituted with an alternative therapy.
Other sympathomimetic bronchodilators should only be used with Berotec HFA 100 mcg/Berotec Solution 0.1% under strict medical supervision. Anticholinergic bronchodilators may, however, be inhaled at the same time.
In the following conditions, Berotec HFA 100 mcg/Berotec Solution 0.1% should only be used after careful risk/benefit assessment, especially when doses higher than recommended are used: Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism and phaeochromocytoma.
In the case of acute, rapidly worsening dyspnea (difficulty in breathing), a physician should be consulted immediately.
Prolonged Use: On demand (symptom-oriented) treatment is preferable to regular use. Patients must be evaluated for the addition or the increase of anti-inflammatory therapy (eg, inhaled corticosteroids) to control airway inflammation and to prevent long-term lung damage.
If bronchial obstruction deteriorates, it is inappropriate and possibly hazardous to simply increase the use of β₂-agonist-containing drugs eg, Berotec HFA 100 mcg/Berotec Solution 0.1% beyond the recommended dose over extended periods of time. The use of increasing amounts of β₂-agonist-containing products like Berotec HFA 100 mcg/Berotec Solution 0.1% on regular basis to control symptoms of bronchial obstruction may suggest declining disease control. In this situation, the patient's therapy plan and, in particular, the adequacy of anti-inflammatory therapy, should be reviewed to prevent potentially life-threatening deterioration of disease control.
Potentially serious hypokalemia may result from β₂-agonist therapy. Particular caution is advised in severe asthma, as this effect may be potentiated by concomitant treatment with xanthine derivatives, glucocorticosteroids and diuretics.
Additionally, hypoxia may aggravate the effects of hypokalemia on cardiac rhythm. Hypokalaemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin.
It is recommended that serum potassium levels are monitored in such situations.
Cardiovascular effects may be seen with sympathomimetic drugs, including Berotec. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with β-agonists.
Patients with underlying severe heart disease (eg, ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Berotec should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.
Attention should be paid to the assessment of symptoms eg, dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Effects on the Ability to Drive or Operate Machinery: No studies on the effect on the ability to drive and use machines have been performed. However, patients should be advised that symptoms eg, dizziness have been reported in clinical trials. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience such symptoms, they should avoid potentially hazardous tasks eg, driving or operating machinery.
Impairment of Fertility: Clinical data in fertility are not available for fenoterol. Nonclinical studies performed with fenoterol showed no adverse effect on fertility (see Toxicology).
Use in pregnancy & lactation: Preclinical data, combined with available experience in humans, have shown no evidence of ill effects in pregnancy. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the 1st trimester, should be exercised.
The inhibitory effect of fenoterol on uterine contraction should be taken into account.
Preclinical studies have shown that fenoterol is excreted into breast milk. Safety during lactation has not been established.