Proventil (Oral)

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

Albuterol is part of a group of medicines called adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and difficulty breathing by increasing air flow through the bronchial tubes.

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

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

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing may get worse. Paradoxical bronchospasm can be life-threatening. Contact your doctor immediately if you or your child experience 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, along with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless your doctor tells you to.

Albuterol may cause allergic reactions. Stop using the medicine and contact your doctor immediately 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 happen while you are using this medicine. Contact 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know about any other allergies you may have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies show that there are no specific problems that limit the use of albuterol in children aged 2 years and older.

Geriatric

There is no information available about how age affects the use of albuterol in older patients. However, elderly patients are more likely to have heart problems related to aging, which may require caution and a dose adjustment for those taking albuterol.

Breast Feeding

There are no sufficient studies to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are prescribed this medicine, it is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are significant and may not be a complete list.

Using this medicine with any of the following is usually not recommended but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare provider about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you use this medicine. Be sure to inform your doctor if you have any other medical conditions, 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. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

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 happen 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 ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen 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.

In the U.S.

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

In Canada

• Apo-Salvent Inhaler

Available Dosage Forms:

• Tablet, Extended Release
• Syrup
• Tablet

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

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.

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