DOSAGE Use only as directed by your doctor. WARNINGS The action of Albuterol Inhalation Aerosol may last up to 6 hours or longer. Albuterol Inhalation Aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of Albuterol Inhalation Aerosol without consulting your doctor. If you find that treatment with Albuterol Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using Albuterol Inhalation Aerosol, other inhaled drugs and asthma medicines should be used only as directed by your doctor. Contents Under Pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. Avoid spraying in eyes. S tore between 15° – 30°C (59°– 86°F). As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold; for best results, the canister should be at room temperature before use. Shake well before using.
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warnings
WARNINGS Paradoxical Bronchospasm Albuterol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Albuterol Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. Cardiovascular Effects Albuterol, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Albuterol Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Albuterol Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Use of Anti-Inflammatory Agents 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. Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of Albuterol Inhalation Aerosol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The contents of Albuterol Inhalation Aerosol are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Avoid spraying in eyes. Keep out of reach of children.
ADVERSE REACTIONS he adverse reactions to albuterol are similar in nature to reactions to other sympathomimetic agents, although the incidence of certain cardiovascular effects is lower with albuterol. Percent Incidence of Adverse Reactions in Patients ≥ 12 Years of Age in a 13-Week Clinical Trial* Percent Incidence Reaction Albuterol Isoproterenol Tremor <15% <15% Nausea <15% <15% Tachycardia 10% 10% Palpitations <10% <15% Nervousness <10% <15% Increased Blood Pressure <5% <5% Dizziness <5% <5% Heartburn <5% <5 Percent Incidence of Adverse Reactions in Children 4 to 11 Years of Age in a 12-Week Trial* Reaction Percent Incidence Central Nervous System Headache 3% Nervousness 1% Lightheadedness <1% Tremor <1% Agitation 1% Nightmares 1% Hyperactivity 1% Aggressive Behavior 1% Gastrointestinal Nausea and/or Vomiting 6% Stomachache 3% Diarrhea 1% Oropharyngeal Throat Irritation 6% Discoloration of Teeth 1% Respiratory Epistaxis 3% Cough 2% Musculoskeletal Muscle Cramp 1% Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol inhalation aerosol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, and unusual taste.
adverse reactions table
<table width="80%"><caption>Percent Incidence of Adverse Reactions in Patients ≥ 12 Years of Age in a 13-Week Clinical Trial*</caption><colgroup><col width="34%" align="left"/><col width="33%" align="center"/><col width="33%" align="center"/></colgroup><thead><tr><th align="left"/><th align="center" colspan="2">Percent Incidence</th></tr><tr><th align="left">Reaction</th><th align="center">Albuterol</th><th align="center">Isoproterenol</th></tr></thead><tbody><tr><td align="left">Tremor</td><td align="center"><15%</td><td align="center"><15%</td></tr><tr><td align="left">Nausea</td><td align="center"><15%</td><td align="center"><15%</td></tr><tr><td align="left">Tachycardia</td><td align="center">10%</td><td align="center">10%</td></tr><tr><td align="left">Palpitations</td><td align="center"><10%</td><td align="center"><15%</td></tr><tr><td align="left">Nervousness</td><td align="center"><10%</td><td align="center"><15%</td></tr><tr><td align="left">Increased Blood Pressure</td><td align="center"><5%</td><td align="center"><5%</td></tr><tr><td align="left">Dizziness</td><td align="center"><5%</td><td align="center"><5%</td></tr><tr><td align="left">Heartburn</td><td align="center"><5%</td><td align="center"><5</td></tr></tbody></table>
adverse reactions table
<table width="80%"><caption>Percent Incidence of Adverse Reactions in Children 4 to 11 Years of Age in a 12-Week Trial*</caption><colgroup><col width="50%" align="left"/><col width="50%" align="center"/></colgroup><thead><tr styleCode="First Last"><th align="left">Reaction</th><th align="center">Percent Incidence</th></tr></thead><tbody><tr><td align="left"><content styleCode="bold">Central Nervous System</content></td><td align="center"/></tr><tr><td align="left"> Headache</td><td align="center">3%</td></tr><tr><td align="left"> Nervousness</td><td align="center">1%</td></tr><tr><td align="left"> Lightheadedness</td><td align="center"><1%</td></tr><tr><td align="left"> Tremor</td><td align="center"><1%</td></tr><tr><td align="left"> Agitation</td><td align="center">1%</td></tr><tr><td align="left"> Nightmares</td><td align="center">1%</td></tr><tr><td align="left"> Hyperactivity</td><td align="center">1%</td></tr><tr><td align="left"> Aggressive Behavior</td><td align="center">1%</td></tr><tr><td align="left"><content styleCode="bold">Gastrointestinal</content></td><td align="center"/></tr><tr><td align="left"> Nausea and/or Vomiting</td><td align="center">6%</td></tr><tr><td align="left"> Stomachache</td><td align="center">3%</td></tr><tr><td align="left"> Diarrhea</td><td align="center">1%</td></tr><tr><td align="left"><content styleCode="bold">Oropharyngeal</content></td><td align="center"/></tr><tr><td align="left"> Throat Irritation</td><td align="center">6%</td></tr><tr><td align="left"> Discoloration of Teeth</td><td align="center">1%</td></tr><tr><td align="left"><content styleCode="bold">Respiratory</content></td><td align="center"/></tr><tr><td align="left"> Epistaxis</td><td align="center">3%</td></tr><tr><td align="left"> Cough</td><td align="center">2%</td></tr><tr><td align="left"><content styleCode="bold">Musculoskeletal</content></td><td align="center"/></tr><tr><td align="left"> Muscle Cramp</td><td align="center">1%</td></tr></tbody></table>