Accuneb

Name: Accuneb

Accuneb 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, or skin rash
  • 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
  • sore throat
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • unusual tiredness or weakness
  • weakness
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
  • 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
  • sneezing
  • stuffy nose
  • swelling
  • tenderness
  • trouble in holding or releasing urine
  • trouble sleeping
  • 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.

Patient Information

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. Accuneb® can 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 1-800-395-3376, 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

Rx Only

Dey Pharma, L.P., Napa, CA 94558; 1-800-395-3376; www.dey.com
© 2003 Printed in U.S.A. H9-307-00 April 2006
U.S. Pat. No. 6,702,997

PRINCIPAL DISPLAY PANEL - 0.63 mg

NDC 49502-692-03

Accuneb®

(albuterol sulfate)
INHALATION SOLUTION
0.63 mg*

*Potency expressed as albuterol, equivalent to 0.75 mg albuterol sulfate.

0.63 mg*/3 mL, 25 Vials

Sterile Unit-Dose Vials

For Inhalation Only

ATTENTION PHARMACIST: Detach
"Patient's Instructions for Use" from package
insert and dispense with solution.

*Potency expressed as albuterol, equivalent to 0.75 mg albuterol sulfate.

INGREDIENTS:
Active: Albuterol sulfate (0.75 mg/3 mL).
Inactive: Sodium chloride, sulfuric acid (to adjust to pH 3.5) and purified water.

STORAGE CONDITIONS: Protect from light. Store between 2°C-25°C
(36°F-77°F). Store the unit-dose vials in the protective foil pouch at all times.
Once removed from the foil pouch, use the vial(s) within one week. Discard the
vial if the solution is not colorless. Keep out of reach of children.

USUAL DOSAGE: FOR USE IN CHILDREN AGES 2 TO 12. See
accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR
PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE.

Rx only.

U.S. Pat. No. 6,702,997

Dey®
A Mylan Company

Dey Pharma, L.P. Napa, CA 94558     ©2001

PRINCIPAL DISPLAY PANEL - 1.25 mg

NDC 49502-693-03

Accuneb®

(albuterol sulfate)
INHALATION SOLUTION
1.25 mg*

*Potency expressed as albuterol, equivalent to 1.5 mg albuterol sulfate.

1.25 mg*/3 mL, 25 Vials

Sterile Unit-Dose Vials

For Inhalation Only

ATTENTION PHARMACIST: Detach
"Patient's Instructions for Use" from package
insert and dispense with solution.

*Potency expressed as albuterol, equivalent to 1.5 mg albuterol sulfate.

INGREDIENTS:
Active: Albuterol sulfate (1.5 mg/3 mL).
Inactive: Sodium chloride, sulfuric acid (to adjust to pH 3.5) and purified water.

STORAGE CONDITIONS: Protect from light. Store between 2°C-25°C
(36°F-77°F). Store the unit-dose vials in the protective foil pouch at all times.
Once removed from the foil pouch, use the vial(s) within one week. Discard the
vial if the solution is not colorless. Keep out of reach of children.

USUAL DOSAGE: FOR USE IN CHILDREN AGES 2 TO 12. See
accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR
PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE.

Rx only.

U.S. Pat. No. 6,702,997

Dey®
A Mylan Company

Dey Pharma, L.P. Napa, CA 94558     ©2001

Accuneb 
albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49502-692
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
albuterol sulfate (albuterol) albuterol 0.63 mg  in 3 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride  
sulfuric acid  
water  
Packaging
# Item Code Package Description
1 NDC:49502-692-03 5 POUCH (POUCH) in 1 CARTON
1 5 VIAL (VIAL) in 1 POUCH
1 3 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020949 02/10/2011
Accuneb 
albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49502-693
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
albuterol sulfate (albuterol) albuterol 1.25 mg  in 3 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride  
sulfuric acid  
water  
Packaging
# Item Code Package Description
1 NDC:49502-693-03 5 POUCH (POUCH) in 1 CARTON
1 5 VIAL (VIAL) in 1 POUCH
1 3 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020949 02/10/2011
Labeler - Dey Pharma, LP (194775557)
Revised: 03/2011   Dey Pharma, LP

Indications

AccuNeb (albuterol sulfate inhalation solution) is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

Warnings

Paradoxical Bronchospasm

As with other inhaled beta-adrenergic agonists, AccuNeb (albuterol sulfate inhalation solution) can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, AccuNeb (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) , 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 (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 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 (albuterol sulfate inhalation solution) 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.

Clinical pharmacology

The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with isoproterenol. While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicate that 10% to 50% of the beta-receptors in the human heart may be beta2-receptors. The precise function of these receptors, however, is not yet established. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.

Pharmacokinetics

Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (IPPB) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus, and expired air. Most of the absorbed dose was recovered in urine collected during the 24 hours after drug administration. Following oral administration of 4 mg albuterol, the elimination half-life was five to six hours. Following a 3 mg dose of nebulized albuterol in adults, the mean maximum albuterol plasma level at 0.5 hours was 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). The pharmacokinetics of albuterol following administration of 0.63 mg or 1.25 mg albuterol sulfate inhalation solution by nebulization have not been determined in children 2 to 12 years old.

Animal Pharmacology/Toxicology

Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those found in whole brain.

Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown.

Clinical Trials

The safety and efficacy of AccuNeb (albuterol sulfate inhalation solution) was evaluated in a 4-week, multicenter, randomized, double-blind, placebo-controlled, parallel group study in 349 children 6 to 12 years of age with mild-to-moderate asthma (mean baseline FEV1 60% to 70% of predicted). Approximately half of the patients were also receiving inhaled corticosteroids. Patients were randomized to receive AccuNeb (albuterol sulfate inhalation solution) 0.63 mg, AccuNeb (albuterol sulfate inhalation solution) 1.25 mg, or placebo three times a day administered via a Pari LC Plus™ nebulizer and a Pari PRONEB™ compressor. Racemic albuterol, delivered by a chlorofluorocarbon (CFC) metered dose inhaler (MDI) or nebulized, was used on an as-needed basis as the rescue medication.

Efficacy, as measured by the mean percent change from baseline in the area under the 6hour curve for FEV1, was demonstrated for both active treatment regimens (n=112 [1.25 mg group] and n=110 [0.63 mg group]) compared with placebo (n=110) on day 1 and day 28. Figures 1 and 2 illustrate the mean percentage change from pre-dose FEV1 on day 1 and day 28, respectively. The mean baseline FEV1 for all patients was 1.49 L.

Figure 1 : % Change from Pre-Dose FEV1 Intent-to-Treat Population
Day 1

Figure 2 : % Change from Pre-Dose FEV1 Intent-to-Treat Population
Day 28

The onset of a 15% increase in FEV1 over baseline for both doses of AccuNeb (albuterol sulfate inhalation solution) was seen at 30 minutes (the first post-dose assessment). The mean time to peak effect was approximately 30 to 60 minutes for both doses on day 1 and after 4 weeks of treatment. The mean duration of effect, as measured by a > 15% increase from baseline in FEV1, was approximately 2.5 hours for both doses on day 1 and approximately 2 hours for both doses after 4 weeks of treatment. In some patients, the duration of effect was as long as 6 hours.

Uses of Accuneb

Inhalational:

  • Albuterol aerosol spray is a prescription medication used in people 4 years of age and older to:
    • treat or prevent bronchospasm (narrowing of airways) in people who have reversible obstructive airway disease (asthma)
    • prevent exercise induced bronchospasm (narrowing of airways)
  • Albuterol solution for nebulization is a prescription medication used for the relief of bronchospasm (narrowing of airways) in patients 2 to 12 years of age with asthma

Oral:

  • Albuterol immediate- and extended-release tablets are used for the relief of bronchospasm (narrowing of airways) in adults and children 6 years of age and older with reversible obstructive airway disease (asthma).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Accuneb Precautions

Inhalational/Oral:

Albuterol may cause serious side effects, including:

  • worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using albuterol and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
  • heart problems including faster heart rate and higher blood pressure
  • possible death in people with asthma who use too much albuterol
  • allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:
    • itchy skin
    • swelling beneath your skin or in your throat
    • rash
    • worsening trouble breathing
  • low potassium levels in your blood
  • worsening of other medical problems in people who also use albuterol including increases in blood sugar

Do not use albuterol if you are allergic to albuterol sulfate or any of the ingredients in albuterol. 

Inform MD

Before you use albuterol, tell your doctor if you:

  • have heart problems
  • have high blood pressure (hypertension)
  • have convulsions (seizures)
  • have thyroid problems
  • have diabetes
  • have low potassium levels in your blood
  • are pregnant or plan to become pregnant. It is not known if albuterol will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if albuterol passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using albuterol.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Accuneb Dosage

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

Syrup

  • Adults And Children Over 14 Years Of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
  • Children 6 To 14 Years Of Age: The usual starting dosage for children 6 to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
  • Children 2 To 6 Years Of Age: Dosing in children 2 to 6 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Aerosol

  • Treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms
    • The usual dosage for adults and children 12 years of age and older is 2 inhalations repeated every 4 to 6 hours
    • In some, 1 inhalation every 4 hours may be sufficient. More frequent use or a larger number of inhalations is not recommended.
    • For maintenance therapy or prevention of exacerbation of bronchospasm, 2 inhalations, 4 times a day should be sufficient.
    • If a previously effective dosage fails to provide the usual response, this may be a sign of worsening asthma and requires reevaluation of the treatment regimen.
  • ‚ÄčExercise-Induced Bronchospasm Prevention
    • ‚ÄčThe usual dosage for adults and children 12 years and older is 2 inhalations, 15 minutes before exercise.

Solution for Nebulization

  • The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of AccuNeb (albuterol for nebulization) taken 3 or 4 times daily, as needed, by nebulization.
  • To take 1.25 mg or 0.63 mg of albuterol, use the entire contents of one vial (3 mL of 1.25 mg or 0.63 mg inhalation solution). Adjust nebulizer flow rate to deliver AccuNeb (albuterol for nebulization) over 5 to 15 minutes.
  • Patients 6 to 12 years of age with more severe asthma, weight >40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Extended Release Tablets

  • Adults and Children over 12 years of age - The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.
  • Children 6 to 12 years of age - The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Regular Release Tablets

  • Adults and Children Over 12 Years of Age - The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day.
  • Children 6 to 12 Years of Age - The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.

Albuterol Levels and Effects while Breastfeeding

Summary of Use during Lactation

Although no published data exist on the use of albuterol by mouth or inhaler during lactation, data from the related drug, terbutaline, indicate that very little is expected to be excreted into breastmilk.[1] The authors of several reviews and an expert panel agree that use of inhaled bronchodilators is acceptable during breastfeeding because of the low bioavailability and maternal serum levels after use.[2][3][4][5][6]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Terbutaline

References

1. Lindberg C, Boreus LO, de Chateau P et al. Transfer of terbutaline into breast milk. Eur J Resp Dis. 1984;65 (Suppl 134):87-91. PMID: 6586490

2. McDonald CF, Burdon JGW. Asthma in pregnancy and lactation. A position paper for the Thoracic Society of Australia and New Zealand. Med J Aust. 1996;165:485-8. PMID: 8937369

3. Ellsworth A. Pharmacotherapy of asthma while breastfeeding. J Hum Lact. 1994;10:39-41. PMID: 7619245

4. Nelson-Piercy C. Asthma in pregnancy. Thorax. 2001;56:325-8. PMID: 11254828

5. Taddio A, Ito S. Drugs and breast-feeding. In: Koren G, ed. Maternal-fetal toxicology. A clinician's guide. 3rd ed. New York: Marcel Dekker, 2001:177-32.

6. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Asthma and Pregnancy Working Group. NAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment-2004 update. 2004;1-57. http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg.htm

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