Drug: Albuterol Sulfate

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate (albuterol sulfate inhalation solution) . Albuterol sulfate (albuterol sulfate inhalation solution) is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate (albuterol sulfate inhalation solution) is α1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate (albuterol sulfate inhalation solution) is 576.7 and the empirical formula is (C13 H21 NO3)2 •H2 SO4. Albuterol sulfate (albuterol sulfate inhalation solution) is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.75 mg of albuterol sulfate (albuterol sulfate inhalation solution) (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (albuterol sulfate inhalation solution) (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 4.0 (see HOW SUPPLIED). Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).

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Adverse events reported in > 1% of patients receiving albuterol sulfate (albuterol sulfate inhalation solution) and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table. Table 1: Adverse Events with an Incidence of > 1% of Patients Receiving Albuterol Sulfate (albuterol sulfate inhalation solution) and Greater than Placebo (expressed as % of treatment group)
  1.25 mg
Albuterol Sulfate (albuterol sulfate inhalation solution)
(N=115) 0.63 mg
Albuterol Sulfate (albuterol sulfate inhalation solution)
(N=117) Placebo
(N=117) Asthma Exacerbation 13 11.1 8.5 Otitis Media 4.3 0.9 0 Allergic Reaction 0.9 3.4 1.7 Gastroenteritis 0.9 3.4 0.9 Cold Symptoms 0 3.4 1.7 Flu Syndrome 2.6 2.6 1.7 Lymphadenopathy 2.6 0.9 1.7 Skin/Appendage Infection 1.7 0 0 Urticaria 1.7 0.9 0 Migraine 0.9 1.7 0 Chest Pain 0.9 1.7 0 Bronchitis 0.9 1.7 0.9 Nausea 1.7 0.9 0.9 There was one case of ST segment depression in the 1.25 mg albuterol sulfate (albuterol sulfate inhalation solution) treatment group. No clinically relevant laboratory abnormalities related to albuterol sulfate (albuterol sulfate inhalation solution) administration were seen in this study. Read the Albuterol Sulfate (albuterol sulfate inhalation solution) Side Effects Center for a complete guide to possible side effectsLearn More »

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The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended. To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes. The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution. Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose. Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above. 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. The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established. The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established. Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

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Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol sulfate (albuterol sulfate inhalation solution) . Albuterol sulfate (albuterol sulfate inhalation solution) should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic anti-depressants or within 2 weeks of discontinuation of such agents, since the action of albuterol on the vascular system may be potentiated. Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol sulfate (albuterol sulfate inhalation solution) , but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution. The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol. Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

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Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

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Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of the pharmacological effects listed in ADVERSE REACTIONS. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate (albuterol sulfate inhalation solution) . Treatment consists of discontinuation of albuterol sulfate (albuterol sulfate inhalation solution) 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 sulfate (albuterol sulfate inhalation solution) . The oral median lethal dose of albuterol sulfate (albuterol sulfate inhalation solution) in mice is greater than 2000 mg/kg (approximately 580 times the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). The subcutaneous median lethal dose of albuterol sulfate (albuterol sulfate inhalation solution) in mature rats and small young rats is approximately 450 mg/kg and 2000 mg/kg, respectively (approximately 260 and 1200 times the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). The inhalation median lethal dose has not been determined in animals.

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Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches. Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton Storage Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless. Keep out of the reach of children. Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007 Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

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General Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. As with other beta-agonists, inhaled and intravenous albuterol may produce a 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 potassium supplementation. Information for Patients The action of albuterol sulfate (albuterol sulfate inhalation solution) may last up to six hours, and therefore it should not be used more frequently than recommended. Do not increase the dose or frequency of medication without consulting your physician. If you find that treatment with albuterol sulfate (albuterol sulfate inhalation solution) becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. All asthma medication should only be used under the supervision and direction of a physician. Common effects with medications such as albuterol sulfate (albuterol sulfate inhalation solution) include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about the use of albuterol sulfate. Effective and safe use of albuterol sulfate (albuterol sulfate inhalation solution) includes an understanding of the way it should be administered. If the solution in the vial changes color or becomes cloudy, you should not use it. The drug compatibility (physical and chemical), clinical efficacy, and safety of albuterol sulfate (albuterol sulfate inhalation solution) solution, when mixed with other drugs in a nebulizer, has not been established. See illustrated Patient's Instructions for Use. Carcinogenesis, Mutagenesis, and Impairment of Fertility In a 2-year study in Sprague-Dawley rats, albuterol sulfate (albuterol sulfate inhalation solution) caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium and above dietary doses of 2 mg/kg (approximately equivalent to the maximum recommended daily inhalation dose for albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). In another study, this effect was blocked by the co-administration of propranolol, a non-selective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate (albuterol sulfate inhalation solution) showed no evidence of tumorigenicity at dietary doses up to 500 mg/kg (approximately 140 times the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). In a 22-month study in Golden hamsters, albuterol sulfate (albuterol sulfate inhalation solution) showed no evidence of tumorigenicity at dietary doses up to 50 mg/kg (approximately 20 times the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). Albuterol sulfate (albuterol sulfate inhalation solution) was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate (albuterol sulfate inhalation solution) was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay. Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate (albuterol sulfate inhalation solution) up to 50 mg/kg (approximately 30 times the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). Pregnancy Teratogenic Effects Pregnancy Category C: Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis) and cleft palate formation in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately equal to the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). Cleft palate formation also occurred in 23 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg isoproterenol (positive control). A reproduction study in Stride rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate (albuterol sulfate inhalation solution) was administered orally at 50 mg/kg (approximately 60 times the maximum recommended daily inhalation dose of albuterol sulfate (albuterol sulfate inhalation solution) on a mg/m² basis). A study in which pregnant rats were dosed with radiolabelled albuterol sulfate (albuterol sulfate inhalation solution) demonstrated that drug-related material was transferred from the maternal circulation to the fetus. There are no adequate and well-controlled studies of the use of albuterol sulfate (albuterol sulfate inhalation solution) in pregnant women. Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established. Labor and Delivery Oral albuterol has been shown to delay pre-term labor in some reports. There are presently no well-controlled studies that demonstrate that it will stop pre-term labor or prevent labor at term. Because of the potential for beta agonist interference with uterine contractility, use of albuterol sulfate (albuterol sulfate inhalation solution) for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Albuterol has not been approved for the management of pre-term labor. The benefit: risk ratio when albuterol is administered for tocolysis has not been established. Serious adverse reactions, including pulmonary edema, have been reported following administration of albuterol to women in labor. Nursing Mothers It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has been established in pediatric patients between the ages of 2 and 12 years. The use of albuterol sulfate (albuterol sulfate inhalation solution) in these age groups is supported by evidence from adequate and well-controlled studies of albuterol sulfate (albuterol sulfate inhalation solution) in children age 6 to 12 years and published reports of albuterol sulfate (albuterol sulfate inhalation solution) trials in pediatric patients 3 years of age and older. The safety and effectiveness of albuterol sulfate (albuterol sulfate inhalation solution) in children below 2 years of age have not been established.Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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