Ventolin Inhaler

Ventolin Inhaler

salbutamol

Manufacturer:

GlaxoSmithKline Indonesia
Full Prescribing Info
Contents
Salbutamol sulfate.
Description
Ventolin Inhaler is a pressurised metered-dose inhaler which delivers 100 micrograms salbutamol (as sulphate) per actuation, into the mouthpiece of a specially designed actuator. The inhaler also contains the CFC-free propellant HFA 134a. Each canister contains at least 200 actuations.
Action
Salbutamol 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 beta1 adrenoceptors of the heart.
With its fast onset of action, it is particularly suitable for the management and prevention of attack in asthma. 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 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
VENTOLIN is particularly valuable as relief medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy.
Dosage/Direction for Use
Salbutamol has a duration of action of 4-6 hrs in most patients.
Increasing use of beta2-agonists may be a sign of worsening asthma. Under these conditions, a re-assessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice. It is administered by the inhalational route only. In patients who find coordination of a pressurized metered-dose inhaler difficult, a volumatic spacer may be used with Ventolin Inhaler. Babies and young children using the VENTOLIN Inhaler may benefit from the use of a paediatric spacer device with a face mask (for example the BABYHALER).
Adults: For the relief of acute bronchospasm, 100 or 200 mcg. For chronic therapy, up to 200 mcg 4 times daily. To prevent allergen- or exercise-induced bronchospasm, 200 mcg should be taken before challenge or exertion.
Children: 100 mcg for the relief of acute bronchospasm-the dose may be increased to 200 mcg if required, in the prevention of allergen- or exercise-induced bronchospasm, before exercise-100 mcg before challenge or exertion. These doses may be increased to 200 mcg if necessary. For chronic therapy, up to 200 mcg 4 times daily.
Overdosage
The most common signs and symptoms of overdose with VENTOLIN are transient beta agonist pharmacologically mediated events. Hypokalaemia may occur following overdose with salbutamol. 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 is contra-indicated in patients with a history of hypersensitivity to any of its 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 bronchodilators, in particular beta2 agonists to relieve 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 should be administered cautiously to patients with thyrotoxicosis. 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 Inhaler should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
In the event of a previously effective dose of inhaled VENTOLIN failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken. The patient's inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of the drug to the lungs.
Use in pregnancy & lactation: Fertility: There is no information on the effects of salbutamol 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 VENTOLIN. 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 to 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 salbutamol 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 fetus. 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 VENTOLIN. 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 to 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.
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
Salbutamol and nonselective beta-blocking drugs eg, propranolol, should not be prescribed together. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
Caution For Usage
Directions for Use: Remove the mouthpiece cover by gently squeezing the sides of the cover and check the mouthpiece inside and outside to see that it is clean.
Shake the inhaler well.
Hold the inhaler upright between fingers and thumb with the thumb on the base, below the mouthpiece.
Breath out as far as it is comfortable and then place the mouthpiece in the mouth between the teeth and close lips around it but do not bite.
Just after starting to breath in through the mouth, press down on the top of the inhaler to release salbutamol while still breathing in steadily and deeply.
While holding breath, take the inhaler from the mouth and take the finger from the top of the inhaler. Continue holding breath for as long as it is comfortable.
If further puffs are to be taken, keep the inhaler upright and wait about ½ min before repeating the previous steps. The mouthpiece cover is replaced by firmly pushing and snapping the cap into position.
Storage
Replace the mouthpiece cover firmly and snap it into position.
VENTOLIN Inhaler should be stored below 30°C. Protected from frost and direct sunlight.
As with most inhaled medications in aerosol canisters, the therapeutic effects of this medication may decrease when the canister is cold. The canister should not be broken, punctured or burnt, even when apparently empty.
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
Inhaler 100 mcg/puff x 1's.
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