Serevent Diskus 50mcg Oral Inh (60)
WARNING: Drugs like this one may raise the chance of asthma-related deaths in people with asthma who do not also use an inhaled steroid. It appears that this effect does not apply to people with COPD. If you have questions, talk with the doctor.Drugs like this one may raise the chance of asthma-related hospital stays in children and teenagers with asthma who do not also use an inhaled steroid. If you have questions, talk with the doctor.Do not use this drug to treat asthma if you are not also using an inhaled steroid. Do not use this drug to treat asthma if your asthma is well controlled by an inhaled steroid. @ COMMON USES: It is used to treat asthma.It is used to treat COPD (chronic obstructive pulmonary disease).It is used to prevent breathing problems that happen with exercise.Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
Drug Class
Bronchodilator
Pharmacologic Class
Long-acting beta2-adrenergic agonist (LABA)
Pregnancy Category
Not available
FDA Approved
Feb 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Salmeterol is a medicine that helps open up the airways in your lungs, making it easier to breathe. It's used for long-term control of breathing problems like asthma and COPD, but it's not for sudden breathing attacks. For asthma, it must always be used with another type of inhaler called a corticosteroid.
How to Use This Medicine
Proper Use of Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using the provided inhaler, and should be breathed directly into the lungs. Continue using the medication as directed by your doctor or healthcare provider, even if you feel well.
Important Usage Instructions
Always hold the device in a level, flat position when using it.
Do not disassemble or wash the device.
Do not use the device with a spacer.
Avoid breathing out into the device.
If you don't taste or feel the powder, do not take an extra dose.
Close the device after each use, and only open it when you're ready to take a dose.
Preventing Exercise-Induced Breathing Problems
If you're using this medication to prevent breathing problems caused by exercise, use it at least 30 minutes before exercising. Wait at least 12 hours before taking another dose.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep the inhaler in its foil pouch until you're ready to use it. The inhaler has a built-in dose counter to track the number of doses remaining. Dispose of the inhaler when the counter reaches "0", 6 weeks after opening the foil container, or after the expiration date, whichever occurs first.
Missing a Dose
If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or extra doses. Limit your daily use to no more than two doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using the provided inhaler, and should be breathed directly into the lungs. Continue using the medication as directed by your doctor or healthcare provider, even if you feel well.
Important Usage Instructions
Always hold the device in a level, flat position when using it.
Do not disassemble or wash the device.
Do not use the device with a spacer.
Avoid breathing out into the device.
If you don't taste or feel the powder, do not take an extra dose.
Close the device after each use, and only open it when you're ready to take a dose.
Preventing Exercise-Induced Breathing Problems
If you're using this medication to prevent breathing problems caused by exercise, use it at least 30 minutes before exercising. Wait at least 12 hours before taking another dose.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep the inhaler in its foil pouch until you're ready to use it. The inhaler has a built-in dose counter to track the number of doses remaining. Dispose of the inhaler when the counter reaches "0", 6 weeks after opening the foil container, or after the expiration date, whichever occurs first.
Missing a Dose
If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or extra doses. Limit your daily use to no more than two doses.
Lifestyle & Tips
- Do not use Serevent Diskus for sudden breathing problems; always carry a rescue inhaler (e.g., albuterol) for acute symptoms.
- Use Serevent Diskus regularly, twice a day (morning and evening), about 12 hours apart, even if you feel well.
- Do not exceed the prescribed dose.
- Rinse your mouth with water after each use to help prevent oral thrush, especially if using a combination product with a corticosteroid (though Serevent Diskus is salmeterol alone, good practice for inhalers).
- Keep the Diskus device clean and dry.
- Do not stop using Serevent Diskus or other asthma medications without talking to your doctor, even if you feel better.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mcg (1 inhalation) twice daily, approximately 12 hours apart
Dose Range:
50 - 50 mg
Condition-Specific Dosing:
asthma:
50 mcg (1 inhalation) twice daily
COPD:
50 mcg (1 inhalation) twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4 years and older: 50 mcg (1 inhalation) twice daily for asthma
Adolescent:
50 mcg (1 inhalation) twice daily for asthma
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment recommended
Moderate:
No dosage adjustment recommended
Severe:
No dosage adjustment recommended
Dialysis:
No specific recommendations; use with caution due to limited data.
Hepatic Impairment:
Mild:
No dosage adjustment recommended
Moderate:
Use with caution; consider lower starting dose or increased monitoring due to potential for increased systemic exposure.
Severe:
Use with caution; consider lower starting dose or increased monitoring due to potential for increased systemic exposure.
Pharmacology
Mechanism of Action
Salmeterol is a long-acting beta2-adrenergic agonist (LABA). It selectively binds to and activates beta2-adrenergic receptors on the smooth muscle cells of the bronchi, leading to relaxation of these muscles and bronchodilation. This action is mediated by the activation of adenyl cyclase, which increases intracellular cyclic AMP (cAMP) levels, leading to relaxation of bronchial smooth muscle.
Pharmacokinetics
Absorption:
Bioavailability:
Low (systemic absorption is minimal after inhalation)
Tmax:
Approximately 20 minutes (for bronchodilation effect), systemic Tmax not well characterized due to low absorption
FoodEffect:
Not applicable (inhaled)
Distribution:
Vd:
Not well characterized due to low systemic absorption
ProteinBinding:
Approximately 96% (to human plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 5.5 hours (terminal half-life after inhalation)
Clearance:
Not well characterized due to low systemic absorption
ExcretionRoute:
Feces (approximately 60%), Urine (approximately 25%)
Unchanged:
Less than 5% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 30-45 minutes
PeakEffect:
Approximately 2 hours
DurationOfAction:
12 hours
Safety & Warnings
BLACK BOX WARNING
Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, increase the risk of asthma-related death. Data from a large, placebo-controlled US study in asthma patients showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABAs. Therefore, salmeterol is not indicated for the treatment of acute bronchospasm and should not be used as monotherapy for asthma. It should only be used in conjunction with an inhaled corticosteroid (ICS) for asthma. For COPD, LABAs may be used alone.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Extreme nervousness or excitability
Shakiness
Fever
Seizures
Severe nausea or vomiting
Feeling extremely tired or weak
Trouble sleeping
Respiratory Emergency
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Nose or throat irritation
* Flu-like symptoms
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Extreme nervousness or excitability
Shakiness
Fever
Seizures
Severe nausea or vomiting
Feeling extremely tired or weak
Trouble sleeping
Respiratory Emergency
This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Nose or throat irritation
* Flu-like symptoms
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening asthma or COPD symptoms (e.g., increased shortness of breath, wheezing, chest tightness)
- Increased need for your rescue inhaler
- Paradoxical bronchospasm (sudden worsening of breathing right after using the inhaler)
- Chest pain, fast or irregular heartbeat, palpitations
- Severe headache, dizziness, nervousness, tremor
- Muscle cramps or weakness (signs of low potassium)
- Allergic reactions (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have a milk allergy.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
If you are taking any of the following medications:
+ Atazanavir
+ Clarithromycin
+ Indinavir
+ Itraconazole
+ Ketoconazole
+ Nefazodone
+ Nelfinavir
+ Ritonavir
+ Saquinavir
+ Telithromycin
Please note that this list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to avoid potential interactions and ensure safe treatment.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have a milk allergy.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
If you are taking any of the following medications:
+ Atazanavir
+ Clarithromycin
+ Indinavir
+ Itraconazole
+ Ketoconazole
+ Nefazodone
+ Nelfinavir
+ Ritonavir
+ Saquinavir
+ Telithromycin
Please note that this list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to avoid potential interactions and ensure safe treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have diabetes (high blood sugar), be aware that this drug may occasionally increase your blood sugar levels. Consult with your doctor to discuss strategies for maintaining control over your blood sugar.
Regularly monitor your blood pressure as instructed by your healthcare provider. Immediately contact your doctor if you experience worsening breathing problems, if your rescue inhaler becomes less effective, or if you need to use it more frequently.
Do not exceed the prescribed dose or use this medication more often than recommended. Overdose of this type of medication has been associated with fatal outcomes. If you have any concerns, discuss them with your doctor.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Regularly monitor your blood pressure as instructed by your healthcare provider. Immediately contact your doctor if you experience worsening breathing problems, if your rescue inhaler becomes less effective, or if you need to use it more frequently.
Do not exceed the prescribed dose or use this medication more often than recommended. Overdose of this type of medication has been associated with fatal outcomes. If you have any concerns, discuss them with your doctor.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Tachycardia (fast heart rate)
- Arrhythmias (irregular heart rhythm)
- Palpitations
- Tremor
- Headache
- Nervousness
- Nausea
- Dizziness
- Fatigue
- Malaise
- Hypokalemia (low potassium)
- Hyperglycemia (high blood sugar)
What to Do:
Seek immediate medical attention. Treatment is supportive and symptomatic. Consider a cardioselective beta-blocker if necessary, but use with extreme caution due to risk of bronchospasm. Monitor cardiac function and serum potassium levels. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Beta-blockers (non-selective and selective, unless compelling reasons exist and with extreme caution)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, telithromycin, nefazodone)
- Other long-acting beta2-adrenergic agonists (LABAs)
- Monoamine oxidase inhibitors (MAOIs)
- Tricyclic antidepressants (TCAs)
Moderate Interactions
- Diuretics (loop or thiazide) - potential for hypokalemia and ECG changes
- Xanthine derivatives (e.g., theophylline) - increased risk of arrhythmias
- Corticosteroids (systemic) - increased risk of hypokalemia
Minor Interactions
- Not specifically identified as minor, but caution with other sympathomimetics.
Monitoring
Baseline Monitoring
Pulmonary function tests (e.g., FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy
Cardiovascular assessment (heart rate, blood pressure, ECG if indicated)
Rationale: To identify pre-existing cardiovascular conditions that may be exacerbated by beta-agonists.
Timing: Prior to initiation of therapy
Serum potassium
Rationale: To establish baseline, especially if patient is on diuretics or has risk factors for hypokalemia.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma/COPD symptom control (e.g., frequency of rescue inhaler use, nocturnal symptoms)
Frequency: Regularly, at each follow-up visit
Target: Minimal symptoms, infrequent rescue inhaler use
Action Threshold: Increased symptoms, increased rescue inhaler use, or worsening lung function indicates need for re-evaluation of therapy.
Pulmonary function tests (e.g., FEV1)
Frequency: Periodically (e.g., every 3-12 months or as clinically indicated)
Target: Stable or improved lung function
Action Threshold: Decline in lung function
Adverse effects (e.g., tremor, palpitations, headache, paradoxical bronchospasm)
Frequency: At each follow-up visit
Target: Absence or minimal tolerable side effects
Action Threshold: Persistent or severe adverse effects requiring intervention.
Growth in pediatric patients
Frequency: Regularly (e.g., every 6-12 months)
Target: Normal growth trajectory
Action Threshold: Growth retardation (though less common with inhaled LABAs alone, important for combination products).
Symptom Monitoring
- Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, chest tightness)
- Increased need for rescue inhaler (short-acting beta-agonist)
- Paradoxical bronchospasm (immediate worsening of breathing after inhalation)
- Cardiovascular symptoms (e.g., palpitations, chest pain, rapid heart rate)
- Neurological symptoms (e.g., tremor, nervousness, headache)
- Signs of hypokalemia (e.g., muscle weakness, cramps, abnormal heart rhythm)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown reproductive toxicity at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for developmental effects observed in animal studies at high doses; human data limited.
Second Trimester:
Human data limited; continue to monitor asthma control.
Third Trimester:
Potential for interference with uterine contractility during labor due to beta-agonist effects. Monitor for neonatal effects (e.g., tachycardia, hyperglycemia).
Lactation
Salmeterol is excreted in the milk of lactating rats. It is not known whether salmeterol is excreted in human milk. Caution should be exercised when salmeterol is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for salmeterol and any potential adverse effects on the breastfed infant from salmeterol or from the underlying maternal condition.
Infant Risk:
Low risk, but monitor for irritability, poor feeding, or changes in heart rate.
Pediatric Use
Approved for asthma in children 4 years and older. Safety and efficacy not established in children younger than 4 years. LABAs carry a Black Box Warning regarding increased risk of asthma-related death, and should only be used in conjunction with an inhaled corticosteroid for asthma in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more sensitive to the effects of sympathomimetic amines, particularly cardiovascular effects. Use with caution in patients with co-morbid cardiovascular conditions.
Clinical Information
Clinical Pearls
- Salmeterol is a maintenance bronchodilator and should NOT be used for acute asthma attacks. Patients must have a short-acting beta-agonist (SABA) for rescue.
- For asthma, salmeterol must always be used in combination with an inhaled corticosteroid (ICS) due to the Black Box Warning regarding increased risk of asthma-related death when used as monotherapy.
- Ensure patients understand the difference between their LABA (Serevent Diskus) and their rescue inhaler.
- Patients should be instructed on the correct use of the Diskus device, including loading the dose and inhaling deeply.
- Regular follow-up is crucial to assess asthma/COPD control and adherence to therapy.
- Caution with concomitant use of strong CYP3A4 inhibitors, as this can significantly increase systemic salmeterol exposure and risk of adverse effects.
Alternative Therapies
- Other LABAs (e.g., formoterol, arformoterol, indacaterol, olodaterol)
- Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, umeclidinium, glycopyrronium)
- Inhaled corticosteroids (ICS) (e.g., fluticasone, budesonide, mometasone)
- Oral corticosteroids (for severe exacerbations)
- Leukotriene receptor antagonists (LTRAs) (e.g., montelukast)
- Methylxanthines (e.g., theophylline)
- Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab)
Cost & Coverage
Average Cost:
Varies, typically $150-$300 per 60-dose inhaler
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.