Drugs Details

Drugs Info of Accuneb, ProAir HFA, Proventil, Proventil HFA, ReliOn Ventolin HFA, Ventolin HFA
Drugs Details
  • Drugs Type  : Multum
  • Date : 29th Dec 2014 11:53 pm
  • Brand Name : Accuneb, ProAir HFA, Proventil, Proventil HFA, ReliOn Ventolin HFA, Ventolin HFA
  • Generic Name : albuterol inhalation (Pronunciation: al BYOO ter all)
Descriptions

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-mxylene-α, α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows:

 

AccuNeb® (albuterol sulfate) Structural Formula Illustration

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 (albuterol sulfate inhalation solution) , 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 (albuterol sulfate inhalation solution) should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).

What are the possible side effects of albuterol inhalation?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • tremor, nervousness;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp...

Read All Potential Side Effects and See Pictures of AccuNeb »


This monograph has been modified to include the generic and brand name in many instances.

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).

Dosage Administration

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of AccuNeb (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) over 5 to 15 minutes.

The use of AccuNeb (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) solution, when mixed with other drugs in a nebulizer have not been established.

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

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

How Supplied

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) (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

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.

Keep out of the reach of children.

DEY®, Napa, CA 94558. JAN 07


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trial Experience: Adverse events reported in > 1% of patients receiving AccuNeb (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) and Greater than Placebo (expressed as % of treatment group)

  1.25 mg AccuNeb
(N=115)
0.63 mg AccuNeb
(N=117)
Placebo
(N=117)
Asthma Exacerbation 13 11.1 8.5
Otitis Media 4.3 0.9 0
Allergic Reaction 0.9 3.4 1.7
Gastroenteritis 0.9 3.4 0.9
Cold Symptoms 0 3.4 1.7
Flu Syndrome 2.6 2.6 1.7
Lymphadenopathy 2.6 0.9 1.7
Skin/Appendage Infection 1.7 0 0
Urticaria 1.7 0.9 0
Migraine 0.9 1.7 0
Chest Pain 0.9 1.7 0
Bronchitis 0.9 1.7 0.9
Nausea 1.7 0.9 0.9

There was one case of ST segment depression in the 1.25 mg AccuNeb (albuterol sulfate inhalation solution) treatment group.

No clinically relevant laboratory abnormalities related to AccuNeb (albuterol sulfate inhalation solution) administration were seen in this study.

Postmarketing Experience

Metabolic acidosis has been reported after the use of albuterol sulfate inhalation solution. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure..

Read the AccuNeb (albuterol sulfate inhalation solution) Side Effects Center for a complete guide to possible side effects

Interactions

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with AccuNeb (albuterol sulfate inhalation solution) .

AccuNeb (albuterol sulfate inhalation solution) 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 potentiated.

Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as AccuNeb (albuterol sulfate inhalation solution) , but may produce severe bronchospasm 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-adrenergic 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 coadministration 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.


This monograph has been modified to include the generic and brand name in many instances.

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.

Precautions

General

Large doses of intravenous albuterol have been reported to aggravate preexisting 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) include palpitations, chest pain, rapid heart rate, tremor, or nervousness.

If you are pregnant or nursing, contact your physician about the use of AccuNeb (albuterol sulfate inhalation solution) . Effective and safe use of AccuNeb (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) on a mg/m² basis). In another study, this effect was blocked by the coadministration 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 AH1 strain 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) 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 tocolysis 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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) in these age groups is supported by evidence from adequate and well-controlled studies of AccuNeb (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) in children below 2 years of age have not been established.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

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 (albuterol sulfate inhalation solution) . Treatment consists of discontinuation of AccuNeb (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) .

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 (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) on a mg/m² basis). The inhalation median lethal dose has not been determined in animals.

ContrainDications

AccuNeb (albuterol sulfate inhalation solution) is contraindicated in patients with a history of hypersensitivity to any of its components.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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

View Enlarged Table

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

View Enlarged Table

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.


This monograph has been modified to include the generic and brand name in many instances.

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® (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 AccuNeb® (albuterol sulfate inhalation solution) ?

AccuNeb® (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. AccuNeb® (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 AccuNeb® (albuterol sulfate inhalation solution) ?

Do not give your child AccuNeb® (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 AccuNeb® (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 non-prescription medicines, vitamins and herbal supplements. AccuNeb® (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 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® (albuterol sulfate inhalation solution) be given?

Read the Patient's Instructions for Use that comes with AccuNeb® (albuterol sulfate inhalation solution) . Ask your pharmacist for these instructions if they are not with your medicine. Keep the instructions with AccuNeb® (albuterol sulfate inhalation solution) because you may want to read them again.

  • Give AccuNeb® (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.
  • AccuNeb® (albuterol sulfate inhalation solution) is breathed into the lungs. AccuNeb® (albuterol sulfate inhalation solution) is used with a special breathing machine called a nebulizer. Do not mix other medicines with AccuNeb® (albuterol sulfate inhalation solution) in the nebulizer. Do not use AccuNeb® (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 AccuNeb® (albuterol sulfate inhalation solution) .
  • Call your child's doctor right away if your child needs to use AccuNeb® (albuterol sulfate inhalation solution) more often than prescribed.
  • AccuNeb® (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 AccuNeb® (albuterol sulfate inhalation solution) , call your child's doctor right away.

What are the side effects with AccuNeb® (albuterol sulfate inhalation solution) ?

AccuNeb® (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 AccuNeb® (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 AccuNeb® (albuterol sulfate inhalation solution) include a fast or irregular heartbeat, chest pain, shakiness, or nervousness.

How should AccuNeb® (albuterol sulfate inhalation solution) be stored?

  • Store AccuNeb® (albuterol sulfate inhalation solution) 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® (albuterol sulfate inhalation solution) after the expiration (EXP) date printed on the vial. Do not use AccuNeb® (albuterol sulfate inhalation solution) that is not clear and colorless.
  • Safely, discard AccuNeb® (albuterol sulfate inhalation solution) that is out-of-date or no longer needed.
  • Keep AccuNeb® (albuterol sulfate inhalation solution) and all medicines out of the reach of children.

General Information about AccuNeb® (albuterol sulfate inhalation solution)

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use AccuNeb® (albuterol sulfate inhalation solution) for a condition for which it was not prescribed. Do not give AccuNeb® (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 AccuNeb® (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 AccuNeb® (albuterol sulfate inhalation solution) that is written for health professionals. You can also call the company that makes AccuNeb® (albuterol sulfate inhalation solution) 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 (albuterol sulfate inhalation solution) should only be used under the direction of a physician. Your physician and pharmacist have more information about AccuNeb (albuterol sulfate inhalation solution) and the condition for which it has been prescribed. Contact them if you have additional questions.

Storing your Medicine

Store AccuNeb (albuterol sulfate inhalation solution) 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 (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).

 

Instructions for Use - Illustration 1

Figure 1

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

 

Instructions for Use - Illustration 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.

 

Instructions for Use - Illustration 3

Figure 3

 

Instructions for Use - Illustration 4

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).


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Accuneb, ProAir HFA, Proventil, Proventil HFA, ReliOn Ventolin HFA, Ventolin HFA

Generic Name: albuterol inhalation (Pronunciation: al BYOO ter all)

  • What is albuterol inhalation (AccuNeb)?
  • What are the possible side effects of albuterol inhalation?
  • What is the most important information I should know about albuterol inhalation?
  • What should I discuss with my healthcare provider before using albuterol inhalation?
  • How should I use albuterol inhalation?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using albuterol inhalation?
  • What other drugs will affect albuterol inhalation?
  • Where can I get more information?

What is albuterol inhalation (AccuNeb)?

Albuterol is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Albuterol inhalation is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Albuterol is also used to prevent exercise-induced bronchospasm.

Albuterol inhalation may also be used for purposes not listed in this medication guide.

Albuterol 0.083%-RXE

What are the possible side effects of albuterol inhalation?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • tremor, nervousness;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • headache, dizziness;
  • sleep problems (insomnia);
  • cough, hoarseness, sore throat, runny or stuffy nose;
  • mild nausea, vomiting;
  • dry mouth and throat;
  • muscle pain; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the AccuNeb (albuterol sulfate inhalation solution) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about albuterol inhalation?

It is important to keep this medication on hand at all times. Get your prescription refilled before you run out of medicine completely. Keep using all of your other medications as prescribed by your doctor.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor. An increased need for medication could be an early sign of a serious asthma attack.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of albuterol can be fatal.

Extreme heat can cause the medicine canister to burst. Do not store your inhaler in your car on hot days. Do not throw an empty canister into open flame.

Side Effects Centers
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Patient Detailed How Take

What should I discuss with my healthcare provider before using albuterol inhalation?

You should not use this medication if you are allergic to albuterol.

To make sure you can safely use albuterol, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure, or congestive heart failure;
  • a heart rhythm disorder;
  • a seizure disorder such as epilepsy;
  • diabetes; or
  • overactive thyroid.

FDA pregnancy category C. It is not known whether albuterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether albuterol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using albuterol.

An albuterol inhaler should not be given to a child younger than 4 years old. Albuterol solution in a nebulizer should not be given to a child younger than 2 years of age.

How should I use albuterol inhalation?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Use only the prescribed dose of this medicine and follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using albuterol.

When using the inhaler device for the first time, prime it by spraying 4 test sprays into the air, away from your face. Shake well before priming. Also prime the inhaler if you have not used it for 2 weeks or longer, or if you have dropped the inhaler.

The instructions below are for standard use of the inhaler and nebulizer devices. Your doctor may want you to use your device differently. Use only the inhaler device provided with your medicine or you may not get the correct dose.

To use the inhaler:

  • Shake the canister well just before each spray.
  • Uncap the mouthpiece of the inhaler. Breathe out fully. Put the mouthpiece into your mouth and close your lips. Breathe in slowly while pushing down on the canister. Hold your breath for 10 seconds, then breathe out slowly.
  • If you use more than one inhalation at a time, wait at least 1 minute before using the second inhalation and shake the inhaler again.
  • Keep your inhaler clean and dry, and store it with the cap on the mouthpiece. Clean your inhaler once a week by removing the canister and placing the mouthpiece under warm running water for at least 30 seconds. Shake out the excess water and allow the parts to air dry completely before putting the inhaler back together.

To use the solution with a nebulizer:

  • Measure the correct amount of medicine using the dropper provided, or use the proper number of ampules. Place the liquid into the medication chamber of the nebulizer.
  • Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor.
  • Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.
  • Breathe in slowly and evenly until you have inhaled all of the medicine (usually 5 to 15 minutes). The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.
  • Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

An increased need for medication could be an early sign of a serious asthma attack.

It is important to keep this medication on hand at all times. Get your prescription refilled before you run out of medicine completely. Keep using all of your other medications as prescribed by your doctor.

Store this medication at room temperature away from moisture and heat. Extreme heat can cause the medicine canister to burst. Do not store it in your car on hot days. Do not throw an empty canister into open flame.

Side Effects Centers
  • Proventil
  • Proair
  • Ventolin HFA
  • Albuterol Sulfate
  • AccuNeb

Patient Detailed Avoid Taking

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of albuterol can be fatal.

Overdose symptoms may include nervousness, headache, tremor, dry mouth, chest pain or heavy feeling, rapid or uneven heart rate, pain spreading to the arm or shoulder, nausea, sweating, dizziness, seizure (convulsions), feeling light-headed or fainting.

What should I avoid while using albuterol inhalation?

Avoid getting this medication in your eyes. If this does happen, rinse the eyes with water and seek medical attention.

What other drugs will affect albuterol inhalation?

Tell your doctor about all other medicines you use, especially:

  • a diuretic (water pill);
  • digoxin (digitalis, Lanoxin);
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or
  • other bronchodilators such as levalbuterol (Xopenex), pirbuterol (Maxair), terbutaline (Brethine, Bricanyl), salmeterol (Advair, Serevent), metaproterenol (Alupent, Metaprel), or isoproterenol (Isuprel Mistometer).

This list is not complete and other drugs may interact with albuterol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about albuterol inhalation.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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