in this study; when LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone Use of drug for the treatment of asthma as monotherapy without a concomitant ICS is contraindicated; use only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS; do not use drug for patients whose asthma is adequately controlled on low-or medium-dose ICS Pediatric and Adolescent Patients Available data from controlled clinical trials suggest that LABA as monotherapy increase risk of asthma-related hospitalization in pediatric and adolescent patients For pediatric and adolescent patients with asthma who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs In cases where use of an ICS and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components; if adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA recommended Contraindications Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to drug or excipients Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid Cautions Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; therapy can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms; although such effects are uncommon after administration of salmeterol at recommended doses, if they occur, the drug may need to be discontinued Drug should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs; patients should not use another medicine containing a LABA (e.g., formoterol fumarate, arformoterol tartrate, indacaterol) for any reason Use caution in diabetes mellitus and ketoacidosis; clinically significant and dose-related changes in blood glucose and/or serum potassium seen infrequently during clinical trials at recommended doses Not for acute asthma; for acute asthma exacerbations, use short-acting beta-agonists (eg, albuterol) Not for acute episodes of COPD May increase risk of severe, potentially fatal asthma attacks; small but significant increase in asthma-related deaths for patients using salmeterol vs placebo, with greater risk in African-Americans Therapy may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has potential to produce adverse cardiovascular effects; decrease in serum potassium is usually transient, not requiring supplementation Use caution in patients with hypokalemia, hepatic impairment, seizure disorders, and hyperthyroidism Paradoxical bronchospasm may occur with therapy; if it occurs it should be treated immediately with an inhaled, short-acting bronchodilator; treatment should be discontinued immediately and alternative therapy instituted; upper airway symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported in patients receiving therapy When initiating and throughout treatment in patients receiving oral or ICS for treatment of asthma, patients must continue taking a suitable dosage of corticosteroids to maintain clinical stability even if they feel better as a result of initiating salmeterol; any change in corticosteroid dosage should be made only after clinical evaluation Use Serevent Diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS; do not use Serevent Diskus for patients whose asthma is adequately controlled on low- or medium-dose ICS Immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur with therapy; anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose reported Use only for shortest duration of time Deterioration of disease Not for use in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD, including patients with significantly increased symptoms Worsening or acutely deteriorating asthma is associated with increase in need for inhaled, short-acting beta2-agonists; decreasing response to usual medications; increasing need for systemic corticosteroids; recent emergency room visits; deteriorating lung function Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma; in this situation, the patient requires immediate reevaluation with reassessment of treatment regimen, giving special consideration to possible need for adding additional ICS or initiating systemic corticosteroids; patients should not use drug more than 1 inhalation twice daily Drug interaction overview Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) not recommended because increased cardiovascular adverse effects may occur Pregnancy Available data from published epidemiological studies and case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Beta-agonists may interfere with uterine contractility There are clinical considerations in pregnant women with asthma In women with poorly or moderately controlled asthma, there is increased risk of pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate Severe asthma during pregnancy has been associated with maternal mortality, fetal mortality, or both Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control Animal data Oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 50 times maximum recommended human daily inhaled dose (MRHDID) on an AUC basis Labor and delivery There are no adequate and well-controlled human studies that have evaluated effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom the benefits clearly outweigh the risks Lactation There is no information regarding presence of salmeterol in human milk, effects on breastfed child, or on milk production Drug is detected in rat milk; drug concentrations in human plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be low The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from treatment or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Long-acting beta-2 agonist; action on beta-2 receptors relaxes bronchial smooth muscle with little effect on heart rate 50 times more selective than albuterol Pharmacokinetics Peak serum time: 20 min Half-Life: 5.5 hr Onset: 30-48 min (asthma); 2 hr (COPD) Duration: 12 hr Absorption: Minimal (undetectable) Protein Bound: 96% Metabolism: Liver Excretion: Feces (60%); urine (25%) BRAND FORM. UNIT PRICE PILL IMAGE Serevent Diskus inhalation- 50 mcg/dose aerosolSerevent Diskus inhalation- 50 mcg/dose aerosolCopyright © 2010 First DataBank, Inc.Print Patient Educationsalmeterol inhalation SALMETEROL DISK INHALER - ORAL INHALATION (sal-MET-er-all) COMMON BRAND NAME(S): Serevent Diskus WARNING: Rarely, when treating asthma, serious (sometimes fatal) asthma-related breathing problems have occurred with the use of long-acting inhaled beta agonists (such as salmeterol). In patients with asthma, this drug should only be prescribed when one long-term medication (such as inhaled corticosteroids) does not control breathing problems or when more than one long-term medication is clearly needed to control breathing problems. Salmeterol must not be used alone to treat asthma. Before using this medication, it is important to learn how to use it properly. Discuss the risks and benefits of treatment with this medication with your doctor.Once asthma symptoms are controlled, if possible, your doctor may stop treatment with salmeterol and continue only your other asthma medications (such as inhaled corticosteroids). Follow your doctor's directions carefully. USES: Salmeterol is used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids). Salmeterol must not be used alone to treat asthma. (See also Warning section.) It is also used to prevent asthma brought on by exercise (bronchospasm). Salmeterol works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (such as albuterol) for sudden shortness of breath/asthma attacks while you are on this medication. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.This medication should be used in combination with other medications such as long-acting inhaled corticosteroids. However, it should not be used with other long-acting inhaled beta agonists (such as formoterol, combination salmeterol/fluticasone) since this may increase your risk for side effects.It is recommended that children and teenagers, who need to use salmeterol to treat their asthma, should use a combination salmeterol/fluticasone product. Check with your child's doctor to see if this product is the right product for your child.In patients with asthma, this medication should not be used when breathing problems can be controlled with inhaled corticosteroids (such as flunisolide, fluticasone) and occasional use of quick-relief inhalers. (See also Warning section.)If you are regularly taking corticosteroids by mouth (such as prednisone), you should not stop using them or use this inhaled medication instead. Continue to follow your doctor's instructions for taking the corticosteroids by mouth. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using salmeterol and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.Always activate and use this device in a level, horizontal position.Inhale this medication by mouth as directed by your doctor, usually twice daily (in the morning and evening, 12 hours apart). You may or may not taste/feel the drug when you inhale. Either is normal. Never exhale into the device. Do not use with a spacer. Never wash the mouthpiece or any part of the device.If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.The dosage is based on your medical condition and response to therapy. Use this medication regularly to receive the most benefit from it. To help you remember, use it at the same times each day. Do not use it more often than prescribed or use more than 1 inhalation twice daily since this may increase the risk of side effects.Do not stop taking this medication or change your dose without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.If you have been using a quick-relief inhaler on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use it as needed for sudden shortness of breath/asthma attacks. Consult your doctor for details.If you are only using this medication occasionally to prevent asthma brought on by exercise (bronchospasm), use it at least 30 minutes before exercise, and do not use another dose for at least 12 hours. If you have sudden asthma/shortness of breath, use a quick-relief inhaler (such as albuterol). Consult your doctor for details.Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath,