Albuterol Tablets, USP, (2 mg and 4 mg), Rx only

/Albuterol Tablets, USP, (2 mg and 4 mg), Rx only
Albuterol Tablets, USP, (2 mg and 4 mg), Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Albuterol Tablets, USP, (2 mg and 4 mg), Rx only

ID:

d54862de-e3e7-4d44-9a87-2eae12374289

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 α1-[(tert-Butylamino) methyl]- 4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt) and the following structural formula: The molecular weight of albuterol sulfate is 576.71, and the molecular formula is (C13H21NO3)2 •H2SO4. Albuterol sulfate, USP 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 tablet, USP for oral administration contains 2 mg or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively. Each tablet also contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized (corn) starch and sodium lauryl sulfate.

CLINICAL PHARMACOLOGY


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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

The primary action of beta-adrenergic agonist drugs, including albuterol, is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3′,5′- adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP) in beta-adrenergic cells. The cyclic AMP thus formed mediates the cellular responses. Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2 -adrenergic receptors compared with isoproterenol. While it is recognized that beta2– adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established. In controlled clinical trials, albuterol has been shown to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or ECG changes. Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.

INDICATIONS AND USAGE


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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Albuterol tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

CONTRAINDICATIONS


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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of their components.

WARNINGS


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displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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. Deterioration of Asthma 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 re-evaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Use of Anti-Inflammatory Agents 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. 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. 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. Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema. Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral albuterol sulfate in children.

ADVERSE REACTIONS


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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The adverse reactions to albuterol are similar in nature to those of other sympathomimetic agents. Albuterol Tablets Adverse Experience Incidence (% of patients) in Adults and Children 6 Years of Age and Older

Adverse Event Percent Incidence
Central nervous system
Nervousness 20
Tremor 20
Headache 7
Dizziness 2
Weakness 2
Sleeplessness 2
Irritability <1
Drowsiness <1
Restlessness <1
Cardiovascular
Palpitations 5
Tachycardia 5
Flushing <1
Chest discomfort <1
Musculoskeletal
Muscle cramps 3
Gastrointestinal
Nausea 2
Genitourinary
Difficulty in micturition <1
Albuterol Extended-release Tablets Incidence of Adverse Reactions (% of Patients) in a 1-week Clinical Trials*  
Adverse Event Albuterol Extended-release Tablets (4 mg every 12 hours) Albuterol Tablets (2 mg every 6 hours)
Nausea 4 4
Nervousness 2 6
Vomiting 2 4
Somnolence 2 2
*This table includes adverse reactions considered to be possibly or probably treatment related in 1-week clinical trial comparing a 4 mg albuterol extended-release tablet administered every 12 hours to a 2 mg albuterol tablet administered every 6 hours.
Although not reported for albuterol extended-release tablets in the above study, there have been reports of tremor in other trials. When all clinical experience is considered, the incidence of tremor is approximately the same as that seen with albuterol tablets. A placebo-controlled trial of 4 weeks duration in 157 mild-to-moderate asthmatic children aged 6 to 12 years, demonstrated the safety of escalating doses of albuterol extended-release tablets. In this study, the starting dose of albuterol extended-release tablets was 4 mg twice daily. Patients were advanced to a maximum of 12 mg albuterol extended-release tablets twice daily by the investigator, based on patient tolerance and response. Only one of the 79 children treated with albuterol extended-release tablets was advanced to the maximum daily dose of 12 mg twice daily. The following treatment-related adverse events occurred in more than 5 % of treated patients and were greater in albuterol extended-release tablets patients when compared to placebo: Incidence of Adverse Events (% of Patients) in a 4-Week Placebo-Controlled Trial in 157 Children 6 to 12 Years of Age
Adverse Event Albuterol Extended-release Tablets % Placebo %
Headache 22 9
Nervousness 13 6
Insomnia 11 5
Tremor 10 1
Palpitation 8 1
Tachycardia 8 1
Other adverse events were noted in 5% or fewer patients, or had equal or greater rates of occurrence in placebo patients than in albuterol extended-release tablets patients. Cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema and arrhytmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of albuterol tablets. In addition to those adverse reactions reported above, albuterol, like other sympathomimetic agents, can cause adverse reactions such as angina, central nervous system stimulation, drying or irritation of the oropharynx, hypertension, unusual taste, and vertigo. 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. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE


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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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., angina, hypertension tachycardia with rates up to 200 beats per minute, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, and insomnia. In addition, seizures, hypotension, arrhythmias, fatigue, malaise and 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 an mg/m2 basis, and approximately 200 times the maximum recommended daily oral dose for children on an 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 an mg/m2 basis, and approximately 90 times the maximum recommended daily oral dose for children on an mg/m2 basis). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 510 times the maximum recommended daily oral dose for adults on an mg/m2 basis, and approximately 400 times the maximum recommended daily oral dose for children on an mg/m2 basis).

DOSAGE AND ADMINISTRATION


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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The following dosages of albuterol tablets, USP are expressed in terms of albuterol base. Usual Dosage Pediatric Patients 6 to 12 Years of Age: For pediatric patients 6 to 12 years of age, the usual dosage is 2 mg three or four times a day. Adults and Pediatric Patients Over 12 Years of Age: For adults and pediatric patients over 12 years of age, the usual starting dosage is 2 or 4 mg three or four times a day. Dosage Adjustment Pediatric Patients 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day:
For pediatric patients 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).
Adults and Pediatric Patients Over 12 Years of Age: For adults and pediatric patients over 12 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond to lower dose. The dosage should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated if a favorable response does not occur with the 4 mg initial dosage. 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 as tolerated to as much as 8 mg three or four times a day. The total daily dose should not exceed 24 mg per day in pediatric patients from 6 to 12 years of age and 32 mg in adults and pediatric patients over 12 years of age.

HOW SUPPLIED


id: 9ae2187c-bcf2-4f1a-9b66-29a2e9d11192
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Albuterol tablets, USP contain 2 mg or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively. Albuterol Tablets USP, 2 mg are supplied as white, round shaped, uncoated tablets, free from physical defects, debossed with “AA” and “91” on either side of score line and plain on other side. They are available as follows: Bottles of 100:                         NDC 69238-1344-1 Bottles of 500:                         NDC 69238-1344-5 Albuterol Tablets USP, 4 mg are supplied as white, round shaped, uncoated tablets, free from physical defects, debossed with “AA” and “90” on either side of score line and plain on other side. They are available as follows: Bottles of 100:                         NDC 69238-1345-1 Bottles of 500:                         NDC 69238-1345-5 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. Keep this and all drugs out of the reach of children. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2018-00

PRINCIPAL DISPLAY PANEL


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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 69238-1344-1 Albuterol Tablets USP, 2 mg Rx only 100 Tablets Amneal Pharmaceuticals LLC

NDC 69238-1345-1 Albuterol Tablets USP, 4 mg Rx only 100 Tablets Amneal Pharmaceuticals LLC