Pronunciation:

al-BUE-ter-ol

Brand Names:

• Proventil
• Proventil Repetabs
• Ventolin
• Volmax
• VoSpire ER
• Apo-Salvent Inhaler

Dosage Forms:

• Tablet, Extended Release
• Syrup
• Tablet

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Beta-2 Adrenergic Agonist

Uses of This Medicine:

Albuterol is used to treat bronchospasm or wheezing in patients with reversible obstructive airway disease, such as asthma.

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol in children 2 years of age and older.

Older adults—

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Atenolol
• Atomoxetine
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Betaxolol
• Bisoprolol
• Bumetanide
• Carteolol
• Carvedilol
• Celiprolol
• Chlorothiazide
• Chlorthalidone
• Clomipramine
• Clopamide
• Cyclopenthiazide
• Cyclothiazide
• Desipramine
• Diazoxide
• Dibenzepin
• Digoxin
• Doxepin
• Esmolol
• Ethacrynic Acid
• Etozolin
• Furosemide
• Hydrochlorothiazide
• Hydroflumethiazide
• Imipramine
• Indapamide
• Iobenguane I 123
• Isocarboxazid
• Labetalol
• Levalbuterol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methacholine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Nadolol
• Nebivolol
• Nortriptyline
• Opipramol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Piretanide
• Polythiazide
• Procarbazine
• Propranolol
• Protriptyline
• Quinethazone
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Tianeptine
• Timolol
• Torsemide
• Tranylcypromine
• Trichlormethiazide
• Trimipramine
• Xipamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Seizure disorders—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Use this medicine 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 this medicine 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 this medicine 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 this medicine. 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 this medicine, 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 While Using This Medicine:

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

You or your child may also be taking an antiinflammatory medicine, such as a steroid, together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause allergic reactions. Stop using the medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, swelling, or any type of allergic reaction after taking this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Less common

Fast, irregular, pounding, or racing heartbeat or pulse

Rare

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

Incidence not known

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 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:

Less common

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

Rare

Sleepiness

unusual drowsiness

Incidence not known

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.