Albuterol Sulfate (Page 3 of 3)

Post-Marketing Experience:

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, 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 casual relationship to drug exposure.

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 that would require reassessment of therapy.

HOW SUPPLIED :

Unit-dose plastic vial containing Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3 mL* (*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate). 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 0591-3797-83 carton of 25 vials.
NDC 0591-3797-30 carton of 30 vials.
NDC 0591-3797-60 carton of 60 vials.

Storage:

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

Rx only.

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203

To report SUSPECTED ADVERSE REACTIONS, contact Watson Laboratories, Inc.
at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PATIENT’S INSTRUCTIONS FOR USE

Albuterol Sulfate Inhalation Solution, 0.083%*
(*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate).

Note: This is a unit-dose vial. No dilution is required.

Read complete instructions carefully before using.

1. Remove the vial from the foil pouch.

2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).

3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).

4. Connect the nebulizer to the compressor.

5. 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.

6. 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.

7. Clean the nebulizer (see manufacturer’s instructions).

1. Remove the vial from the foil pouch. 2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1). 3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). 4. Connect the nebulizer to the compressor. 5. 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. 6. 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. 7. 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%* between 2° and 25° C (36° and 77° F). Store in pouch until time of use.

ADDITIONAL INSTRUCTIONS: ___________________________________________

________________________________________________________________________

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203

April 2017

PRINCIPAL DISPLAY PANEL

NDC 0591-3797-60
Albuterol Sulfate
Inhalation Solution, 0.083%*
2.5 mg / 3 mL**Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

image
(click image for full-size original)

ALBUTEROL SULFATE albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3797
Route of Administration INTRABRONCHIAL 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:0591-3797-30 30 VIAL in 1 CARTON contains a VIAL
1 3 mL in 1 VIAL This package is contained within the CARTON (0591-3797-30)
2 NDC:0591-3797-60 60 VIAL in 1 CARTON contains a VIAL
2 3 mL in 1 VIAL This package is contained within the CARTON (0591-3797-60)
3 NDC:0591-3797-83 25 VIAL in 1 CARTON contains a VIAL
3 3 mL in 1 VIAL This package is contained within the CARTON (0591-3797-83)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077839 11/04/2010
Labeler — Actavis Pharma, Inc. (119723554)
Establishment
Name Address ID/FEI Operations
The Ritedose Corporation 837769546 ANALYSIS (0591-3797), LABEL (0591-3797), MANUFACTURE (0591-3797), PACK (0591-3797)

Revised: 10/2019 Actavis Pharma, Inc.

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