Albuterol Sulfate (Page 3 of 3)

Post-Marketing Experience

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillations, supraventricular tachycardia, extrasystoles) and metabolic acidosis have been reported after the use of albuterol sulfate inhalation solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

OVERDOSAGE

Manifestations of overdosage may include seizures, anginal pain, hypertension, hypokalemia, tachycardia with rates up to 200 beats/min, and exaggeration of the pharmacological effects listed in ADVERSE REACTIONS. In isolated cases in children 2 to 12 years of age, tachycardia with rates >200 beats/min has been observed.

The oral LD50 in rats and mice was greater than 2,000 mg/kg. The inhalational LD50 could not be determined.

There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol inhalation solution.

DOSAGE AND ADMINISTRATION

Adults and Children 2 to 12 Years of Age

The usual dosage for adults and for children weighing at least 15 kg is 2.5 mg of albuterol (one vial) administered three to four times daily by nebulization. Children weighing < 15 kg who require < 2.5 mg/dose (i.e., less than a full vial) should use albuterol inhalation solution, 0.5% instead of albuterol inhalation solution, 0.083%. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, administer the entire contents of one sterile unit dose vial (3 mL of 0.083% inhalation solution) by nebulization. The flow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes.

The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

HOW SUPPLIED

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 33261-0789-01 25 vials per carton / 25 vials per foil pouch


2
(Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate)

Storage

PROTECT FROM LIGHT. Store in pouch until time of use. Store between 2° and 25° C (36° and 77° F).

Rx only.

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

RPIN0032
October 2012

Repackaged By :
Aidarex Pharmaceuticals LLC,Corona, CA 92880

PATIENT’S INSTRUCTIONS FOR USE

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).
Figures
(click image for full-size original)

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

RPIN0032
October 2012

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880


3
(Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate).

PRINCIPAL DISPLAY PANEL — 2.5 mg Carton

NDC 33261-0789-01

Albuterol Sulfate
Inhalation Solution, 0.083%*

2.5 mg / 3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

Each mL contains 1 mg albuterol sulfate, equivalent to 0.83 mg albuterol
in an aqueous solution containing sodium chloride and sulfuric acid
to adjust pH between 3 and 5. Contains no preservatives.
Please consult your physician before use. Do not exceed recommended dosage.
Usual Dosage: See package insert. Protect from light.
Store between 2° and 25°C (36° and 77°F). Discard if solution becomes discolored.(Note: Albuterol Sulfate Inhalation Solution is a clear, colorless to light yellow solution.)

Rx Only

25 x 3 mL Sterile Unit-Dose Vials

IMAGE LABEL
(click image for full-size original)
ALBUTEROL SULFATE albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-789(NDC:76204-200)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 2.5 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SULFURIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-789-01 1 POUCH (1 POUCH) in 1 CARTON contains a POUCH
1 25 AMPULE (25 AMPULE) in 1 POUCH This package is contained within the CARTON (33261-789-01) and contains a AMPULE
1 3 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (33261-789-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077839 12/05/2011
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 11/2013 Aidarex Pharmaceuticals LLC

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