Albuterol Oral Inhalation

What is Albuterol Oral Inhalation?

• Albuterol Oral Inhalation is a beta2-adrenergic agonist used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), used to prevent breathing difficulties during exercise.
• Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older.
• Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 years of age and older.
• Albuterol solution for oral inhalation is used in adults and children 2 years of age and older.

Salbutamol

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What are the uses of this medicine?

Albuterol Oral Inhalation is used for:

• Treatment or prevention of bronchospasm.
• Prevention of exercise-induced bronchospasm.

How does this medicine work?

• Albuterol is a beta2-adrenergic agonist.
• The beta adrenergic agonists are potent bronchodilators that are widely used in the management of bronchial asthma.
• These agents act by engaging the beta-2 adrenergic receptors on smooth muscle of bronchial tissue, relieving bronchospasm and reducing airway resistance.
• They also act on smooth muscle of the vascular system, intestines and uterus.
• Common forms of beta adrenergic agonists include albuterol, bitolterol, fenoterol, formoterol, levalbuterol, metaproterenol, salmeterol, pirbuterol and terbutaline, which all have similar mechanisms of action, chemical structure, side effects and efficacy, but somewhat different pharmacokinetics allowing for differences in dosing regimens and duration of action.
• Most of these agents are administered by inhalation (alone or in combination with other bronchodilators or corticosteroids), with only albuterol and terbutaline being available in oral forms in the United States.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to albuterol sulfate or any of the ingredients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• digoxin (Lanoxin)
• diuretics ('water pills')
• epinephrine (Epipen, Primatene Mist)
• other inhaled medications used to relax the air passages such as metaproterenol and levalbuterol (Xopenex)
• and medications for colds.

Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past 2 weeks:

• antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline ( Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate)

Is this medicine FDA approved?

* It was approved for medical use in the United States in 1982.

How should this medicine be used?

Recommended dosage: Treatment or prevention of bronchospasm in adults and children 4 years of age and older:

• 2 inhalations every 4 to 6 hours.
• For some patients, 1 inhalation every 4 hours may be sufficient.

Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older:

• 2 inhalations 15 to 30 minutes before exercise.

Administration:

• Albuterol comes as a solution (liquid) to inhale by mouth using a special jet nebulizer (machine that turns medication into a mist that can be inhaled) and as an aerosol or powder to inhale by mouth using an inhaler.
• When the inhalation aerosol or powder for oral inhalation is used to treat or prevent symptoms of lung disease, it is usually used every 4 to 6 hours as needed.
• When the inhalation aerosol or powder for oral inhalation is used to prevent breathing difficulty during exercise, it is usually used 15 to 30 minutes before exercise.
• The nebulizer solution is usually used three or four times a day.
• Each albuterol aerosol inhaler is designed to provide 60 or 200 inhalations, depending on its size. Each albuterol powder inhaler is designed to provide 200 inhalations.
• Dispose of the aerosol inhaler after you have used the labeled number of inhalations, even if it still contains some liquid and continues to release a spray when it is pressed. Dispose of the powder inhaler 13 months after you open.
• Be careful not to get albuterol inhalation into your eyes.
• Do not use your albuterol inhaler when you are near a flame or source of heat.
• The inhaler may explode if it is exposed to very high temperatures.
• If your inhaler does not come with an attached counter, you will need to keep track of the number of inhalations you have used.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As as a solution (liquid) to inhale
• and as an aerosol or powder to inhale

This medicine is available in fallowing brand namesː

• Accuneb
• Proair HFA
• Proair Respiclick
• Proventil HFA
• Ventolin HFA

What side effects can this medication cause?

The most common side effects of this medicine include:

• throat irritation
• viral respiratory infections
• upper respiratory inflammation
• cough
• musculoskeletal pain
• uncontrollable shaking of a part of the body
• nervousness
• headache
• nausea
• vomiting
• muscle, bone, or back pain

What special precautions should I follow?

• Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol sulfate inhalation aerosol should be discontinued immediately and alternative therapy instituted.
• Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
• 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, to the therapeutic regimen.
• Albuterol sulfate inhalation aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Therefore, Albuterol sulfate inhalation aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
• Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.
• Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
• It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four "test sprays" into the air, away from the face.
• KEEPING THE PLASTIC MOUTHPIECE CLEAN IS VERY IMPORTANT TO PREVENT MEDICATION BUILDUP AND BLOCKAGE. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR DRIED THOROUGHLY AT LEAST ONCE A WEEK. INHALER MAY CEASE TO DELIVER MEDICATION IF NOT PROPERLY CLEANED.
• The action of Albuterol sulfate inhalation aerosol should last up to 4 to 6 hours. Albuterol sulfate inhalation aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of doses of Albuterol sulfate inhalation aerosol without consulting your physician.
• It is not known whether the components of Albuterol sulfate inhalation aerosol are excreted in human milk. Caution should be exercised when albuterol sulfate is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• seizures
• angina
• hypertension or hypotension
• tachycardia with rates up to 200 beats/min
• arrhythmias
• nervousness
• headache
• tremor
• dry mouth
• palpitation
• nausea
• dizziness
• fatigue
• malaise
• sleeplessness
• Hypokalemia

Management of overdosage:

• Treatment consists of discontinuation of albuterol together with appropriate symptomatic therapy.
• There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol.
• A cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Albuterol sulfate inhalation aerosol or albuterol sulfate in pregnant women.
• Albuterol sulfate inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older.
• Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 years of age and older.
• Albuterol solution for oral inhalation is used in adults and children 2 years of age and older.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ALBUTEROL SULFATE

Inactive ingredients:

• OLEIC ACID
• NORFLURANE
• ALCOHOL

Who manufactures and distributes this medicine?

Manufactured for:

• Mylan Pharmaceuticals Inc.
• Morgantown, WV U.S.A.

Manufactured by:

• The Ritedose Corporation
• Columbia, SC U.S.A.

What should I know about storage and disposal of this medication?

• Keep this medication in the container it came in, tightly closed, and out of reach of children.
• Keep unused vials of nebulizer solution in the foil pouch until you are ready to use them.
• Store nebulizer solution vials in the refrigerator or at room temperature away from excess heat and moisture.
• Store the the inhaler at room temperature and away from excess heat and moisture.
• Do not puncture the aerosol canister, and do not discard it in an incinerator or fire.

• Dailymed label info on Albuterol Oral Inhalation
• FDA Albuterol Oral Inhalation

Albuterol Oral Inhalation Resources
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