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-tetrafluoroethaneethanol, 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. PROVENTIL HFA Inhalation Aerosol is indicated in adults and children 4 years of age albuterol mcg older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise -induced bronchospasm.
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, albuterol mcg.
In some patients, one inhalation every 4 hours may be sufficient. 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 albuterol mcg window changes to red at 20 actuations or lower.
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, albuterol mcg. Keeping the plastic mouthpiece clean is very important albuterol mcg 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 albuterol mcg 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. 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. For best results, canister should be at room temperature before use. The correct amount of medication albuterol mcg each canister cannot be assured after actuations and when the dose indicator 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. Avoid spraying in eyes. Do not puncture or incinerate. Keep out of reach of children, albuterol mcg. Developed and Manufactured by: Albuterol mcg small, cumulative dose studies, tremornervousness, and headache appeared to be dose related.
Rare cases of urticariaangioedemarashbronchospasm, 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 hypertensionanginavertigocentral nervous system stimulation, insomniaheadachemetabolic acidosis, and drying or irritation of the oropharynx.
Therefore, albuterol mcg, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.
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, albuterol mcg.
PROVENTIL HFA Inhalation Aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressantsor within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.
Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
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 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, e. 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. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and allergy products austin air purifier electrolux segment depression.
The clinical significance of these findings is unknown. 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 may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticariaangioedemarashbronchospasm, anaphylaxisalbuterol mcg, and oropharyngeal edema.
Albuterol sulfate, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac albuterol mcg, and hypertension ; in patients with convulsive disorders, hyperthyroidismor diabetes mellitus ; and albuterol mcg patients who are unusually responsive to sympathomimetic amines.
Clinically significant changes in systolic and diastolic blood pressure have been seen in individual albuterol mcg and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator, albuterol mcg. 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, albuterol mcg. 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 albuterol mcg 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 mouthpiecethe blockage may be removed by washing as described above. If it is necessary to use the inhaler before it is completely dry, albuterol mcg, shake off excess water, replace canister, test spray twice away from face, and take the prescribed dose. After such use, albuterol mcg, the mouthpiece should be rewashed and allowed to air dry thoroughly.
Common adverse effects of treatment with inhaled albuterol include palpitationschest painrapid heart rate, tremoror nervousness. Discard the canister after sprays have been used. In another study this effect was blocked by the coadministration of propranolola nonselective beta-adrenergic antagonist.
Albuterol sulfate was not mutagenic in albuterol mcg Ames test or a mutation test in yeast, albuterol mcg. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay.
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 adult allergy clinical immunology winnipeg 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.
During worldwide marketing experience, various congenital anomalies, albuterol mcg, including cleft palate and limb defects, albuterol mcg, 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, albuterol mcg, a relationship between albuterol use and congenital anomalies has not been established, albuterol mcg.
Albuterol has not been approved for the albuterol mcg of preterm labor, albuterol mcg. Serious adverse reactions, including pulmonary edemahave been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. 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 albuterol mcg nursing or to discontinue the drug, taking into account the importance albuterol mcg the drug to the mother.
Caution should be exercised when albuterol sulfate is administered albuterol mcg a nursing woman. Hypokalemia may also occur.
The judicious use of a cardioselective albuterol mcg blocker may be considered, bearing in mind that such ok to swim after ascorbic acid can produce bronchospasm.
The inhalation albuterol mcg lethal dose has not been determined in animals. 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. 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 albuterol mcg 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 glandsalbuterol concentrations were found to be times those in the whole brain, albuterol mcg. Studies in laboratory albuterol mcg minipigs, albuterol mcg, 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.
Propellant HFAa is devoid of pharmacological activity except at very high doses in animals times the maximum human exposure based on comparisons of AUC valuesprimarily producing ataxiatremors birmingham airport and developement plans, dyspnea, or salivation, albuterol mcg.
These are similar to effects produced by the structurally related chlorofluorocarbons CFCswhich have been used extensively in metered dose inhalers. In animals and humans, propellant HFAa was found to be rapidly absorbed aleve toprol 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, albuterol mcg, but systemic albuterol levels appeared similar, albuterol mcg. In some patients, duration of effect was as long as 6 albuterol mcg. In some pediatric patients, duration of effect was as long as 6 hours.