Berodual N Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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 & especially chronic bronchitis w/ or w/o emphysema, consider concomitant anti-inflammatory therapy in patients w/ bronchial asthma & steroid-responsive COPD.

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Dosage/Direction for Use

Adult & childn >6 yr Acute asthma 2 actuations. Severe cases 2 further actuations may be taken if breathing has not noticeably improved after 5 min. Further actuations may be required if an attack has not been relieved by 4 actuations. Intermittent & long-term treatment 1-2 actuations for each administration. Max: 8 actuations daily (ave: 1-2 actuations tds).

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Overdosage

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Contraindications

Hypersensitivity to fenoterol HBr or atropine-like substances. Hypertrophic obstructive cardiomyopathy, tachyarrhythmia.

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Warnings

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Special Precautions

Hypersensitivity. Discontinue use if paradoxical bronchospasm occurs. Patients predisposed to narrow-angle glaucoma; insufficiently controlled DM, recent MI, severe organic heart or vascular disorders, hyperthyroidism, phaeochromocytoma, preexisting urinary outflow tract obstruction eg, prostatic hyperplasia or bladder-neck obstruction; underlying severe heart disease eg, ischaemic heart disease, arrhythmia or severe heart failure; hypokalaemia; cystic fibrosis; acute, rapidly worsening dyspnoea. Avoid contact w/ eyes. Positive doping test result. Prolonged use. Concomitant use w/ other sympathomimetic bronchodilators. May affect ability to drive & use machines. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic BP, nervousness.

Drug Interactions

Enhanced bronchodilatory effect w/ other β-adrenergics, anticholinergics, xanthine derivatives eg, theophylline. Potentially serious reduced bronchodilation w/ β-blockers. Increased β₂-agonist-induced hypokalaemia w/ xanthine derivatives, corticosteroids, diuretics. Increased susceptibility to arrhythmias w/ digoxin. Enhanced action w/ MAOIs or TCAs. Increased susceptibility on CV effects w/ halogenated hydrocarbon anaesth inhalation eg, halothane, trichloroethylene & enflurane. Not recommended in co-administration w/ other anticholinergic drugs.

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Caution For Usage

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Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

Form

Berodual N MDI

Packing/Price

(200 metered doses/10 mL) 1's

Berodual N

ipratropium + fenoterol

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH