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Berodual F UDV

Berodual F UDV

ipratropium + fenoterol

Manufacturer:

Laboratoire Unither

Distributor:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Per 4 mL unit dose vial (UDV) Fenoterol HBr 1.25 mg, ipratropium Br monohydrate 500 mcg
Indications/Uses
Prevention & treatment of symptoms in chronic obstructive airway disorders w/ reversible airflow limitation eg, bronchial asthma & especially chronic bronchitis w/ or w/o emphysema.
Dosage/Direction for Use
Adult (including elderly) & adolescent >12 yr Acute episodes of bronchospasm 1 vial for prompt relief. Very severe cases 2 vials may be required for symptom relief.
Contraindications
Hypersensitivity to fenoterol HBr or atropine-like substances. Hypertrophic obstructive cardiomyopathy & tachyarrhythmia.
Special Precautions
Immediate hypersensitivity reactions after administration eg, rare cases of urticaria, angiooedema, rash, bronchospasm, oropharyngeal oedema & anaphylaxis. Discontinue immediately & substitute w/ alternative therapy if paradoxical bronchospasm occurs. Patients predisposed to narrow-angle glaucoma. Reports of ocular complications (ie, mydriasis, increased IOP, narrow-angle glaucoma, eye pain) when aerosolised ipratropium Br either alone or in combination w/ adrenergic β2-agonist, has come in contact w/ eyes. Do not allow product to enter the eyes. Insufficiently controlled DM, recent MI, severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, or w/ pre-existing urinary outflow tract obstruction (eg, prostatic hyperplasia or bladder-neck obstruction). Patients w/ underlying severe heart disease (eg, ischaemic heart disease, arrhythmia or severe heart failure). Potentially serious hypokalaemia; GI motility disturbances in patients w/ cystic fibrosis; acute, rapidly worsening dyspnoea. Prolonged use. Review patient's therapy plan, & in particular the adequacy of anti-inflammatory therapy w/ inhaled corticosteroid to prevent potentially life threatening deterioration of disease control. Concomitant use w/ other sympathomimetic bronchodilators. Monitor serum K levels in situations when hypokalaemia increased susceptibility to arrhythmias in patients receiving digoxin & when hypoxia may aggravate effects of hypokalaemia on cardiac rhythm. +ve results w/ regard to fenoterol in tests for non-clinical substance abuse eg, doping. May experience dizziness, tremor, accommodation disorder, mydriasis & blurred vision during treatment; advise caution when driving a car or operating machinery. Pregnancy (especially during 1st trimester) & lactation. Not recommended in childn ≤12 yr.
Adverse Reactions
Cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic BP & nervousness.
Drug Interactions
Coadministration w/ other anticholinergic drugs is not recommended. Enhanced bronchodilatory effect w/ other β-adrenergics & anticholinergics & xanthine derivatives (eg, theophylline). Increased adverse reactions w/ other β-mimetics, systemically available anticholinergics & xanthine derivatives (eg, theophylline). Potentially serious reduction in bronchodilation during concurrent administration of β-blockers. Hypokalaemia induced by β2-agonists may be increased by concomitant treatment w/ xanthine derivatives, corticosteroids, & diuretics. Hypokalaemia may result in increased susceptibility to arrhythmias in patients receiving digoxin. Enhanced action of β-adrenergic agonists w/ MAOIs or TCAs. Increased susceptibility on CV effects of β-agonists w/ halogenated hydrocarbon anaesth eg, halothane, trichloroethylene & enflurane.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AL01 - fenoterol and ipratropium bromide ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Berodual F UDV soln for inhalation
Packing/Price
(unit dose vial) 4 mL x 20 × 1's
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