Albuterol

Name: Albuterol

Albuterol Overview

Albuterol is a prescription medication used to treat bronchospasm (narrowing of airways) in people who have reversible obstructive airway disease. It may also used to prevent exercise-induced bronchospasm. Albuterol belongs to a group of drugs called beta agonists. These cause the smooth muscle of the airways to relax, making it easier to breathe.

Albuterol comes as a tablet, a syrup, and an extended release tablet to take by mouth. The tablets and syrup are usually taken three or four times a day. The extended release tablets are usually taken once every 12 hours. 

Albuterol also comes as a solution to be inhaled into the mouth using a nebulizer and is usually used 3 or 4 times a day.

This medication also comes as aerosol to inhale by mouth using an inhaler. When the aerosol is used to treat or prevent symptoms of lung disease, it is usually used every 4 to 6 hours as needed. When the aerosol is used to prevent breathing difficulty during exercise, it is usually used 15 to 30 minutes before exercise.

Common side effects include fast heartbeat, shakiness, and nervousness.

Albuterol Description

Albuterol tablets contain Albuterol sulfate, USP, the racemic form of Albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(salt) and the following structural formula:

Albuterol sulfate has a molecular weight of 576.71, and the molecular formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in ethanol.

The World Health Organization recommended name for Albuterol base is salbutamol.

Each Albuterol sulfate tablet, for oral administration contains 2 or 4 mg of Albuterol as 2.4 or 4.8 mg of Albuterol sulfate, respectively. Each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, pregelatinized (corn) starch, and sodium starch glycolate.

Albuterol Dosage and Administration

The following dosages of Albuterol tablets are expressed in terms of Albuterol base.

Usual Dosage

Adults and Children Over 12 Years of Age

The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day.

Children 6 to 12 Years of Age

The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.

Dosage Adjustment

Adults and Children Over 12 Years of Age

For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day

For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).

Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators

An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.

The total daily dose should not exceed 32 mg in adults and children 12 years and older.

PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label

NDC 53489-177-01

Albuterol
Tablets USP

4 mg

Rx Only
100 Tablets

SUN
PHARMA

Albuterol SULFATE 
Albuterol sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53489-176
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albuterol sulfate (Albuterol) Albuterol 2 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose  
magnesium stearate  
starch, corn  
sodium starch glycolate type a potato  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code MP;47
Contains     
Packaging
# Item Code Package Description
1 NDC:53489-176-02 50 TABLET in 1 BOTTLE
2 NDC:53489-176-01 100 TABLET in 1 BOTTLE
3 NDC:53489-176-03 250 TABLET in 1 BOTTLE
4 NDC:53489-176-05 500 TABLET in 1 BOTTLE
5 NDC:53489-176-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072637 12/05/1989
Albuterol SULFATE 
Albuterol sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53489-177
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albuterol sulfate (Albuterol) Albuterol 4 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose  
magnesium stearate  
starch, corn  
sodium starch glycolate type a potato  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code MP;88
Contains     
Packaging
# Item Code Package Description
1 NDC:53489-177-02 50 TABLET in 1 BOTTLE
2 NDC:53489-177-01 100 TABLET in 1 BOTTLE
3 NDC:53489-177-03 250 TABLET in 1 BOTTLE
4 NDC:53489-177-05 500 TABLET in 1 BOTTLE
5 NDC:53489-177-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072637 12/05/1989
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Frontida BioPharm Inc. 080243260 manufacture(53489-176, 53489-177)
Revised: 01/2017   Sun Pharmaceutical Industries, Inc.

Duration of Action

Nebulization/oral inhalation: 2 to 6 hours; Oral: Immediate release: 4 to 6 hours; Extended release tablets: Up to 12 hours

Half-Life Elimination

Inhalation: 3.8 to ~5 hours; Oral: 3.7 to 5 hours

Protein Binding

10%

Off Label Uses

Asthma (children younger than 4 years) (metered-dose inhaler)

Current practice standards recommend albuterol MDI in the treatment of intermittent and persistent asthma in children younger than 4 years.

Hyperkalemia (Inhalation)

Data from small controlled trials and a systematic review support the use of nebulized albuterol in the treatment of hyperkalemia (Allon 1989, Batterink 2015, Mandelberg 1999). Additional trials may be necessary to further define the role of nebulized albuterol in this condition.

Based on AHA evidence-based guidelines, nebulized albuterol is recommended as adjuvant therapy for acute treatment of moderate to severe hyperkalemia (AHA [Vanden Hoek 2010]).

Reconstitution

Solution for nebulization: To prepare a 2.5 mg dose, dilute 0.5 mL of solution to a total of 3 mL with normal saline; also compatible with cromolyn or ipratropium nebulizer solutions.

IV [Canadian product]: Dilute 5 mg in 500 ml of NS, D5W or D5NS. Use within 24 hours.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, tremor, pharyngitis, back pain, aches, pains, or rhinorrhea. Have patient report immediately to prescriber signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), uncontrolled breathing attack, angina, tachycardia, severe anxiety, severe headache, severe dizziness, passing out, decreased peak flow measurement, signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), painful urination, difficult urination, or wheezing, coughing, or difficult breathing (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Important information

It is important to keep albuterol on hand at all times. Get your prescription refilled before you run out of medicine completely. Keep using all of your other medications as prescribed by your doctor.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor. An increased need for medication could be an early sign of a serious asthma attack.

An overdose of albuterol can be fatal. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Before taking this medicine

You should not use this medicine if you are allergic to albuterol. You should not use ProAir RespiClick if you are allergic to milk proteins.

To make sure albuterol inhalation is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, congestive heart failure;

  • a heart rhythm disorder;

  • a seizure disorder such as epilepsy;

  • diabetes;

  • overactive thyroid; or

  • low levels of potassium in your blood.

It is not known whether albuterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether albuterol inhalation passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Albuterol inhalation is not approved for use by anyone younger than 4 years old.

What should I avoid while using albuterol inhalation?

Rinse with water if this medicine gets in your eyes.

Usual Adult Dose for Reversible Airways Disease - Maintenance

Inhalation powder:
-1 or 2 inhalations (90 to 180 mcg) orally every 4 to 6 hours

Inhalation capsules:
-1 inhalation (200 mcg) orally every 4 to 6 hours
-Maximum dose: 4 inhalations (800 mcg) per day

Nebulizer inhalation solution:
-2.5 mg three or four times a day by nebulization, over approximately 5 to 15 minutes

Oral tablets:
Immediate-release tablets:
-Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated (maximum of 32 mg/day).
-Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day; dosage may be gradually increased up to 8 mg three or four times a day.

Extended-release tablets:
-Initial dose: 4 mg or 8 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 32 mg/day in divided doses (e.g., every 12 hours). In unusual circumstances, such as adults of low body weight, use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

Oral syrup:
-Initial dose: 2 mg or 4 mg orally three or four times a day. Dosage may be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
-Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

Uses:
-Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor
-Relief of bronchospasm in patients with reversible obstructive airway disease

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Tremor, a headache, and nervousness.
  • May sometimes affect heart rate and blood pressure, possibly causing chest pain and palpitations. This is because beta2 receptors are also present in the heart, at concentrations of approximately 10-50%. Seek medical advice if these side effects occur. ECG changes have also been reported.
  • Albuterol may not be suitable for some people with cardiovascular disease, arrhythmia, high blood pressure, seizures, or an overactive thyroid.
  • May aggravate diabetes and cause low potassium levels.
  • Very rarely, may cause a paradoxical bronchospasm (instead of opening the airways it closes them). Discontinue immediately and contact emergency services.
  • May interact with other drugs including antidepressants, beta-blockers, diuretics, and digoxin.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

(web3)