AccuNeb® (albuterol sulfate) inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta₂-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α₁ [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α´-diol sulfate (2:1) (salt), and its established chemical structure is as follows:

The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C₁₃H₂₁NO₃)₂•H₂SO₄. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol.

AccuNeb (albuterol sulfate) Inhalation Solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.75 mg of albuterol sulfate (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED).

AccuNeb (albuterol sulfate) Inhalation Solution does not require dilution prior to administration by nebulization. For AccuNeb, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. AccuNeb should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).

Last updated on RxList: 8/8/2008

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

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of AccuNeb administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 1.25 mg or 0.63 mg inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver AccuNeb over 5 to 15 minutes.

The use of AccuNeb can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV₁ less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

AccuNeb has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of AccuNeb solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of AccuNeb have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of AccuNeb when administered with other nebulizer systems have not been established.

AccuNeb should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

AccuNeb (albuterol sulfate) Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg and 1.25 mg, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of AccuNeb (albuterol sulfate) Inhalation Solution is available in a shelf carton containing multiple foil pouches.

AccuNeb® (albuterol sulfate) Inhalation Solution, 0.63 mg (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-692-03..............................5 foil pouches, each containing 5 vials, total 25 vials per carton

AccuNeb® (albuterol sulfate) Inhalation Solution, 1.25 mg (potency expressed as albuterol) contains 1.50 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-693-03..............................5 foil pouches, each containing 5 vials, total 25 vials per carton Rx Only.

Storage

Store between 2°C and 25°C (36°F - 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 one week. Discard the vial if the solution is not colorless.

DEY®, Napa, CA 94558. 1-800-755-5560; www.dey.com. April 2006 U.S. FDA rev date: 06/02/06

Last updated on RxList: 8/8/2008

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)

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.

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with AccuNeb.

AccuNeb should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or within 2 weeks of discontinuation of such agents, since the action of albuterol on the vascular system may be poten-tiated.

Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as AccuNeb, but may produce severe bron-chospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adren-ergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.

The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

Last updated on RxList: 8/8/2008

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 adequatetocontrolasthma inmany patients.Earlyconsideration shouldbegiventoadding 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., cortico-steroids).

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebuliz-ers. 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.

General: Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. As with other beta-agonists, inhaled and intravenous albuterol may produce a significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring potassium supplementation.

Information for Patients: The action of AccuNeb may last up to six hours, and therefore it should not be used more frequently than recommended. Do not increase the dose or frequency of medication without consulting your physician. If you find that treatment with AccuNeb becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. All asthma medication should only be used under the supervision and direction of a physician. Common effects with medications such as AccuNeb include palpitations, chest pain, rapid heart rate, tremor, or nervousness.

If you are pregnant or nursing, contact your physician about the use of AccuNeb. Effective and safe use of AccuNeb includes an understanding of the way it should be administered.

If the solution in the vial changes color or becomes cloudy, you should not use it.

The drug compatibility (physical and chemical), clinical efficacy, and safety of AccuNeb solution, when mixed with other drugs in a nebulizer, has not been established.

See illustrated Patient's Instructions for Use.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium and above dietary doses of 2 mg/kg (approximately equivalent to the maximum recommended daily inhalation dose for AccuNeb on a mg/m² basis). In another study, this effect was blocked by the co-administration of propranolol, a non-selective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 500 mg/kg (approximately 140 times the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis). In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 50 mg/kg (approximately 20 times the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis).

Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH₁strain mouse micronucleus assay.

Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate up to 50 mg/kg (approximately 30 times the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis).

Pregnancy: Teratogenic Effects: Pregnancy Category C: Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis) and cleft palate formation in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately equal to the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis). The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis). Cleft palate formation also occurred in 23 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg isoproterenol (positive control). A reproduction study in Stride rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate was administered orally at 50 mg/kg (approximately 60 times the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis).

A study in which pregnant rats were dosed with radiolabelled albuterol sulfate demonstrated that drug-related material was transferred from the maternal circulation to the fetus.

There are no adequate and well-controlled studies of the use of albuterol sulfate in pregnant women. Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established.

Labor and Delivery: Oral albuterol has been shown to delay pre-term labor in some reports. There are presently no well-controlled studies that demonstrate that it will stop pre-term labor or prevent labor at term. Because of the potential for beta agonist interference with uterine contractility, use of AccuNeb for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Albuterol has not been approved for the management of pre-term labor. The benefit:risk ratio when albuterol is administered for tocol-ysis has not been established. Serious adverse reactions, including pulmonary edema, have been reported following administration of albuterol to women in labor.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of AccuNeb 1.25 mg and 0.63 mg have been established in pediatric patients between the ages of 2 and 12 years. The use of AccuNeb in these age groups is supported by evidence from adequate and well-controlled studies of AccuNeb in children age 6 to 12 years and published reports of albuterol sulfate trials in pediatric patients 3 years of age and older. The safety and effectiveness of AccuNeb in children below 2 years of age have not been established.

Last updated on RxList: 8/8/2008

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of the pharmacological effects listed in ADVERSE REACTIONS. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of AccuNeb. Treatment consists of discontinuation of AccuNeb together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of AccuNeb.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 580 times the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 mg/kg and 2000 mg/kg, respectively (approximately 260 and 1200 times the maximum recommended daily inhalation dose of AccuNeb on a mg/m² basis). The inhalation median lethal dose has not been determined in animals.

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

Last updated on RxList: 8/8/2008

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 neb-ulizer 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 was evaluated in a 4-week, multi-center, 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 0.63 mg, AccuNeb 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 6-hour 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 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.

Last updated on RxList: 8/8/2008

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 1-800-755-5560, 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

PATIENT'S INSTRUCTIONS FOR USE

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.

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

Storing your Medicine

Store AccuNeb between 2° and 25°C (36°and 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

AccuNeb 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).

Figure 1

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

Figure 2

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.

Figure 3

Figure 4

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).

Last updated on RxList: 8/8/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ALBUTEROL PEDIATRIC PRE-MIXED SOLUTION - INHALATION

(al-BUE-ter-ol)

COMMON BRAND NAME(S): AccuNeb

USES: Albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. This product is used in children or in adults who may need smaller doses of this medication. Albuterol belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles. Controlling symptoms of breathing problems can decrease time lost from work or school.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn all instructions for the use of this medication and the nebulizer. A parent or other responsible adult should supervise a child using this medication. If you have any questions, consult your doctor, pharmacist, or respiratory therapist.

This product should be clear and colorless to light yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

This medication does not require any mixing before use. Using a mouthpiece or face mask with the nebulizer, inhale the prescribed dose of medication into your lungs, usually 3 or 4 times daily as needed or as directed by your doctor. Each treatment usually takes about 5 to 15 minutes. Give this medication only through a nebulizer. Do not swallow the solution. Do not mix with other medicines in your nebulizer. To prevent infections, clean the nebulizer and mouthpiece/face mask according to the manufacturer's directions.

Dosage is based on your medical condition, age, body weight, and response to treatment. Do not increase your dose or use it more frequently than prescribed without your doctor's approval.

If you use other asthma drugs (including inhaled medications), ask your doctor about how to properly use this medication with your other asthma medicines.

If this medication stops working well, or if your breathing symptoms become worse, or if you need to use this medication more frequently than usual, seek immediate medical attention.

SIDE EFFECTS: Nervousness, shaking (tremor), mouth/throat dryness or irritation, cough, dizziness, headache, trouble sleeping, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, muscle cramps/weakness.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, irregular heartbeat.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, seek immediate medical attention.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (e.g., metaproterenol, terbutaline); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat, angina, heart attack), high blood pressure, diabetes, low levels of potassium in the blood, seizure, overactive thyroid (hyperthyroidism).

This drug may make you dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised when using this drug in older adults since they may be more sensitive to its effects, especially the effects on the heart.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, or after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: adrenaline-like drugs (e.g., ephedrine, epinephrine), beta blockers (e.g., atenolol, propranolol), digoxin, tricyclic antidepressants (e.g., amitriptyline, nortriptyline), "water pills" (diuretics such as furosemide, hydrochlorothiazide).

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase heart rate or blood pressure. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/pounding/irregular heartbeat, severe shaking (tremors), seizures.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., pulmonary function tests, blood pressure, levels of potassium in the blood) may 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.

MISSED DOSE: If you are using this medication on a prescribed schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature or in a refrigerator between 36-77 degrees F (2-25 degrees C) away from light. Do not store in the bathroom. Keep all medicines away from children and pets.

Keep the vials stored in the foil pouches until ready to use. Once the vials are removed from the foil pouch, use them within 7 days. Discard any unused portions of the vials.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.