Brand Name
US Brand Name
Accuneb
ProAir Digihaler
ProAir HFA
Proair Respiclick
Proventil
Proventil HFA
ReliOn Ventolin HFA
Ventolin
Ventolin HFA
Canadian Brand Name
Alti-Salbutamol Inhalation Aerosol
Apo-Salvent
Salbutamol
Salbutamol Nebuamp
Salbutamol Respirator Solution
Ventolin Inhaler
Ventolin Nebules P.F.
Ventolin Respirator
Ventolin Rotacaps
Description
Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. It is also used to prevent bronchospasm caused by exercise.
Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder
- Solution
- Suspension
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ProAir® Digihaler™, ProAir® HFA, ProAir® Respiclick®, Proventil® HFA, and Ventolin® HFA in children 4 years of age and older and Accuneb® in children 2 years of age and older. However, safety and efficacy have not been established for ProAir® Digihaler™, ProAir® HFA, ProAir® Respiclick®, Proventil® HFA, and Ventolin® HFA in children younger than 4 years of age and Accuneb® in children younger than 2 years of age.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of Proventil® HFA in the geriatric population. However, elderly patients are more likely to have age-related heart problems, which may require caution in the dose for patients receiving Proventil® HFA.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ProAir® Digihaler™, ProAir® HFA, ProAir® Respiclick®, and Ventolin® HFA in geriatric patients. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving ProAir® Digihaler™, ProAir® HFA, ProAir® Respiclick®, and Ventolin® HFA.
No information is available on the relationship of age to the effects of albuterol inhalation solution (eg, Accuneb®) in geriatric patients.
Breastfeeding
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.
Drug Interactions
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
- Amphetamine
- Atenolol
- Atomoxetine
- Bemetizide
- Bendroflumethiazide
- Benzthiazide
- Betaxolol
- Bisoprolol
- Bumetanide
- Carteolol
- Carvedilol
- Celiprolol
- Chlorothiazide
- Chlorthalidone
- Clomipramine
- Clopamide
- Cyclopenthiazide
- Cyclothiazide
- Desipramine
- Dextroamphetamine
- Diazoxide
- Dibenzepin
- Digoxin
- Doxepin
- Esmolol
- Ethacrynic Acid
- Etozolin
- Furosemide
- Hydrochlorothiazide
- Hydroflumethiazide
- Imipramine
- Indapamide
- Iobenguane I 123
- Isocarboxazid
- Labetalol
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:
- Allergy to milk proteins, history or—ProAir® Digihaler™ and ProAir® Respiclick® should not be used in patients with this condition.
- Diabetes or
- Heart or blood vessel disease (eg, coronary insufficiency) or
- Heart rhythm problems (eg, arrhythmia, QT prolongation) or
- Hypertension (high blood pressure) or
- Hyperthyroidism (overactive thyroid) or
- Hypokalemia (low potassium in the blood) or
- Ketoacidosis (high ketones in the blood) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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 using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.
The albuterol inhalation solution (eg, Accuneb®) should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To use the inhalation solution in the nebulizer:
- Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.
- Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.
- Connect the nebulizer to the face mask or mouthpiece.
- Use the face mask or mouthpiece to breathe in the medicine.
- Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.
- Clean all the parts of the nebulizer after each use.
The albuterol inhalation aerosol (eg, ProAir® HFA, Proventil® HFA, Ventolinr® HFA) and albuterol inhalation powder (eg, ProAir® Digihaler™, ProAir® Respiclick®) are used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you or your child use the inhaler to make sure you are using it properly.
To use the inhalation aerosol:
- The inhaler should be at room temperature before you use it.
- Insert the metal canister firmly and fully into the actuator. This actuator should not be used with other inhaled medicines.
- Remove the cap and look at the mouthpiece to make sure it is clean.
- Point the inhaler away from your face. Avoid spraying in your eyes. Shake the inhaler well and test spray it in the air 3 times for ProAir® HFA or 4 times for Proventil® HFA and Ventolin® HFA before using it for the first time or if the inhaler has not been used for more than 2 weeks.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
- Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.
- Hold your breath for about 10 seconds, then breathe out slowly.
- If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.
- When you have finished all of your doses, rinse your mouth with water and spit the water out.
- Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and air dry it completely.
- If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.
- After using the inhaler, wash the mouthpiece again and dry it completely.
- If the mouthpiece becomes blocked, washing it will help.
- The Proventil® HFA inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The counter will turn red when there are only 20 doses left, to remind you to refill your prescription.
To use the inhalation powder:
- Take the inhaler from the foil pouch before you use it for the first time.
- The inhaler provides about 200 inhalations. The dose counter will change to red when there are "20" doses left. Call your doctor or pharmacist for a refill of prescription or medicine.
- Make sure the cap is closed before using this medicine. Do not open the cap unless you are going to use it.
- Hold the inhaler upright as you open the cap fully until you hear a "click". Your inhaler is now ready to use.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it.
- Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
- Do not block the vent above the mouthpiece with your lips or fingers.
- Hold your breath for about 10 seconds or as long as you comfortably can.
- Remove the inhaler from your mouth and check the dose counter to make sure you received the medicine.
- Close the cap firmly over the mouthpiece after using the inhaler. Always close the cap after each use.
- If you are supposed to use more than one puff, repeat these steps for the second puff, starting with opening the cap fully.
- Do not use a spacer or volume holding chamber together with the ProAir® Digihaler™.
- Keep the inhaler clean and dry at all times. Do not wash or put any part of the inhaler in water. Replace the ProAir® Digihaler™ if it has been washed or placed in water.
- If you need to clean the mouthpiece, wipe it gently with a dry cloth or tissue.
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 inhalation aerosol dosage form (inhaler):
- For treatment or prevention of bronchospasm:
- Adults and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
- Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For prevention of exercise-induced bronchospasm:
- Adults and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
- Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For treatment or prevention of bronchospasm:
- For inhalation powder dosage form (inhaler):
- For treatment or prevention of bronchospasm:
- Adults and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
- Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For prevention of exercise-induced bronchospasm:
- Adults and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
- Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For treatment or prevention of bronchospasm:
- For inhalation solution dosage form (used with a nebulizer):
- For prevention of bronchospasm:
- Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.
- Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.
- Children younger than 2 years of age—Use and dose must be determined by your child's doctor.
- For prevention of bronchospasm:
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
Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.
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.
Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Store Proventil® HFA or Ventolin® HFA inhaler with the mouthpiece down.
Throw away the ProAir® Digihaler™ or ProAir® Respiclick® 13 months after opening the foil pouch, when the dose counter reaches "0", or after the expiration date, whichever comes first.
Precautions
It is very important that your doctor check your 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.
Do not use this medicine together with other similar inhaled medicines, including isoproterenol (Isuprel®), levalbuterol (Xopenex™), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, or wheezing after using this medicine.
Talk to your doctor or get medical help right away if:
- Your symptoms do not improve or they become worse after using this medicine.
- Your inhaler does not seem to be working as well as usual and you need to use it more often.
You or your child may also be taking an antiinflammatory medicine, including steroid (cortisone-like medicine), together 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 serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using 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 decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea, vomiting, numbness or tingling in the hands, feet, or lips, trouble breathing, seizures, 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
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
- Fast, irregular, pounding, or racing heartbeat or pulse
- shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
Less common
- Bladder pain
- bloody or cloudy urine
- chest discomfort, tightness, or pain
- chills
- cough
- cough producing mucus
- diarrhea
- difficult or labored breathing
- difficulty with swallowing
- dizziness
- feeling of warmth
- fever
- frequent urge to urinate
- hives, itching, or skin rash
- hoarseness
- loss of appetite
- lower back or side pain
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- sore throat
- stomach pain
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- unusual tiredness or weakness
Rare
- Hives or welts
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- noisy breathing
- swelling of the mouth or throat
Incidence not known
- Agitation
- arm, back, or jaw pain
- chest heaviness
- confusion
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- extra heartbeat
- fainting
- flushed, dry skin
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- irritability
- lightheadedness
- muscle pain or cramps
- nervousness
- nightmares
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- rapid, deep breathing
- restlessness
- seeing, hearing, or feeling things that are not there
- seizures
- slow or fast heartbeat
- stomach cramps
- sweating
- unexplained weight loss
- 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:
More common
- Body aches or pain
- congestion
- voice changes
Less common
- Difficult, burning, or painful urination
- earache
- headache, severe and throbbing
- muscle or bone pain
- pain
- redness or swelling in the ear
- redness, swelling, or soreness of the tongue
- sneezing
- stuffy nose
- swelling
- tenderness
- trouble in holding or releasing urine
- trouble sleeping
Rare
- Sleepiness or 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.
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