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Serevent (Salmeterol Xinafoate) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Short-Acting Beta2-Agonists

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

Salmeterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol on the vascular system may be potentiated by these agents.

Corticosteroids and Cromoglycate

In clinical trials, inhaled corticosteroids and/or inhaled cromolyn sodium did not alter the safety profile of SEREVENT Inhalation Aerosol when administered concurrently.

Methylxanthines

The concurrent use of intravenously or orally administered methylxanthines (e.g., aminophylline, theophylline) by patients receiving SEREVENT Inhalation Aerosol has not been completely evaluated. In 1 clinical asthma trial, 87 patients receiving SEREVENT Inhalation Aerosol 42 mcg twice daily concurrently with a theophylline product had adverse event rates similar to those in 71 patients receiving SEREVENT Inhalation Aerosol without theophylline. Resting heart rates were slightly higher in the patients on theophylline but were little affected by SEREVENT Inhalation Aerosol therapy.

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as SEREVENT Inhalation Aerosol, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

OVERDOSAGE

The expected signs and symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Overdosage with SEREVENT Inhalation Aerosol may be expected to result in exaggeration of the pharmacologic adverse effects associated with beta-adrenoceptor agonists, including tachycardia and/or arrhythmia, tremor, headache, and muscle cramps. Overdosage with SEREVENT Inhalation Aerosol can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias. Other signs of overdosage may include hypokalemia and hyperglycemia.

As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of SEREVENT Inhalation Aerosol.

Treatment consists of discontinuation of SEREVENT Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of SEREVENT Inhalation Aerosol. Cardiac monitoring is recommended in cases of overdosage.

No deaths were seen in rats at inhalation doses of 2.9 mg/kg (approximately 240 times the maximum recommended human daily inhalation dose on a mg/m2 basis) and in dogs at 0.7 mg/kg (approximately 190 times the maximum recommended human daily inhalation dose on a mg/m2 basis). By the oral route, no deaths occurred in mice at 150 mg/kg (approximately 6,100 times the maximum recommended human daily inhalation dose on a mg/m2 basis) and in rats at 1,000 mg/kg (approximately 81,000 times the maximum recommended human daily inhalation dose on a mg/m2 basis).

CONTRAINDICATIONS

SEREVENT Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to salmeterol or any other component of the drug product (see DESCRIPTION).

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