Albuterol Sulfate
Albuterol Sulfate Prescribing Information
Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.
In clinical trials, the most frequent adverse reactions to albuterol tablets were:
Reaction | Percent Incidence |
|---|---|
Central nervous system | |
Nervous | 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.
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol tablets. In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.
The concomitant use of albuterol tablets and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving albuterol tablets. Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.
Albuterol tablets contain albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(
Albuterol sulfate has a molecular weight of 576.71, and the molecular formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in ethanol.
The World Health Organization recommended name for albuterol base is salbutamol.
Each albuterol sulfate tablet, for oral administration contains 2 or 4 mg of albuterol as 2.4 or 4.8 mg of albuterol sulfate, respectively. Each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, pregelatinized (corn) starch, and sodium starch glycolate.