Product Elements:
Albuterol albuterol albuterol sulfate albuterol lactose magnesium stearate starch, corn sodium lauryl sulfate round ac;2 albuterol albuterol albuterol sulfate albuterol lactose magnesium stearate starch, corn sodium lauryl sulfate round ac;4
Indications and Usage:
Indications & usage albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
Warnings:
Warnings 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. 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, especial
Read more...ly coronary insufficiency, cardiac arrhythmias, and hypertension. 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 reevaluation 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. immediate hypersensitivity reactions immediate hypersensitivity reactions may occur after administration of albuterol tablets, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema. albuterol tablets, 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.
Dosage and Administration:
Dosage & 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 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 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 cau
Read more...tiously 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 over 12 years and older.
Contraindications:
Contraindications albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of their components.
Adverse Reactions:
Adverse reactions in clinical trials, the most frequent adverse reactions to albuterol tablets were: percent incidence of adverse reactions reaction incidence percent central nervous system nervousness 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 tablets. in addition, albuterol tablets, 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 t
Read more...ablets. 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.
Adverse Reactions Table:
| Reaction Incidence | Percent |
| Central nervous system |
| Nervousness | 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% |
Overdosage:
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 and 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).
Description:
Description albuterol tablets, usp contain albuterol sulfate, usp, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator. albuterol sulfate has the chemical name 4-hydroxy- 3-hydroxymethyl-α-[(tert-butylamino) methyl]benzyl alcohol, sulfate and the following structural formula: the molecular weight of albuterol sulfate is 576, and the molecular formula is (c 13 h 21 n o 3 ) 2 ⢠h 2 s o 4 . albuterol sulfate, usp is a white or practically white powder, freely soluble in water and slightly soluble in alcohol, in chloroform, and ether. the world health organization recommended name for albuterol base is salbutamol. each albuterol tablet for oral administration contains 2 or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, usp respectively. the inactive ingredients for albuterol tablets, 2 mg and 4 mg include: co-processed starch , lactose hydrate , magnesium stearate, partially pregelatinized maize starch and sodium lauryl sulfate. structure
Clinical Pharmacology:
Clinical pharmacology in vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. while it is recognized that beta 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta 2 -receptors in the human heart existing in a concentration between 10% and 50%. the precise function of these receptors has not been established (see warnings). the pharmacologic effects of beta-adrenergic agonist drugs, including albuterol tablets, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (atp) to cyclic-3',5'- adenosine monophosphate (cyclic amp). increased cyclic amp levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensi
Read more...tivity from cells, especially from mast cells. albuterol tablets have been shown in most controlled clinical trials 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. 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. preclinical intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of the plasma concentrations. in structures outside the blood brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain. studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. the clinical significance of these findings is unknown. pharmacokinetics albuterol tablets are rapidly absorbed after oral administration of one 4 mg albuterol tablet in normal volunteers. maximum plasma concentrations of about 18 ng/ml of albuterol are achieved within 2 hours, and the drug is eliminated with a half-life of about 5 hours. in other studies, the analysis of urine samples of patients given 8 mg of tritiated albuterol tablets orally showed that 76% of the dose was excreted over 3 days, with the majority of the dose being excreted within the first 24 hours. sixty percent of this radioactivity was shown to be the metabolite. feces collected over this period contained 4% of the administered dose. clinical trials in controlled clinical trials in patients with asthma, the onset of improvement in pulmonary function, as measured by maximum midexpiratory flow rate (mmef), was noted within 30 minutes after a dose of albuterol tablets, with peak improvement occurring between 2 and 3 hours. in controlled clinical trials in which measurements were conducted for 6 hours, clinically significant improvement (defined as maintaining a 15% or more increase in forced expiratory volume in 1 second [fev1] and a 20% or more increase in mmef over baseline values) was observed in 60% of patients at 4 hours and in 40% at 6 hours. in other single-dose, controlled clinical trials, clinically significant improvement was observed in at least 40% of the patients at 8 hours. no decrease in the effectiveness of albuterol tablets was reported in patients who received long-term treatment with the drug in uncontrolled studies for periods up to 6 months.
How Supplied:
How supplied albuterol tablets, usp for oral administration contains 2 mg or 4 mg albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, usp respectively. albuterol tablets, usp containing 2 mg albuterol as the sulfate are white, round shaped, scored tablets debossed with âac 2â on one side and plain on other side. they are available as follows: ndc 64980-442-01 bottles of 100 tablets ndc 64980-442-50 bottles of 500 tablets albuterol tablets, usp containing 4 mg albuterol as the sulfate are white, round shaped, scored tablets debossed with âac 4â on one side and plain on other side. they are available as follows: ndc 64980-443-01 bottles of 100 tablets ndc 64980-443-50 bottles of 500 tablets store albuterol tablets, usp at 20° to 25°c (68° to 77°f). [see usp for controlled room temperature.] protect from light. dispense in a tight, light-resistant container as defined in the usp using a child-resistant closure. manufactured by: appco pharma llc. piscataway,
Read more... new jersey 08854 distributed by: rising pharmaceuticals, inc. saddle brook, nj 07663 revised: 01/2022 200229 pir44350-00
Package Label Principal Display Panel:
Package label.principal display panel package label.principal display panel-2 mg-100's count rising ndc 64980-442-01 albuterol tablets, usp 2 mg 100 tablets rx only 2 mg-100's count container label package label.principal display panel-2 mg-500's count rising ndc 64980-442-50 albuterol tablets, usp 2 mg 500 tablets rx only 2 mg-500's count container label package label.principal display panel-4 mg-100's count rising ndc 64980-443-01 albuterol tablets, usp 4 mg 100 tablets rx only 4 mg-100's count container label package label.principal display panel-4 mg-500's count rising ndc 64980-443-50 albuterol tablets, usp 4 mg 500 tablets rx only 4 mg-500's count container label