istration 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. 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/m 2 basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m 2 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/m 2 basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m 2 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/m 2 basis and approximately 110 times the maximum recommended daily inhalation dose for children on a mg/m 2 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/m 2 basis). pregnancy teratogenic effects pregnancy 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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 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 inhalation aerosol for relief of bronchospasm 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 or following treatment of premature labor with beta 2 -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 inhalation aerosol 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 proventil hfa 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 inhalation aerosol in pediatric patients below the age of 4 years have not been established. geriatrics proventil hfa inhalation aerosol has not been studied in a geriatric population. as with other beta 2 -agonists, special caution should be observed when using proventil hfa inhalation aerosol in elderly patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug.

nsideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen. cardiovascular effects: proventil hfa inhalation aerosol, like other beta-adrenergic agonists, 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 inhalation aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 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. 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.

sable inhalations, the background behind the number in the dose indicator display window changes to red at 20 actuations or lower. proventil hfa inhalation aerosol should be discarded when the dose indicator display window shows zero. 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 precautions, information for patients section). 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.

elated to drug) which occurred at an incidence rate of at least 3% 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. 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 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. to report suspected adverse reactions, contact sandoz inc., at 1-800-525-8747 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

istration 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. 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/m 2 basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m 2 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/m 2 basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m 2 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/m 2 basis and approximately 110 times the maximum recommended daily inhalation dose for children on a mg/m 2 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/m 2 basis). pregnancy teratogenic effects pregnancy 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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 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 inhalation aerosol for relief of bronchospasm 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 or following treatment of premature labor with beta 2 -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 inhalation aerosol 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 proventil hfa 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 inhalation aerosol in pediatric patients below the age of 4 years have not been established. geriatrics proventil hfa inhalation aerosol has not been studied in a geriatric population. as with other beta 2 -agonists, special caution should be observed when using proventil hfa inhalation aerosol in elderly patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug.

ults on a mg/m 2 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/m 2 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 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.

sulting 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 beta 2 -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 fev 1 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 fev 1 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 fev 1 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 fev 1 within 80% of baselie 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 fev 1 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 fev 1 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 fev 1 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. figure

ity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 110 times the maximum recommended daily inhalation dose for children on a mg/m 2 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/m 2 basis).

ntil hfa inhalation aerosol taken 30 minutes before exercise prevented exercise-induced bronchospasm as demonstrated by the maintenance of fev 1 within 80% of baselie 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 fev 1 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 fev 1 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 fev 1 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. figure

cator display window shows zero, 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. distributed by: sandoz inc.princeton, nj 08540 copyright © 1996, 2011, 2012, 2017, 2018, 2020 all rights reserved. proventil® is a registered trademark of organon & co., licensed for use by kindeva drug delivery l.p.. all other trademarks depicted in this piece are owned by kindeva drug delivery l.p. and sandoz inc. respectively. rev. 12/2020 34-8726-3834-0

ry 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 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 dose 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 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 inhalation aerosol. 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 actuator supplied with the product. discard the canister after 200 sprays have been used. in general, the technique for administering proventil hfa inhalation aerosol to children is similar to that for adults. children should use proventil hfa inhalation aerosol under adult supervision, as instructed by the patient's physician. ( see patient's instructions for use .)