Serevent Special Precautions

SEREVENT should be used only as an adjunct to corticosteroids in the management of asthma.
SEREVENT should not be initiated in patients with significantly worsening or acutely deteriorating asthma. Sudden and progressive deterioration in control of asthma is potentially life-threatening and consideration should be given to increasing corticosteroid therapy. In patients at risk, daily peak flow monitoring may be instituted. For maintenance treatment of asthma salmeterol should be given in combination with inhaled or oral corticosteroids.
Increasing use of bronchodilators, in particular short-acting inhaled beta-2 agonists, to relieve symptoms indicates deterioration of asthma control.
Patients must be warned not to stop steroid therapy and not to reduce it without medical advice even if they feel better on SEREVENT.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast and short-acting inhaled bronchodilator. Salmeterol should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary (see Adverse Reactions).
The pharmacological side-effects of beta-2 agonist treatment, such as tremor, subjective palpitations and headache have been reported, but tend to be transient and to reduce with regular therapy (see Adverse Reactions).
Cardiovascular effects, such as increases in systolic blood pressure and heart rate, may occasionally be seen with all sympathomimetic drugs, especially at higher than therapeutic doses. For this reason, salmeterol should be used with caution in patients with pre-existing cardiovascular disease.
There have been very rare reports of increases in blood glucose levels (see Adverse Reactions) and this should be considered when prescribing to patients with a history of diabetes mellitus.
Salmeterol should be administered with caution in patients with thyrotoxicosis.
A transient decrease in serum potassium may occur with all sympathomimetic drugs at higher than therapeutic doses. Therefore, SEREVENT should be used with caution in patients predisposed to low levels of serum potassium.
Data from a large US study (SMART) comparing the safety of SEREVENT or placebo added to usual therapy showed an increase in asthma-related deaths in patients receiving SEREVENT. Data from this study suggested that African-American patients may be at greater risk of serious respiratory-related events or deaths when using SEREVENT compared to placebo. It is not known if this was due to pharmacogenetic or other factors. Long-acting beta2-agonists, such as SEREVENT, should be prescribed with corticosteroids. (See Indications/Uses and Pharmacology: Pharmacodynamics: Clinical Studies under Actions.)
It was observed in a drug interaction study that concomitant use of systemic ketoconazole increases exposure to SEREVENT. This may lead to prolongation in the QTc interval. Caution should be exercised when strong CYP3A4 inhibitors (e.g. ketoconazole) are co-administered with SEREVENT. (See Interactions and Pharmacology: Pharmacokinetics under Actions.)
Patients should be instructed in the proper use of their inhaler and their technique checked to ensure optimum delivery of the inhaled drug to the lungs.
This medicine should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinue, if possible, once asthma control is achieved. This medicine should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
Effects on Ability to Drive and Use Machines: None reported.