Albuterol Inhalation Solution

Before using albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (such as metaproterenol, terbutaline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as irregular heartbeat, angina, heart attack), high blood pressure, diabetes, seizure.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Do not share this medication with others.Laboratory and/or medical tests (such as a lung/breathing test, blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Avoid allergens/irritants such as smoke, pollen, pet dander, dust, or molds that may worsen breathing problems.Learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).Ask your doctor or pharmacist whether you should have an annual flu shot.

• It is used to open the airways in lung diseases where spasm may cause breathing problems.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• If you are not able to get the breathing attack under control. Get help right away.
• Chest pain or pressure or a fast heartbeat.
• Very nervous and excitable.
• Very bad headache.
• Very bad dizziness or passing out.
• Peak flow measurement low.
• This medicine may sometimes cause very bad breathing problems. This may be life-threatening. When this happens with a puffer (inhaler) or with liquid for breathing in, most of the time it happens right after a dose and after the first use of a new canister or vial of albuterol inhalation solution. If you have trouble breathing, breathing that is worse, wheezing, or coughing, get medical help right away.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take albuterol inhalation solution or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to albuterol inhalation solution. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Paradoxical Bronchospasm:

Albuterol sulfate inhalation solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol sulfate inhalation solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Albuterol sulfate inhalation solution contains the preservative benzalkonium chloride. Benzalkonium chloride has been associated with bronchospasm in a dose-dependent manner. In patients who receive high doses (e.g., continuous nebulization) of albuterol sulfate inhalation solution and bronchospasm does not resolve, consider a trial of short-acting bronchodilator that does not contain the preservative benzalkonium chloride [see Dosage and Administration].

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

Albuterol sulfate inhalation solution, like all 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 after administration of albuterol sulfate inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (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, albuterol sulfate inhalation solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

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 albuterol sulfate inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

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.

Use of Anti-inflammatory Agents

The use of beta-adrenergic agonist 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.

Microbial Contamination

It is recommended that each multi-dose bottle of albuterol be used for only one patient. Nosocomial outbreaks of pneumonia have occurred in hospitals when one multi-dose bottle of albuterol was used to treat more than one patient. To avoid microbial contamination, proper aseptic technique should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used.

Albuterol Sulfate Inhalation Solution, 0.5% is a clear, colorless sterile solution, and is supplied in amber glass bottles of 20 mL fill (NDC 50383-741-20) with accompanying calibrated dropper; boxes of one. Store between 2° and 25°C (36° and 77°F).

KEEP OUT OF REACH OF CHILDREN.

Rx only.

FOR ORAL INHALATION ONLY.

Manufactured by

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

Rev.741:04 02/17

PHARMACIST DETACH HERE AND GIVE LOWER PORTION TO PATIENT

Albuterol Sulfate Inhalation Solution, 0.5%*

*Potency expressed as albuterol

Note: The Albuterol Sulfate Inhalation Solution contained in the 20 mL multiple-dose bottles is concentrated and must be diluted.

Read complete instructions carefully before using.

1. Draw the appropriate volume of Albuterol Sulfate Inhalation Solution, 0.5% into the specially marked dropper that comes with each multidose bottle (Figure 1). For children 12 years of age and under, the volume is based upon body weight. Use the dropper volume prescribed by your doctor.

Figure 1

2. Squeeze the solution into the nebulizer reservoir through the appropriate opening, taking care not to touch the tip of the dropper (Figure 2).

Figure 2

3. Add sterile normal saline solution, as your doctor has directed. A general guideline for the amount of saline to add is: For children using 0.25 mL or 1.25 mg of albuterol sulfate inhalation solution, add 2.75 mL of sterile normal saline. For children or adults using 0.5mL or 2.5mg of albuterol sulfate inhalation solution, add 2.5 mL of sterile normal saline.

4. Gently swirl the nebulizer to mix the contents and connect it with the mouthpiece or face mask (Figure 3).

Figure 3

5. Connect the nebulizer to the compressor.

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

Figure 4

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

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

Note: Use only as directed by your physician.More frequent administration or higherdoses are not recommended.

Store Albuterol Sulfate Inhalation Solution, 0.5% between 2° and 25°C (36°- 77° F).

To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used. The safety and effectiveness of albuterol sulfate inhalation solution have not been determined when one or more drugs are mixed with it in a nebulizer. Check with your doctor before mixing any medications in your nebulizer.

Call your doctor for medical advice about side effects. You may report side effects to Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088.

ADDITIONAL INSTRUCTIONS:

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Tightening and swelling of the muscles around the airways (bronchospasm)

Generic: albuterol

Form: Nebulizer solution Strengths:

• 1.25 mg/3 mL
• 0.63 mg/3 mL

Brand: Accuneb

Form: Nebulizer solution Strengths:

• 1.25 mg/3 mL
• 0.63 mg/3 mL

Adult Dosage (ages 18 years and older)

• 2.5 mg given 3–4 times per day by nebulization

Child Dosage (ages 12–17 years)

• 2.5 mg given 3–4 times per day by nebulization

Child Dosage (ages 2–11 years)

• Children who weigh at least 15 kg (33 lbs): The usual dose is 2.5 mg given 3–4 times per day by nebulization.
• Children who weigh less than 15 kg (33 lbs): Your doctor will decide a dose that’s right for you.

Child Dosage (ages 0–1 years)

The safety and effectiveness of this drug hasn’t been established in children younger than 4 years of age.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you. Important considerations for taking albuterol

You can take albuterol with or without food

Take this drug at the time(s) recommended by your doctor

Store albuterol inhalation solution between 36°F to 77°F (2°C to 25°C)

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A prescription for this medication is refillable

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Travel

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Self-management

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Clinical monitoring

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Hidden costs

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Are there any alternatives?