Berodual MDI/Berodual F UDV

Berodual MDI/Berodual F UDV Special Precautions

ipratropium + fenoterol

Manufacturer:

Boehringer Ingelheim

Distributor:

Metro Drug
Full Prescribing Info
Special Precautions
In the case of acute, rapidly worsening dyspnea (difficulty in breathing), the 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-agonist-containing products eg, Berodual/F UDV 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 eg, Berodual/F UDV, 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/F UDV under medical supervision.
In the following conditions, Berodual/F UDV 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 pheochromocytoma.
Potentially serious hypokalemia may result from β2-agonist therapy.
Berodual/F UDV should be used with caution in patients with prostatic hypertrophy 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 and corneal congestion may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Patients must be instructed in the correct administration of Berodual inhalation 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.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Genotoxicity and carcinogenicity studies were not conducted with Berodual/F UDV. But in vitro and in vivo assays revealed that neither fenoterol HBr nor ipratropium bromide have a mutagenic potential.
Besides carcinogenicity, studies over 2 years with inhalative administration of fenoterol HBr in rats with doses up to 2 mg/kg/day and with oral administration of ipratropium bromide in mice and rats with doses up to 6 mg/kg/day revealed no pathological effects.
After oral administration of very high doses of fenoterol HBr (25 mg/kg/day), uterine leiomyoma in mice and mesovarian leiomyoma in rats occurred. These results can be explained by the pharmacodynamic effects of this type of compound at the β-receptors of the uterine smooth muscle.
Epidemiologically, there is no indication that comparable tumors develop in humans under therapeutic conditions.
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 Berodual/F UDV 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. Although lipid-insoluble quaternary bases pass into breast milk, 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/F UDV is administered to a nursing woman.
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