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Albuterol Sulfate (Albuterol Sulfate)

Trade Name : Albuterol Sulfate

Nephron SC Inc.

SOLUTION

Strength 2.5 mg/.5mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 SC Inc.. It is available in strength of 2.5 mg/.5mL 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.

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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
  • Albuterol Sulfate Inhalation Solution, 0.5% contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective betan n n -adrenergic bronchodilator (see n n n section below). Albuterol sulfate has the chemical name u03b1n n n -[(n n n -Butylamino) methyl]-4-hydroxy-n n n -xylene-u03b1,u03b1u2032-diol sulfate (2:1) (salt) and the following chemical structure:n nn
  • (Cn n n Hn n n NOn n n )n n n u2022 Hn n n SOn n n n
  • Mol. Wt. 576.7
  • Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organizationu2019s recommended name for albuterol base is salbutamol.
  • Albuterol sulfate inhalation solution, 0.5%, is in concentrated form.u00a0 Dilute 0.5 mL of the solution to 3 mL with sterile normal saline solution prior to administration by nebulization (see n n n ).n nn
  • Each 0.5 mL Unit-of-Use Vial Contains:
  • Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution.
  • In vitron- in vivo
  • The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, 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-3u2019,5u2019-adenosine monophosphate (cyclic AMP). 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.
  • Albuterol has 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.
  • 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 the urine 24 hours after drug administration. Following a 3 mg dose of nebulized albuterol, the maximum albuterol plasma level at 0.5 hour was 2.1 ng/mL (range 1.4 to 3.2 ng/mL). There was a significant dose-related response in FEVn n n and peak flow rate. It has been demonstrated that following oral administration of 4 mg of albuterol, the elimination half-life was 5 to 6 hours.n nn
  • Preclinical:
  • 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 were administered concurrently. The significance of these findings is unknown.
  • In controlled clinical trials in adults, most patients exhibited an onset of improvement in pulmonary function within 5 minutes as determined by FEVn n n . FEVn n n measurements also showed that the maximum average improvement in pulmonary function usually occurred at approximately 1 hour following inhalation of 2.5 mg of albuterol by compressor-nebulizer and remained close to peak for 2 hours. Clinically significant improvement in pulmonary function (defined as maintenance of a 15% or more increase in FEVn n n over baseline values) continued for 3 to 4 hours in most patients and in some patients continued up to 6 hours.n nn
  • Published reports of trials in asthmatic children aged 3 years or older have demonstrated significant improvement in either FEVn n n or PEFR within 2 to 20 minutes following single doses of albuterol inhalation solution. An increase of 15% or more in baseline FEVn n n has been observed in children aged 5 to 11 years up to 6 hours after treatment with doses of 0.10 mg/kg or higher of albuterol inhalation solution. Single doses of 3, 4, or 10 mg resulted in improvement in baseline PEFR that was comparable in extent and duration to a 2 mg dose, but doses above 3 mg were associated with heart rate increases of more than 10%.n nn
  • Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
  • Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.
  • No data
  • No data
  • The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related:
  • No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution were determined in these studies.
  • Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of albuterol sulfate inhalation solution.
  • The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under n n n , e.g., 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, and sleeplessness. Hypokalemia may also occur. In isolated cases in children 2 to 12 years of age, tachycardia with rates > 200 beats/min has been observed. As with all sympathomimetic l 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 810 times the maximum recommended daily inhalation dose for adults on an mg/mn n n basis or approximately 300 times the maximum recommended daily inhalation dose for children on a mg/mn n n basis). In mature rats, the subcutaneous (sc) median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximatelyu00a0 365 times the maximum recommended daily inhalation dose for adults on an mg/mn n n basis or approximately 135 times the maximum recommended daily inhalation dose for children on a mg/mn n n basis). In small young rats, the sc median lethal dose is approximately 2000 mg/kg (approximately 1600 times the maximum recommended daily inhalation dose for adults on a mg/mn n n basis or approximately 600 times the maximum recommended daily inhalation dose for children on a mg/mn n n basis). The inhalational median lethal dose has not been determined in animals.n nn
  • The usual dosage for adults and pediatric patients 12 years of age and older is 2.5 mg of albuterol (one unit-of-use vial) administered 3 to 4 times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% solution for inhalation to a total volume of 3 mL with sterile normal saline solution and administer by nebulization. The flow rate is regulated to suit the particular nebulizer so that albuterol sulfate inhalation solution will be delivered over approximately 5 to 15 minutes.
  • Drug compatibility (physical and chemical), efficacy, and safety of albuterol sulfate inhalation solution when mixed with other drugs in a nebulizer have not been established.
  • The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During treatment, most patients gain optimum benefit from regular use of the nebulizer solution.
  • 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 nebulizer should be cleaned in accordance with the manufactureru2019s instructions. Failure to do so could lead to bacterial contamination of the nebulizer and possible infection.
  • Albuterol Sulfate Inhalation Solution, 0.5%, is a clear, colorless to light yellow solution, and is supplied in plastic sterile unit-of-use vials of 0.5 mL each, supplied in individual foil pouches:
  • NDC 0487-9901-30: 30 vials, each in an individual pouch.
  • Store between 2u00b0C and 25u00b0C (36u00b0F - 77u00b0F).
  • Rx Only
  • Manufactured By:n n nNephron Pharmaceuticals Corporationn n nWest Columbia, SC 29172n
  • Note: The Albuterol Sulfate Inhalation Solution is concentrated and must be diluted.
  • Read complete instructions carefully before using.
  • Note: tUse only as directed by your physician.u00a0 More frequent administration or higher doses are not recommended.
  • Mixing Compatibility:u00a0 The safety and effectiveness of Albuterol sulfate solution for inhalation have not been determined when one or more drugs are mixed with it in a nebulizer.
  • Store Albuterol Sulfate Inhalation Solution, 0.5%, between 2u00b0 and 25u00b0 C (36u00b0 and 77u00b0 F).
  • Principal Display Panel u2013 Pouch Label (individually wrapped vials)
  • NDC 0487-9901-30
  • Principal Display Panel u2013 Carton (30 individually wrapped vials)
  • NDC 0487-9901-30

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