Albuterol Sulfate Inhalation Solution (Page 4 of 5)

STORAGE

Store between 2°C to 25°C (36°F to 77°F). Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within two weeks. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

The brands listed are trademarks of their respective owners.

Manufactured for:
Ritedose Pharmaceuticals, LLC
Columbia, SC 29203 U.S.A.

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203 U.S.A.

RPIN0159 May 2022

PATIENT INFORMATION

Albuterol Sulfate Inhalation Solution

(al bue’ ter ol sul’ fate)
0.63 mg*/3 mL and 1.25 mg*/3 mL
(*Equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL)

Read the patient information that comes with Albuterol Sulfate Inhalation Solution 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 Albuterol Sulfate Inhalation Solution?

Albuterol Sulfate Inhalation Solution 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. Albuterol Sulfate Inhalation Solution can help relax these airway muscles for up to 6 hours so that your child may breathe more easily.

Who should not use Albuterol Sulfate Inhalation Solution?

Do not give your child Albuterol Sulfate Inhalation Solution 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 Albuterol Sulfate Inhalation Solution?

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 nonprescription medicines, vitamins and herbal supplements. Albuterol Sulfate Inhalation Solution 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 tricycllic 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 Albuterol Sulfate Inhalation Solution be given?

Read the Patient’s Instructions for Use that comes with Albuterol Sulfate Inhalation Solution. Ask your pharmacist for these instructions if they are not with your medicine. Keep the instructions with Albuterol Sulfate Inhalation Solution because you may want to read them again.

Give Albuterol Sulfate Inhalation Solution 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.

Albuterol Sulfate Inhalation Solution is breathed into the lungs. Albuterol Sulfate Inhalation Solution is used with a special breathing machine called a nebulizer. Do not mix other medicines with Albuterol Sulfate Inhalation Solution in the nebulizer. Do not use Albuterol Sulfate Inhalation Solution 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 Albuterol Sulfate Inhalation Solution.
  • Call your child’s doctor right away if your child needs to use Albuterol Sulfate Inhalation Solution more often than prescribed.
  • Albuterol Sulfate Inhalation Solution 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 Albuterol Sulfate Inhalation Solution call your child’s doctor right away.

What are the side effects with Albuterol Sulfate Inhalation Solution?

Albuterol Sulfate Inhalation Solution 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 Albuterol Sulfate Inhalation Solution.
  • 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 Albuterol Sulfate Inhalation Solution include a fast or irregular heartbeat, chest pain, shakiness, or nervousness.

How should Albuterol Sulfate Inhalation Solution be stored?

  • Store Albuterol Sulfate Inhalation Solution at room temperature, 2° C to 25° C (36° F to 77° F) 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 two weeks.
  • Do not use Albuterol Sulfate Inhalation Solution after the expiration (EXP) date printed on the vial.
  • Do not use Albuterol Sulfate Inhalation Solution that is not clear and colorless.
  • Safely, discard Albuterol Sulfate Inhalation Solution that is out-of-date or no longer needed.
  • Keep Albuterol Sulfate Inhalation Solution and all medicines out of the reach of children.

General Information about Albuterol Sulfate Inhalation Solution

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use Albuterol Sulfate Inhalation Solution for a condition for which it was not prescribed. Do not give Albuterol Sulfate Inhalation Solution 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 Albuterol Sulfate Inhalation Solution. If you would like more information, talk with your child’s doctor. You can ask your child’s doctor or pharmacist for information about Albuterol Sulfate Inhalation Solution that is written for health professionals.

To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in Albuterol Sulfate Inhalation Solution?

Active Ingredient: albuterol sulfate

Inactive Ingredients : sodium chloride, edetate disodium (EDTA), and sulfuric acid

Rx only

Manufactured for:
Ritedose Pharmaceuticals, LLC
Columbia, SC 29203 U.S.A.

Manufactured by:
The Ritedose Corporation Columbia, SC 29203 U.S.A.

PATIENT’S INSTRUCTIONS FOR USE

Albuterol Sulfate Inhalation Solution

0.63 mg*/3 mL and 1.25 mg*/3 mL

(*Equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL)

Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication, as you may want to read them again.

Albuterol Sulfate Inhalation Solution should only be used under the direction of a physician. Your physician and pharmacist have more information about Albuterol Sulfate Inhalation Solution and the condition for which it has been prescribed. Contact them if you have additional questions.

Storing your Medicine

Store Albuterol Sulfate Inhalation Solution between 2°C to 25°C (36°F to 77°F). Vials should be protected from light before use, therefore, keep unused vials in the foil pouch. Do not use after the expiration (EXP) date printed on the vial.

Dose

Albuterol Sulfate Inhalation Solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use one new vial with each nebulizer treatment.

Instructions for Use

1. Remove one vial from the foil pouch. Place remaining vials back into foil pouch for storage.

2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).

image-04

3. Connect the nebulizer to the mouthpiece or face mask (Figure 2).

image-05

4. Connect the nebulizer to the compressor.

5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor.

image-06
(click image for full-size original)

6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5-15 minutes). At this point, the treatment is finished.

7. Clean the nebulizer (see manufacturer’s instructions).

Manufactured for:
Ritedose Pharmaceuticals, LLC
Columbia, SC 29203 U.S.A.

Manufactured by:
The Ritedose Corporation Columbia, SC 29203 U.S.A.

RPIN0159 May 2022

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