ALBUTEROL SULFATE solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

থেকে পাওয়া:

Cardinal Health

INN (আন্তর্জাতিক নাম):

ALBUTEROL SULFATE

রচনা:

ALBUTEROL 1.5 mg in 3 mL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
CARDINAL HEALTH
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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