AccuNeb | for the Relief of Bronchospasms Caused by Asthma in Children


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AccuNeb

AccuNeb (Albuterol Sulfate)

AccuNeb (Ack-u-neb) (albuterol sulfate) Inhalation Solution 1.25 mg*/3 mL and 0.63 mg*/3 mL (*Potency expressed as albuterol, equivalent to 1.5 mg and 0.75 mg albuterol sulfate)

Read the patient information that comes with AccuNeb before using it and each time you get a refill for your child. There may be new information. This leaflet does not take the place of talking to your child’s doctor about your child’s medical condition or treatment.


What is AccuNeb?

AccuNeb is a medicine that is used for the relief of bronchospasms caused by asthma in children ages 2 to 12 years. Bronchospasm is the tightening and swelling of the muscles around the airways. AccuNebcan help relax these airway muscles for up to 6 hours so that your child may breathe more easily.


Who should not use AccuNeb?

Do not give your child AccuNeb if he or she is allergic to any of its ingredients. The active ingredient is albuterol sulfate. See the end of this leaflet for a complete list of ingredients.

What should I tell my child’s doctor before giving AccuNeb?
Tell your child’s doctor about all of your child’s medical conditions including if your child has:
• Heart problems
• High blood pressure
• Seizures
• A thyroid problem called hyperthyroidism
• Diabetes

Tell your child’s doctor about all the medicines your child takes, including prescription and non- prescription medicines, vitamins and herbal supplements. AccuNeb and some other medicines can affect each other and may cause serious side effects. Especially tell your child’s doctor if your child is taking or using:
• Any short-acting bronchodilator medicines (sometimes called rescue inhalers)
• Epinephrine
• Medicines called monoamine oxidase inhibitors (MAOIs) or tricyclic anti-depressants or has stopped taking them in the past 2 weeks. These medicines are usually used for mental problems.
• Medicines called beta-blockers (used for heart problems and high blood pressure)
• Certain diuretic medicines (water pills)
• Digoxin

Know the medicines your child takes. Keep a list of them and show it to your child’s doctor and pharmacist each time your child gets a new medicine.


How should AccuNeb be given?

Read the Patient’s Instructions for Use that comes with AccuNeb. Ask your pharmacist for these instructions if they are not with your medicine. Keep the instructions with AccuNeb because you may want to read them again.
• Give AccuNeb exactly as prescribed for your child. Do not change your child’s dose or how often it is used without talking to your child’s doctor first.
• AccuNeb is breathed into the lungs. AccuNeb is used with a special breathing machine called a nebulizer. Do not mix other medicines with AccuNeb in the nebulizer. Do not use AccuNeb that is not clear and colorless.
• Call your child’s doctor or get emergency help right away if your child’s breathing is not helped or gets worse during treatment with AccuNeb.
• Call your child’s doctor right away if your child needs to use AccuNeb more often than prescribed.
• AccuNeb has not been studied for treating acute attacks of bronchospasm (rescue use). Your child may need a different medicine for rescue use.
• If you give your child too much AccuNeb, call your child’s doctor right away.


What are the side effects with AccuNeb?

AccuNeb may cause the following serious side effects:
• Worsening of the tightening and swelling of the muscles around your child’s airways
(bronchospasm). This side effect can be life threatening. Call your child’s doctor or get emergency help right away if your child’s breathing is not helped or gets worse during treatment with AccuNeb.
• Serious and life threatening allergic reactions. Symptoms of a serious allergic reaction include:
• Hives, rash
• Swelling of your child’s face, eyelids, lips, tongue, or throat, and trouble swallowing
• Worsening of your child’s breathing problems such as wheezing, chest tightness or shortness of breath
• Shock (loss of blood pressure and consciousness).

The most common side effects with AccuNeb include a fast or irregular heartbeat, chest pain, shakiness, or nervousness.


How should AccuNeb be stored?

• Store AccuNeb at room temperature, 36° to 77°F (2° to 25°C) in its tightly closed container.
• Protect vials from light before use. Therefore, keep unused vials in the foil pouch or carton. Once removed from the foil pouch, use vial(s) within one week.
• Do not use AccuNeb after the expiration (EXP) date printed on the vial. Do not use AccuNeb that is not clear and colorless.
• Safely, discard AccuNeb that is out-of-date or no longer needed.
• Keep AccuNeb and all medicines out of the reach of children.


General Information about AccuNeb

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use AccuNeb for a condition for which it was not prescribed. Do not give AccuNeb to other people, even if they have the same symptoms your child has. It may harm them.

This leaflet summarizes the most important information about AccuNeb. If you would like more information, talk with your child’s doctor. You can ask your child’s doctor or pharmacist for information about AccuNeb that is written for health professionals. You can also call the company that makes AccuNeb toll free at 1-800-755-5560, or visit their website at www.dey.com.

What are the ingredients in AccuNeb?
Active Ingredient: albuterol sulfate
Inactive Ingredients: sodium chloride and sulfuric acid.

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