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:

Mylan Pharmaceuticals Inc.

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 0.75 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

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.

Product summary:

Albuterol Sulfate Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg/3 mL and 1.25 mg/3 mL, 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, 0.63 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 0378-6991-52    5 foil pouches, each containing 5 vials, total 25 vials per carton Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL (potency expressed as albuterol) contains 1.5 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0378-6992-52      5 foil pouches, each containing 5 vials, total 25 vials per carton Rx only

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
MYLAN PHARMACEUTICALS INC.
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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 0.63 mg of albuterol equivalent to 0.75
mg of albuterol
sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol
sulfate 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 3.5 (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 (1.25 mg strength) and 39% of albuterol
(0.63 mg
strength) at a mean flow rate of 3.6 L/min. The mean nebulization time
was 15 minutes
or less. Albuterol sulfate inhalation solution should be administered
from a jet nebuliz