Albuterol Sulfate

Name: Albuterol Sulfate

Patient information

PROVENTIL® HFA
(albuterol sulfate) Inhalation Aerosol

FOR ORAL INHALATION ONLY

Patient's Instructions for Use

Figure 1

Figure 2

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 thatindicates 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.

Figure B

Allow mouthpiece to air dry, such as overnight.

Figure C

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.

Introduction

Bronchodilator; relatively selective, short-acting β2-adrenergic agonist.j

Cautions for Albuterol Sulfate

Contraindications

  • Known hypersensitivity to albuterol or any ingredients in the formulations.j

  • Known history of hypersensitivity to soya lecithin or related food products such as soybeans or peanuts; atropine and its derivatives; or any other ingredient in the specific formulation (albuterol sulfate in fixed combination with ipratropium bromide).233 243

Warnings/Precautions

Warnings

Acute or Worsening Asthma

Oral inhalation therapy is intended for the acute symptomatic relief of bronchospasm.188 189 190 191 192 249 If control of mild asthma deteriorates such that regular (i.e., exceeding 4 times daily) use of a short-acting β2-agonist becomes necessary, institute maintenance therapy (e.g., inhaled corticosteroids)188 189 191 249 and discontinue regular use of short-acting β2-agonists in such patients; instead, use short-acting β2-agonists only as a supplement for relief of acute asthma symptoms.188 189 190 191 192 194 197 249 Contact a clinician for reevaluation if control of mild asthma deteriorates.114 154 192 193 196

Failure to respond to a previously effective dosage of albuterol may indicate seriously worsening asthma.156 157 181 188 189 190 191 192 193 194 196 197 237 241 242 243 244 249 Reevaluate asthma therapy and institute alternative regimens or therapy.156 157 181 188 189 190 191 192 193 194 196 197 237 241 242 243 244 249 Discontinue and contact a clinician if decreased effectiveness occurs; do not increase the dose or frequency of administration.241

Excessive Doses

Possible fatalities associated with excessive use of inhaled sympathomimetic drugs.114 139 153 237 241 243 255 258 145 154 212 262 208 146 181 233 The safety of concomitant use of >8 inhalations per day of a short-acting β2-adrenergic agonist with a long-acting β2-agonist (e.g., salmeterol) oral inhalation therapy has not been established.192 287 (See Sympathomimetic Agents under Interactions.)

Paradoxical Bronchospasm

Possible life-threatening, acute paradoxical bronchospasm.181 241 255 Frequently occurs with the first use of a new canister or vial (oral inhalation aerosol),181 241 255 but also may occur with orally administered conventional or extended-release tablets.271 280

Discontinue therapy immediately if bronchoconstriction occurs and institute alternative therapy.271 280

Cardiovascular Effects

Possible clinically important cardiovascular effects, including cardiac arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia, extrasystoles) , increased or decreased BP, and related symptoms.146 153 181

Cautious use recommended in patients with cardiovascular disorders (e.g., coronary insufficiency, cardiac arrhythmias), hypertension, and those with sensitivity to sympathomimetic amines.114 181 237 241 281 May require drug discontinuance.139 181

Sensitivity Reactions

Immediate hypersensitivity reactions (e.g., urticaria,139 146 153 181 angioedema,139 146 153 181 227 rash,100 139 146 153 181 bronchospasm,139 146 153 181 anaphylaxis,146 oropharyngeal edema)139 146 153 181 have been reported.139 153 181 Possible acute bronchospasm.181 185 186 (See Paradoxical Bronchospasm under Cautions.)

General Precautions

Nervous System Effects

Possible CNS stimulation and adverse nervous system effects.100 139 181

Cautious use recommended in patients with seizure disorders and in those with sensitivity to sympathomimetic amines.114 237

Metabolic Effects

Possible hypokalemia, which may increase risk of adverse cardiovascular effects.100 114 139 153 237 241 243 255 258 145 154 212 262 208 146 181 233 (See Cardiovascular Effects under Cautions.) Serum potassium decrease generally is transient and usually does not require supplementation.181 281

Diabetes mellitus or increased blood glucose in patients receiving orally inhaled or nebulized albuterol.112 181

Cautious use recommended in patients with diabetes mellitus or hyperthyroidism.181 237 241 281

GI Effects

Possible GI obstruction when extended-release tablets are used in patients with preexisting GI narrowing; cautious use recommended.154

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.237

Lactation

Not known whether albuterol is distributed into milk.114 154 Discontinue nursing or the drug.114 154

Pediatric Use

Safety and efficacy of orally inhaled albuterol sulfate inhalation aerosols (ProAir HFA, Proventil HFA, Ventolin HFA) not established in children <4 years of age.181 237 295 Safety and efficacy of orally inhaled racemic albuterol sulfate inhalation solution (Proventil) not established in children <12 years of age.241 244 Safety and efficacy of some albuterol inhalation solutions for nebulization (e.g., AccuNeb, albuterol sulfate 0.083%) not established in children <2 years of age.242 255 258 Safety and efficacy of albuterol sulfate in fixed combination with ipratropium bromide not established in pediatric patients233 243 <18 years of age.243

Safety and efficacy of albuterol conventional and extended-release tablets not established in children <6 years of age.100 139 154 Safety and efficacy of albuterol sulfate oral solutions not established in children younger <2 years of age.270 281

Geriatric Use

No overall differences in safety and efficacy observed between geriatric and younger patients for albuterol sulfate in fixed combination with ipratropium bromide inhalation solution.243

Special caution should be used in geriatric patients who have cardiovascular disease.181 (See Cautions: Cardiovascular Effects.) Cannot rule out possibility that some geriatric patients may exhibit increased sensitivity to the drug.243

Substantially eliminated by kidneys; assess renal function periodically since geriatric patients more likely to have decreased renal function.279 282 Risk of toxicity greater in patients with renal impairment, including geriatric patients.282

Common Adverse Effects

Albuterol sulfate: Tremor,100 139 146 153 181 208 asthma exacerbation, bronchospasm, nervousness, shakiness, otitis media, nausea, cough, bronchitis, headache, tachycardia/palpitations, muscle cramps, hypokinesia, insomnia, weakness, dizziness, excitement, hyperactivity, increased appetite, flu syndrome, lymphadenopathy, skin/appendage infection, urticaria.100 114 139 146 153 181 208 212 241 255 258 154 262 208

Albuterol sulfate in fixed combination with ipratropium bromide: Bronchitis, upper respiratory tract infection, lung disease, headache, dyspnea, pharyngitis, coughing, chest pain, pain, respiratory disorder, sinusitis, nausea, diarrhea, urinary tract infection, influenza, pneumonia, leg cramps, dyspepsia, constipation, voice alterations, bronchospasm.233 243

Albuterol Sulfate Pharmacokinetics

Absorption

Single-dose oral bioavailability of extended-release albuterol sulfate tablets is about 80% that of conventional tablets.271

Efficacy of orally inhaled drug appears to result from local action rather than systemic absorption.j Drug plasma concentrations do not predict therapeutic effect.j

Onset

Oral conventional tablets or solution: Within 30 minutes.100 208 262 281

Oral inhalation aerosol: Within 5–15 minutes.145 146 181 237

Oral nebulization solution: Within 5 minutes.114 153 212 241 258

Duration

Oral inhalation aerosol: 3–6 hours.145 146 181 237

Oral nebulization solution: 2–4 hours, occasionally ≥6 hours.114 153 212 237 255

Oral conventional tablets: Up to 8 hours.100

Oral extended-release tablets: Up to 12 hours.271

Oral solution: Up to 6 hours.281

Food

Reduces the rate of absorption of albuterol sulfate extended-release tablets.271

Distribution

Extent

Albuterol crosses the placenta.j Not known whether albuterol distributes into milk.100

Elimination

Metabolism

Extensively metabolized in the intestinal wall282 and liver to inactive metabolites.279

Elimination Route

Substantially eliminated by kidneys.279 282 Approximately 72% of a dose (oral inhalation) excreted in urine as unchanged drug and metabolites within 24 hours.145 About 76% of a single dose (oral administration) excreted in urine over 3 days; about 4% is excreted in feces.280 281

Half-life

Oral inhalation: 3.8–6 hours in healthy adults,145 282 j 1.7–7.1 hours in patients with asthma.j

Conventional tablets: 5–7.2 hours.271 280

Extended-release tablets: 9.3 hours.271

Oral solution: 5 hours in healthy individuals.270 281

Stability

Storage

Oral

Extended-release tablets: 20–25°C; protect from light.271

Conventional tablets: 20–25°C; protect from light.280

Oral solution: 2–30°C or 20–25°C, depending on manufacturer; protect from light.270 281

Oral Inhalation

Albuterol sulfate inhalation aerosol: 15–25°C (ProAir HFA, Proventil HFA, Ventolin HFA).181 237 282 Failure to use inhalers within these respective temperature ranges could result in delivery of improper doses.145

Albuterol sulfate in fixed combination with ipratropium bromide inhalation aerosol: 25°C (may be exposed to 15–30°C); protect from excessive humidity.233

Albuterol sulfate oral inhalation solution: 2–25°C or 15–30°C depending on manufacturer.114 241 242 244 272 Discard albuterol sulfate oral inhalation concentrate solution if the solution changes color or becomes cloudy.244 Discard albuterol sulfate solution for nebulization (in single-use units) if it becomes discolored.242 255

Albuterol sulfate in fixed combination with ipratropium bromide oral inhalation solution: 2–25°C.243

Advice to Patients

  • Importance of providing patient with a copy of the manufacturer’s patient information.153

  • Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the nebulization delivery system.146 153 181

  • Importance of adherence to dosing schedules of albuterol and concomitant therapy, including not exceeding the recommended dose or frequency of use unless otherwise instructed by a clinician.145 237 241 255 282

  • Importance of administering albuterol at least 15–30 minutes prior to exercise for prevention of exercise-induced bronchospasm.237 145 146 181

  • If decreased effectiveness occurs, discontinue albuterol and contact a clinician; do not increase the dose or frequency of administration.114 154 227

  • Advise that the outer coating of albuterol extended-release tablets may be excreted in feces where it may be noticeable.154

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.237 270

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.100 114 153

  • Importance of informing patients of other important precautionary information. (See Cautions.)

What is albuterol inhalation (accuneb, proair hfa, proventil, proventil hfa, relion ventolin hfa, ventolin 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.

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.

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