Albuterol

Name: Albuterol

Albuterol Precautions

Inhalational/Oral:

Albuterol may cause serious side effects, including:

  • worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using albuterol and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
  • heart problems including faster heart rate and higher blood pressure
  • possible death in people with asthma who use too much albuterol
  • allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:
    • itchy skin
    • swelling beneath your skin or in your throat
    • rash
    • worsening trouble breathing
  • low potassium levels in your blood
  • worsening of other medical problems in people who also use albuterol including increases in blood sugar

Do not use albuterol if you are allergic to albuterol sulfate or any of the ingredients in albuterol. 

Albuterol and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Albuterol falls into category C. There are no good studies that have been done in humans with albuterol. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Albuterol Usage

Use albuterol exactly as your doctor tells you to use it.

Inhalational:

  • Aerosol Spray
    • If your child needs to use albuterol, watch your child closely to make sure your child uses the inhaler correctly. Your doctor will show you how your child should use albuterol.
    • Each dose of albuterol should last up to 4 hours to 6 hours.
    • Do not increase your dose or take extra doses of albuterol without first talking to your doctor.
    • Get medical help right away if albuterol no longer helps your symptoms.
    • Get medical help right away if your symptoms get worse or if you need to use your inhaler more often.
    • While you are using albuterol, do not use other inhaled rescue medicines and asthma medicines unless your doctor tells you to do so.
    • Call your doctor if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Your doctor may need to give you another medicine (for example, corticosteroids) to treat your symptoms.
  • Solution for Nebulization
    • The albuterol for nebulization is usually taken 3 or 4 times daily, as needed. More frequent use is not recommended.
    • Use the entire contents of one unit-dose vial. Adjust the flow rate to deliver albuterol over 5 to 15 minutes.
    • To control recurring bouts of bronchospasm, using albuterol for nebulization on a regular basis works best.
    • If the medication does not seem to be working, seek medical advice immediately. This is often a sign of seriously worsening asthma.
    • Efficacy and safety of this medication, when mixed with other drugs in a nebulizer, have not been determined.
    • The safety and efficacy of this medication have been established with the Pari LC Plus nebulizer and Pari PRONEB compressor. The safety and efficacy of albuterol for nebulization with other nebulizer systems have not been determined.
    • Albuterol for nebulization should be used with a jet nebulizer connected to an air compressor with adequate air flow. It should also be used with a mouthpiece or suitable face mask.

Oral

  • The regular release tablets and syrup are usually taken three or four times a day.
  • Albuterol extended release tablets must be swallowed whole with the aid of liquids.
  • Do not crush or chew extended release tablets.

Albuterol Dosage

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

Syrup

  • Adults And Children Over 14 Years Of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
  • Children 6 To 14 Years Of Age: The usual starting dosage for children 6 to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
  • Children 2 To 6 Years Of Age: Dosing in children 2 to 6 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Aerosol

  • Treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms
    • The usual dosage for adults and children 12 years of age and older is 2 inhalations repeated every 4 to 6 hours
    • In some, 1 inhalation every 4 hours may be sufficient. More frequent use or a larger number of inhalations is not recommended.
    • For maintenance therapy or prevention of exacerbation of bronchospasm, 2 inhalations, 4 times a day should be sufficient.
    • If a previously effective dosage fails to provide the usual response, this may be a sign of worsening asthma and requires reevaluation of the treatment regimen.
  • ​Exercise-Induced Bronchospasm Prevention
    • ​The usual dosage for adults and children 12 years and older is 2 inhalations, 15 minutes before exercise.

Solution for Nebulization

  • The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of AccuNeb (albuterol for nebulization) taken 3 or 4 times daily, as needed, by nebulization.
  • To take 1.25 mg or 0.63 mg of albuterol, use the entire contents of one vial (3 mL of 1.25 mg or 0.63 mg inhalation solution). Adjust nebulizer flow rate to deliver AccuNeb (albuterol for nebulization) over 5 to 15 minutes.
  • Patients 6 to 12 years of age with more severe asthma, weight >40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Extended Release Tablets

  • Adults and Children over 12 years of age - The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.
  • Children 6 to 12 years of age - The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Regular Release Tablets

  • 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.

Commonly used brand name(s)

In the U.S.

  • Proventil
  • Proventil Repetabs
  • Ventolin
  • Volmax
  • VoSpire ER

In Canada

  • Apo-Salvent Inhaler

Available Dosage Forms:

  • Tablet
  • Syrup
  • Tablet, Extended Release

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Proper Use of albuterol

Use albuterol only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking albuterol or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

Swallow the extended-release tablet whole with water or liquids. Do not break, crush, or chew the tablet.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of albuterol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of albuterol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For treatment of bronchospasm:
    • For oral dosage form (syrup, tablets):
      • Adults and children older than 12 years of age—2 or 4 milligrams (mg) taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given 4 times per day.
      • Children 6 to 12 years of age—2 mg taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given 4 times per day.
      • Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight per dose, given 3 times per day, and each dose will not be more than 2 mg. Your doctor may increase your dose as needed up to a maximum dose of 12 mg per day, divided and given 3 times a day.
      • Children younger than 2 years of age—Use and dose must be determined by your child's doctor.
    • For oral dosage form (extended-release tablets):
      • Adults and children older than 12 years of age—8 milligrams (mg) every 12 hours. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given every 12 hours.
      • Children 6 to 12 years of age—4 mg every 12 hours. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given every 12 hours.
      • Children younger than 6 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of albuterol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

General

Albuterol, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous Albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, Albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

Information for Patients

The action of Albuterol tablets may last up to 8 hours or longer. Albuterol tablets should not be taken more frequently than recommended. Do not increase the dose or frequency of Albuterol tablets without consulting your physician. If you find that treatment with Albuterol tablets becomes less effective for symptomatic relief, your symptoms get worse, and/or you need to take the product more frequently than usual, you should seek medical attention immediately. While you are taking Albuterol tablets, other asthma medications and inhaled drugs should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, and tremor or nervousness. If you are pregnant or nursing, contact your physician about use of Albuterol tablets. Effective and safe use of Albuterol tablets includes an understanding of the way that it should be administered.

Drug Interactions

The concomitant use of Albuterol tablets and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving Albuterol tablets. Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of Albuterol on the vascular system may be potentiated.

Beta-Blockers

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Albuterol tablets, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Diuretics

The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Digoxin

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of Albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving Albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and Albuterol.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a 2-year study in Sprague-Dawley rats, Albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 2, 10, and 50 mg/kg (approximately 1/2, 3 and 15 times, respectively, the maximum recommended daily oral dose for adults on a mg/m2 basis, or, 2⁄5, 2 and 10 times, respectively, the maximum recommended daily oral dose for children on a mg/m2 basis). In another study this effect was blocked by the coadministration of propranolol, a non-selective beta-adrenergic antagonist.

In an 18-month study in CD-1 mice Albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg, (approximately 65 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 50 times the maximum recommended daily oral dose for children on a mg/m2 basis). In a 22-month study in the Golden hamster Albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg, (approximately 8 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 7 times the maximum recommended daily oral dose for children on a mg/m2 basis).

Albuterol sulfate was not mutagenic in the Ames test with or without metabolic activation using tester strains S. typhimurium TA1537, TA1538, and TA98 or E. Coli WP2, WP2uvrA, and WP67. No forward mutation was seen in yeast strain S. cerevisiae S9 nor any mitotic gene conversion in yeast strain S. cerevisiae JD1 with or without metabolic activation. Fluctuation assays in S. typhimurium TA98 and E. Coli WP2, both with metabolic activation, were negative. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay at intraperitoneal doses of up to 200 mg/kg.

Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 15 times the maximum recommended daily oral dose for adults on a mg/m2 basis).

Pregnancy

Teratogenic Effects. Pregnancy Category C

Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice at subcutaneous (sc) doses of 0.025, 0.25, and 2.5 mg/kg, (approximately 3/1000, 3/100, and 3/10 times, respectively, the maximum recommended daily oral dose for adults on a mg/m2 basis), showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. The drug did not induce cleft palate formation at the lowest dose, 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg of isoproterenol (positive control) subcutaneously (approximately 3/10 times the maximum recommended daily oral dose for adults on a mg/m2 basis).

A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when Albuterol was administered orally at a 50 mg/kg dose (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis).

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

During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with Albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between Albuterol use and congenital anomalies has not been established.

Use In Labor And Delivery

Because of the potential for beta-agonist interference with uterine contractility, use of Albuterol tablets for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Tocolysis

Albuterol has not been approved for the management of preterm labor. The benefit/risk ratio when Albuterol is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including Albuterol.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for Albuterol in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children below 6 years of age have not been established.

How is Albuterol Supplied

Albuterol tablets, USP; 2 mg of Albuterol as the sulfate, are white, round, scored, debossed MP 47

Bottles of 50 NDC 53489-176-02
Bottles of 100 NDC 53489-176-01
Bottles of 250 NDC 53489-176-03
Bottles of 500 NDC 53489-176-05
Bottles of 1000 NDC 53489-176-10

Albuterol tablets, USP; 4 mg of Albuterol as the sulfate, are white, round, scored, debossed MP 88

Bottles of 50 NDC 53489-177-02
Bottles of 100 NDC 53489-177-01
Bottles of 250 NDC 53489-177-03
Bottles of 500 NDC 53489-177-05
Bottles of 1000 NDC 53489-177-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rev 02, July 2014

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

ProAir RespiClick: 90 mcg/actuation (1 ea) [contains milk protein]

Aerosol Solution, Inhalation:

ProAir HFA: 90 mcg/actuation (8.5 g)

Proventil HFA: 90 mcg/actuation (6.7 g)

Ventolin HFA: 90 mcg/actuation (8 g, 18 g)

Nebulization Solution, Inhalation:

Generic: 0.63 mg/3 mL (3 mL); 0.083% [2.5 mg/3 mL] (3 mL); 0.5% [2.5 mg/0.5 mL] (20 mL)

Nebulization Solution, Inhalation [preservative free]:

Generic: 0.63 mg/3 mL (3 mL); 1.25 mg/3 mL (3 mL); 0.083% [2.5 mg/3 mL] (3 mL); 0.5% [2.5 mg/0.5 mL] (1 ea)

Syrup, Oral:

Generic: 2 mg/5 mL (473 mL)

Tablet, Oral:

Generic: 2 mg, 4 mg

Tablet Extended Release 12 Hour, Oral:

VoSpire ER: 4 mg [contains fd&c blue #1 aluminum lake, fd&c yellow #10 aluminum lake]

VoSpire ER: 8 mg

Generic: 4 mg, 8 mg

How should I use albuterol inhalation?

Use albuterol inhalation exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use albuterol inhalation in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

You may need to prime your albuterol inhaler device before the first use. Your medicine comes with directions for priming if needed.

You may also need to shake your albuterol device just before each use.

Follow all medication instructions very carefully.

Do not allow a young child to use albuterol inhalation without help from an adult.

The usual dose of albuterol inhalation is 2 inhalations every 4 to 6 hours. To prevent exercise-induced bronchospasm, use 2 inhalations 15 to 30 minutes before you exercise. The effects of albuterol inhalation should last about 4 to 6 hours.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Use the dose counter on your albuterol inhaler device and get your prescription refilled before you run out of medicine completely. Always use the new inhaler device provided with your refill. Do not float a medicine canister in water to see if it is empty.

Follow all product instructions on how to clean your albuterol inhaler device and mouthpiece. Do not try to clean or take apart the ProAir RespiClick inhaler device.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture, heat, or cold temperatures.

Keep the albuterol canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

In Summary

Commonly reported side effects of albuterol include: tremor. Other side effects include: hypersensitivity reaction, tachycardia, and tremor. See below for a comprehensive list of adverse effects.

Usual Adult Dose for Bronchitis

Intravenous infusion solution:
-Dilute 5 mL of this drug (1000 mcg/mL) in 500 mL of Sodium Chloride Injection, or Sodium Chloride and Dextrose.
-Infusion rates can be started at 5 mcg/min, and can be increased to 10 mcg/min and 20 mcg/min at 15 at 30 minute intervals, if necessary.

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

Comments:
-Never inject the IV infusion undiluted. Do not administer in the same infusion with other medications.
-Check the IV infusion for clarity, particulate matter, precipitate, discoloration and leakage prior to administration.
-Discard unused infusion solution 24 hours after preparation.

Uses:
-Relief of severe bronchospasm associated with acute exacerbations of chronic bronchitis and bronchial asthma, and acute attack of bronchospasm
-Treatment of status asthmaticus

Usual Pediatric Dose for Bronchospasm Prophylaxis

Less than 4 years: Not indicated

4 years or older:
-Inhalation powder: 2 inhalations (180 mcg) orally 15 to 30 minutes before exercise
-Inhalation capsule: 1 inhalation (200 mcg) 15 minutes before exercise

Uses: Prevention of exercise-induced bronchospasm

Upsides

  • Allows adults and children aged over the age of six (applies to tablets) or four (applies to inhalation) with asthma or other types of reversible airway disease to breathe easier (relieves bronchospasm).
  • Albuterol inhalation is useful at treating exercise-induced bronchospasm.
  • Available as an inhaler, a nebulizing solution and as a tablet.
  • Generic albuterol inhalers, nebulizing solutions, and tablets are available.

Response and Effectiveness

  • Effects of albuterol usually last four to six hours, sometimes eight hours or longer. Unless your doctor has told you to, resist the temptation to increase the dose of albuterol or to take it more frequently if the effects appear to be wearing off sooner. Instead, seek medical attention immediately, as this can be a sign of deteriorating asthma control that can be masked by albuterol overuse.
  • Albuterol can also be fatal if too much is taken. If you think somebody has taken too much albuterol, seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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