ALBUTEROL SULFATE solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Ritedose Pharmaceuticals, LLC

INN (Nama Internasional):

ALBUTEROL SULFATE

Komposisi:

ALBUTEROL 2.5 mg in 3 mL

Rute administrasi :

RESPIRATORY (INHALATION)

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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% 3 Note: This is a unit-dose vial. No dilution is required. Read complete instructions carefully before using. - Remove the vial from the foil pouch. - Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1). - Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). - Connect the nebulizer to the compressor. - 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. - Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. - Clean the nebulizer (see manufacturer's instructions). Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended . Store Albuterol Sulfate Inhalation Solution 0.083% 3 between 2° and 25° C (36° and 77° F). Store in pouch until time of use. ADDITIONAL INSTRUCTIONS: Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203 To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch RPIN0052 March 2014

Ringkasan produk:

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 76204-200-25 25 vials per carton / 25 vials per foil pouch NDC 76204-200-30 30 vials per carton / 30 vials per foil pouch NDC 76204-200-01 30 vials per carton / 1 vial per foil pouch NDC 76204-200-60 60 vials per carton / 30 vials per foil pouch PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F). Rx only.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
RITEDOSE PHARMACEUTICALS, LLC
----------
ALBUTEROL SULFATE INHALATION SOLUTION, 0.083%
2.5 MG/3 ML (RDP)
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
1
(Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate)
2
1
13
21
3
2
2
4
2
2
pr