Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Bausch & Lomb Incorporated
ALBUTEROL SULFATE
ALBUTEROL 5 mg in 1 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 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.
Albuterol sulfate inhalation solution, 0.5% is supplied in amber glass bottles, with a calibrated dropper and with patient instructions in the following size: 20 mL bottles - NDC 24208-347-20 Storage: Store between 2°-25°C (36°-77°F). KEEP OUT OF REACH OF CHILDREN. Revised: February 2017 9116502 (Folded) 9116602 (Flat) Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION BAUSCH & LOMB INCORPORATED ---------- ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%* *Potency expressed as albuterol RX ONLY FOR ORAL INHALATION ONLY DESCRIPTION: Albuterol Sulfate Inhalation Solution, 0.5% contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta -adrenergic bronchodilator _(see CLINICAL PHARMACOLOGY_ section below). Albuterol sulfate has the chemical name α -[(_tert_—Butylamino)methyl]-4-hydroxy-_m_- xylene-α, α’-diol sulfate (2:1) (salt), and the following structural formula: (C H NO ) •H SO Mol. Wt. 576.71 Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution, 0.5% is in concentrated form. Dilute the appropriate volume of the solution _(see DOSAGE AND ADMINISTRATION)_ with sterile normal saline solution to a total volume of 3 mL and administer by nebulization. EACH ML CONTAINS: ACTIVE: Albuterol sulfate equivalent to 5 mg of albuterol in an aqueous solution. Sulfuric Acid may be added to adjust pH (3.0-5.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Albuterol sulfate inhalation solution contains no sulfiting agents. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution. CLINICAL PHARMACOLOGY: _In vitro _studies and _in vivo _pharmacologic studies have demonstrated that albuterol has a preferential effect on beta -adrenergic receptors compared with isoproterenol. While it is recognized that beta - adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta -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, are at least in part attributable to stimu Perskaitykite visą dokumentą