Trade Name: Albuterol Sulfate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: SYRUP, HUMAN PRESCRIPTION DRUG

Strength: 2 mg/5mL

Storage and handling

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

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Rx only
  • Albuterol Sulfate Syrup contains albuterol sulfate, USP the racemic form of albuterol and a relatively selective beta-adrenergic bronchodilator. Albuterol sulfate has the chemical name u03b1- [(tert-butylamino) methyl] - 4 hydroxy - m xylene - u03b1,u03b1' -diolsulfate (2:1) (salt) and the following chemical structure:
  • (CHNO)u2219HSO M.W. 576.7
  • Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition.
  • The World Health Organization recommended name for albuterol base is salbutamol.
  • Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Citric Acid, FD & C Yellow No. 6, Hypromellose, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, and Strawberry Flavor. The pH of the syrup is 3.2 to 4.2.
  • In vitron- in vivon- Array
  • 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 - 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 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. 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--methyl transferase.
  • Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.
  • Albuterol Sulfate Syrup is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.
  • No data
  • No data
  • In clinical trials, the most frequent adverse reactions to albuterol sulfate syrup in adults and older children were:
  • In clinical trials, the following adverse reactions to albuterol sulfate syrup were noted more frequently in young children 2 to 6 years of age than in older children and adults:
  • Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate syrup.
  • In addition, albuterol, 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 sulfate syrup. 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.
  • The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under , 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. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate syrup. Treatment consists of discontinuation of albuterol sulfate syrup 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 syrup.
  • The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 240 times the maximum recommended daily oral dose for adults and children on a mg/m 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 and children on a mg/m basis).
  • The following dosages of albuterol sulfate syrup are expressed in terms of albuterol base.
  • Albuterol Sulfate Syrup, a clear, yellow liquid with a strawberry flavor, contains 2 mg of albuterol (present as the sulfate) per 5 mL and is supplied in the following containers:
  • Note: The unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.
  • Dispense contents with a child resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Manufactured By:
  • VistaPharm, Inc.
  • VP1074R1Rev 06/16
  • NDC 66689-100-16
  • Arrayn- VistaPharmn
  • ALBUTEROL SULFATESYRUP
  • STRAWBERRY FLAVORED
  • 2 mg (base)/5 mL
  • Rxonly
  • 16 fl oz (473 mL)
  • Manufactured by:VistaPharm, Inc., Largo, FL 33771

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Albuterol (Albuterol Sulfate) which is also known as Albuterol Sulfate and Manufactured by VistaPharm, Inc.. It is available in strength of 2 mg/5mL.

Albuterol (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.

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