Eformoterol Other names: Formoterol

Caution should be observed when treating patients with prolongation of the QTc-interval, e.g. congenital or drug-induced (QTc >0.44 seconds) and in patients treated with drugs affecting the QTc-interval.

There is a theoretical risk that concomitant treatment with other drugs known to prolong the QTc-interval may give rise to a pharmacodynamic interaction with formoterol and increase the possible risk of ventricular arrhythmias. Examples of such drugs include certain antihistamines (e.g. terfenadine, astemizole, mizolastine), certain antiarrhythmics (e.g. quinidine, disopyramide, procainamide), erythromycin and tricyclic antidepressants.

Administration of formoterol to patients being treated with monoamine oxidase inhibitors should be performed with caution, since the action of β₂-adrenergic stimulants on the cardiovascular system may be potentiated.

The bronchodilating effects of formoterol can be enhanced by anticholinergic drugs.

Concomitant administration of formoterol with other sympathomimetic substances such as other β₂-agonists or ephedrine may potentiate the undesirable effects of formoterol and may require titration of the dose.

Administration of formoterol to patients being treated with tricyclic antidepressants should be performed with caution, since the action of β₂-adrenergic stimulants on the cardiovascular system may be potentiated.

Caution should be observed with administration of formoterol when treating patients with severe heart failure.

Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.

β-adrenergic blockers may weaken or inhibit the effect of formoterol. Therefore, formoterol should not be given together with β-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.

There is an elevated risk of arrhythmias in patients receiving concomitant formoterol and anaesthesia with halogenated hydrocarbons. If anaesthesia with halogenated anaesthetics is planned, it should be ensured that formoterol is not administered for at least 12 hours before the start of anaesthesia.

Concomitant treatment with xanthine derivatives, steroids, or diuretics such as thiazides and loop diuretics may potentiate a rare hypokalaemic adverse effect of β₂-agonists.

Compounds which themselves potentiate sympathomimetic effects, such as L-dopa, L-thyroxine, oxytocin or alcohol, can also affect cardiovascular regulation when taken at the same time as formoterol.

The simultaneous use of formoterol and theophylline can result in mutual potentiation of effects, and there is also the likelihood of increased undesirable effects such as cardiac dysrhythmia.

Caution should be observed with administration of formoterol when treating patients with idiopathic subvalvular aortic stenosis.

Caution should be observed with administration of formoterol when treating patients with third degree atrioventricular block.

Caution should be observed with administration of formoterol when treating patients with third degree atrioventricular block.

Caution should be observed with administration of formoterol when treating patients with severe hypertension.

Caution should be observed with administration of formoterol when treating patients with ischaemic heart disease.

Caution should be observed with administration of formoterol when treating patients with aneurysm.

Caution should be observed with administration of formoterol when treating patients with hypertrophic obstructive cardiomyopathy.

Caution should be observed with administration of formoterol when treating patients with tachyarrhythmias.

Caution should be observed with administration of formoterol when treating patients with arteriosclerosis.

Due to the hyperglycaemic effects of β₂-agonists, additional blood glucose monitoring is recommended initially in diabetic patients.

Caution should be observed with administration of formoterol when treating patients with thyrotoxicosis.

There are no or limited amount of data from the use of formoterol in pregnant women. In animal studies formoterol has caused implantation losses as well as decreased early postnatal survival and birth weight. The effects appeared at considerably higher systemic exposures than those reached during clinical use of formoterol. Treatment with formoterol may be considered at all stages of pregnancy if needed to obtain asthma control, and if the expected benefit to the mother is greater than any possible risk to the fetus. The potential risk for human is unknown.

It is unknown whether formoterol are excreted in human milk. In rats, small amounts of formoterol have been detected in maternal milk. Administration of formoterol to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

A risk to the newborns/infants cannot be excluded.

Formoterol has no influence on the ability to drive and use machines.

The most commonly reported adverse events of β₂-agonist therapy, such as tremor and palpitations, tend to be mild and disappear within a few days of treatment.

Adverse reactions, which have been associated with formoterol, are listed below by system organ class and frequency. Frequency is defined as: Very Common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000).

Nausea, dysgeusia, throat irritation, hyperhidrosis, restlessness, headache, dizziness and muscle cramps may resolve spontaneously within one to two weeks of continued treatment.

Central nervous system stimulating effects have been sporadically reported following inhalation of β₂-sympathomimetics, manifesting as hyperexcitability. These effects were mainly observed in children up to 12 years of age.

Treatment with β₂-agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.