Salmeterol

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Generic Name: Salmeterol Brand Name(s): Generics only. No brands available.

Uses

What is Salmeterol used for?

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. It is also used to prevent asthma brought on by exercise (bronchospasm). Salmeterol works in the airways by relaxing muscles and opening air passages to improve breathing. 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 (e.g., 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 (e.g., 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 (e.g., flunisolide, fluticasone) and occasional use of quick-relief inhalers.

If you are regularly taking corticosteroids by mouth (e.g., 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 should I take Salmeterol?

Always activate and use this device in a level, horizontal position.

Inhale this medication by mouth, usually twice daily in the morning and evening (12 hours apart), or use as directed by your doctor. 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 (e.g., albuterol). Consult your doctor for details.

If this medication stops working well, or you need to use your quick-relief inhaler more often than usual (4 or more puffs daily or use of more than 1 inhaler every 8 weeks), seek immediate medical attention. It may be a sign of worsening asthma, which is a serious condition.

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, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if your symptoms do not improve or if they worsen.

How do I store Salmeterol?

Salmeterol is best stored at room temperature away from direct light and moisture.

Store in foil pouch until ready for use. After opening, throw away any part not used after 6 weeks or when the indicator reads zero, whichever comes first. Protect from heat. To prevent drug damage, you should not store Salmeterol in the bathroom or the freezer. There may be different brands of Salmeterol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Salmeterol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Salmeterol?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this drug, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., angina, irregular heartbeat), high blood pressure, diabetes, liver problems, seizures, thyroid problems (e.g., overactive thyroid).

Salmeterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using salmeterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using salmeterol safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Salmeterol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Salmeterol. Salmeterol is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Salmeterol?

Hoarseness, throat irritation, headache, rapid heartbeat, nervousness, cough, dry mouth/throat, or upset stomach may occur.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting, seizures.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Salmeterol?

Many drugs besides salmeterol may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using salmeterol, report all medications you are currently using to your doctor or pharmacist.

Other medications can affect the removal of salmeterol from your body, which may affect how salmeterol works. Examples include cobicistat, nefazodone, telithromycin, azole antifungals (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir, saquinavir), among others.

Salmeterol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Salmeterol?

Salmeterol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Salmeterol?

Salmeterol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Salmeterol.

What is the dose of Salmeterol for an adult?

Usual Adult Dose for Asthma – Maintenance

50 mcg (1 inhalation) orally twice a day, approximately 12 hours apart.

Comments:

-Reevaluate the therapeutic regimen if a previously effective dosage fails to provide the usual response, as this is often a sign of destabilization of asthma.

-If symptoms arise in the period between doses, an inhaled, short-acting beta2-­agonist should be taken for immediate relief.

Uses:

-Treatment of asthma and prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in patients with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma.

Usual Adult Dose for Bronchospasm Prophylaxis

Prevention of Exercise Induced Bronchospasm (EIB):

-50 mcg (1 inhalation) orally at least 30 minutes before exercise

Comments:

-Protection may last up to 9 hours when used intermittently as needed for prevention.

-Additional doses should not be taken for 12 hours.

-Patients receiving twice daily doses for the treatment of asthma should not use additional doses for the prevention of EIB.

Uses:

-For the prevention of EIB, as a single agent, in patients with no persistent asthma.

-In patients with persistent asthma use of this drug for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease – Maintenance

50 mcg (1 inhalation) orally twice daily, approximately 12 hours apart

Use: Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis

Liver Dose Adjustments

Use with caution.

Other Comments

Administration advice:

-For oral inhalation only.

-This drug should not be used more often or at doses higher than recommended.

-If a dose is missed, skip that dose and take the next dose at the usual time. Do not take 2

doses at one time.

-Consult the manufacturer product information for instructions on how to use the inhaler.

Storage requirements:

-Store in a dry place away from direct heat or sunlight.

-Store inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use.

General:

-This drug should only be used with a long-term asthma control medicine, such as an inhaled corticosteroid; it should not be used as the only asthma medicine.

-Patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids should not use this drug.

Limitation of use:

-This drug is not indicated for the relief of acute bronchospasm.

Monitoring:

-Cardiac monitoring is recommended in cases of overdosage.

Patient advice:

-Patients should seek immediate attention if their condition deteriorates.

-Dose or frequency should not be increased without consulting the prescribing physician.

-Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

-Concomitant asthma therapy should not be stopped or reduced without medical advice.

-Other LABA should not be used when using this drug.

What is the dose of Salmeterol for a child?

Usual Pediatric Dose for Asthma – Maintenance

Less than 4 years: Not approved.

4 years or older: 50 mcg (1 inhalation) orally twice a day, approximately 12 hours apart

Comments:

-For patients with asthma less than 18 years of age requiring addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should be used to ensure adherence with both drugs.

-If the use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and LABA is clinically indicated, take appropriate steps to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.

Uses:

-Treatment of asthma and prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma.

Usual Pediatric Dose for Bronchospasm Prophylaxis

Prevention of Exercise Induced Bronchospasm:

-Less than 4 years: Not approved.

-4 years or older: 50 mcg (1 inhalation) orally at least 30 minutes before exercise

Comments:

-Protection may last up to 9 hours in adolescents and up to 12 hours in pediatrics aged 4 to 11 years, when used intermittently as needed for prevention.

-Additional doses should not be used for 12 hours.

-Patients receiving twice daily doses for the treatment of asthma should not use additional doses for the prevention of EIB.

Uses:

-For the prevention of EIB, as a single agent in patients with no persistent asthma

-In patients with persistent asthma use of this drug for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.

Precautions

ASTHMA: Safety and efficacy have not been established in patients younger than 4 years.

COPD: Safety and efficacy have not been established in patients younger than 18 years

How is Salmeterol available?

Salmeterol is available in the following dosage forms and strengths:

  • Inhalation aerosol with adapter,
  • Inhalation aerosol,
  • Inhalation powder.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Salmeterol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: April 26, 2018

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