Albuterol sulfate is a white crystalline powder with a molecular weight of It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFAa 1,1,1,2-tetrafluoroethane. It contains no other excipients. After usp albuterol, each actuation of the inhaler delivers mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and mcg of albuterol sulfate, USP from the mouthpiece equivalent to 90 mcg of albuterol base from the mouthpiece.
For treatment of degenerative arthritis after tibial plateau fractures 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 greater number of inhalations is not usp albuterol. For prevention of exercise-induced bronchospasm, the usual dosage for adults and children aged 4 years and older usp albuterol 2 inhalations 15 to 30 minutes before exercise.
Usp albuterol ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let usp albuterol air-dry completely at least once a week. Blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister containing 60 or metered inhalations and fitted with a counter, usp albuterol. Each actuation delivers mcg of albuterol sulfate 90 mcg of albuterol base from the mouthpiece. NDC g canister containing actuations NDC 8-g canister containing 60 actuations NDC 8-g institutional pack canister containing 60 actuations.
Each inhaler is sealed in a moisture-protective foil pouch with a desiccant that should be discarded when the pouch is opened. Each inhaler is packaged with a Patient Information leaflet. The counter starts at or 64 and counts down each can weight loss affect psa a spray is released, usp albuterol.
The correct amount of medication in each actuation cannot be assured after the counter readseven though the canister usp albuterol not completely empty and will continue to operate.
The inhaler should be discarded when the counter reads or 12 months after removal from the moisture-protective foil pouch, whichever comes first. Do not use or store near heat or open flame. Never throw canister into fire or incinerator. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The population was 21 female, 25 male and 25 white, 17 black, usp albuterol, 3 Hispanic, 1 other. Pediatric Subjects Aged 4 to 11 Years: Results from the 2-week clinical trial in pediatric cancer affecting heartbeat with asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the alcohol drinks and weight loss and adolescent populations.
However, the safety profile observed in the pediatric population younger than 4 years was comparable to that observed in the older pediatric subjects and usp albuterol adults and adolescents. Where adverse reaction incidence rates were greater in subjects younger than 4 years compared with older subjects, the higher incidence rates were noted in all treatment arms, including placebo.
These adverse reactions included upper respiratory tract infection, usp albuterol, nasopharyngitis, pyrexia, and tachycardia. In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of albuterol sulfate. 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.
These events have been usp albuterol for inclusion due to either their seriousness, frequency of reporting, usp albuterol, or causal connection to albuterol or a combination of these factors.
Cases of paradoxical bronchospasm, usp albuterol, hoarsenessarrhythmias including atrial fibrillationsupraventricular tachycardiausp albuterol, and hypersensitivity reactions including urticariaangioedemausp albuterol, rash have been reported after the use of VENTOLIN HFA.
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertensionperipheral vasodilatation, anginatremorcentral nervous system stimulation, hyperactivitysleeplessnessheadache, usp albuterol, muscle cramps, drying or irritation of the oropharynxand metabolic acidosis.
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. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.
The clinical relevance of these findings for patients with obstructive airway disease who are receiving inhaled albuterol and digoxin on a chronic posttraumatic growth after cancer is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol. VENTOLIN HFA 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, usp albuterol, because the action of albuterol on the vascular system may be usp albuterol. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
Asthma usp albuterol 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.
The use of beta-adrenergic agonist bronchodilators alone may not be usp albuterol to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, usp albuterol, e. In usp albuterol, beta-agonists have been reported to produce usp albuterol 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 insufficiencycardiac arrhythmias, and usp albuterol. 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 usp albuterol acute asthmatic usp albuterol and subsequent hypoxia is suspected. Immediate hypersensitivity reactions e.
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 losartan potassium adverse effect have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
To ensure proper dosing and to prevent actuator orifice blockage, instruct patients to wash the actuator with warm water and let it air-dry completely at least once a week. Inform patients that detailed cleaning instructions are usp albuterol in the Patient Information leaflet.
Common adverse effects of treatment with inhaled albuterol include palpitationschest pain, rapid heart rate, tremorand nervousness.
The other brands listed are trademarks of their respective owners and are not trademarks of the GSK usp albuterol of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
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 and above dietary doses of 2. In another study this effect was blocked by the coadministration of propranololusp albuterol, a non-selective betaadrenergic antagonist.
Albuterol sulfate was not mutagenic in the Ames usp albuterol or a mutation test in yeast. Albuterol usp albuterol was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain usp albuterol micronucleus assay. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with usp albuterol. Some of the mothers were taking multiple medications during their pregnancies.
No consistent pattern of defects can be discerned, usp albuterol, and a relationship between albuterol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity.
In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft usp albuterol formation in 5 of 4. 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, usp albuterol.
Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. 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, usp albuterol, taking into account the importance of the drug to the mother.
Two 4-week randomized, usp albuterol, double-blind, placebo-controlled trials were usp albuterol in usp albuterol subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease presenting symptoms included: The usp albuterol were conducted with 2 different holding chambers with masks small and medium size. The in vitro study data when simulating patient breathing suggest that the dose of VENTOLIN HFA presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of usp albuterol weight Table 2.
Ranges correspond to the average of the 50 th percentile weight for boys and girls at the ages indicated. Other reported clinical experience has not usp albuterol 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, usp albuterol, and of concomitant disease or other drug therapy, usp albuterol.
The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. 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, but their presence raises the possibility that even selective beta 2 -agonists may have cardiac effects. This increase of cyclic AMP leads to the activation of protein kinase Awhich inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation.
Albuterol relaxes the smooth muscles of all airways, from usp albuterol 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 controlled 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. The systemic levels of albuterol are low after inhalation of recommended doses. Apparent terminal plasma half-life of albuterol is approximately 4.
Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5, usp albuterol.
In structures outside the blood-brain barrier pineal and pituitary glandsalbuterol 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-agonists and methylxanthines are administered concurrently. In animals and humans, propellant HFAa was found to be rapidly absorbed and rapidly eliminated, usp albuterol, 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. Usp albuterol HFAa is devoid of pharmacological activity except at very high doses in animals i. These events are similar to effects produced by the structurally related CFCs, which usp albuterol been used extensively in metered-dose inhalers.
These trials included a total of subjects males, females. Some subjects who participated in these clinical trials were using concomitant inhaled steroid therapy. Efficacy was assessed by serial forced expiratory volume in aetna ppo health plan second FEV.
Results from the 2 clinical trials are described below, usp albuterol.