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Albuterol Sulfate (Albuterol Sulfate)

Trade Name : Albuterol Sulfate

Nephron Pharmaceuticals Corporation

SOLUTION

Strength 0.63 mg/3mL

ALBUTEROL SULFATE Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Albuterol Sulfate (Albuterol Sulfate) which is also known as Albuterol Sulfate and Manufactured by Nephron Pharmaceuticals Corporation. It is available in strength of 0.63 mg/3mL per ml. Read more

Albuterol Sulfate (Albuterol Sulfate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • *Potency expressed as albuterol equivalent to 0.75 mg and 1.5 mg albuterol sulfate.
  • Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective betan n n -adrenergic bronchodilator (see n n n ). The chemical name for albuterol sulfate is u03b1n n n -[(n n n -Butylamino)methyl]-4-hydroxy-n n n -xylene-u03b1,u03b1'-diol sulfate (2:1) (salt), and its established chemical structure is as follows:n nn
  • The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (Cn n n Hn n n NOn n n )n n n u2022 Hn n n SOn n n . Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organizationu2019s recommended name for albuterol is salbutamol.n nn
  • Albuterol sulfate inhalation solution is supplied in two strengths in unit-dose vials. Each unit-dose vial contains either 0.75 mg of albuterol sulfate (equivalent to 0.021% or 0.63 mg of albuterol) or 1.5 mg of albuterol sulfate (equivalent to 0.042% or 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 between 3 and 5 (see n n n ).n nn
  • Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate 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 Plusu2122 nebulizer (with face mask or mouthpiece) connected to a Pari PRONEBu2122 compressor, under n n n conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (0.042% or 1.25 mg strength) and 39% of albuterol (0.021% or 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 inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see n n n ).n nn
  • The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',-5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. n n n studies and n n n pharmacologic studies have demonstrated that albuterol has a preferential effect on betan n n -adrenergic receptors compared with isoproterenol. While it is recognized that betan n n -adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicate that 10% to 50% of the beta-receptors in the human heart may be betan n n -receptors. The precise function of these receptors, however, is not yet established. 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 electrocardiographic 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-n n n -methyl transferase.n nn
  • Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (IPPB) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus, and expired air. Most of the absorbed dose was recovered in urine collected during the 24 hours after drug administration. Following oral administration of 4 mg albuterol, the elimination half-life was five to six hours. Following a 3 mg dose of nebulized albuterol in adults, the mean maximum albuterol plasma level at 0.5 hours was 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). The pharmacokinetics of albuterol following administration of 0.63 mg (0.021%) or 1.25 mg (0.042%) albuterol sulfate inhalation solution by nebulization have not been determined in children 2 to 12 years old.
  • 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 plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those found in 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.
  • The safety and efficacy of albuterol sulfate inhalation solution was evaluated in a 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in 349 children 6 to 12 years of age with mild-to-moderate asthma (mean baseline FEVn n n 60% to 70% of predicted). Approximately half of the patients were also receiving inhaled corticosteroids. Patients were randomized to receive albuterol sulfate inhalation solution 0.63 mg (0.021%), albuterol sulfate inhalation solution 1.25 mg (0.042%), or placebo three times a day administered via a Pari LC Plusu2122 nebulizer and a Pari PRONEBu2122 compressor. Racemic albuterol, delivered by a chlorofluorocarbon (CFC) metered dose inhaler (MDI) or nebulized, was used on an as-needed basis as the rescue medication.n nn
  • Efficacy, as measured by the mean percent change from baseline in the area under the 6-hour curve for FEVn n n , was demonstrated for both active treatment regimens (n=112 [1.25 mg or 0.042% group] and n=110 [0.63 mg or 0.021% group]) compared with placebo (n=110) on day 1 and day 28. Figures 1 and 2 illustrate the mean percentage change from pre-dose FEVn n n on day 1 and day 28, respectively. The mean baseline FEVn n n for all patients was 1.49 L.n nn
  • The onset of a 15% increase in FEVn n n over baseline for both doses of albuterol sulfate inhalation solution was seen at 30 minutes (the first post-dose assessment). The mean time to peak effect was approximately 30 to 60 minutes for both doses on day 1 and after 4 weeks of treatment. The mean duration of effect, as measured by a >15% increase from baseline in FEVn n n , was approximately 2.5 hours for both doses on day 1 and approximately 2 hours for both doses after 4 weeks of treatment. In some patients, the duration of effect was as long as 6 hours.n nn
  • Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
  • Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.
  • No data
  • No data
  • Clinical Trial Experience:
  • There was one case of ST segment depression in the 1.25 mg (0.042%) albuterol sulfate inhalation solution treatment group.
  • No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were seen in this study.
  • Postmarketing Experience:
  • 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 n n n . Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate inhalation solution. Treatment consists of discontinuation of 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 inhalation solution.n nn
  • The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 580 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/mn n n basis). The subcutaneous median lethal dose of albuterol sulfate 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 on a mg/mn n n basis). The inhalation median lethal dose has not been determined in animals.n nn
  • The usual starting dosage for patients 2 to 12 years of age is 1.25 mg (0.042%) or 0.63 mg (0.021%) of albuterol sulfate 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 3 mL of 0.021% [0.63 mg] inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate inhalation solution over 5 to 15 minutes.
  • The use of albuterol sulfate 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 FEVn n n 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.n nn
  • Albuterol sulfate 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 inhalation solution, when mixed with other drugs in a nebulizer have not been established.
  • The safety and efficacy of albuterol sulfate inhalation solution have been established in clinical trials when administered using the Pari LC Plusu2122 nebulizer and Pari PRONEBu2122 compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.
  • Albuterol sulfate 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.
  • Albuterol sulfate inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg (0.021%) of albuterol (equivalent to 0.75 mg of albuterol sulfate in 3 mL) and 1.25 mg (0.042%) of albuterol (equivalent to 1.5 mg of albuterol sulfate in 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 1 unit-dose LDPE vial. Each strength of albuterol sulfate inhalation solution is available in a shelf carton containing multiple foil pouches.
  • Albuterol Sulfate Inhalation Solution 0.021% (0.63 mg / 3 mL)
  • NDC 0487-0301-01: 30 foil pouches, each containing 1 vial, total 30 vials per carton
  • Albuterol Sulfate Inhalation Solution, 0.042% (1.25 mg / 3 mL)
  • NDC 0487-9904-25 25 foil pouches, each containing 1 vial, total 25 vials per carton
  • NDC 0487-9904-01 30 foil pouches, each containing 1 vial, total 30 vials per carton
  • Store between 2u00b0C and 25u00b0C (36u00b0F and 77u00b0F). 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 within one week. Discard the vial if the solution is not colorless.
  • Keep out of the reach of children.
  • Rx Only
  • Manufactured By:n n nNephron Pharmaceuticals Corporationn n nWest Columbia, SC 29172n
  • Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication, as you may want to read them again.
  • Albuterol sulfate inhalation solution should only be used under the direction of a physician. Your physician and pharmacist have more information about albuterol sulfate inhalation solution and the condition for which it has been prescribed. Contact them if you have additional questions.
  • Principal Display u2013 Pouch Label (Individually Wrapped Vials)
  • NDC 0487-0301-01
  • Albuterol Sulfate Inhalation Solution, 0.021%
  • Principal Display u2013 Carton (30 Individually Wrapped Vials)
  • NDC 0487-0301-01
  • Albuterol Sulfate Inhalation Solution, 0.021%
  • Principal Display u2013 Pouch Label (Individually Wrapped Vials)
  • NDC 0487-9904-25
  • Albuterol Sulfate Inhalation Solution, 0.042%
  • Principal Display u2013 Carton (25 Individually Wrapped Vials)
  • NDC 0487-9904-25
  • Albuterol Sulfate Inhalation Solution, 0.042%
  • Principal Display u2013 Pouch Label (Individually Wrapped Vials)
  • NDC 0487-9904-01
  • Albuterol Sulfate Inhalation Solution, 0.042%
  • Principal Display u2013 Carton (30 Individually Wrapped Vials)
  • NDC 0487-9904-01
  • Albuterol Sulfate Inhalation Solution, 0.042%

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