Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Sandoz Inc.
ALBUTEROL SULFATE
ALBUTEROL 2.5 mg in 3 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 any of its components.
Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL 2. Equivalent to 0.5 mL albuterol (as the sulfate) 0.5% (2.5 mg albuterol) diluted to 3 mL. Supplied in cartons as listed below. NDC 0781-7155-86 carton of 25 vials. NDC 0781-7155-64 carton of 30 vials. NDC 0781-7155-29 carton of 60 vials. PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F).
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION SANDOZ INC. ---------- ALBUTEROL SULFATE INHALATION SOLUTION 0.083% 1 PRESCRIBING INFORMATION FOR INHALATION USE ONLY-NOT FOR INJECTION. DESCRIPTION Albuterol sulfate inhalation solution is a relatively selective beta -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α -[( _tert_-Butylamino)methyl]-4-hydroxy- _m_-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula: Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C H NO ) • H SO . Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each milliliter of albuterol sulfate inhalation solution 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol sulfate inhalation solution 0.083% contains no sulfiting agents or preservatives. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution. CLINICAL PHARMACOLOGY 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. _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, 10% to 50% of the beta-receptors in the human heart may be beta -receptors. The precise function of these receptors, however, is Pročitajte cijeli dokument