Berodual N

Berodual N

ipratropium + fenoterol

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Per metered dose Ipratropium Br 20 mcg, fenoterol HBr 50 mcg
Indications/Uses
Bronchodilator for symptomatic prevention & treatment of chronic obstructive airway disorders w/ reversible airflow limitation (eg, bronchial asthma & chronic bronchitis w/ or w/o emphysema). Consider concomitant anti-inflammatory therapy in patient w/ bronchial asthma & steroid-responsive COPD.
Dosage/Direction for Use
Individualized dosage. Adult & childn >6 yr Acute asthma episodes 2 actuations. Severe cases May take 2 further actuations if breathing has not noticeably improved after 5 min. If an attack has not been relieved by 4 actuations, further actuations may be required. Intermittent & long-term treatment 1-2 actuations for each administration. Max: 8 actuations daily (ave: 1-2 actuations tds).
Contraindications
Hypersensitivity to fenoterol HBr or atropine-like substances. Hypertrophic obstructive cardiomyopathy & tachyarrhythmia.
Special Precautions
Immediate hypersensitivity reactions may occur after administration. Mouthpiece must never be used w/ any other metered aerosol; Berodual N must never be used w/ any other mouthpiece other than the one supplied. Container is under pressure; do not open by force or expose to temp >50°C. Discontinue immediately if paradoxical bronchospasm occurs. Patients predisposed to narrow-angle glaucoma; avoid contact w/ eyes. Carefully assess risk/benefit when higher doses are used in insufficiently controlled DM, recent MI, severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, 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. Patients w/ cystic fibrosis may be prone to GI motility disturbances. Advise patients to immediately consult physician in case of acute rapidly worsening dyspnoea. Prolonged use. Concomitant use w/ other sympathomimetic bronchodilators. May lead to +ve doping test results. Contains ethanol 13 mg in each actuation (equiv to <1 mL beer/wine). May experience undesirable effects (eg, dizziness, tremor, accommodation disorder, mydriasis & blurred vision) during treatment; may affect ability to drive & use machines. Pregnancy (especially 1st trimester) & lactation. Should only be used in childn upon medical advice & under adult supervision.
Adverse Reactions
Cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic BP & nervousness.
Drug Interactions
Chronic co-administration w/ other anticholinergics is not recommended. May enhance bronchodilatory effect w/ other β-adrenergics, anticholinergics & xanthine derivatives (eg, theophylline). Potentially serious reduction in bronchodilation w/ β-blockers. Induced hypokalaemia may be increased w/ xanthine derivatives, corticosteroids & diuretics. May increase susceptibility to arrhythmias w/ digoxin. May enhance action by MAOIs or TCAs. May increase susceptibility on CV effects w/ halogenated hydrocarbon anaesth inhalation (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 N MDI
Packing/Price
(200 puffs/10 mL) 1's ($19.35/box)
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