Albuterol

Inhalational/Oral:

Albuterol may cause serious side effects. See "Albuterol Precautions" section.

The most common side effects of albuterol include:

• your heart feels like it is pounding or racing (palpitations)
• chest pain
• fast heart rate
• shakiness
• nervousness
• headache
• dizziness
• sore throat
• runny nose

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of albuterol. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Albuterol and other medicines may affect each other and cause side effects. Albuterol may affect the way other medicines work, and other medicines may affect the way albuterol works.

Especially tell your doctor if you take:

• other inhaled medicines or asthma medicines
• beta blocker medicines
• diuretics
• digoxin
• monoamine oxidase inhibitors
• tricyclic antidepressants

This is not a complete list of albuterol drug interactions. Ask your doctor or pharmacist for more information.

Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

NDC 53489-176-01

Albuterol
Tablets USP

2 mg

Rx Only
100 Tablets

SUN
PHARMA

Peak effect:

Nebulization/oral inhalation: 0.5 to 2 hours

CFC-propelled albuterol: 10 minutes (peak plasma concentration)

Inhalation powder: 30 minutes (peak plasma concentration)

HFA inhalers: 25 minutes (peak plasma concentration); ~56 minutes (peak FEV1 effect)

Oral: Immediate release: 2 to 3 hours

Inhalation, Oral: Hypersensitivity to albuterol or any component of the formulation; severe hypersensitivity to milk proteins (dry powder inhalers).

Injection [Canadian product]: Hypersensitivity to albuterol or any component of the formulation; tachyarrhythmias; risk of abortion during first or second trimester

IV: Infusion solution [Canadian product]: Do not inject undiluted. Reduce concentration by at least 50% before infusing. Administer as a continuous infusion via infusion pump.

Inhalation:

Metered-dose inhalers: Shake well before use; prime prior to first use, and whenever inhaler has not been used for >2 weeks or when it has been dropped, by releasing 3 to 4 test sprays into the air (away from face). Airomir [Canadian product] labeling recommends releasing a minimum of 4 test sprays when priming. HFA inhalers should be cleaned with warm water at least once per week; allow to air dry completely prior to use. A spacer device or valved holding chamber is recommended for use with metered-dose inhalers.

Dry powder inhalers:

Proair Respiclick: Inhaler device is breath-actuated; does not require priming. Do not use with spacer or volume holding chamber. Keep inhaler clean and dry by wiping with dry cloth or tissue as needed; do not wash or put any part of inhaler in water.

Ventolin Diskus [Canadian product]: For oral inhalation route only. To activate Diskus, patient should slide lever using the thumb grip away from them as far as it will go (click should be heard). Before inhaling the dose, breathe out fully; do not exhale into the Diskus device. Bring mouthpiece to lips and inhale steadily and deeply through the Diskus; hold breath for about 10 seconds or for as long as comfortable and exhale slowly. To close Diskus slide thumb grip back as far as it will go towards its original position. To prevent a wasted dose, the lever should not be manipulated until administration of next dose. Diskus counts down from 60 to 1 and when 5 doses remain the numbers appear in red. Diskus should be kept dry.

Nebulization solution: Concentrated solution should be diluted prior to use. Blow-by administration is not recommended, use a mask device if patient unable to hold mouthpiece in mouth for administration.

Oral: Do not crush or chew extended release tablets.

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Concerns related to adverse effects:

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents (may be fatal); this should be distinguished from inadequate response.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, oropharyngeal edema), including anaphylaxis, have been reported.

Disease-related concerns:

• Asthma: Albuterol is a short-acting beta2-agonist (SABA) that should be used as needed for quick relief of asthma symptoms. Based on a step-wise treatment approach using asthma guidelines, monotherapy without concurrent use of a long-term controller medication should only be reserved for patients with mild, intermittent forms of asthma without the presence of risk factors (Step 1 and/or exercise-induced) (GINA 2016; NAEPP 2007).

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, hypertension, heart failure); beta-agonists may produce ECG changes (flattening of the T wave, prolongation of the QTc interval, ST segment depression) and/or cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias. In a scientific statement from the American Heart Association, albuterol has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate to major) (AHA [Page 2016]).

• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose and aggravate preexisting diabetes and ketoacidosis.

• Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure.

• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Use spacer for children <5 years of age and consider adding a face mask for infants and children <4 years of age.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Lactose: Powder for oral inhalation contains lactose; hypersensitivity reactions (eg, anaphylaxis, angioedema, pruritus, and rash) have been reported in patients with milk protein allergy.

Other warnings/precautions:

• Appropriate use: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

• Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed. A spacer device or valved holding chamber is recommended when using a metered-dose inhaler.

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

Overdose symptoms may include dry mouth, tremors, chest pain, fast heartbeats, nausea, general ill feeling, seizure (convulsions), feeling light-headed or fainting.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other inhaled medicines or bronchodilators;

• digoxin;

• a diuretic or "water pill";

• an antidepressant - amitriptyline, desipramine, imipramine, doxepin, nortriptyline, and others;

• a beta blocker - atenolol, carvedilol, labetalol, metoprolol, propranolol, sotalol, and others; or

• an MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This list is not complete. Other drugs may interact with albuterol inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to albuterol: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• inhalation aerosol powder, inhalation capsule, inhalation powder, inhalation solution, inhalation suspension

Along with its needed effects, albuterol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking albuterol:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Fast, irregular, pounding, or racing heartbeat or pulse

• Cough
• difficulty breathing
• difficulty with swallowing
• hives or welts
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• redness of the skin
• shortness of breath
• skin rash
• slow or irregular breathing
• swelling of the mouth or throat
• tightness in the chest
• wheezing

• Agitation
• anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• confusion
• convulsions
• extra heartbeats
• fainting
• hallucinations
• headache
• irritability
• lightheadedness
• mood or mental changes
• muscle pain or cramps
• muscle spasm or jerking of all extremities
• nervousness
• nightmares
• pounding in the ears
• restlessness
• sudden loss of consciousness
• sweating
• total body jerking
• unusual feeling of excitement
• vomiting

Some side effects of albuterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness
• feeling of warmth
• irritability
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleeplessness
• trouble with holding or releasing urine
• trouble sleeping
• unable to sleep

• Sleepiness
• unusual drowsiness

• Bad, unusual, or unpleasant (after) taste
• change in taste
• feeling of constant movement of self or surroundings
• gagging
• rough, scratchy sound to voice
• sensation of spinning
• tightness in the throat

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

Inhalation powder and capsules:
Less than 4 years: Not indicated
4 years or older:
-Inhalation powder: 1 or 2 inhalations (90 or 180 mcg) orally every 4 to 6 hours
-Inhalation capsules:1 inhalation (200 mcg) orally every 4 to 6 hours. The total daily dose should not exceed 4 inhalations (800 mcg).

Nebulizer inhalation solution:
Less than 2 years: Not indicated
2 to 12 years:
-Less than 15 kg: 0.1 to 0.15 mg/kg/dose (one 3 mL unit-dose vial of 1.25 mg or 0.63 mg inhalation solution) by nebulization. The appropriate volume of the 0.5% inhalation solution should be diluted in sterile normal saline solution to a total of 3 mL prior administration. Dosing should not exceed 2.5 mg three to four times daily.
-15 kg or more: 2.5 mg (one 3 mL unit-dose vial of 0.0083%) three or four times a day by nebulization, over approximately 5 to 15 minutes. The 0.5% inhalation solution should be diluted with 2.5 mL of sterile normal saline solution

13 years or older:
-Inhalation solution 0.5% (5 mg/mL): 2.5 mg (0.5 mL diluted with 2.5 mL of sterile saline solution) three or four times a day by nebulization, over approximately 5 to 15 minutes.

Oral Tablets:
Less than 6 years: Not indicated
6 to 12 years:
-Immediate-release tablets: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).
-Extended-release tablets: Initial dose: 4 mg orally every 12 hours. Dosage may be cautiously increased stepwise under the control of the supervising physician to a maximum 24 mg/day in divided doses (e.g., every 12 hours).

13 years or older:
-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).
-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).

Oral syrup:
-Less than 2 years: Not indicated
-2 to 5 years: Initial dose: 0.1 mg/kg (do not exceed 2 mg) orally three times a day. Dosage may be increased stepwise to 0.2 mg/kg three times a day. A maximum dose of 4 mg three times a day should not be exceeded.
-6 to 14 years: Initial dose: 2 mg orally three or four times a day. Dosage may be cautiously increased stepwise, but not exceed 24 mg/day (in divided doses).
-15 years or older: 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.

Uses: Treatment or prevention of bronchospasm due to bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor

Data not available

Administration advice:
-Inhalation solution, powder, and capsules are for oral inhalation only.
-More frequent administration or a larger number of inhalations are not recommended.
-Oral tablets should not be chewed or crushed; tablets should be swallowed whole with liquids.
-The manufacturer product information should be consulted for instructions of use.

Inhalation powder HFA:
-Prime the inhalation device before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped.
-To prime, release 4 sprays into the air away from the face, shaking well before each spray.
-To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.

Inhalation powder RESPICLICK:
-Inhaler does not require priming.
-Keep the inhaler clean and dry at all times. Never wash or put any part of the inhaler in water.

Switching from oral immediate release to extended release products:
-The administration of one 4 mg extended-release tablet every 12 hours is comparable to one 2 mg immediate tablet every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Patient advice:
-Other inhaled drugs and asthma medications should be taken only as directed by the physician while taking this drug.
-Seek medical advice if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual is required. Do not increase the dose or its frequency of administration.