Pulmodual/Pulmodual MDI 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 Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 2.5 mL of Pulmodual soln for inhalation Ipratropium Br 500 mcg, salbutamol sulfate 2.5 mg. Per actuation of Pulmodual MDI Ipratropium Br 20 mcg, salbutamol sulphate 100 mcg

Indications/Uses

Pulmodual Reversible airways obstruction eg, asthma & COPD for patients in need of more than a single bronchodilator or who require 2nd bronchodilator. Pulmodual MDI Relief & prevention of asthma & asthmatic symptoms.

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Dosage/Direction for Use

Pulmodual Adult & adolescent >12 yr 2.5 mL every 6-8 hr. Acute attacks 2.5 mL is sufficient for the prompt relief of symptom. Severe cases 5 mL if attack has not been relieved by 2.5 mL. Childn 2-12 yr 3 drops/kg/dose every 6-8 hr. Max: 2.5 mg of salbutamol. Elderly Adult dose. Pulmodual MDI 2 inhalations qid. Max dose of 12 inhalations in 24 hr.

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Overdosage

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Contraindications

Hypersensitivity to ipratropium Br, salbutamol or to atropine or its derivatives. Pulmodual Hypertrophic obstructive cardiomyopathy or tachyarrhythmia.

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Warnings

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Special Precautions

Paradoxical bronchospasm; patients w/ CV disorders especially coronary insufficiency, cardiac arrhythmias & HTN; cardiac arrest following an unexpected development of a severe acute asthmatic crisis & subsequent hypoxia; immediate hypersensitivity reactions; narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction; history of diabetes, heart disease (eg, irregular heart beat, coronary insufficiency), high BP, glaucoma, hypokalemia, seizure, hyperthyroidism, urination problems (eg, enlarged prostate, urinary retention). Hepatic or renal insufficiency. Do not drive, use machinery or do any activity that requires alertness or clear vision. Limit alcohol beverages. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dry mouth, nausea, headache, nervous tension. Pulmodual Constipation, fine tremor (particularly in the hands), muscle cramps & palpitations; tachycardia, atrial fibrillation, arrhythmias, peripheral vasodilation, disturbances of sleep & behavior; paradoxical bronchospasm, urticaria, angioedema, hypotension & collapse. Pulmodual MDI Trouble in sleeping, dizziness, coughing, runny nose.

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Drug Interactions

Additive interaction w/ anticholinergic agents. Increased risk of adverse CV effects w/ β-adrenergic agents. Salbutamol: Inhibits the effect of each other w/ β-receptor blocking agents, caution in patients w/ hyperreactive airways. Possibly may reduce plasma conc of digoxin. Increased risk of hypokalemia w/ diuretics (eg, loop or thiazide diuretics) & theophylline (high-dose). May potentiate action on CVS w/ MAOIs or TCAs.

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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

R03AL02 - salbutamol 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

Pulmodual MDI metered dose inhaler

Packing/Price

(w/ pump actuator) 12 g x 1's (P831.6/box)

Form

Pulmodual inhalation soln

Packing/Price

2.5 mL x 30 × 1's (P859.32/box);20 mL x 1's (P145.04/bottle)

Pulmodual/Pulmodual MDI

ipratropium bromide + salbutamol

Manufacturer:

Cathay Drug

Distributor:

Cathay Drug