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Proventil HFA - FDA prescribing information, side effects and uses
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 Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. It contains a microcrystalline suspension of albuterol sulfate in propellant HFAa 1,1,1,2-tetrafluoroethane , ethanol, and oleic acid.
Each actuation delivers mcg albuterol sulfate, USP from the valve and mcg albuterol sulfate, USP from the mouthpiece equivalent to 90 mcg of albuterol base from the mouthpiece. Each canister provides inhalations. Mechanism of Action In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. The precise function of these receptors has not been established.
Activation of beta 2 -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.
In structures outside the blood-brain barrier pineal and pituitary glands , albuterol concentrations were found to be 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 HFAa is devoid of pharmacological activity except at very high doses in animals 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 HFAa 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 HFAa in the blood with no evidence of accumulation. No formal pharmacokinetic analyses were possible for either treatment, but systemic albuterol levels appeared similar.
In some patients, duration of effect was as long as 6 hours. In some pediatric patients, duration of effect was as long as 6 hours. 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.
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. 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.
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. Patients should be given the following information:. 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 buildup 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. 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.
Effective and safe use of Proventil HFA Inhalation Aerosol includes an understanding of the way that it should be administered. Discard the canister after 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. In another study this effect was blocked by the coadministration of propranolol, a nonselective beta-adrenergic antagonist.
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. 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 4. The drug did not induce cleft palate formation at a dose of 0. Cleft palate also occurred in 22 of 72 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. 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.
Albuterol has not been approved for the management of preterm labor. Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. Plasma levels of albuterol sulfate and HFAa 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. The safety and effectiveness of Proventil HFA Inhalation Aerosol in pediatric patients below the age of 4 years have not been established. 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.
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. 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 inhalation median lethal dose has not been determined in animals.
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 mcg of albuterol sulfate equivalent to 90 mcg of albuterol base from the mouthpiece.
The canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable 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. 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.
Proventil HFA albuterol sulfate Inhalation Aerosol is supplied as a pressurized aluminum canister, with an attached dose indicator, a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers mcg of albuterol sulfate from the valve and mcg of albuterol sulfate from the mouthpiece equivalent to 90 mcg of albuterol base. Canisters with a labeled net weight of 6. Store the inhaler with the mouthpiece down.