Ventolin Nebules

Ventolin Nebules

salbutamol

Manufacturer:

GlaxoSmithKline Indonesia
Full Prescribing Info
Contents
Salbutamol sulfate.
Description
VENTOLIN Nebules 2.5 mg: contain a concentration of salbutamol of 0.1% (1 mg salbutamol, as the sulphate, in 1 mL). Each Nebule contains 2.5 mL of solution equivalent to 2.5 mg salbutamol.
Action
VENTOLIN is a selective beta2 adrenoceptor agonist. At therapeutic doses it acts on the beta2 adrenoceptors of bronchial muscle, with little or no action on the heart.
Bronchodilators should not be the only or the main treatment in patients with severe or unstable asthma.
Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and Peak Expiratory Flow (PEF) values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (e.g >1 mg/day beclomethasone dipropionate) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.
Indications/Uses
With the fast onset of action of salbutamol, it is particularly suitable for the management and prevention of asthma attack.
Routine management of chronic bronchospasm unresponsive to conventional therapy.
Treatment of acute severe bronchospasm (Status asthmaticus).
Dosage/Direction for Use
VENTOLIN has a duration of action of 4 to 6 hours in most patients. VENTOLIN Nebules are intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using sterile normal saline as a diluent may be required. VENTOLIN Nebules are to be used with a nebuliser, under the direction of a physician.
The solution must not be injected, or swallowed. Increasing use of beta2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice. As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment.
VENTOLIN nebules should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers in the same space at the same time.
Adults and Children: A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams. This may be increased to 5 milligrams. Treatment may be repeated four times daily. In adults higher dosing, up to 40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction. Clinical efficacy of nebulised VENTOLIN in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
Overdosage
The most common signs and symptoms of overdose with VENTOLIN are transient beta agonist pharmacologically mediated events. Hypokalaemia may occur following overdosage with VENTOLIN. Serum potassium levels should be monitored. Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Contraindications
VENTOLIN Nebules are contraindicated in patients with a history of hypersensitivity to any of their components.
Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.
Special Precautions
The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.
Increasing use of short-acting inhaled beta2 agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted. VENTOLIN Nebules must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed. Patients receiving treatment at home with VENTOLIN Nebules must be warned that if either the usual relief is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.
VENTOLIN Nebules should be used with caution in patients known to have received large doses of other sympathomimetic drugs. VENTOLIN should be administered cautiously to patients with thyrotoxicosis. A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised VENTOLIN and ipratropium bromide. A combination of nebulised VENTOLIN with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enters the eye. Potentially serious hypokalaemia may result from beta2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. VENTOLIN nebules should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use. In common with other beta-adrenoceptor agonists, VENTOLIN can induce reversible metabolic changes, for example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Side Effects). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
Use in pregnancy & lactation: Fertility: There is no information on the effects of VENTOLIN on human fertility. There were no adverse effects on fertility in animals.
Pregnancy: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.
Lactation: As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Use In Pregnancy & Lactation
Fertility: There is no information on the effects of VENTOLIN on human fertility. There were no adverse effects on fertility in animals.
Pregnancy: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.
Lactation: As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Side Effects
Immune System Disorders: Very Rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and Nutrition Disorders: Rare: Hypokalemia. Potentially serious hypokalemia may result from Beta2 agonist therapy. Very rare: Lactic acidosis.
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation.
Nervous System Disorders: Common: Tremor, headache. Very rare: Hyperactivity.
Cardiac Disorder: Common: Tachycardia. Very Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Vascular Disorder: Rare: Peripheral vasodilation.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Paradoxical bronchospasm.
Gastrointestinal Disorder: Uncommon: Mouth and throat irritation.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Muscle cramps.
Drug Interactions
VENTOLIN and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together. VENTOLIN is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Caution For Usage
Direction For Use: Once a nebule has been detached from the plastic bar, it is open and should be used immediately.
Prepare the nebulizer for filling.
Separate one Ventolin nebule and detach by twisting it firmly.
The nebule is now open. Take care not to spill the contents.
Squeeze the contents of the nebule into the reservoir of the nebulizer. Do not dilute the contents unless instructed to do so by the doctor.
Assemble the nebulizer and use it as directed.
After use, discard any remaining solution and clean the nebulizer in the usual way. If the dilution is necessary, this should be carried out only as prescribed by the doctor. The usual method of dilution is to empty the Ventolin nebule into the nebulizer reservoir, as previously mentioned, and then to add the prescribed amount of sterile normal saline. The reservoir should then be gently shaken to mix the contents.
Dilution: VENTOLIN Nebules may be diluted with sterile normal saline. Any unused solution in the chamber of the nebuliser must be discarded.
Storage
Ventolin nebules should be stored at a temperature below 30°C and protected from light.
ATC Classification
R03AC02 - salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Nebulizer soln 2.5 mg x 20's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in