Berodual Uses

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Berodual indications

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BERODUAL is a bronchodilator for the prevention and treatment of symptoms in chronic obstructive airway disorders with reversible airflow limitation such as bronchial asthma and especially chronic bronchitis with or without emphysema. Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid responsive chronic obstructive pulmonary disease (COPD).

Berodual description

Each mL of inhalation solution contains Fenoterol/Ipratropium Bromide 250 mcg (corresponding to anhydrous Berodual 260 mcg) and Berodual HBr 500 mcg.

Berodual is (8r)-3α-hydroxy-8-isopropyl-1αH,5αH-tropanium bromide (±)-tropate monohydrate.

Berodual HBr is 1-(3,5-dihydroxy-phenyl)-2-[[1-(4-hydroxy-benzyl)-ethyl]-amino]-ethanol hydrobromide.

Berodual is a clear, colourless or almost colourless solution.

Berodual dosage

Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in patients when a low dose rapid acting beta-agonist bronchodilator such as Berodual metered dose inhaler has been insufficient in providing relief after consultation with an experienced physician. It can also be recommended in patients who are in need for nebuliser treatment for other reasons e.g. handling issues of metered dose inhaler or requirement of higher doses in experienced patients. The treatment with the solution for inhalation should always be started with the lowest recommended dose. The dosage should be adapted to the individual requirements and tailored according to the severity of the acute episode. Administration should be stopped when sufficient symptom relief is achieved.

Adults (Including Elderly) and Adolescents ≥12 Years of Age: Acute Episodes of Bronchospasm: Depending on the severity of the acute episode doses ranging between 261 mcg Berodual/500 mcg Berodual hydrobromide (i.e.1 mL=20 drops) and 652.5 mcg Berodual/1250 mcg Berodual hydrobromide (i.e.2.5 mL =50 drops) may be used. In exceptional particular severe cases doses up to 1,044 mcg Berodual/2,000 mcg Berodual hydrobromide (i.e. 4 mL=80 drops) may be used.

Children 6-12 Years: Acute Asthma Episodes: Depending on the severity of the acute episode and age doses ranging between 130.5 mcg Berodual/250 mcg Berodual hydrobromide (i.e. 0.5 mL=10 drops) and 522 mcg Berodual/1,000 mcg Berodual hydrobromide (i.e. 2 mL=40 drops) may be used.

Children <6 Years (Below 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 26.1 mcg Berodual/ 50 mcg Berodual hydrobromide (i.e. 0.1 mL=2 drops) per kg body weight = up to a maximum of 0.5 mL (=10 drops).

Instructions For Use: The solution for inhalation is intended only for inhalation with suitable nebulising devices and must not be taken orally.

The recommended dose is to be diluted with physiological saline to a final volume of 3-4 mL and nebulised and inhaled until sufficient symptom relief is achieved. BERODUAL solution for inhalation may, however, not be diluted with distilled water.

The solution should be freshly diluted each time before use; any residual diluted solution should be discarded. The diluted solution should be inhaled directly after preparation of the solution.

The duration of inhalation can be controlled by the dilution volume.

BERODUAL solution for inhalation can be administered using a range of commercially available nebulising devices. The lung and systemic drug exposure is dependent on the nebulizer used and may be higher than with BERODUAL metered dose aerosol HFA and CFC depending on the efficiency of the device.

Where wall oxygen is available the solution is best admininistered at a flow rate of 6-8 litres per minute.

The instructions provided by the manufacturer of the nebulising device for proper care, maintenance and cleaning of the equipment should be followed.

Berodual interactions

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The chronic co-administration of BERODUAL with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of BERODUAL with other anticholinergic drugs is not recommended.

Other beta-adrenergics and anticholinergics and xanthine derivatives (such as theophylline) may enhance the bronchodilatatory effect. The concurrent administration of other beta-mimetics, systemically available anticholinergics and xanthine derivatives (e.g. theophylline) may increase the adverse reactions.

A potentially serious reduction in bronchodilatation may occur during concurrent administration of beta-blockers.

Hypokalaemia induced by beta2-agonist may be increased by concomitant treatment with xanthine derivatives, corticosteroids, and diuretics. This should be taken into account particularly in patients with severe airway obstruction.

Hypokalaemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. Additionally, hypoxia may aggravate the effects of hypokalaemia on cardiac rhythm. It is recommended that serum potassium levels are monitored in such situations.

Beta2-agonist containing medicinal products should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta-adrenergic agonists may be enhanced.

Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility on the cardiovascular effects of beta-agonists.

Berodual side effects

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Adverse reactions of Berodual are nervousness, dryness of the mouth, headache, dizziness and fine tremor of skeletal muscles. Tachycardia, increased heart rate and palpitations may occur. Gastrointestinal motility disturbances (eg, vomiting, constipation, diarrhoea) and urinary retention albeit reversible have been reported.

Ocular side effects (including accommodation disturbances and glaucoma) may occur. Skin reactions or allergic-type reactions eg, skin rash, angio-oedema of the tongue, lips and face, urticaria, laryngospasm and anaphylactic reactions have been reported. Potentially serious hypokalaemia may result from β2-agonist therapy.

As with other β-agonist-containing products, nausea, vomiting, sweating, weakness and myalgia/muscle cramps may occur. Decrease in diastolic blood pressure and increase in systolic blood pressure have been observed. Arrhythmias (particularly after higher doses), atrial fibrillation, supraventricular tachycardia and myocardial ischaemia may occur.

In individual cases, psychological alterations have been reported under inhalational therapy with β-agonist-containing products.

As with use of other inhalation therapy, cough, local irritation (eg, pharyngitis, throat irritation) and inhalation-induced bronchospasm have been reported.

Berodual contraindications

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BERODUAL is contraindicated in patients with known hypersensitivity to Berodual hydrobromide or atropine-like substances or to any of the excipients of the product. BERODUAL is also contraindicated in patients with hypertrophic obstructive cardiomyopathy and tachyarrhythmia.

Active ingredient matches for Berodual:

Fenoterol/Ipratropium Bromide in Argentina, Austria, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, El Salvador, Estonia, Georgia, Germany, Guatemala, Honduras, Hungary, Indonesia, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Philippines, Poland, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Thailand, Venezuela, Vietnam.

Fenoterol in Latvia.

Fenoterol HBr/ipratropium Br in Singapore.

Fenoterol Hbr/Ipratropium Bromide

Ipratropium Bromide in Denmark.


Unit description / dosage (Manufacturer)Price, USD
Solution; Inhalation; Fenoterol Hydrobromide 0.5 mg; Ipratropium Bromide 0.25 mg / ml
Berodual 20 mL$ 12.81
Berodual N 200 doses
Berodual 10 mL$ 30.62
Berodual F UDV / unit dose vial 4 mL x 20's$ 27.78
Berodual 200 puff/10 mL
Berodual 20 mL
Berodual Forte / unit dose vial 4 mL x 20's
Berodual 10 mL x 1's$ 15.69
Berodual 20 mL x 1's$ 19.65
Berodual 1 tube
Berodual inhalation soln 20 mL x 1's (Boehringer Ingelheim)$ 19.65

List of Berodual substitutes (brand and generic names):

Solution; Inhalation; Fenoterol Hydrobromide 50 mcg; Ipratropium Bromide 20 mcg / ml
Berodual F UDV inhalation soln / unit dose vial 4 mL x 20 x 1's (Boehringer Ingelheim)$ 35.16
Berodual MDI 10 mL x 1's (Boehringer Ingelheim)$ 38.78
Aerosol, Metered-Dose; Inhalation; Fenoterol Hydrobromide 50 mcg; Ipratropium Bromide Monohydrate 20 mcg (Boehringer Ingelheim)
Aerosol, Metered-Dose; Inhalation; Fenoterol Hydrobromide; Ipratropium Bromide (Boehringer Ingelheim)
Berodual N 10ml 200doses - 1 Inhaler (Boehringer Ingelheim)$ 33.00
Berodual N 200 puff x 1's (Boehringer Ingelheim)$ 19.35
Berodual N 200 puff/10 mL (Boehringer Ingelheim)$ 12.67
Berodual N MDI / 10 mL 200 puff x 1's (Boehringer Ingelheim)$ 19.35
Berodual N MDI / 200 puff/10 mL 1's (Boehringer Ingelheim)
Berodual soln 20 mL x 1's (Boehringer Ingelheim)
Berodual MDI 10 mL x 1's (Boehringer Ingelheim)
Berodual Forte nebuliser soln / unit dose vial 4 mL x 20 x 1's (Boehringer Ingelheim)
Berogin 2.5 mg
Aerosol, Metered-Dose; Fenoterol Hydrobromide 100 mcg / dose (Boehringer Ingelheim)
Solution; Inhalation; Fenoterol Hydrobromide 1 mg / ml (Boehringer Ingelheim)
Tablet; Oral; Fenoterol Hydrobromide 2.5 mg (Boehringer Ingelheim)
Berotec N 100 mcg/1 puff x 200 doses (Boehringer Ingelheim)
Berotec 1.25 mg/2 mL x 20's (Boehringer Ingelheim)
Berotec 100 mcg/1 puff x 10 mL x 1's (Boehringer Ingelheim)$ 14.44
Berotec 0.1 % x 50 mL x 1's (Boehringer Ingelheim)$ 24.17
Berotec 100 mcg x 1 Bottle 10 mL töông öùng vôùi 200 lieàu xòt (Boehringer Ingelheim)
Aerosol, Metered-Dose; Inhalation; Oral; Fenoterol Hydrobromide 0.2 mg / dose
Capsule; Inhalation; Fenoterol Hydrobromide
Solution; Inhalation; Oral; Fenoterol Hydrobromide 1 mg / ml
Aerosol, Metered-Dose; Inhalation; Oral; Fenoterol Hydrobromide 0.1 mg / dose (Boehringer Ingelheim)
Aerosol, Metered-Dose; Inhalation; Fenoterol Hydrobromide 100 mcg / dose (Boehringer Ingelheim)
Berotec N 100mg/dose 200doses 10ml - 1 Aerosol (Boehringer Ingelheim)$ 24.00
Berotec N 100 mcg/1 puff x 200 puffs/10 mL (Boehringer Ingelheim)$ 6.30
Berotec N 100 mcg/1 puff x 200 puff x 1's (Boehringer Ingelheim)$ 10.10
Berotec N inhaler 100 mcg/puff / 200 puffs/10 mL 1's (Boehringer Ingelheim)

References

  1. DailyMed. "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "ipratropium". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "ipratropium bromide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Berodual are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Berodual. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported useful

Was the Berodual drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful1
100.0%


1 consumer reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Berodual drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Not expensive1
100.0%


3 consumers reported time for results

To what extent do I have to use Berodual before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Berodual. To get the time effectiveness of using Berodual drug by other patients, please click here.
Users%
1 month1
33.3%
> 3 month1
33.3%
2 weeks1
33.3%


13 consumers reported age

Users%
> 6010
76.9%
6-152
15.4%
16-291
7.7%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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