Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)
Cardinal Health
ALBUTEROL SULFATE
ALBUTEROL 1.5 mg in 3 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION CARDINAL HEALTH ---------- ALBUTEROL SULFATE INHALATION SOLUTION 0.63 MG* / 3 ML AND 1.25 MG* / 3 ML *Potency expressed as albuterol equivalent to 0.75 mg and 1.5 mg albuterol sulfate. DESCRIPTION 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 beta -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α -[(_tert_- Butylamino)methyl]-4-hydroxy-_m_-xylene-α,α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C H NO ) • H SO . Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol is salbutamol. 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 HOW SUPPLIED). 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 Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under _in vitro_ conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (0.042% or 1.25 mg strength) and Lestu allt skjalið