Albuterol (Page 3 of 3)
OVERDOSAGE
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol tablets. Treatment consists of discontinuation of albuterol tablets together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol tablets. The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 250 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 200 times the maximum recommended daily oral dose for children on a mg/m2 basis). In mature rats, the subcutaneous (sc) median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 90 times the maximum recommended daily oral dose for children on a mg/m2 basis). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 500 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 400 times the maximum recommended daily oral dose for children on a mg/m2 basis).
DOSAGE AND 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 mg 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 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.
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 Stimulators
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.
HOW SUPPLIED
Albuterol Tablets, USP 2 mg are white to off-white, uncoated, circular, flat face bevel edged tablets debossed “S” above and “2” below the score on one side and plain on other side. They are available as follows:
Bottles of 100 NDC 59651-333-01
Bottles of 500 NDC 59651-333-05
Albuterol Tablets, USP 4 mg are white to off-white, uncoated, circular, flat face bevel edged tablets debossed “S” above and “4” below the score on one side and plain on other side. They are available as follows:
Bottles of 100 NDC 59651-334-01
Bottles of 500 NDC 59651-334-05
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 12/2022
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2 mg (100 Tablets Bottle)
NDC 59651-333-01
Rx only
Albuterol Tablets, USP
2 mg AUROBINDO 100 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 4 mg (100 Tablets Bottle)
NDC 59651-334-01
Rx only
Albuterol Tablets, USP
4 mg AUROBINDO 100 Tablets
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| Labeler — Aurobindo Pharma Limited (650082092) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| APL HEALTHCARE LIMITED | 650918514 | ANALYSIS (59651-333), ANALYSIS (59651-334), MANUFACTURE (59651-333), MANUFACTURE (59651-334) | |
Revised: 12/2022 Aurobindo Pharma Limited
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