ALBUTEROL SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 0.63 mg in 3 mL

Administration route:

INTRABRONCHIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease). Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components. Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication, as you may want to read them again. Albuterol sulfate inhalation solution should only be used under the direction of a physician. Your physician and pharmacist have more information about albuterol sulfate inhalation solution and the condition for which it has been prescribed. Contact them if you have additional questions. Storing your Medicine Store albuterol sulfate inhalation solution between 20° and 25° C (68° and 77° F). [See USP Controlled Room Temperature]. Vials should be protected from light before use, therefore, keep unused vials in the foil pouch. D

Product summary:

Albuterol sulfate inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate inhalation solution is available in a shelf carton containing multiple foil pouches. Albuterol sulfate inhalation solution, 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton Albuterol sulfate inhalation solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
ACTAVIS PHARMA, INC.
----------
ALBUTEROL SULFATE INHALATION SOLUTION
0.042% (1.25 MG*/3 ML) AND 0.021% (0.63 MG*/3 ML)
(*POTENCY EXPRESSED AS ALBUTEROL, EQUIVALENT TO 1.5 MG
AND 0.75 MG ALBUTEROL SULFATE)
REVISED: JANUARY 2017
RX ONLY
PRESCRIBING INFORMATION
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 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 0.63 mg of
albuterol) or 1.50 mg of albuterol
sulfate (equivalent to 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 4.0 (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 albuter