VENTOLIN HFA 100 MCG — DIN 02241497

What is VENTOLIN HFA?

VENTOLIN HFA 100 MCG contains SALBUTAMOL (SALBUTAMOL SULFATE) : 100 MCG. It is listed in the Health Canada Drug Product Database under DIN 02241497, held by GLAXOSMITHKLINE INC, supplied as METERED-DOSE AEROSOL for INHALATION administration. Health Canada currently lists it as marketed, status dated 22-Nov-2001. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is VENTOLIN HFA used for?

VENTOLIN HFA (salbutamol pressurised inhalation, suspension) is indicated for: • the symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor. • the prevention of exercise-induced bronchospasm.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The dosage should be individualised, and the patient's response should be monitored by the prescribing physician on an ongoing basis. Adults and Adolescents (≥ 12 years): Relief of Acute Episodes of Bronchospasm: One to two puffs [100 to 200 mcg salbutamol] as needed. Prevention of Bronchospasm: One to two puffs [100 to 200 mcg salbutamol] every 4 to 6 hours, as needed, to a maximum of four times per day. Prevention of Exercise-induced Bronchospasm: Two puffs [200 mcg salbutamol] 15 minutes before exercise. Maximum Daily Dose: Eight puffs [800 mcg salbutamol]. Children (4 to < 12 years): Relief of Acute Episodes of Bronchospasm: One puff [100 mcg salbutamol] as needed. May be increased to two puffs (200 mcg salbutamol), if required. Prevention of Bronchospasm: One puff [100 mcg salbutamol] every 4 to 6 hours, as needed, to a maximum of four times per day. Prevention of Exercise-induced Bronchospasm: One puff [100 mcg salbutamol] 15 minutes before exercise. May be increased to two puffs (200 mcg salbutamol), if required. Maximum Daily Dose: Four puffs [400 mcg salbutamol]. VENTOLIN HFA is administered by the inhaled route only. To ensure administration of the proper dose of the drug, the patient should be instructed by the physician or other healthcare professional on the proper use of the pressurised inhalation, suspension. Inhaler actuation should be synchronised with inspiration to ensure optimum delivery of drug to the lungs. In patients who find coordination of a pressurised metered dose inhaler difficult, a spacer may be used with VENTOLIN HFA. Priming: It is recommended to test spray VENTOLIN HFA into the air four times, away from the face, before using for the first time and in cases where the aerosol has not been used for more than 5 days. The inhaler contains enough salbutamol for 200 actuations (puffs) only. After 200 actuations (puffs), the inhaler can continue to spray but without the prescribed dose of salbutamol. Maintaining a record of the number of actuations (puffs) administered to the patient should be considered, towards avoiding inadvertent use of an empty inhaler. Keeping a back-up inhaler could be considered.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. As a tocolytic in patients at risk of premature labour or threatened abortion.

Warnings and precautions

Patients should always carry their VENTOLIN HFA to use immediately if an episode of asthma is experienced. If therapy does not produce a significant improvement or if the patient's condition worsens, medical advice must be sought to determine a new plan of treatment. In the case of acute or rapidly worsening dyspnea, a physician should be consulted immediately. Cardiovascular: In individual patients, any beta2-adrenergic agonist, including salbutamol, may have a clinically significant cardiac effect. Care should be taken with patients suffering from cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension. Special care and supervision are required in patients with idiopathic hypertrophic subvalvular aortic stenosis, in whom an increase in the pressure gradient between the left ventricle and the aorta may occur, causing increased strain on the left ventricle. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. Endocrine and Metabolism: Metabolic Effects: Salbutamol sulfate can induce reversible metabolic changes such as potentially serious hypokalemia, particularly following nebulised or especially infused administration. Particular caution is advised in acute severe asthma since hypokalemia may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics and by hypoxia. Hypokalemia will increase the susceptibility of digitalis-treated patients to cardiac arrhythmias. It is recommended that serum potassium levels be monitored in such situations. Care should be taken with patients with diabetes mellitus. Salbutamol can induce reversible hyperglycemia during nebulised administration or especially during infusions of the drug. 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. Care should be taken with patients with hyperthyroidism. Immune: Hypersensitivity: Immediate hypersensitivity reactions may occur after administration of salbutamol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, hypotension, anaphylaxis and oropharyngeal edema. Care should be taken in patients who are unusually responsive to sympathomimetic amines. Neurologic: Care should be taken with patients with convulsive disorders. Respiratory: As with other inhaled medications, paradoxical bronchospasm may occur characterized by an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator to relieve acute asthmatic symptoms. VENTOLIN HFA should be discontinued immediately, the patient assessed and if necessary, alternative therapy instituted. Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality.