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:

Nephron Pharmaceuticals Corporation

INN (International Name):

ALBUTEROL SULFATE

Composition:

ALBUTEROL 1.25 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 (0.021%) of albuterol (equivalent to 0.75 mg of albuterol sulfate in 3 mL) and 1.25 mg (0.042%) of albuterol (equivalent to 1.5 mg of albuterol sulfate in 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 1 unit-dose LDPE vial. 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 equivalent to 0.75 mg albuterol sulfate per 3 mL) in unit-dose vials and is available in the following packaging configurations: NDC 0487-0301-01: 30 foil pouches, each containing 1 vial, total 30 vials per carton NDC 0487-0301-02 30 foil pouches, each containing 1 vial, total 30 vials per carton, robot ready Albuterol Sulfate Inhalation Solution, 0.042% (1.25 mg / 3 mL) (potency expressed as albuterol equivalent to 1.5 mg albuterol sulfate per 3 mL) in unit-dose vials and is available in the following packaging configurations: NDC 0487-9904-25 25 foil pouches, each containing 1 vial, total 25 vials per carton NDC 0487-9904-01 30 foil pouches, each containing 1 vial, total 30 vials per carton NDC 0487-9904-02 30 foil pouches, each containing 1 vial, total 30 vials, per carton, robot ready Store between 2°C and 25°C (36°F and 77°F). Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial within one week. Discard the vial if the solution is not colorless. Keep out of the reach of children. Rx Only Manufactured By: Nephron Pharmaceuticals Corporation Orlando, FL 32811 For Customer Service, call 1-800-443-4313. IC#228 Rev. 03-16-11

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBUTEROL SULFATE- ALBUTEROL SULFATE SOLUTION
NEPHRON PHARMACEUTICALS CORPORATION
----------
ALBUTEROL SULFATE INHALATION SOLUTION 0.021% & 0.042%
*Potency expressed as albuterol equivalent to 0.75 mg and 1.5 mg
albuterol sulfate.
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’s 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 0.021% or
0.63 mg of albuterol) or 1.5 mg of
albuterol sulfate (equivalent to 0.042% or 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
between 3 and 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 (0.042% or 1.25 mg strength) an