Asmalin broncho?



Answer:
DESCRIPTION

The active component of Albuterol Inhalation Aerosol is albuterol, USP racemic (alpha1-((Ttert-butylamino)met... a relatively selective beta2-adrenergic bronchodilator.

Albuterol is the representative generic name within the United States. The World Health Organization recommended name for the drug is salbutamol. The molecular substance of albuterol is 239.3, and the empirical formula is C13H21NO3. Albuterol is a white to off-white crystalline solid. It is soluble in ethanol, sparingly soluble within water, and outstandingly soluble in chloroform.

ACTIONS/CLINICAL PHARMACOLOGY

In Vitro studies and In Vivo pharmacologic studies enjoy demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared near isoproterenol. While it is recognized that beta2-adrenergic receptors are thepredominant receptors contained by bronchial smooth muscle, recent data indicate that here is a population of beta2-receptors in the human heart existing within a concentration between 10-50%. The precise function of these, however, is not yet established. The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at smallest in segment attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5' adenosine monophosphate (c-AMP). Increased c-AMP levels are associated next to relaxation of bronchial smooth muscle and inhibition of release of mediators of direct hypersensitivity from cells, especially from flagstaff cells. Albuterol have been shown surrounded by most controlled clinical trials to have more effect on the respiratory tract, contained by the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience own shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect within some patients, as measured by pulse rate, blood pressure, symptoms, and/or ECG changes.

Albuterol is longer acting than isoproterenol by any route of rule in most patients because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.

Because of its gradual digestion from the bronchi, systemic levels of albuterol are low after inhalation of recommended doses. Studies undertake with four subjects administered tritiated albuterol, resulted contained by maximum plasma concentrations occurring within 2 to 4 hours. Due to the sensitivity of the assay method, the metabolic rate and half-life of closure of albuterol in plasma could not be determined. However, urinary excretion provided notes indicating that albuterol has an closure half-life of 3.8 hours. Approximately 72% of the inhaled dose is excreted within 24 hours contained by the urine, and consists of 28% of unchanged drug and 44% as metabolite.

Results of animal studies show that albuterol does not go past the blood-brain barrier.

Recent studies surrounded by laboratory animals (minipigs, rodents, and dogs) recorded the fact of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines be administered concurrently. The significance of these findings when applied to humans is currently unknown.

The effects of rising doses of albuterol and isoproterenol aerosols be studied in volunteers and asthmatic patients. Results within normal volunteers indicated that albuterol is 1/2 to 1/4 as live as isoproterenol in producing increases within heart rate. In asthmatic patients similar cardiovascular differentiation between the two drugs was also see.

INDICATIONS AND USAGE

Albuterol Inhalation Aerosol is indicated for the prevention and relief of bronchospasm surrounded by patients with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm.

In controlled clinical trials the start of improvement contained by pulmonary function was inwardly 15 minutes, as determined by both maximal midexpiratory flow rate (MMEF) and FEV1. MMEF measurements also showed that near maximum expansion in pulmonary function roughly occurs inside 60 to 90 minutes following 2 inhalations of albuterol and that clinically significant improvement mostly continues for 3 to 4 hours in most patients. In clinical trials, some patients beside asthma showed a therapeutic response (defined by maintain FEV1 values 15% or more above baseline) which was still adjectives at 6 hours. Continued effectiveness of albuterol be demonstrated over a 13-week period within these same trials.

In clinical studies, 2 inhalations of albuterol taken approximately 15 minutes prior to exercise prevented exercise-induced bronchospasm, as demonstrated by the maintenance of FEV1 inwardly 80 percent of baseline values in the majority of patients. One of these studies also evaluated the duration of the prophylactic effect to repeated exercise challenge, which was adjectives at 4 hours in the majority of patients, and at 6 hours within approximately one third of the patients.

CONTRAINDICATIONS

Albuterol Inhalation Aerosol is contraindicated in patients near a history of hypersensitivity to any of its components.

WARNINGS

As with other inhaled beta-adrenergic agonists, Albuterol Inhalation Aerosol can produce paradoxical bronchospasm that can be life-threatening. If it occur the preparation should be discontinued immediately and alternative psychoanalysis instituted.

Fatalities have be reported in association next to excessive use of inhaled sympathomimetic drugs. The exact cause of departure is unknown, but cardiac arrest following the unexpected nouns of a severe acute asthmatic crisis and subsequent hypoxia is suspected. Immediate hypersensitivity reactions may go on after administration of albuterol inhalation aerosol, as demonstrated by pink cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

The contents of Albuterol Inhalation Aerosol are below pressure. Do not puncture. Do not use or store near boil or open flame. Exposure to temperature above 120 deg F may cause bursting. Never throw container into fire or incinerator. Keep out of conquer of children.

PRECAUTIONS

GENERAL: Albuterol, as with adjectives sympathomimetic amines, should be used with tell in patients near cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients near convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.

Large doses of intravenous albuterol enjoy been reported to aggravate preexisting diabetes and ketoacidosis. Additionally, beta-agonists, including albuterol, when given intravenously may impose a decrease contained by serum potassium, possibly through intracellular shunting. The relevance of this observation to the use of Albuterol Inhalation Aerosol is unknown, since the aerosol dose is much lower than the doses given intravenously.

Although within have be no reports concerning the use of Albuterol Inhalation Aerosol during labor and delivery, it have been reported that illustrious doses of albuterol administered intravenously inhibit uterine contractions. Although this effect is extremely unlikely as a consequence of aerosol use, it should be kept in mind.

INFORMATION FOR PATIENTS: The commotion of Albuterol Inhalation Aerosol may last up to six hours and as a consequence it should not be used more frequently than recommended. Increasing the number or frequency of doses without consulting your physician can be perilous. If recommended dosage does not provide relief of symptoms or symptoms become worse, want immediate medical attention. While taking Albuterol Inhalation Aerosol, other inhaled medicine should not be used unless prescribed.

DRUG INTERACTIONS: Other sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If more adrenergic drugs are to be administered by any route, they should be used with wariness to avoid deleterious cardiovascular effects.

Albuterol should be administered with suspicion to patients being treated near monoamine oxidase inhibitors or tricyclic antidepressants, since the action of albuterol on the vascular system may be potentiated.

Beta-receptor blocking agents and albuterol inhibit the effect of respectively other.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY: In a 2 year study in the rat, albuterol sulfate cause a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at doses corresponding to 111, 555, and 2,800 times the maximum human inhalational dose. In another study this effect be blocked by the coadministration of propranolol. The relevance of these findings to humans is not known. An 18-month study within mice revealed no evidence of tumorigenicity. Studies with albuterol revealed no evidence of mutagenesis. Reproduction studies within rats revealed no evidence of impaired fertility.

TERATOGENIC EFFECTS -- PREGNANCY CATEGORY C: Albuterol have been shown to be teratogenic within mice when given in doses corresponding to 14 times the human dose. There are no so-so and well-controlled studies in pregnant women. Albuterol should be used during pregnancy single if the potential benefit justifies the potential risk to the fetus. A reproduction study contained by CD-1 mice with albuterol (0.025, 0.25, and 2.5 mg/kg, corresponding to 1.4, 14, and 140 times the maximum human inhalational dose) showed cleft palate formation within 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. None be observed at 0.025 mg/kg. Cleft palate also occurred surrounded by 22 of 72 (30.5%) fetuses treated with 2.5 mg/kg isoproterenol (positive control). A reproduction study surrounded by Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses at 50 mg/kg, corresponding to 2,800 times the maximum human inhalational dose of albuterol. During marketing, multiple congenital anomalies, including cleft palate and limb defect, have be reported in the litter of patients being treated beside albuterol. Some of the mothers were taking multiple medication during their pregnancies. Because no consistent pattern of defect can be discerned, a relationship between albuterol use and congenital anomalies cannot be established.

NURSING MOTHERS: It is not known whether this drug is excreted surrounded by human milk. Because of the potential for tumorigenicity shown for albuterol in animal studies, a judgment should be made whether to discontinue nursing or to discontinue the drug, taking into account the stress of the drug to the mother.

PEDIATRIC USE: Safety and effectiveness contained by children below the age of 12 years have not be established.

DRUG INTERACTIONS

Other sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If spare adrenergic drugs are to be administered by any route, they should be used with counsel to avoid deleterious cardiovascular effects.

Albuterol should be administered with tip off to patients being treated beside monoamine oxidase inhibitors or tricyclic antidepressants, since the action of albuterol on the vascular system may be potentiated.

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