Accuneb

This medicine is also used to prevent exercise-induced bronchospasm.

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, 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.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although these uses are not included in product labeling, albuterol is used in certain patients with the following medical condition:

• Hyperkalemia (too much potassium in the blood)

This product is available in the following dosage forms:

• Aerosol Powder


• Solution


• Capsule


• Powder

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 albuterol inhalation aerosol (e.g., Proair(R) HFA) in children 4 years of age and older and albuterol inhalation solution (e.g., Accuneb(R)) in children 2 years of age and older .

Geriatric

No information is available on the relationship of age to the effects of albuterol inhalation solution (e.g., Accuneb(R)) in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair(R) HFA) in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

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

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


• Alprenolol


• Arotinolol


• Atenolol


• Atomoxetine


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Brofaromine


• Bucindolol


• Bupranolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Furazolidone


• Iproniazid


• Isocarboxazid


• Labetalol


• Landiolol


• Lazabemide


• Levobetaxolol


• Levobunolol


• Linezolid


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Nipradilol


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Rasagiline


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine

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


• Seizuresa€”Use with caution. May make these conditions worse.

• Kidney diseasea€”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 taking this medicine or any asthma medicine without telling your doctor . To do so may increase the chance for breathing problems .

The albuterol inhalation solution (e.g., Accuneb(R)) 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 inhalation aerosol (e.g., Proair(R) HFA) is 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 you or your child on a regular basis to make sure you are using it properly.

To use the inhaler:

• The inhaler should be at room temperature before you use it.


• Insert the metal canister firmly and fully into the clear end of the Proair(R) HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.


• Remove the cap and look at the mouthpiece to make sure it is clean.


• Shake the inhaler well and test spray it in the air 3 times 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 every day with warm running water for 30 seconds. Dry it thoroughly before use.

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 prevention of bronchospasm:
  
  
  
  • For inhalation aerosol dosage form (inhaler):
    
    
    
    • Adults, teenagers, and children 4 years of age and oldera€”Two puffs every 4 to 6 hours as needed.
    
    
    • Children younger than 4 years of agea€”Use and dose must be determined by your child`s doctor .
    
    
    
    
  
  
  
  
  
  
  • For inhalation solution dosage form (used with a nebulizer):
    
    
    
    • Adults and children older than 12 years of agea€”2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.
    
    
    • Children 2 to 12 years of agea€”0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.
    
    
    • Children younger than 2 years of agea€”Use and dose must be determined by your child`s doctor .
    
    
    
    
  
  
  
  


• For prevention of exercise-induced bronchospasm:
  
  
  
  • For inhalation aerosol dosage form (inhaler):
    
    
    
    • Adults, teenagers, and children 4 years of age and oldera€”Two puffs taken 15 to 30 minutes before exercise.
    
    
    • Children younger than 4 years of agea€”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 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 .

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 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

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

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

• Abdominal or stomach pain


• Bladder pain


• Bloody or cloudy urine


• Chest discomfort


• Chest pain


• Cough or hoarseness


• Cough producing mucus


• Diarrhea


• Difficult or labored breathing


• Difficulty with swallowing


• Dizziness


• Feeling of warmth


• Fever or chills


• Frequent urge to urinate


• Hives


• Itching


• 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


• Shortness of breath


• Skin rash


• Sore throat


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Tightness in the chest


• Unusual tiredness or weakness


• Weakness


• Wheezing

Rare

• Hives or welts


• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• Noisy breathing


• Redness of the skin


• Swelling of the mouth or throat


• Trouble breathing

Incidence not known

• Agitation


• Anxiety


• Arm, back, or jaw pain


• Chest tightness or heaviness


• Confusion


• Convulsions


• Decreased urine


• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• Drowsiness


• Dry mouth


• Extra heartbeats


• Fainting


• Flushed, dry skin


• Fruit-like breath odor


• Hallucinations


• 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


• Shakiness


• 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


• Fever


• Runny nose


• Tender, swollen glands in the neck


• Trouble with swallowing


• Voice changes

Less common

• Difficult, burning, or painful urination


• Earache


• Headache, severe and throbbing


• Muscle or bone pain


• Pain


• Redness of the skin


• Redness or swelling in the ear


• Redness, swelling, or soreness of the tongue


• Sleeplessness


• Sneezing


• Stuffy nose


• Swelling


• Tenderness


• Trouble in holding or releasing urine


• Trouble sleeping


• Unable to sleep


• Warmth on the skin

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.