ALBUTEROL SULFATE- albuterol sulfate solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Aurobindo Pharma Limited

INN (Jina la Kimataifa):

ALBUTEROL SULFATE

Tungo:

ALBUTEROL 0.83 mg in 1 mL

Njia ya uendeshaji:

RESPIRATORY (INHALATION)

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. Albuterol Sulfate Inhalation Solution 0.083%* (*potency expressed as albuterol) Note: This is a unit-dose vial. No dilution is required. Read complete instructions carefully before using. 1. Remove vial from the foil pouch. 2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1). 3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). 4. Connect the nebulizer to the compressor. 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) (or put on the face mask); and turn on the compressor. 6.

Bidhaa muhtasari:

Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL* (*potency expressed as albuterol). 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 65862-858-25            25 vials per carton/5 vials per foil pouch NDC 65862-858-30            30 vials per carton/5 vials per foil pouch NDC 65862-858-60            60 vials per carton/5 vials per foil pouch NDC 65862-858-03            30 vials per carton/1 vial per foil pouch Storage PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25°C (36° and 77°F).

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ALBUTEROL SULFATE - ALBUTEROL SULFATE SOLUTION
AUROBINDO PHARMA LIMITED
----------
ALBUTEROL SULFATE INHALATION SOLUTION 0.083%*
(*POTENCY EXPRESSED AS ALBUTEROL)
RX ONLY
PRESCRIBING INFORMATION
FOR INHALATION USE ONLY–NOT FOR INJECTION.
ALBUTEROL SULFATE INHALATION SOLUTION 0.083%*
(*POTENCY EXPRESSED AS ALBUTEROL)
RX ONLY
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 576.71 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.
2
1
13
21
3
2
2
4
Each mL 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 edetate
disodium, sodium chloride, and sodium citrate (dihydrate);
hydrochloric acid is used to
adjust the pH between 3 and 5. Albuterol sulfate inhalation solution
(0.083%) contains
no sulfiting agents.
Albuterol sulfate inhalation solution is a clear, colorless 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
isoprot