Description

Tulobuterol is indicated for prophylaxis and control of bronchospasm in bronchial asthma, chronic bronchitis, asthmatic bronchitis, pulmonary emphysema, bronchiectasis, tracheobronchitis with emphysema and other bronchospastic disorders and conditions characterized by bronchoconstriction. Because oral tulobuterol is long acting, it is ideally suited for routine maintenance therapy in chronic asthma and chronic bronchitis. Tulobuterol has been shown in controlled single and multiple-dose studies to be more effective than terbutaline and fenoterol and at least as effective as salbutamol (albuterol) in relieving bronchospasm associated with reversible obstructive airways disease such as asthma, and also chronic bronchitis and emphysema. Clinically significant improvement in pulmonary function, as demonstrated by an increase in FEV of 15% or more, occurred within 30 minutes after oral dosing with peak improvement occurring within two to three hours. In some patients, a therapeutic response was still apparent at 12 hours. Continued effectiveness was demonstrated over a one-year period.

Increased risk of arrhythmia with digoxin. Hypokalaemia with concomitant admin of xanthines, corticosteroids and diuretics.

The adverse reactions of tulobuterol are similar in nature to those of other sympathomimetic agents, however the incidence of certain cardiovascular effects is less with tulobuterol. Dose-related finger tremor is common with these agents, but the effects tend to lessen with continued administration of the drug. Oral formulations of tulobuterol, like other sympathomimetic agents, can also cause less frequent adverse reactions such as hypertension, palpitations, angina, tachycardia, vomiting, vertigo, central nervous system stimulation, insomnia and headache.

Safety of this product for use during pregnancy has not been established. It is not known whether tulobuterol is excreted in human breast milk nor whether it has a harmful effect on the newborn. Therefore, as with any medication, the use of the drug in pregnancy, lactation, or women of childbearing potential requires that the expected therapeutic benefit of the drug be weighed against its possible hazards to the mother and child.

Long-Acting Beta Agonists should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications alone. Tulobuterol should be used with caution in patients with diabetes mellitus, hypertension, hyperthyroidism, and seizure disorders. Caution should be observed in patients with renal failure in view of the kidney being the principle route of elimination of the drug. Dosage may also require individualization in patients with impaired liver function as normally tulobuterol is extensively metabolized by the liver. As with other sympathomimetic bronchodilator agents, tulobuterol should be administered cautiously to cardiac patients, especially those with associated arrhythmias, coronary insufficiency, or myocardial ischemia.

Short-acting selective & β2-adrenoceptor stimulants