Serevent Inhaler CFC Free

/ GSK

Asthma
Adults: Two actuations of 25 micrograms salmeterol twice daily.
In asthma patients with more severe airways obstruction up to four inhalations of 25 micrograms of salmeterol twice daily may be of benefit.
Children aged 4 years and older: Two actuations of 25 micrograms salmeterol twice daily.
Children below 4 years of age: Serevent Inhaler CFC Free is not recommended for use in children below four years of age due to insufficient data on safety and efficacy.
COPD
Adults: Two actuations of 25 micrograms salmeterol twice daily.
Children: There is no relevant indication for use of Serevent Inhaler CFC Free in children.
Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available on the use of Serevent Inhaler CFC Free in patients with hepatic impairment.
For full details see prescribing information.

Treatment of reversible airways obstruction (including nocturnal asthma and prevention of excercise-induced asthma) in patients requiring long-term regular bronchodilator therapy, chronic obstructive pulmonary disease (COPD).

Hypersensitivity to any ingredient of the preparation.

Acute airway obstruction, thyrotoxicosis, cardiovascular impairment, hypertension. This is not a replacement for oral or inhaled corticosteroids. Its use is complementary to them. Patients must be warned not to stop steroid therapy and not to reduce it without medicdbal advice, even if they feel better with treatment.

Pharmacologically predictable extra-pulmonary effects of beta2-adrenoceptor agonists and respiratory related disorders such as asthma and acute nasopharyngitis. Tremor, subjective palpitations and headache have been reported, but tend to be transient and to reduce with regular therapy. Cardiac arrhythmias and tachycardia may occur in some patients. Potentially serious hypokalemia, paradoxical bronchospasm. Arthralgia, hypersensitivity reactions including rash edema and angioedema. Oropharyngeal irritation. Less frequent reports of muscle cramps, abdominal pain, nausea and vomiting.

Beta-adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non-selective and selective beta-blockers should be avoided unless there are compelling reasons for their use.
Potentially serious hypokalaemia may result from β2 agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
Potent CYP3A4 inhibitors: Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4fold Cmax and 15-fold AUC). This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone. Clinically significant effects were not seen on blood pressure, heart rate, blood glucose and blood potassium levels. Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing. The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment. There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g. itraconazole, telithromycin, ritonavir).
Moderate CYP 3A4 inhibitors: Co-administration of erythromycin (500mg orally three times a day) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC). Co-administration with erythromycin was not associated with any serious adverse effects.

A moderate amount of clinical data on pregnant women (between 300 to 1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of salmeterol. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity with the exception of evidence of some harmful effects on the fetus at very high dose levels. As a precautionary measure, it is preferable to avoid the use of Serevent during pregnancy.
Available pharmacodynamic/toxicological data in animals have shown excretion of salmeterol in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Serevent therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Studies of HFA-134a revealed no effects on the reproductive performance and lactation of adult or two successive generations of rats or on the fetal development of rats or rabbits.

Symptoms and signs: The signs and symptoms of salmeterol overdose are those typical of beta2-adrenergic stimulation including dizziness, increases in systolic blood pressure, tremor, headache and tachycardia.
Additionally hypokalaemia can occur and therefore serum potassium levels should be monitored. Potassium replacement should be considered.
Treatment: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.