Ipratropium bromide + Salbutamol


Concise Prescribing Info
Indications/Uses
COPD.
Dosage/Direction for Use
Adult : Inhalation As inhalation spray releasing ipratropium bromide 20 mcg and salbutamol 100 mcg/actuation: 1 inhalation 4 times daily. Max: 6 inhalations/24 hours. As solution for nebulisation containing ipratropium bromide 500 mcg and salbutamol 2.5 mg/2.5 mL: 2.5 mL 3 or 4 times daily.
Dosage Details
Inhalation/Respiratory
Chronic obstructive pulmonary disease
Adult: Available preparations:
Ipratropium bromide 20 mcg and salbutamol 100 mcg/actuation inhalation spray
1 inhalation 4 times daily, may give additional inhalations as required. Max: 6 inhalations per 24 hours.

Ipratropium bromide 500 mcg and salbutamol 2.5 mg/2.5 mL solution for nebulisation
2.5 mL 3 or 4 times daily.
Contraindications
Hypersensitivity to salbutamol, ipratropium or fenoterol, atropine or its derivatives. Hypertrophic obstructive cardiomyopathy, tachyarrhythmia.
Special Precautions
Patient with CV disorders (e.g. ischaemic heart disease, arrhythmia, severe heart failure), severe airway obstruction, cystic fibrosis, prostatic hyperplasia or bladder-neck obstruction, convulsive disorders, hyperthyroidism, diabetes mellitus. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. urticaria, angioedema, rash, anaphylaxis, bronchospasm, oropharyngeal oedema), paradoxical bronchospasm, ocular complications (e.g. mydriasis, blurred vision, narrow-angle glaucoma, eye pain), serious hypokalaemia, gastrointestinal motility disturbances, rapidly worsening dyspnoea, ECG changes, lactic acidosis, urinary retention. Rarely, myocardial ischaemia.
Cardiac disorders: Palpitations, tachycardia.
Eye disorders: Accommodation disorders.
Gastrointestinal disorders: Dry mouth, nausea.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Coughing, dysphonia.
Inhalation/Respiratory: C
Patient Counseling Information
Avoid spraying into the eyes. This drug may cause dizziness and blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor FEV1, and other pulmonary function tests, blood pressure, heart rate, CNS stimulation, serum glucose, serum K; signs and symptoms of glaucoma, hypersensitivity reactions, urinary retention, shortness of breath.
Overdosage
Symptoms: Salbutamol: Anginal pain, hyper/hypotension, hypokalaemia, tachycardia, arrhythmia, chest pain, tremor, flushing, restlessness and dizziness. Management: Supportive therapy. Administer cardioselective beta-blocking agent (e.g. metoprolol) if necessary.
Drug Interactions
Increased adverse adverse effects with corticosteroids, xanthine derivatives, diuretics.
Salbutamol: Enhanced effect with MAOIs or TCAs. Increased CV effects with anaesthetics containing halogenated hydrocarbons (e.g. halothane, enflurane).
Action
Description: Ipratropium is a nonselective competitive antimuscarinic agent. It causes bronchodilation by blocking the action of acetylcholine-induced stimulation of guanyl cyclase, hence reducing formation of cyclic guanosine monophosphate (cGMP) at parasympathetic site.
Salbutamol activates adenyl cyclase, the enzyme that stimulates the production of cyclic adenosine-3’, 5’-monophosphate (cAMP). Increased cAMP leads to activation of protein kinase A, which inhibits phosphorylation of myosin and lowers intracellular ionic Ca concentrations, resulting in smooth muscle relaxation.
Synonym: Salbutamol: Albuterol.
Onset: Ipratropium: Bronchodilation: Within 15 minutes.
Salbutamol: Within 5 minutes.
Duration: Ipratropium: 4-8 hours.
Salbutamol: Approx 3-6 hours.
Pharmacokinetics:
Absorption: Ipratropium: Rapidly absorbed after inhalation. Bioavailability: <10%.
Salbutamol: Rapidly and completely absorbed after inhalation. Time to peak plasma concentration: Within 3 hours.
Distribution: Ipratropium: Plasma protein binding: <20%.
Metabolism: Ipratropium: Partially metabolised to inactive ester hydrolysis products.
Salbutamol: Undergoes first-pass metabolism in the liver and possibly in the gut wall. Metabolised to inactive sulfate conjugate.
Excretion: Ipratropium: Via urine and faeces. Terminal elimination half-life: 1.6 hours.
Salbutamol: Via urine (as metabolites and unchanged drug); faeces (small amounts). Elimination half-life: 3-7 hours.
Chemical Structure

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Storage
Store below 25°C. Do not freeze. Protect from light.
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.
Disclaimer: This information is independently developed by MIMS based on Ipratropium bromide + Salbutamol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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