The safety data described below reflects exposure to VENTOLIN HFA in 248 subjects treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol sulfate inhalation solution.FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Bronchospasm 1.2 Exercise-Induced Bronchospasm 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage for Bronchospasm (Acute Episodes or Symptoms Associated with Bronchospasm) 2.2 Recommended Dosage for Prevention of Exercise-Induced Bronchospasm 2.3 Administration Information 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Paradoxical Bronchospasm 5.2 Deterioration of Asthma 5.3 Use of Anti-inflammatory Agents 5.4 Cardiovascular Effects 5.5 Do Not Exceed Recommended Dose 5.6 Hypersensitivity Reactions, including Anaphylaxis 5.7 Coexisting Conditions 5.8 Hypokalemia 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Beta-Adrenergic Receptor Blocking Agents 7.2 Non–Potassium-Sparing Diuretics 7.3 Digoxin 7.4 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Bronchospasm Associated with Asthma 14.2 Exercise-Induced Bronchospasm 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.īecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Treatment consists of discontinuation of albuterol sulfate inhalation solution together with appropriate symptomatic therapy. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate inhalation solution. The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of the pharmacological effects listed in ADVERSE REACTIONS. Generally this medication is an as needed medication, and not required to be on a set schedule. Always take this medication as prescribed. If the latter is true, skip the missed dose and wait until the next one. According to Mayo Clinic, if you miss a dose of albuterol, take it immediately, unless you are closer to your next dosing time.
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