ALBUTEROL SULFATE syrup

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

ATLANTIC BIOLOGICALS CORP.

INN (আন্তর্জাতিক নাম):

ALBUTEROL SULFATE

রচনা:

ALBUTEROL 2 mg in 5 mL

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

NDC:17856-0740-3 in a CUP of 5 SYRUPS

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ALBUTEROL SULFATE- ALBUTEROL SULFATE SYRUP
ATLANTIC BIOLOGICALS CORP.
----------
ALBUTEROL SULFATE SYRUP
DESCRIPTION
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 (±)α -[( -butylamino)
methyl]-4-hydroxy- -xylene-a,a'-diol sulfate (2:1) (salt), and the
following chemical structure:
_tertm_
Albuterol sulfate has a molecular weight of 576.70 and the molecular
formula (C H NO ) o H SO .
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.
Each 5 mL (teaspoonful), for oral administration contains 2.4 mg of
albuterol sulfate equivalent to 2 mg
of albuterol. Albuterol Sulfate Syrup also contains the inactive
ingredients citric acid anhydrous, FD &
C Yellow No. 6, hydroxypropyl methylcellulose, orange flavor, purified
water, saccharin, sodium
benzoate, and sodium citrate.
The pH of the syrup is 3.5 to 4.5.
CLINICAL PHARMACOLOGY
studies and 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 ).
_In vitroin vivo_
WARNINGS
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 br