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| Content: |
| Per puff of Berodual MDI Ipratropium Br 0.02 mg, fenoterol HBr 0.05 mg. Per mL Berodual soln Ipratropium Br 0.25 mg, fenoterol HBr 0.5 mg. Per Berodual Forte unit dose vial (UDV) Ipratropium Br 0.5 mg, fenoterol HBr 1.25 mg |
Dosage and Administration
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The dosage should be adapted to the individual requirements; patients should also be kept under medical observation during treatment. Unless otherwise prescribed, the following dosages are recommended.
Berodual: Metered-Dose Inhaler: Adults and Children >6 years: Acute Asthma Episodes: 2 puffs are sufficient for prompt symptom relief in many cases. In more severe cases, if breathing has not noticeably improved after 5 min, 2 further puffs may be taken.
If an attack has not been relieved by 4 puffs, further puffs may be required. In these cases, patients should consult the doctor or the nearest hospital immediately.
Intermittent and Long-Term Treatment: 1-2 puffs for each administration, up to a maximum of 8 puffs/day (average 1-2 puffs 3 times daily).
In children, Berodual metered aerosol should only be used on medical advice and under the supervision of an adult.
Solution: Acute Asthma Episodes: Adults (Including the Elderly) and Adolescents >12 years: 1 mL (20 drops) is sufficient for prompt symptom relief in many cases of mild to moderate exacerbations.
In particular severe cases eg, for patients in the emergency room not responding to the doses mentioned, higher doses up to 2.5 mL (50 drops) may be required.
For particular severe cases, up to 4 mL (80 drops) may be administered under medical supervision.
Intermittent and Long-Term Treatment: If repeated dosing is required, 1-2 mL (20-40 drops) for each administration, up to 4 times daily.
In cases of moderate bronchospasm or with assisted ventilation, a dose in the lower range of 0.5 mL (10 drops) is recommended.
Children 6-12 years: 0.5-1 mL (10-20 drops) is sufficient for prompt symptom relief in many cases.
In severe cases, higher doses up to 2 mL (40 drops) may be required.
For particular severe cases, up to 3 mL (60 drops) may be administered under medical supervision.
Intermittent and Long-Term Treatment: If repeated dosing is required, 0.5-1 mL (10-20 drops) for each administration, up to 4 times daily.
In cases of moderate bronchospasm or with assisted ventilation, a dose in the lower range of 0.5 mL (10 drops) is recommended.
Children <6 years (<22 kg body weight): Because there is limited information in this age group, the following dose is recommended to be given under medical supervision only:
About 25 mcg ipratropium bromide and 50 mcg fenoterol HBr per kg body weight per dose up to 0.5 mL (10 drops) up to 3 times daily.
Treatment should usually be started with the lowest recommended dose.
The recommended dose is to be diluted with physiological saline to a final volume of 3-4 mL and nebulized and inhaled until the solution is consumed.
Berodual solution may, however, not be diluted with distilled water.
The solution should be re-diluted each time before use; any residual diluted solution should be discarded.
Dosage may be dependent upon the mode of inhalation and the quality of the nebulization. The duration of inhalation can be controlled by the dilution volume.
Berodual solution can be administered using a range of commercially available nebulizing devices. Where wall oxygen is available, the solution is best administered at a flow rate of 6-8 L/min.
The dose may be repeated after intervals of at least 4 hrs, if required.
Berodual Forte: The solution is ready for use and requires no dilution.
Adults (Including the Elderly) and Children >12 years: Acute Asthma Episodes: 1 unit-dose vial is sufficient for prompt symptom relief in most cases, typically the hospital-based treatment of moderate to severe asthma attacks or the home- and hospital-based treatment of patients with moderate to severe COPD. If in very severe cases, 2 unit-dose vials are required for symptom relief, these should be administered under medical supervision.
Intermittent and Long-Term Treatment: 1 unit-dose vial up to 4 times daily.
Berodual Forte can be administered using a range of commercially available nebulizing devices. Where wall oxygen is available, the solution is best administered at a flow rate of 6-8 L/min.
Administration: Metered-Dose Inhaler: Instruction for Use: The correct administration of the metered-dose inhaler apparatus is essential for successful therapy.
Depress the valve twice before the metered aerosol is used for the first time.
Before each use, the following rules should be observed:
Remove the protective cap. Breathe out deeply. Hold the metered-dose inhaler and close lips around the mouthpiece. The arrow and the base of the container should be pointing upwards.
Breathe in as deeply as possible, pressing the base of the container firmly at the same time; this releases 1 metered dose. Hold the breath for a few seconds, then remove the mouthpiece from the mouth and breathe out.
The same action should be repeated for a 2nd inhalation.
Replace the protective cap after use.
If the metered aerosol has not been used for >3 days, the valve has to be actuated once.
The mouthpiece should always be kept clean and can be washed with warm water. If soap or detergent is used, the mouthpiece should be thoroughly rinsed in clean water.
Warning: The plastic mouthpiece has been specially designed for use with Berodual to ensure that the right amount of the medicine is delivered. The mouthpiece must never be used with any other aerosol nor must the Berodual metered aerosol be used with any mouthpiece other than the one supplied with the product.
The container is under pressure and should by no account be opened by force or exposed to temperatures above 50°C.
The solution is intended only for inhalation with suitable nebulizing devices and should not be taken orally. The diluted solution should be inhaled directly after preparation of the solution. Patients should follow the instructions provided by the manufacturer of the nebulizing device for proper care, maintenance and cleaning of the equipment.
Solution: The unit-dose vials are intended only for inhalation with suitable nebulizing devices and should not be taken orally or administered parenterally.
Prepare the nebulizer for filling, according to the instructions provided by the manufacturer or doctor.
Tear 1 unit-dose vial from the strip.
Open the unit-dose vial by firmly twisting the top.
Squeeze the contents of the unit-dose vial into the nebulizer reservoir.
Assemble the nebulizer and use as directed.
After use, throw away any solution left in the reservoir and clean the nebulizer, following the manufacturer's instructions. |
| Overdosage |
Symptoms: The effects of overdosage are expected to be primarily related to fenoterol.
The expected symptoms with overdosage are those of excessive β-adrenergic stimulation, the most prominent being tachycardia, palpitation, tremor, hypertension, hypotension, widening of the pulse pressure, anginal pain, arrhythmias and flushing.
Expected symptoms of overdosage with ipratropium bromide (eg, dry mouth, visual accommodation disturbances) are mild because the systemic availability of inhaled ipratropium is very low.
Treatment: Administration of sedatives, tranquilizers, in severe cases intensive therapy.
Beta-receptor blockers, preferably β1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma or COPD because of the risk of precipitating severe bronchospasm, which may be fatal. |
| Contraindications: |
Hypertrophic obstructive cardiomyopathy and tachyarrhythmia. Hypersensitivity to fenoterol HBr or atropine-like substances, or to any of the excipients of Berodual/Forte.
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| 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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