Albuterol Aerosol

Name: Albuterol Aerosol

Albuterol Inhalation Aerosol

Bronchodilator Aerosol
For Oral Inhalation Only

Rx only

Warnings

Paradoxical Bronchospasm

Albuterol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Albuterol Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Cardiovascular Effects

Albuterol, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Albuterol Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Deterioration of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Albuterol Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Use of Anti-Inflammatory Agents

The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.

Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of Albuterol Inhalation Aerosol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

The contents of Albuterol Inhalation Aerosol are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Avoid spraying in eyes. Keep out of reach of children.

Adverse Reactions

The adverse reactions to albuterol are similar in nature to reactions to other sympathomimetic agents, although the incidence of certain cardiovascular effects is lower with albuterol.

Percent Incidence of Adverse Reactions in Patients ≥ 12 Years of Age in a 13-Week Clinical Trial*
Percent Incidence
Reaction Albuterol Isoproterenol
* A 13-week double-blind study compared albuterol and isoproterenol inhalation aerosols in 147 asthmatic patients.
Tremor <15% <15%
Nausea <15% <15%
Tachycardia 10% 10%
Palpitations <10% <15%
Nervousness <10% <15%
Increased Blood Pressure <5% <5%
Dizziness <5% <5%
Heartburn <5% <5%
Percent Incidence of Adverse Reactions in Children 4 to 11 Years of Age in a 12-Week Trial*
Reaction Percent Incidence
* A 12-week double-blind trial in 104 patients aged 4 to 11 years.
Central Nervous System
  Headache 3%
  Nervousness 1%
  Lightheadedness <1%
  Tremor <1%
  Agitation 1%
  Nightmares 1%
  Hyperactivity 1%
  Aggressive Behavior 1%
Gastrointestinal
  Nausea and/or Vomiting 6%
  Stomachache 3%
  Diarrhea 1%
Oropharyngeal
  Throat Irritation 6%
  Discoloration of Teeth 1%
Respiratory
  Epistaxis 3%
  Cough 2%
Musculoskeletal
  Muscle Cramp 1%

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol inhalation aerosol.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, and unusual taste.

Overdosage

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension, hypotension, tachycardia with rates up to 200 beats/minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur.

As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Albuterol Inhalation Aerosol. Treatment consists of discontinuation of Albuterol Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Albuterol Inhalation Aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis, or, approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In mature rats, the sc median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis, or, approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In small young rats, the sc median lethal dose of albuterol sulfate is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis, or, approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). The inhalation median lethal dose has not been determined in animals.

How is Albuterol Aerosol Supplied

Albuterol Inhalation Aerosol is supplied in 17 g canisters containing 200 metered inhalations (NDC 17270-721-01) in boxes of one. Each actuation delivers 100 mcg of albuterol from the valve and 90 mcg of albuterol from the mouthpiece. Each canister is supplied with a blue oral adapter and patient's instructions. Also available, Albuterol Inhalation Aerosol Refill with patient's instructions (NDC 17270-721-02).

The blue adapter supplied with Albuterol Inhalation Aerosol should not be used with any other product canisters, and the adapters from other products should not be used with an Albuterol Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

Store between 15°–30°C (59°–86°F). As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold; for best results, the canister should be at room temperature before use.

Shake well before using.

Note: The indented statement below is required by the Federal government Clean Air Act for all products containing chlorofluorocarbons (CFC's).

  WARNING: This product contains trichloromonofluoro-methane and dichlorodifluoromethane (CFC's), substances which harm public health and environment by destroying ozone in the upper atmosphere.

A notice similar to the above warning has been placed in the patient instruction leaflet of this package insert pursuant to the regulations of the U.S. Environmental Protection Agency (EPA). The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.

Rx only.

Manufactured by

Armstrong Pharmaceuticals, Inc.
West Roxbury, MA 02132
An Amphastar Company
Rev. 4/06 F068B

Patient's Instructions for Use

Before using your Albuterol Inhalation Aerosol, read complete instructions carefully.

Children should use Albuterol Inhalation Aerosol under adult supervision, as instructed by the patient's doctor.

The blue adapter supplied with Albuterol Inhalation Aerosol should not be used with any other product canisters, and adapters from other products should not be used with an Albuterol Inhalation Aerosol canister.

The refill canister is to be used only with the blue Albuterol Inhalation Aerosol adapter ID#720.

1. SHAKE THE INHALER WELL immediately before each use. Then remove the cap from the mouthpiece. Should the cap be dislodged or lost, the inhaler mouthpiece should be inspected for the presence of foreign objects before each use. Make sure the canister is fully and firmly inserted into the actuator. 2. BREATHE OUT FULLY THROUGH THE MOUTH, expelling as much air from your lungs as possible. Place the mouthpiece fully into the mouth, holding the inhaler in its upright position (see Figure 1) and closing the lips around it. 3. WHILE BREATHING IN DEEPLY AND SLOWLY THROUGH THE MOUTH, FULLY DEPRESS THE TOP OF THE METAL CANISTER with your index finger. (See Figure 2). 4. HOLD YOUR BREATH AS LONG AS POSSIBLE. Before breathing out, remove the inhaler from your mouth and release your finger from the canister. 5. Wait one minute and SHAKE the inhaler again. Repeat steps 2 through 4 for each inhalation prescribed by your doctor. 6. CLEANSE THE INHALER THOROUGHLY AND FREQUENTLY. Remove the metal canister and cleanse the plastic case and cap by rinsing thoroughly in warm, running water, at least once a day. After thoroughly drying the plastic case and cap, gently replace the canister into the case with a twisting motion and put the cap back onto the mouthpiece. 7. As with all aerosol medications, it is recommended to "test spray" into the air before using for the first time and in cases where the aerosol has not been used for a prolonged period of time. 8. DISCARD THE CANISTER AFTER YOU HAVE USED THE LABELED NUMBER OF INHALATIONS.
The correct amount of medication in each inhalation cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. Before you reach the specific number of actuations, you should consult your doctor to determine whether a refill is needed. Just as you should not take extra doses without consulting your doctor, you also should not stop using Albuterol Inhalation Aerosol without consulting your doctor.


DOSAGE

Use only as directed by your doctor.


WARNINGS

The action of Albuterol Inhalation Aerosol may last up to 6 hours or longer. Albuterol Inhalation Aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of Albuterol Inhalation Aerosol without consulting your doctor. If you find that treatment with Albuterol Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using Albuterol Inhalation Aerosol, other inhaled drugs and asthma medicines should be used only as directed by your doctor.

Contents Under Pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. Avoid spraying in eyes.

Store between 15° – 30°C (59°– 86°F). As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold; for best results, the canister should be at room temperature before use.

Shake well before using.

Note: The indented statement below is required by the Federal government Clean Air Act for all products containing chlorofluorocarbons (CFC's).

  This product contains trichloromonofluoromethane and dichlorodifluoromethane (CFC's), substances which harm the environment by depleting ozone in the upper atmosphere.

Your doctor has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR DOCTOR. If you have any questions about alternatives, consult your doctor.


Manufactured by

Armstrong Pharmaceuticals, Inc.
West Roxbury, MA 02132
An Amphastar Company
Rev. 4/06 F068B

ALBUTEROL 
Albuterol Aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17270-721
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albuterol (Albuterol) Albuterol 90 ug
Inactive Ingredients
Ingredient Name Strength
trichloromonoflueormethane 60.9 mg  in 1 
dichlorofluoromethane 25.97 mg  in 1 
oleic acid 0.011 mg  in 1 
Packaging
# Item Code Package Description
1 NDC:17270-721-02 200 AEROSOL, METERED (200 INHALATION) in 1 CANISTER
Labeler - Armstrong Pharmaceuticals, Inc.
Revised: 11/2007   Armstrong Pharmaceuticals, Inc.
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