Berodual/Berodual Forte

Berodual/Berodual Forte Special Precautions

ipratropium + fenoterol

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
When using the new formulation of Berodual metered aerosol for the first time, some patients may notice that the taste is slightly different from that of the CFC-containing formulation. Patients should be made aware of this when changing from one formulation to the other. They should also be told that the formulations have been shown to be interchangeable for all practical purposes and that the difference in taste has no consequences in terms of the safety or the efficacy of the new formulation.
In the case of acute, rapidly worsening dyspnea (difficulty in breathing), a doctor should be consulted immediately.
Prolonged Use: In patients with bronchial asthma and mild COPD, on demand (symptom-oriented) treatment may be preferable to regular use.
The addition or the increase of anti-inflammatory therapy to control airway inflammation and to prevent deterioration of disease control should be considered for patients with bronchial asthma and with steroid-responsive COPD.
The use of increasing amounts of β2-agonists-containing products on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. If bronchial obstruction deteriorates, it is inappropriate and possibly hazardous to simply increase the use of β2-agonist-containing products beyond the recommended dose over extended periods of time. In this situation, the patient's therapy plan, and in particular, the adequacy of anti-inflammatory therapy with inhaled corticosteroids, should be reviewed to prevent potentially life-threatening deterioration of disease control. Other sympathomimetic bronchodilators should only be used with Berodual/Forte under medical supervision.
In the following conditions, Berodual/Forte 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, pheochromocytoma.
Potentially serious hypokalemia may result from β2-agonist therapy.
Berodual/Forte should be used with caution in patients with prostatic hyperplasia or bladder-neck obstruction or predisposed to narrow-angle glaucoma.
There have been isolated reports of ocular complications (ie, mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolized ipratropium bromide either alone or in combination with an adrenergic β2-agonist was sprayed into the eyes. Thus, patients must be instructed in the correct administration of Berodual metered aerosol. Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist's advice sought immediately.
Patients must be instructed in the correct administration of Berodual/Forte solution. Care must be taken not to allow the solution or mist to enter into the eyes. It is recommended that the nebulized solution be administered via a mouthpiece. If this is not available and a nebulizer mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Immediate hypersensitivity reactions may occur after administration of Berodual/Forte, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema and anaphylaxis.
Use in Pregnancy & Lactation: Preclinical data, combined with available experience in humans have shown no evidence of ill-effects in pregnancy of fenoterol or ipratropium. 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 HBr is excreted into breast milk. It is not known whether ipratropium is excreted in breast milk. But it is unlikely that ipratropium would reach the infant to an important extent, especially when taken by aerosol. However, because many drugs are excreted in breast milk, caution should be exercised when Berodual/Forte is administered to a nursing woman.
Use in Children: Berodual metered-dose inhaler should only be used on medical advice and under the supervision of an adult. Because of insufficient information, the general use of Berodual Forte in children <12 years is not recommended.
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