VENTOLIN

GlaxoSmithKline LLC

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA.VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol Initial U.S. Approval: 1981INDICATIONS AND USAGEVENTOLIN HFA is a beta2-adrenergic agonist indicated for: •Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1) •Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2) DOSAGE AND ADMINISTRATIONFOR ORAL INHALATION ONLY. •Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient. (2.1) •Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise. (2.2) •Priming information: Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. (2.3) •Cleaning information: At least once a week, wash the actuator with warm water and let it air-dry completely. (2.3) DOSAGE FORMS AND STRENGTHSInhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base) from mouthpiece per actuation. Supplied in 18-g canister containing 200 actuations and 8-g canister containing 60 actuations. (3) CONTRAINDICATIONSHypersensitivity to albuterol sulfate or any of the ingredients of VENTOLIN HFA. (4) WARNINGS AND PRECAUTIONS •Paradoxical bronchospasm may occur and should be treated immediately with alternative therapy. (5.1) •Need for more doses of VENTOLIN HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. (5.2) •Cardiovascular effects may occur with beta-adrenergic agonists use. Consider discontinuation of VENTOLIN HFA if these effects occur. Use with caution in patients with underlying cardiovascular disorders. (5.4) •Immediate hypersensitivity reactions may occur. Discontinue VENTOLIN HFA if immediate hypersensitivity reactions occur. (5.6) Side EffectsMost common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS •Beta-blockers: May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. (7.1) •Diuretics: Electrocardiographic changes and/or hypokalemia associated with diuretics may worsen with concomitant beta-agonists. Consider monitoring potassium levels. (7.2) •Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the vascular system. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. (7.4)

FULL PRESCRIBING INFORMATION: CONTENTS*

• 1 VENTOLIN INDICATIONS AND USAGE
  • 1.1 Bronchospasm
  • 1.2 Exercise-Induced Bronchospasm
• 2 VENTOLIN DOSAGE AND ADMINISTRATION
  • 2.1 Bronchospasm
  • 2.2 Exercise-Induced Bronchospasm
  • 2.3 Administration Information
• 3 DOSAGE FORMS AND STRENGTHS
• 4 VENTOLIN CONTRAINDICATIONS
• 5 WARNINGS AND PRECAUTIONS
  • 5.1 Paradoxical Bronchospasm
  • 5.2 Deterioration of Asthma
  • 5.3 Use of Anti-Inflammatory Agents
  • 5.4 Cardiovascular Effects
  • 5.5 Do Not Exceed Recommended Dose
  • 5.6 Immediate Hypersensitivity Reactions
  • 5.7 Coexisting Conditions
  • 5.8 Hypokalemia
• 6 VENTOLIN ADVERSE REACTIONS
  • 6.1 Clinical Trials Experience
  • 6.2 Postmarketing Experience
• 7 DRUG INTERACTIONS
  • 7.1 Beta-Blockers
  • 7.2 Diuretics
  • 7.3 Digoxin
  • 7.4 Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
• 8 USE IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy
  • 8.2 Labor and Delivery
  • 8.3 Nursing Mothers
  • 8.4 Pediatric Use
  • 8.5 Geriatric Use
• 10 OVERDOSAGE
• 11 VENTOLIN DESCRIPTION
• 12 CLINICAL PHARMACOLOGY
  • 12.1 Mechanism of Action
  • 12.2 Pharmacokinetics
• 13 NONCLINICAL TOXICOLOGY
  • 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
  • 13.2 Animal Toxicology and/or Pharmacology
• 14 CLINICAL STUDIES
  • 14.1 Bronchospasm Associated With Asthma
  • 14.2 Exercise-Induced Bronchospasm
• 16 HOW SUPPLIED/STORAGE AND HANDLING
• 17 PATIENT COUNSELING INFORMATION
  • 17.1 Frequency of Use
  • 17.2 Priming and Cleaning
  • 17.3 Dose Counter
  • 17.4 Paradoxical Bronchospasm
  • 17.5 Concomitant Drug Use
  • 17.6 Common Adverse Effects
  • 17.7 Pregnancy

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Bronchospasm

VENTOLIN^® HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

1.2 Exercise-Induced Bronchospasm

VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

2 DOSAGE AND ADMINISTRATION

Administer VENTOLIN HFA by oral inhalation only. Shake VENTOLIN HFA well before each spray.

2.1 Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children is 2 inhalations repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not recommended.

2.2 Exercise-Induced Bronchospasm

The usual dosage for adults and children 4 years of age and older is 2 inhalations 15 to 30 minutes before exercise.

2.3 Administration Information

Priming: Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray.

Cleaning: To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.

Dose Counter: VENTOLIN HFA has a dose counter attached to the canister that starts at 204 or 64 and counts down each time a spray is released [see Dosage Forms and Strengths (3)]. When the counter reads 020, the patient should contact the pharmacist for a refill of medication or consult the physician to determine whether a prescription refill is needed.

VENTOLIN HFA comes in a moisture-protective foil pouch, which should be removed prior to use. Discard VENTOLIN HFA when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first [see Dosage Forms and Strengths (3)].

See Patient Information tear-off leaflet for instructions on how to prime and clean the inhaler to ensure proper dosing and to prevent actuator orifice blockage.

3 DOSAGE FORMS AND STRENGTHS

VENTOLIN HFA is an inhalation aerosol. Each actuation contains 108 mcg albuterol sulfate (90 mcg albuterol base) from the mouthpiece. VENTOLIN HFA is supplied as an 18-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 200 actuations. VENTOLIN HFA is also supplied as an 8-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 60 actuations.

4 CONTRAINDICATIONS

VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of VENTOLIN HFA. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate.

5 WARNINGS AND PRECAUTIONS

5.1 Paradoxical Bronchospasm

Inhaled albuterol sulfate can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, VENTOLIN HFA 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.

5.2 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 VENTOLIN HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3 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, e.g., corticosteroids, to the therapeutic regimen.

5.4 Cardiovascular Effects

VENTOLIN HFA, like all other beta₂-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, VENTOLIN HFA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical relevance of these findings is unknown. Therefore, VENTOLIN HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.5 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.

5.6 Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of albuterol sulfate inhalation aerosol, as demonstrated by cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Discontinue VENTOLIN HFA if immediate hypersensitivity reactions occur.

5.7 Coexisting Conditions

VENTOLIN HFA, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8 Hypokalemia

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.

6 ADVERSE REACTIONS

Use of VENTOLIN HFA may be associated with the following:

• •Paradoxical bronchospasm [see Warnings and Precautions (5.1)]
• •Cardiovascular effects [see Warnings and Precautions (5.4)]
• •Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)]
• •Hypokalemia [see Warnings and Precautions (5.8)]

6.1 Clinical Trials Experience

The safety data described below reflects exposure to VENTOLIN HFA in 248 patients treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents is based upon 2 clinical trials in which 202 patients with asthma 12 years of age and older were treated with VENTOLIN HFA 2 inhalations 4 times daily for 12 weeks’ duration. The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other. The data from pediatric patients are based upon 1 clinical trial in which 46 patients with asthma 4 to 11 years of age were treated with VENTOLIN HFA 2 inhalations 4 times daily for 2 weeks’ duration. The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 Years of Age and Older: The two 12-week, randomized, double-blind studies in 610 adolescent and adult patients with asthma that compared VENTOLIN HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. Overall, the incidence and nature of the adverse reactions reported for VENTOLIN HFA and a CFC 11/12-propelled albuterol inhaler were comparable. Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these studies that occurred at a rate of 3% or greater in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group.

Adverse reactions reported by less than 3% of the adolescent and adult patients receiving VENTOLIN HFA and by a greater proportion of patients receiving VENTOLIN HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to VENTOLIN HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitation and dizziness have also been observed with VENTOLIN HFA.

Pediatric Patients: Results from the 2-week pediatric clinical study in patients with asthma 4 to 11 years of age showed that this pediatric population had an adverse reaction profile similar to that of the adolescent and adult populations.

Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in patients between birth and 4 years of age. The results of these studies did not establish the efficacy of VENTOLIN HFA in this age-group [see Pediatric Use (8.4)]. Since the efficacy of VENTOLIN HFA has not been demonstrated in children between birth and 48 months of age, the safety of VENTOLIN HFA in this age-group cannot be established. However, the safety profile observed in the pediatric population under 4 years of age was comparable to that observed in the older pediatric patients and in adolescents and adults. Where adverse reaction incidence rates were greater in patients under 4 years of age compared with older patients, the higher incidence rates were noted in all treatment arms, including placebo. These adverse reactions included upper respiratory tract infection, nasopharyngitis, pyrexia, and tachycardia.

6.2 Postmarketing Experience

In addition to the adverse reactions listed in section 6.1, the following adverse reactions have been identified during postapproval use of VENTOLIN HFA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cases of paradoxical bronchospasm, hoarseness, arrhythmias (including atrial fibrillation, supraventricular tachycardia), and hypersensitivity reactions (including urticaria, angioedema, rash) have been reported after the use of VENTOLIN HFA.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertension, peripheral vasodilatation, angina, tremor, central nervous system stimulation, hyperactivity, sleeplessness, headache, muscle cramps, drying or irritation of the oropharynx, and metabolic acidosis.

7 DRUG INTERACTIONS

Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

7.1 Beta-Blockers

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as VENTOLIN HFA, but may produce severe bronchospasm in patients with asthma. 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.

7.2 Diuretics

The ECG changes and/or hypokalemia that 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 relevance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics. Consider monitoring potassium levels.

7.3 Digoxin

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 relevance of these findings for patients with obstructive airway disease who are receiving inhaled 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.

7.4 Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

VENTOLIN HFA 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 vascular system may be potentiated. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C.

There are no adequate and well-controlled studies of VENTOLIN HFA or albuterol sulfate in pregnant women. 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. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity. VENTOLIN HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at exposures approximately equal to the maximum recommended human dose (MRHD) for adults on a mg/m² basis and in 10 of 108 (9.3%) fetuses at approximately 8 times the MRHD. Similar effects were not observed at approximately one eleventh of the MRHD. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control).

In a rabbit reproduction study, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 680 times the MRHD.

In another rabbit study, an albuterol sulfate/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHD [see Animal Toxicology and/or Pharmacology (13.2)].

8.2 Labor and Delivery

Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

8.3 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 VENTOLIN HFA are excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of VENTOLIN HFA 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 VENTOLIN HFA is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of VENTOLIN HFA in children 4 years of age and older has been established based upon two 12-week clinical trials in patients 12 years of age and older with asthma and one 2-week clinical trial in patients 4 to 11 years of age with asthma [see Clinical Studies (14.1), Adverse Reactions (6.1)]. The safety and effectiveness of VENTOLIN HFA in children under 4 years of age has not been established. Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in patients under 4 years of age and the findings are described below.

Two 4-week randomized, double-blind, placebo-controlled studies were conducted in 163 pediatric patients from birth to 48 months of age with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). VENTOLIN HFA or placebo HFA was delivered with either an AeroChamber Plus^® Valved Holding Chamber or an Optichamber^® Valved Holding Chamber with mask 3 times daily. In one study, VENTOLIN HFA 90 mcg (N = 26), VENTOLIN HFA 180 mcg (N = 25), and placebo HFA (N = 26) were administered to children between 24 and 48 months of age. In the second study, VENTOLIN HFA 90 mcg (N = 29), VENTOLIN HFA 180 mcg (N = 29), and placebo HFA (N = 28) were administered to children between birth and 24 months of age. Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving VENTOLIN HFA 90 mcg, VENTOLIN HFA 180 mcg, and placebo in either study.

In a third study, VENTOLIN HFA was evaluated in 87 pediatric patients younger than 24 months of age for the treatment of acute wheezing. VENTOLIN HFA was delivered with an AeroChamber Plus Valved Holding Chamber in this study. There were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between VENTOLIN HFA 180 mcg and VENTOLIN HFA 360 mcg.

In vitro dose characterization studies were performed to evaluate the delivery of VENTOLIN HFA via holding chambers with facemasks. The studies were conducted with 2 different holding chambers with facemasks (small and medium size). The in vitro study data when simulated to patients suggest that the dose of VENTOLIN HFA presented for inhalation via a valved holding chamber with facemask will be comparable to the dose delivered in adults without a spacer and facemask per kilogram of body weight (Table 2). However, clinical studies in children under 4 years of age described above suggest that either the optimal dose of VENTOLIN HFA has not been defined in this age-group or VENTOLIN HFA is not effective in this age-group. The safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children under 4 years of age has not been demonstrated.

8.5 Geriatric Use

Clinical studies of VENTOLIN HFA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

10 OVERDOSAGE

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/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, sleeplessness. Hypokalemia and metabolic acidosis may also occur.

As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of VENTOLIN HFA. Treatment consists of discontinuation of VENTOLIN HFA 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 VENTOLIN HFA.

The oral median lethal dose of albuterol sulfate in mice is greater than 2,000 mg/kg (approximately 6,800 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 3,200 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 3,000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 1,400 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 6,400 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.

11 DESCRIPTION

The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta₂-adrenergic bronchodilator. Albuterol sulfate has the chemical name α¹-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure: