Albuterol Sulfate
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Questions & Answers
Side Effects & Adverse Reactions
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.
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. 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 tablets, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol tablets 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.
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 may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Albuterol, like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.
Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral albuterol sulfate in children.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
History
There is currently no drug history available for this drug.
Other Information
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-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(salt) and the following structural formula:
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.
Sources
Albuterol Sulfate Manufacturers
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American Health Packaging
![Albuterol Sulfate Tablet [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Albuterol Sulfate | American Health Packaging
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual DosageAdults 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 of age is 2 mg three or four times a day.
Dosage AdjustmentAdults 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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic StimulatorsAn initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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Actavis Mid Atlantic Llc
Albuterol Sulfate | Actavis Mid Atlantic Llc
The usual dosage for adults and children 12 years and older is 2.5 mg of albuterol administered 3 to 4 times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the contents of one unit-dose vial (3 mL of 0.083% nebulizer solution) by nebulization. The flow rate is regulated to suit the particular nebulizer so that the albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During treatment, most patients gain optimum benefit from regular use of the nebulizer solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.
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Actavis Mid Atlantic Llc
Albuterol Sulfate | Actavis Mid Atlantic Llc
The following dosages of Albuterol Sulfate Syrup are expressed in terms of albuterol base.
Usual Dosage:
Adults And Children Over 14 Years Of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
Children 6 To 14 Years Of Age: The usual starting dosage for children 6 to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
Children 2 To 6 Years Of Age: Dosing in children 2 to 6 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.
Dosage Adjustment:
Adults And Children Over 14 Years Of Age: For Adults and children over 14 years of age, 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.
Children From 6 To 14 Years Of Age Who Fail To Respond To The Initial Starting Dosage Of 2 mg Four Times A Day: For children 6 to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Children 2 To 6 Years Of Age Who Do Not Respond Satisfactorily To The Initial Dosage: For children from 2 to 6 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.
Elderly Patients And Those Sensitive To Beta-Adrenergic Stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.
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Bausch & Lomb Incorporated
Albuterol Sulfate | Bausch & Lomb Incorporated
The usual dosage for adults and pediatric patients 12 years of age and older is 2.5 mg of albuterol administered 3 to 4 times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the entire contents of one unit-dose vial (3 mL of 0.083% nebulizer solution) by nebulization. The flow rate is regulated to suit the particular nebulizer so that the albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol sulfate inhalation solution when mixed with other drugs in a nebulizer have not been established.
The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During treatment, most patients gain optimum benefit from regular use of the nebulizer solution.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.
Microbial ContaminationTo avoid microbial contamination, the entire contents of the unit-dose vial should be administered immediately after the vial has been opened for the first time.
The nebulizer should be cleaned in accordance with the manufacturer’s instructions. Failure to do so could lead to bacterial contamination of the nebulizer and possible infection.
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Bryant Ranch Prepack
Albuterol Sulfate | Bryant Ranch Prepack
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual DosageAdults 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 of age is 2 mg three or four times a day.
Dosage AdjustmentAdults 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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic StimulatorsAn initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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Physicians Total Care, Inc.
Albuterol Sulfate | Physicians Total Care, Inc.
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual DosageAdults 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 of age is 2 mg three or four times a day.
Dosage AdjustmentAdults 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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic StimulatorsAn initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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Bryant Ranch Prepack
Albuterol Sulfate | Bryant Ranch Prepack
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual DosageAdults 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 of age is 2 mg three or four times a day.
Dosage AdjustmentAdults 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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic StimulatorsAn initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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Remedyrepack Inc.
Albuterol Sulfate | Remedyrepack Inc.
The following dosages of albuterol tablets are expressed in terms of albuterol base.
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 of age is 2 mg three or four times a day.
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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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Remedyrepack Inc.
Albuterol Sulfate | Remedyrepack Inc.
The following dosages of albuterol tablets are expressed in terms of albuterol base.
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 of age is 2 mg three or four times a day.
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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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Mylan Pharmaceuticals Inc.
Albuterol Sulfate | Pharmaderm, A Division Of Fougera Pharmaceuticals Inc.
Apply a thin film of CUTIVATE® Lotion to the affected skin areas once daily. Rub in gently.
Discontinue use when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
The safety and efficacy of CUTIVATE® Lotion have not been established beyond 4 weeks of use.
Avoid use with occlusive dressings or application to the diaper area [see Warnings and Precautions (5.1) and (5.2)].
CUTIVATE® Lotion is for topical use only, and not for ophthalmic, oral, or intravaginal use.
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Mutual Pharmaceutical Company, Inc.
Albuterol Sulfate | Mutual Pharmaceutical Company, Inc.
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual DosageAdults 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 of age is 2 mg three or four times a day.
Dosage AdjustmentAdults 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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic StimulatorsAn initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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Preferred Pharmaceuticals, Inc.
Albuterol Sulfate | Preferred Pharmaceuticals, Inc.
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual DosageAdults 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 of age is 2 mg three or four times a day.
Dosage AdjustmentAdults 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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic StimulatorsAn initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
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American Health Packaging
Albuterol Sulfate | American Health Packaging
The following dosages of albuterol tablets are expressed in terms of albuterol base.
Usual DosageAdults 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 of age is 2 mg three or four times a day.
Dosage AdjustmentAdults 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.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
Elderly Patients and Those Sensitive to Beta-adrenergic StimulatorsAn initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
![Albuterol Sulfate (Albuterol Sulfate) Inhalant [Actavis Mid Atlantic Llc]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Albuterol Sulfate Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7fe2669f-ca2a-fd31-e09c-fd2819a8308c&name=label1datamaxfda679.jpg)
![Albuterol Sulfate Tablet [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b49edc01-1ea6-4f88-883a-bb4bc2bf4b3f&name=2mgpackagelabel.jpg)
![Albuterol Sulfate Tablet [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=42bfd443-1d9d-4806-b044-6ff874b92b25&name=27361.jpg)
![Albuterol Sulfate Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a7c031a5-3bf8-4548-8fe7-0c308a45152a&name=MM2.jpg)
![Albuterol Sulfate Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=708615b8-79b1-4eaa-b765-abb01be3233a&name=MM2.jpg)
![Albuterol Sulfate Tablet, Film Coated, Extended Release [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cc79e200-ce69-4ffd-be5b-8c1a6bb88c5c&name=cut01-0010-04.jpg)
![Albuterol Sulfate Tablet [Mutual Pharmaceutical Company, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=87b8cd3c-2849-4b50-b63e-9ea379165c07&name=albuterol-02.jpg)
![Albuterol Sulfate Tablet [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d8f090fb-c591-4d6a-98b7-925b0bb17c38&name=albuterol-02.jpg)
![Albuterol Sulfate Tablet [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b0f73459-baeb-42a7-be48-2c3647d9b205&name=image-02.jpg)
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