Indicated for:

Bronchospasm:

• The treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 

Exercise-Induced Bronchospasm:

• The prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. 

The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.

VENTOLIN HFA can produce paradoxical bronchospasm, which may be life-threatening.If paradoxical bronchospasm occurs following dosing with VENTOLIN HFA, it should be discontinued immediately and alternative therapy should be instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister. 

VENTOLIN HFA, like all other beta₂-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. VENTOLIN HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

VENTOLIN HFA, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.

Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of VENTOLIN HFA.

Beta-blockers not only block the pulmonary effect of beta-agonists, such as VENTOLIN HFA, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers.

The ECG changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists.

VENTOLIN HFA should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days.

There are no adequate and well-controlled trials with VENTOLIN HFA or albuterol sulfate in pregnant women. Animal studies: cleft palate in mice and delayed ossification.

Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. VENTOLIN HFA has not been approved for the management of preterm labor. Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta₂-agonists, including albuterol.

Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of VENTOLIN HFA by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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• Use in patients under 4 years of age. GoToSource 

• Pulmonary edema. GoToSource 

• Intubation-induced bronchoconstriction. GoToSource

Paradoxical bronchospasm. GoToSource

Increased risk of myocardial infarction, congestive heart failure, cardiac arrest and sudden cardiac death. GoToSource 

Gastritis (inflammation of the lining of the stomach), ulcers and bleeding. GoToSource 

Lactic acidosis (too much acid in the body). GoToSource 

Hypokalemia (low blood potassium level). GoToSource

Tremor, nervousness, insomnia, allergic reaction, otitis media (inflammation of middle ear), epistaxis (nose bleed), urinary tract infection and hyperhidrosis (excessive sweating). GoToSource

Acute angle-closure glaucoma. GoToSource

Lawsuits filed for heart attacks.