Albuterol
Generic Name: albuterol
Brand Names:
Albuterol
DESCRIPTION Albuterol Tablets, USP contain albuterol sulfate, USP the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 4-hydroxy- 3-hydroxymethyl-α-[(tert-butylamino) methyl]benzyl alcohol, sulfate and the following structural formula: The molecular weight of albuterol sulfate is 576, and the molecular formula is (C13 H21N O3 )2• H2S O4.
Overview
DESCRIPTION Albuterol Tablets, USP contain albuterol sulfate, USP the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 4-hydroxy- 3-hydroxymethyl-α-[(tert-butylamino) methyl]benzyl alcohol, sulfate and the following structural formula: The molecular weight of albuterol sulfate is 576, and the molecular formula is (C13 H21N O3 )2• H2S O4.
Uses
INDICATIONS & USAGE Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
Dosage
DOSAGE & ADMINISTRATION The following dosages of albuterol tablets are expressed in terms of albuterol base. Usual Dosage Adults and Children Over 12 Years of Age The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day. Children 6 to 12 Years of Age: The usual starting dosage for children 6 to 12 years age is 2 mg three or four times a day. Dosage Adjustment Adults and Children Over 12 Years of Age For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Side Effects
ADVERSE REACTIONS In clinical trials, the most frequent adverse reactions to albuterol tablets were: Percent Incidence of Adverse Reactions Reaction Incidence Percent Central nervous system Nervousness 20% Tremor 20% Headache 7% Sleeplessness 2% Weakness 2% Dizziness 2% Drowsiness <1% Restlessness <1% Irritability <1% Cardiovascular Tachycardia 5% Palpitations 5% Chest discomfort <1% Flushing <1% Musculoskeletal Muscle cramps 3% Gastrointestinal Nausea 2% Genitourinary Difficulty in micturition <1% Rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema have been reported after the use of albuterol tablets.
Warnings
WARNINGS Paradoxical Bronchospasm Albuterol tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol tablets should be discontinued immediately and alternative therapy instituted. Cardiovascular Effects Albuterol tablets, 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 tablets at recommended doses, if they occur, the drug may need to be discontinued. CONTRAINDICATIONS Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.
Storage
HOW SUPPLIED Albuterol Tablets, USP containing 4 mg albuterol as the sulfate are white, round shaped, scored tablets debossed with “AC 4” on one side and plain on other side. NDC 63629-2611-1: 20 TABLETs in a BOTTLE NDC 63629-2611-2: 30 TABLETs in a BOTTLE NDC 63629-2611-3: 60 TABLETs in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Frequently Asked Questions
What is Albuterol used for?▼
INDICATIONS & USAGE Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
What are the side effects of Albuterol?▼
ADVERSE REACTIONS In clinical trials, the most frequent adverse reactions to albuterol tablets were: Percent Incidence of Adverse Reactions Reaction Incidence Percent Central nervous system Nervousness 20% Tremor 20% Headache 7% Sleeplessness 2% Weakness 2% Dizziness 2% Drowsiness <1% Restlessness <1% Irritability <1% Cardiovascular Tachycardia 5% Palpitations 5% Chest discomfort <1% Flushing <1% Musculoskeletal Muscle cramps 3% Gastrointestinal Nausea 2% Genitourinary Difficulty in micturition <1% Rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema have been reported after the use of albuterol tablets.
What are the important warnings for Albuterol?▼
WARNINGS Paradoxical Bronchospasm Albuterol tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol tablets should be discontinued immediately and alternative therapy instituted. Cardiovascular Effects Albuterol tablets, 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 tablets at recommended doses, if they occur, the drug may need to be discontinued. CONTRAINDICATIONS Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.