Accuneb

Name: Accuneb

Uses For Accuneb

Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (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.

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Accuneb. Please read with care.

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) and albuterol inhalation powder (eg, Proair® Respiclick®) 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 inhalation aerosol:

  • 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® 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 at least once a week with warm running water for 30 seconds, and 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.

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.
  • Keep the inhaler clean and dry at all times. Do not wash or put any part of the inhaler 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 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 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.

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.

Throw away Proair® Respiclick® 13 months after opening the foil pouch, when the dose counter reaches "0", or after the expiration date, whichever comes first.

Contraindications

Accuneb is contraindicated in patients with a history of hypersensitivity to any of its components.

Warnings

Paradoxical Bronchospasm

As with other inhaled beta-adrenergic agonists, Accuneb can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Accuneb should be discontinued immediately and alternative therapy instituted. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Use of Anti-Inflammatory Agents

The use of beta-adrenergic bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids).

Deterioration of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Accuneb than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids).

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is, therefore, essential that the physician instruct the patient in the need for further evaluation, if his/her asthma becomes worse.

Cardiovascular Effects

Accuneb, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for Accuneb at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Accuneb like all other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.

Adverse Reactions

Clinical Trial Experience

Adverse events reported in >1% of patients receiving Accuneb and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.

Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Accuneb and Greater than Placebo (expressed as % of treatment group)
  1.25 mg Accuneb
(N=115)
0.63 mg Accuneb
(N=117)
Placebo
(N=117)
Asthma Exacerbation 13 11.1 8.5
Otitis Media 4.3 0.9 0
Allergic Reaction 0.9 3.4 1.7
Gastroenteritis 0.9 3.4 0.9
Cold Symptoms 0 3.4 1.7
Flu Syndrome 2.6 2.6 1.7
Lymphadenopathy 2.6 0.9 1.7
Skin/Appendage Infection 1.7 0 0
Urticaria 1.7 0.9 0
Migraine 0.9 1.7 0
Chest Pain 0.9 1.7 0
Bronchitis 0.9 1.7 0.9
Nausea 1.7 0.9 0.9

There was one case of ST segment depression in the 1.25 mg Accuneb treatment group.

No clinically relevant laboratory abnormalities related to Accuneb administration were seen in this study.

Postmarketing Experience

Metabolic acidosis has been reported after the use of albuterol sulfate inhalation solution. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure.

For the Consumer

Applies to albuterol: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

  • inhalation aerosol powder, inhalation capsule, inhalation powder, inhalation solution, inhalation suspension

Along with its needed effects, albuterol (the active ingredient contained in AccuNeb) 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 while taking albuterol:

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 of albuterol 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

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