Salmeterol

Salmeterol is a prescription medication used to treat asthma, exercised-induced bronchospasm and chronic obstructive pulmonary disorder (COPD).

Salmeterol belongs to a group of drugs called beta agonists. It works by relaxing the muscles that surround the airways.

This medication comes in powder form and is inhaled via the mouth usually twice daily

Common side effects of salmeterol include rash, headache, nasal congestion and throat irritation.

Salmeterol is a prescription medication used to treat asthma, exercised-induced bronchospasm and chronic obstructive pulmonary disorder (COPD).

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Asthma:

The usual dosage for adults and children aged 4 years and older is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart).

COPD:

For maintenance treatment of bronchospasm associated with COPD, the dosage for adults is 1 inhalation (50 mcg) twice daily (morning and evening, approximately 12 hours apart).

Excercise-induced bronchospasm:

 One inhalation of salmeterol at least 30 minutes before exercise has been shown to protect patients against EIB.

Additional doses of salmeterol should not be used for 12 hours after the first dose of this drug.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, the active ingredient in Serevent Diskus, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (Serevent Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.

Because of this risk, use salmeterol for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use salmeterol only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue salmeterol) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use salmeterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

Pediatric and Adolescent Patients: Available data from controlled clinical trials suggest that LABA increase the 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 inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) 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 inhaled corticosteroid and a LABA is recommended.

Salmeterol can cause serious side effects, including:

1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as salmeterol, have an increased risk of death from asthma problems. Call your healthcare provider if breathing problems worsen over time while using salmeterol. You may need a different treatment.

Get emergency treatmet if:

• breathing problems worsen quickly
• you use your rescue inhaler medicine, but it does not relieve your breathing problems

Do not take salmeterol:

• to treat your asthma without an asthma medicine known as an inhaled corticosteroid
• if you are allergic to salmeterol or any of the ingredients in salmeterol
• breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems

2. Do not use salmeterol as your only asthma medicine. Salmeterol must only be used with a long-term asthma-control medicine, such as an inhaled corticosteroid.

3. When your asthma is well controlled, your healthcare provider may tell you to stop taking salmeterol. Your healthcare provider will decide if you can stop salmeterol without loss of asthma control. You will continue taking your long-term asthma-control medicine, such as an inhaled corticosteroid.

4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Salmeterol can cause serious side effects, including:

• See “Salmeterol Precautions”.
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
• sudden breathing problems immediately after inhaling your medicine
• effects on heart
• effects on nervous system
• changes in blood (sugar, potassium)

• rash
• hives
• swelling of the face, mouth, and tongue
• breathing problems
• increased blood pressure
• a fast and irregular heartbeat
• chest pain
• tremor
• nervousness

Common side effects of salmeterol include:

Asthma in adults and children:

• headache
• nasal congestion
• bronchitis
• throat irritation
• runny nose
• flu

Chronic obstructive pulmonary disease:

• headache
• musculoskeletal pain
• throat irritation
• cough
• respiratory infection

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with salmeterol. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Salmeterol and certain other medicines, especially those used to treat infections, may interact with each other. This may cause serious side effects.

Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding. It is not known if salmeterol passes into your milk and if it can harm your baby.