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Albuterol Sulfate Inhalation is a brand name for Albuterol (also known as Salbutamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Albuterol Sulfate Inhalation Aeroso is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, one inhalation every 4 hours may be sufficient.
1 ) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise. 2 ) Priming information: Prime Albuterol Sulfate Inhalation Aerosol before using for the first time, or when the inhaler has not been used for more than 2 weeks.
To prime Albuterol Sulfate Inhalation Aerosol, release 3 sprays into the air away from the face. Shake well before each spray. 3 ) Cleaning information: At least once a week, wash the actuator with warm water, shake off excess, and air dry thoroughly.
3 ) Albuterol Sulfate Inhalation Aerosol inhaler should be discarded when the dose counter displays 0 or after the expiration date on the product, whichever comes first. 1 Bronchospasm For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two inhalations repeated every 4 to 6 hours.
More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient. 2 Exercise-Induced Bronchospasm The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.
3 Administration Information Administer Albuterol Sulfate Inhalation Aerosol by oral inhalation only. Shake well before each spray. To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.
Priming:
Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.
Cleaning:
As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly. The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried.
0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. gov/medwatch . 1 Clinical Trials Experience A total of 1090 subjects were treated with Albuterol Sulfate Inhalation Aerosol, or with the same formulation of albuterol as in Albuterol Sulfate Inhalation Aerosol, during the worldwide clinical development program.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adult and Adolescents 12 Years of Age and Older:
The adverse reaction information presented in the table below concerning Albuterol Sulfate Inhalation Aerosol is derived from a 6-week, blinded study which compared Albuterol Sulfate Inhalation Aerosol (180 mcg four times daily) with a double-blinded matched placebo HFA-Inhalation Aerosol and an evaluator-blinded marketed active comparator HFA-134a albuterol inhaler in 172 asthmatic patients 12 to 76 years of age.
The table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the Albuterol Sulfate Inhalation Aerosol treatment group and more frequently in the Albuterol Sulfate Inhalation Aerosol treatment group than in the matched placebo group.
Overall, the incidence and nature of the adverse events reported for Albuterol Sulfate Inhalation Aerosol and the marketed active comparator HFA-134a albuterol inhaler were comparable. 0% in the Albuterol Sulfate Inhalation Aerosol group and more frequently in the Albuterol Sulfate Inhalation Aerosol group than in the placebo HFA Inhalation Aerosol group.
5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue Albuterol Sulfate immediately and treat with alternative therapy. 1 ) Need for more doses of Albuterol Sulfate than usual may be a sign of deterioration of asthma and requires reevaluation of treatment.
2 ) Albuterol Sulfate is not a substitute for corticosteroids. 3 ) Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders. 7 ) Excessive use may be fatal.
Do not exceed recommended dose. 5 ) Immediate hypersensitivity reactions may occur. Discontinue Albuterol Sulfate immediately. 6 ) Hypokalemia and changes in blood glucose may occur. 1 Paradoxical Bronchospasm Albuterol Sulfate Inhalation Aerosol can produce paradoxical bronchospasm that may be life threatening.
If paradoxical bronchospasm occurs, Albuterol Sulfate 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.
2 Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. , corticosteroids. 3 Use of Anti-inflammatory Agents The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients.
, corticosteroids, to the therapeutic regimen. 4 Cardiovascular Effects Albuterol Sulfate Inhalation Aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms.
Although such effects are uncommon after administration of Albuterol Sulfate Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.
4 CONTRAINDICATIONS Albuterol Sulfate Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other Albuterol Sulfate Inhalation Aerosol components. 6 )] . Hypersensitivity to albuterol and any other Albuterol Sulfate Inhalation Aerosol Components.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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To clean:
Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week. If the patient has more than one Albuterol Sulfate Inhalation Aerosol inhaler, the patient should wash each one separately to prevent attaching the wrong canister to the wrong plastic actuator.
In this way, the patient can be sure to always know the correct number of remaining doses. Never attach a canister of medication from any other inhaler to the Albuterol Sulfate Inhalation Aerosol actuator and never attach the Albuterol Sulfate Inhalation Aerosol canister to an actuator from any other inhaler.
If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose.
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Dose Counter:
Albuterol Sulfate Inhalation Aerosol has a dose counter on the front of the actuator. When the patient receives the inhaler, the number “203” will appear in the viewing window until it has been primed 3 times, at which point the number 200 will be displayed.
The dose counter will count down each time a spray is released. The dose-counter window displays the number of sprays left in the inhaler. When the dose counter displays 19, the dose counter will begin to show a red mark at the bottom of the counter window.
The red mark increases in size and becomes completely red with the number “0” printed in white after 200 doses are delivered from the actuator. The red mark is to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill.
Patients should be informed to discard Albuterol Sulfate inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.
Adverse events reported by less than 3% of the patients receiving Albuterol Sulfate Inhalation Aerosol but by a greater proportion of Albuterol Sulfate Inhalation Aerosol patients than the matched placebo patients, which have the potential to be related to Albuterol Sulfate Inhalation Aerosol, included chest pain, infection, diarrhea, glossitis, accidental injury (nervous system), anxiety, dyspnea, ear disorder, ear pain, and urinary tract infection.
In small cumulative dose studies, tremor, nervousness, and headache were the most frequently occurring adverse events.
Pediatric Patients 4 to 11 Years of Age:
Adverse events reported in a 3-week pediatric clinical trial comparing the same formulation of albuterol as in Albuterol Sulfate Inhalation Aerosol (180 mcg albuterol four times daily) to a matching placebo HFA inhalation aerosol occurred at a low incidence rate (no greater than 2% in the active treatment group) and were similar to those seen in adult and adolescent trials.
2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Albuterol Sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Reports have included rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (reported fatal in one case), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging.
The following adverse events have been observed in postapproval use of inhaled albuterol: urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles).
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as: angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.
The clinical significance of these findings is unknown. Therefore, Albuterol Sulfate HFA Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
5 Do Not Exceed Recommended Dose Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving Albuterol Sulfate Inhalation Aerosol. 7 Coexisting Conditions Albuterol Sulfate Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.
Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
8 Hypokalemia As with other beta-agonists, Albuterol Sulfate Inhalation Aerosol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.
The decrease is usually transient, not requiring supplementation.