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 11:03 pm
  • Brand Name : Accuneb, ProAir HFA, Proventil, Proventil HFA, ReliOn Ventolin HFA, Ventolin HFA
  • Generic Name : albuterol inhalation (Pronunciation: al BYOO ter all)
Descriptions

The active component of PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, USP racemic α1[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta2-adrenergic bronchodilator having the following chemical structure:

Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21 NO3)2•H2SO4. Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. PROVENTIL HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece).

Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant.

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 Proventil HFA »

What are the precautions when taking albuterol inhalation (Proventil HFA)?

Before using albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (such as metaproterenol, terbutaline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as irregular heartbeat, angina, heart attack), high blood pressure, seizure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your...

Read All Potential Precautions of Proventil HFA »


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

Indications

PROVENTIL® HFA Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Dosage Administration

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient. Each actuation of PROVENTIL® HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.

Exercise Induced Bronchospasm Prevention

The usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise.

To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week.

The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly (see PATIENT INFORMATION). Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage. The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly.

If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. If a previously effective dose regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

How Supplied

PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NDC 0085-1132-01).

Store between 15°-25°C (59°-77°F). For best results, canister should be at room temperature before use. SHAKE WELL BEFORE USING.

The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product canisters, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.

PROVENTIL® HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Developed and Manufactured by: 3M Health Care Limited, Loughborough UK or 3M Drug Delivery Systems Northridge, CA 91324, USA. Distributed by: Schering Corporation, a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA. Rev. 01/12


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

Side Effects

Adverse reaction information concerning PROVENTIL® HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the PROVENTIL HFA Inhalation Aerosol treatment group and more frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable. Adverse Experience Incidences (% of patients) in a Large 12-week Clinical Trial*

 

Body System/ Adverse Event (Preferred Term) PROVENTIL® HFA Inhalation Aerosol (N=193) CFC 11/12 Propelled Albuterol Inhaler (N=186) HFA-134a Placebo Inhaler (N=186)
Application Site Disorders Inhalation Site Sensation 6 9 2
Inhalation Taste Sensation 4 3 3
Body as a Whole Allergic Reaction/Symptoms 6 4 < 1
Back Pain 4 2 3
Fever 6 2 5
Central and Peripheral Nervous System Tremor 7 8 2
Gastrointestinal System Nausea 10 9 5
Vomiting 7 2 3
Heart Rate and Rhythm Disorder Tachycardia 7 2 < 1
Psychiatric Disorders Nervousness 7 9 3
Respiratory System Disorders Respiratory Disorder (unspecified) 6 4 5
Rhinitis 16 22 14
Upper Resp Tract Infection 21 20 18
Urinary System Disorder Urinary Tract Infection 3 4 2
*This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROVENTIL HFA Inhalation Aerosol group and more frequently in the PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.

Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation Aerosol patients than placebo patients, which have the potential to be related to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation Aerosol.

Adverse events reported in a 4-week pediatric clinical trial comparing PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials. In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.

Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of the oropharynx.

Read the Proventil HFA (albuterol inhalation) Side Effects Center for a complete guide to possible side effects

Interactions

Beta-Blockers

Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as PROVENTIL HFA Inhalation Aerosol, 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., as 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.

Diuretics

The ECG changes and/or hypokalemia which may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Albuterol-Digoxin

Mean decreases of 16% and 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.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

PROVENTIL HFA Inhalation Aerosol 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, because the action of albuterol on the cardiovascular system may be potentiated.

Read the Proventil HFA Drug Interactions Center for a complete guide to possible interactions

Learn More »


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

Warnings

  1. Paradoxical Bronchospasm: Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occur, PROVENTIL® HFA (albuterol inhalation) Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
  2. 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 PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, eg, corticosteroids.
  3. Use of Anti-inflammatory Agents: The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, corticosteroids, to the therapeutic regimen.
  4. Cardiovascular Effects: PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol, like other beta-adrenergic agonist, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of PROVENTIL HFA Inhalation Aerosol 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, PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  5. Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
  6. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

Precautions

General

Albuterol sulfate, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol may produce 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 supplementation.

Information for Patients

See illustrated Patient's Instructions for Use. SHAKE WELL BEFORE USING. Patients should be given the following information:

It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.

KEEPING THE PLASTIC MOUTHPIECE CLEAN IS VERY IMPORTANT TO PREVENT MEDICATION BUILD-UP AND BLOCKAGE. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR DRIED THOROUGHLY AT LEASE ONCE A WEEK. INHALER MAY CEASE TO DELIVER MEDICATION IF NOT PROPERLY CLEANED.

The mouthpiece should be cleaned (with the canister removed) by running warm water through the top and bottom for 30 seconds at least once a week. The mouthpiece must be shaken to remove excess water, then air dried thoroughly (such as overnight). Blockage from medication build-up or improper medication delivery may result from failure to thoroughly air dry the mouthpiece.

If the mouthpiece should become blocked (little or no medication coming out of the mouthpiece), the blockage may be removed by washing as described above.

If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, test spray twice away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly.

The action of PROVENTIL® HFA (albuterol inhalation) Inhalation Aerosol should last up to 4 to 6 hours. PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of doses of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol without consulting your physician. If you find that treatment with PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, medical attention should be sought immediately. While you are taking PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by your physician.

Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol. Effective and safe use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol includes an understanding of the way that it should be administered. Use PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol only with the actuator supplied with the product. Discard the canister after 200 sprays have been used.

In general, the technique for administering PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol to children is similar to that for adults. Children should use PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol under adult supervision, as instructed by the patient's physician. (See Patient's Instructions for Use).

Carcinogenesis, Mutagenesis, and Impairment of Fertility

In a 2-year study in SPRAGUE-DAWLEY® rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at the above dietary doses of 2 mg/kg (approximately 15 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In another study this effect was blocked by the coadministration of propranolol, a nonselective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximately 1700 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In a 22-month study in Golden Hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 110 times the maximum recommended daily inhalation dose for children 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 up to 50 mg/kg (approximately 340 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).

Pregnancy: Teratogenic Effects: Pregnancy Category C

Albuterol sulfate has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol sulfate 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 for adults on a mg/m2 basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately 8 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). The drug did not induce cleft palate formation at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg of isoproterenol (positive control).

A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate was administered orally at 50 mg/kg dose (approximately 680 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).

In an inhalation reproduction study in SPRAGUE-DAWLEY rats, the albuterol sulfate/HFA-134a formulation did not exhibit any teratogenic effects at 10.5 mg/kg (approximately 70 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).

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

There are no adequate and well-controlled studies of PROVENTIL HFA Inhalation Aerosol or albuterol sulfate in pregnant women. PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol 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.

Use in Labor and Delivery

Because of the potential for beta-agonist interference with uterine contractility, use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol for relief of bronchospesm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Tocolysis: Albuterol has not been approved for the management of preterm labor. The benefit:risk ratio when albuterol is administered for tocolysis has not been established. Serious adverse reactions, including pulmonary edema, have been reported during the following treatment of premature labor with beta2-agonists, including albuterol.

Nursing Mothers

Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol are excreated in human milk.

Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol by nursing mothers, 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. Caution should be exercised when albuterol sulfate is administered to a nursing woman.

Pediatrics

The safety and effectiveness of PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol in pediatric patients below the age of 4 years have not been established.

Geriatrics

PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol has not been studied in a geriatric population. As with other beta2-agonists, special caution should be observed when using PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol in elderly patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug.


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 any of the symptoms listed under ADVERSE REACTIONS, e.g., 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, and insomnia.

Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of PROVENTIL® HFA Inhalation Aerosol. Treatment consists of discontinuation of PROVENTIL HFA Inhalation Aerosol 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 PROVENTIL HFA Inhalation Aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m²basis and approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m² basis). The inhalation median lethal dose has not been determined in animals.

ContrainDications

PROVENTIL® HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other PROVENTIL HFA components.


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

Clinical Pharamacology

Mechanism of Action

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 on bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart existing in a concentration between 10% and 50% of cardiac beta-adrenergic receptors. The precise function of these receptors has not been established. (See WARNINGS, Cardiovascular Effects section.)

Activation of beta2-adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3',5'-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway.

Albuterol has been shown in most clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. 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.

Preclinical

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 the plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the 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 beta2-agonist and methylxanthines were administered concurrently. The clinical significance of these findings is unknown.

Propellant HFA-134a is devoid of pharmacological activity except at very high doses in animals (380-1300 times the maximum human exposure based on comparisons of AUC values), primarily producing ataxia, tremors, dyspnea, or salivation. These are similar to effects produced by the structurally related chlorofluorocarbons (CFCs), which have been used extensively in metered dose inhalers.

In animals and humans, propellant HFA-134a was found to be rapidly absorbed and rapidly eliminated, with an elimination half-life of 3 to 27 minutes in animals and 5 to 7 minutes in humans. Time to maximum plasma concentration (Tmax) and mean residence time are both extremely short, leading to a transient appearance of HFA-134a in the blood with no evidence of accumulation.

Pharmacokinetics

In a single-dose bioavailability study which enrolled six healthy, male volunteers, transient low albuterol levels (close to the lower limit of quantitation) were observed after administration of two puffs from both PROVENTIL® HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler. No formal pharmacokinetic analyses were possible for either treatment, but systemic albuterol levels appeared similar.

Clinical Trials

In a 12-week, randomized, double-blind, double-dummy, active-and placebo-controlled trial, 565 patients with asthma were evaluated for the bronchodilator efficacy of PROVENTIL HFA Inhalation Aerosol (193 patients) in comparison to a CFC 11/12 propelled albuterol inhaler (186 patients) and an HFA-134a placebo inhaler (186 patients).

Serial FEV1 measurements (shown below as percent change from test-day baseline) demonstrated that two inhalations of PROVENTIL HFA Inhalation Aerosol produced significantly greater improvement in pulmonary function than placebo and produced outcomes which were clinically comparable to a CFC 11/12 propelled albuterol inhaler.

The mean time to onset of a 15% increase in FEV1 was 6 minutes and the mean time to peak effect was 50 to 55 minutes. The mean duration of effect as measured by a 15% increase in FEV1 was 3 hours. In some patients, duration of effect was as long as 6 hours. In another clinical study in adults, two inhalations of PROVENTIL HFA Inhalation Aerosol taken 30 minutes before exercise prevented exercise-induced bronchospasm as demonstrated by the maintenance of FEV1 within 80% of baseline values in the majority of patients.

In a 4-week, randomized, open-label trial, 63 children, 4 to 11 years of age, with asthma were evaluated for the bronchodilator efficacy of PROVENTIL HFA Inhalation Aerosol (33 pediatric patients) in comparison to a CFC 11/12 propelled albuterol inhaler (30 pediatric patients).

Serial FEV1 measurements as percent change from test-day baseline demonstrated that two inhalations of PROVENTIL HFA Inhalation Aerosol produced outcomes which were clinically comparable to a CFC 11/12 propelled albuterol inhaler. The mean time to onset of a 12% increase in FEV1 for PROVENTIL HFA Inhalation Aerosol was 7 minutes and the mean time to peak effect was approximately 50 minutes. The mean duration of effect as measured by a 12% increase in FEV1 was 2.3 hours. In some pediatric patients, duration of effect was as long as 6 hours.

In another clinical study in pediatric patients, two inhalations of PROVENTIL HFA Inhalation Aerosol taken 30 minutes before exercise provided comparable protection against exercise-induced bronchospasm as a CFC 11/12 propelled albuterol inhaler.


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

Patient Information

PROVENTIL®HFA
(albuterol sulfate) Inhalation Aerosol

FOR ORAL INHALATION ONLY

Patient's Instructions for Use

PROVENTIL HFA Inhaler - Illustration
PROVENTIL HFA Inhaler - Illustration

Before using your PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol, read complete instructions carefully. Children should use PROVENTIL HFA Inhalation Aerosol under adult supervision, as instructed by the patient's doctor Please note that indicates that this inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

  1. SHAKE THE INHALER WELL immediately before each use. Then remove the cap from the mouthpiece (see Figure 1). Check mouthpiece for foreign objects prior to use. Make sure the canister is fully inserted into the actuator.
  2. As with all aerosol medications, it is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing four “test sprays” into the air, away from your face.
  3. BREATHE OUT FULLY THROUGH THE MOUTH, expelling as much air from your lungs as possible. Place the mouthpiece fully into the mouth, holding the inhaler in its upright position (see Figure 2) and closing the lips around it.
  4. WHILE BREATHING IN DEEPLY AND SLOWLY THROUGH THE MOUTH, FULLY DEPRESS THE TOP OF THE METAL CANISTER with your index finger (see Figure 2).
  5. HOLD YOUR BREATH AS LONG AS POSSIBLE, up to 10 seconds. Before breathing out, remove the inhaler from your mouth and release your finger from the canister.
  6. If your physician has prescribed additional puffs, wait 1 minute, shake the inhaler again, and repeat steps 3 through 5. Replace the cap after use.
  7. KEEPING THE PLASTIC MOUTHPIECE CLEAN IS EXTREMELY IMPORTANT TO PREVENT MEDICATION BUILDUP AND BLOCKAGE. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR DRIED THOROUGHLY AT LEAST ONCE A WEEK. INHALER MAY STOP SPRAYING IF NOT PROPERLY CLEANED.

Routine cleaning instructions:

Step 1. To clean, remove the canister and mouthpiece cap. Wash the mouthpiece through the top and bottom with warm running water for 30 seconds at least once a week (see Figure A). Never immerse the metal canister in water.

Figure A

Wash mouthpiece under warm running water - Illustration

Wash mouthpiece under warm running water.

Figure B

Allow mouthpiece to air dry - Illustration

Allow mouthpiece to air dry, such as overnight.

Figure C

When blocked, little or no medicine comes out - Illustration

When blocked, little or no medicine comes out.

Step 2. To dry, shake off excess water and let the mouthpiece air dry thoroughly, such as overnight (see Figure B). When the mouthpiece is dry, replace the canister and the mouthpiece cap. Blockage from medication buildup is more likely to occur if the mouthpiece is not allowed to air dry thoroughly.

IF YOUR INHALER HAS BECOME BLOCKED (little or no medication coming out of the mouthpiece, see Figure C), wash the mouthpiece as described in Step 1 and air dry thoroughly as described in Step 2.

IF YOU NEED TO USE YOUR INHALER BEFORE IT IS COMPLETELY DRY, SHAKE OFF EXCESS WATER, replace the canister, and test spray twice into the air, away from your face, to remove most of the water remaining in the mouthpiece. Then take your dose as prescribed. After such use, rewash and air dry thoroughly as described in Steps 1 and 2.

8. The correct amount of medication in each inhalation cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. Before you reach the specific number of actuations, you should consult your physician to determine whether a refill is needed. Just as you should not take extra doses without consulting your physician, you also should not stop using PROVENTIL HFA Inhalation Aerosol without consulting your physician.

You may notice a slightly different taste or spray force than you are used to with PROVENTIL HFA Inhalation Aerosol, compared to other albuterol inhalation aerosol products.

DOSAGE:

Use only as directed by your physician.

WARNINGS:

The action of PROVENTIL® HFA Inhalation Aerosol should last up to 4 to 6 hours. PROVENTIL HFA Inhalation Aerosol should not be used more frequently than recommended. Do not increase the number of puffs or frequency of doses of PROVENTIL HFA Inhalation Aerosol without consulting your physician. If you find that treatment with PROVENTIL HFA Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, medical attention should be sought immediately. While you are taking PROVENTIL HFA Inhalation Aerosol, other inhaled drugs should be taken only as directed by your physician. If you are pregnant or nursing, contact your physician about the use of PROVENTIL HFA Inhalation Aerosol.

Common adverse effects of treatment with PROVENTIL HFA Inhalation Aerosol include palpitations, chest pain, rapid heart rate, tremor, or nervousness. Effective and safe use of PROVENTIL HFA Inhalation Aerosol includes an understanding of the way that it should be administered. Use PROVENTIL HFA Inhalation Aerosol only with the yellow actuator supplied with the product. The PROVENTIL HFA Inhalation Aerosol actuator should not be used with other aerosol medications.

For best results, use at room temperature. Avoid exposing product to extreme heat and cold.

Shake well before use.

Contents Under Pressure.

Do not puncture. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Store between 15° -25°C (59° -77°F). Avoid spraying in eyes. Keep out of reach of children.

Further Information: Your PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant. Instead, the inhaler contains a hydrofluoroalkane (HFA-134a) as the propellant.


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

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ALBUTEROL (SALBUTAMOL) HFA INHALER - ORAL

 

(al-BUE-ter-ol/sal-BUE-ta-mol)

 

COMMON BRAND NAME(S): Proventil HFA, ProAir HFA, Ventolin HFA

 

USES: Albuterol (also known as salbutamol) is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). It is also used to prevent asthma brought on by exercise. 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. Follow the illustrated directions for the proper use of this medication and proper cleaning of the mouthpiece. If you have any questions, consult your doctor or pharmacist.

Shake the canister well before using. Follow the instructions for test sprays in the air if you are using a canister for the first time or if you have not used it for 2 weeks or more, or if the inhaler has been dropped. A fine mist is a sign that the inhaler is working properly. Avoid spraying the medication in your eyes.

Inhale this medication by mouth as directed by your doctor, usually every 4 to 6 hours as needed. Dosage is based on your medical condition and response to treatment. Do not increase your dose or use it more frequently than prescribed without your doctor's approval.

If you are using this medication to prevent asthma brought on by exercise, inhale as directed by your doctor, usually 2 puffs 15 to 30 minutes before exercise.

It is recommended that you use a spacer device with this medication. Ask your doctor or pharmacist for more information.

If two inhalations are prescribed, wait at least 1 minute between them.

If you are using other inhalers at the same time, wait several minutes between the use of each medication and use the corticosteroid last.

Always have your quick-relief inhaler with you. Keep track of the number of inhalations you use, and discard the inhaler after you have used the labeled number of inhalations on the product package. Also count test sprays used to prime the inhaler.

Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens. Ask your doctor what to do if you have worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, increased use of your quick-relief inhaler, or if your quick-relief inhaler does not seem to be working well. Learn when you can self-medicate and when you should get medical help right away.

Consumer Overview Side Effect

SIDE EFFECTS: Nervousness, shaking (tremor), headache, mouth/throat dryness or irritation, cough, nausea or dizziness 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 right away if you have any serious side effects, including: fast/pounding heartbeat.

Get medical help right away if you have any rare but very serious side effects, including: chest pain, irregular heartbeat, rapid breathing, confusion.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Proventil HFA (albuterol inhalation) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (such as metaproterenol, terbutaline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as irregular heartbeat, angina, heart attack), high blood pressure, seizure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center 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 (such as a lung/breathing test, blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Avoid allergens/irritants such as smoke, pollen, pet dander, dust, or molds that may worsen breathing problems.

Learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).

Ask your doctor or pharmacist whether you should have an annual flu shot.

 

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 away from light and moisture. Do not store in the bathroom. It is best to store the inhaler with the mouthpiece down. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist.

Do not puncture the canister or expose it to high heat or open flame. Keep all medications away from children and pets.

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 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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 (Proventil HFA)?
  • 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 (Proventil HFA)?

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 Proventil HFA (albuterol inhalation) 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.

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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.

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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.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.01. Revision date: 7/12/2012.

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